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Withdrawal of antihypertensive medication in young to middle-aged adults: a prospective, single-group, intervention study

Withdrawal of antihypertensive medication in young to middle-aged adults: a prospective,... Background: Although antihypertensive drug therapy is commonly believed to be a life‑long therapy, several recent guidelines have suggested that antihypertensive medications can be gradually reduced or discontinued for some patients whose blood pressure (BP) is well‑ controlled for an extended period. Thus, this pilot study aimed to describe the success rate of antihypertensive drug discontinuation over 6 months among young and middle‑aged patients with hypertension. Methods: This was a prospective, single‑ group, intervention study. Patients were eligible for inclusion if their car‑ diologist judged them to be appropriate candidates for this study, their BP had been controlled both in the office (< 140/90 mmHg) and 24‑h ambulatory BP monitoring (< 135/85 mmHg) for at least 6 months with a single tablet dose of antihypertensive medication. A total of 16 patients withdrew their antihypertensive medications at baseline after they received the education, and were followed up over 6 months. After the follow‑ups, six patients participated in the in‑ depth interview. Results: The likelihood of remaining normotensive at 30, 90, 180, and 195 days was 1.00, 0.85, 0.51, and 0.28, respec‑ tively. There were also no significant differences in baseline characteristics and self‑ care activities over time between normotensive (n = 8) and hypertensive groups (n = 8). In the interview, most patients expressed ambivalent feelings toward stopping medications. Psychological distress (e.g., anxiety) was the primary reason for withdrawal from this study although the patients’ BP was under control. Conclusions: We found that only a limited portion of antihypertensive patients could stop their medication suc‑ cessively over 6 months. Although we could not identify factors associated with success in maintaining BP over 6 months, we believe that careful selection of eligible patients may increase success in stopping antihypertensive medications. Also, continuous emotional support might be essential in maintaining patients’ off‑medication. Keywords: Hypertension, Antihypertensive agents, Deprescriptions Background Hypertension is a prevalent chronic condition that sig- nificantly contributes to cardiovascular disease and premature death [1, 2]. Lifestyle modifications and anti - hypertensive medication are the major components of *Correspondence: kyounglee@snu.ac.kr hypertension management [3–5]. According to the 2018 Research Institute of Nursing Science, Center for Human‑Caring Nurse guidelines of the Korean Hypertension Society [5], drug Leaders for the Future by Brain Korea 21 (BK 21) Four Project, Seoul National University College of Nursing, Seoul, Republic of Korea treatment is initiated when the systolic/diastolic blood Full list of author information is available at the end of the article pressure (BP) is ≥ 140/90  mmHg, along with lifestyle © The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http:// creat iveco mmons. org/ licen ses/ by/4. 0/. The Creative Commons Public Domain Dedication waiver (http:// creat iveco mmons. org/ publi cdoma in/ zero/1. 0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Lee and Lee Clinical Hypertension (2023) 29:1 Page 2 of 10 modifications. Although antihypertensive medications over 6  months for young to middle-aged patients with are very effective in BP lowering, some patients refuse hypertension; (2) to compare the changes in BP between it or are nonadherent to the treatment. According to a the normotensive group (i.e., those who successfully dis- recent meta-analysis, the overall nonadherence rate to continued their medications) and the hypertensive group antihypertensive medications was 45.2% [6]. The com - over 6 months; and (3) compare the baseline sample char- mon reasons for refusal or nonadherence to taking anti- acteristics and changes in adherence to self-care activities hypertensive drugs are related to concerns about the side for hypertension between the normotensive and hyper- effects of the medications, social stigma, and the burden tensive groups. The secondary aims of this study were of taking drugs for the rest of their lives once they start to describe the retention rate and the reasons for study medications for hypertension [7–10]. One of the most withdrawal and compare the characteristics of patients frequently asked questions from the patients who need who remained in the study and those who dropped out. drug treatment is whether they should take antihyperten- sive medication indefinitely once it is started is. Methods Although antihypertensive drug therapy is commonly Study design and participants believed to be a life-long therapy, several recent guide- This study was a prospective single-group interventional lines [4, 5] have suggested that antihypertensive medica- study and was approved by the Institutional Review tions can be gradually reduced or withdrawn for some Board of the Seoul National University Hospital (No. patients whose BP is well-controlled for an extended H-1902–132-1015). Patients were recruited from a car- period. However, the level of evidence for this recom- diology clinic in Seoul National University Hospital, a mendation is very weak. A recent experimental study tertiary academic medical center in Republic of Korea. suggested that when antihypertensive medications were Patients were eligible for inclusion if their cardiologist stopped from the patients at low-cardiovascular disease judged them to be appropriate candidates for this study, risk, BP control at the 2-year follow-up was not inferior their BP had been controlled in normotensive range to standard care [11]. However, the investigators did (< 140/90 mmHg) for at least 6 months with a single tab- not explore the characteristics of patients who success- let dose of antihypertensive medication; the value of their fully stopped antihypertensive medications. In addition, 24-h ambulatory BP monitoring within 1  month before in this study, it was optional for patients in the inter- the study enrollment was 135/85  mmHg or below; they vention group to consult with their clinicians regarding were between 20 to 60 years old. Patients with secondary their medication withdrawal. About 35% of the patients hypertension, cardiovascular complications (e.g., myo- in the intervention group did not attempt to have their cardial infarction), or renal dysfunction were excluded. medications withdrawn. However, the reasons were not investigated further in that study [11]. This result implies Outcome that some patients with low-cardiovascular disease risk The outcome of this study was the success rate of anti - continued taking their antihypertensive medications hypertensive medication withdrawal, which was assessed even though they were eligible to discontinue them. from the cumulative time-related curve over 6 months. If Another study showed far more pessimistic results. The patients met one or more of the following criteria, they short treatment with the angiotensin receptor blocker were considered unsuccessful in discontinuing their anti- candesartan surveyed by telemedicine (STAR CAST) hypertensive medications, and were categorized in the Study investigated whether treatment with candesartan hypertensive group: (1) office systolic BP of 140  mmHg or nifedipine-controlled release resulted in a sustained above or diastolic BP of 90 mmHg above on two consecu- regression of hypertension in 244 patients with stage 1 tive visits, (2) office systolic BP of 160  mmHg above or essential hypertension [12]. After 1 year of treatment, the diastolic BP of 100 mmHg above on any one visit, or (3) medications were tapered and discontinued. During the resumed antihypertensive medication. 1-year follow-up, there was a substantial reoccurrence of hypertension; at the study end, only one patient remained Blood pressure measurement normotensive without antihypertensive medication [13]. The automated office BP readings were obtained based u Th s, it is important to explore who can successfully dis - on standard procedures. The first BP readings were continue antihypertensive medications and the charac- obtained in both arms, and then patients were instructed teristics of patients who do not want to stop medications to use the arm with a higher BP monitoring throughout despite a low risk for cardiovascular disease. It is also the study. Patients had a series of three BP readings at essential to explore their reasons for such a decision. least 2 minutes apart after resting for at least 5 minutes. The primary aims of this pilot study were to (1) describe A mean of three consecutive automated office BP read - the success rate of antihypertensive drug discontinuation ings was recorded. L ee and Lee Clinical Hypertension (2023) 29:1 Page 3 of 10 Factors related to the success of antihypertensive nurses using the standard clinical procedures (e.g., medication discontinuation removing heavy clothes and shoes). Body mass index Adherence to self‑care activities for hypertension was calculated by weight in kilograms divided by height Adherence to self-care activities for hypertension is in meters. A medical record review for each participant based on the behavior subdomain of the Hypertension was performed to collect the laboratory data (e.g., lipid Self-Care Profile Behavior Scale [14]. The behavior sub - panel). domain consists of 20 items related to recommended lifestyle modifications (e.g., low fat and low sodium Study procedures diet, exercise, smoking cessation, and stress manage- After obtaining ethical approval from the Institutional ment), taking medications as directed, and attending all Review Board at the study site, eligible patients were clinic appointments. Each item is rated on a 1 to 4 Lik- referred to the researchers by their cardiologists. A writ- ert scale, and total scores can range from 20 to 80, with ten signed informed consent was obtained from each higher scores indicating better adherence to self-care patient who received a thorough explanation of the study activities. Because two items related to taking medica- and voluntarily agreed to participate. tions were irrelevant for this study, we used the remain- At baseline, automated office BP was taken using the ing 18 items, with the total scores ranging from 18 to standard procedure, and patients completed the ques- 72. The psychometric validity of the Korean version was tionnaires (e.g., sociodemographic information and supported [15]. health literacy). They also received verbal education, a booklet highlighting the importance of home BP moni- Health literacy toring at least twice daily, and recommended lifestyle Health literacy was measured with the Newest Vital modifications. They were also provided a contact num - Sign [16]. Patients are asked six questions about the ber. Patients were instructed to stop their BP medications "nutrition facts" label from a pint of ice cream. The after the baseline data collection of this study, which was number of correct responses is summed to produce a informed to their cardiologist. total score ranging from 0 to 6. Scores below four indi- Patients were followed up 1, 3, and 6  months after cate limited to possibly limited health literacy. the baseline. Three automated office BP readings were taken. They also completed the questionnaire about their adherence to self-care activities for hypertension at each Depressive symptoms visit. Reasons for withdrawal from the study were also The nine-item Patient Health Questionnaire was used collected. to measure the levels of depressive symptoms [17]. After the 6-month follow-up, participants were invited Patients were asked to rate their depressed moods over to participate in a semistructured, in-depth interview to 2  weeks on a 4-point Likert scale (0–3). The sum of elicit information about their experience with antihyper- each item yields a total score, with higher scores indi- tensive drug discontinuation (e.g., what changes did you cating higher levels of depressive symptoms. A total make after drug discontinuation?). The interviews were score of 10 or greater indicates clinically significant conducted in person in a private space and lasted 20 to depressive symptoms [17]. The validity of the Korean 50 min. Audio-recorded interviews were transcribed ver- version was supported in a previous study [18]. batim. The transcribed interviews were summarized to describe the experience of discontinuing antihyperten- Anxiety sive medications and the reasons for withdrawal from the The anxiety subscale of the Brief Symptom Inven - study, if applicable. Six patients participated in the inter- tory-18 was used to measure anxiety [19]. This subscale views; two in the normotensive group, two in the hyper- consists of six items based on a 5-point Likert scale tensive group, and two who withdrew from the study. (0–4). Total scores were the average of the scores of the six items, with higher scores indicating a higher level of anxiety. The psychometric soundness of the Korean Statistical analyses version of the Brief Symptom Inventory-18 was sup- To describe the success rate of antihypertensive medication ported in a previous study [20]. discontinuation over 6 months, we used the Kaplan–Meier curve of time to have elevated office BP based on the pre - set criteria (i.e., above 140/90  mmHg on two consecutive Sociodemographic information visits, above 160/100  mmHg on any time visit, or physi- Sociodemographic information (e.g., age, family history cians’ prescription for antihypertensive medications). The of hypertension) was obtained based on self-report. survival probability was summarized at 1, 3, and 6 months. Height and weight were measured by trained research The linear mixed model with repeated measures was used Lee and Lee Clinical Hypertension (2023) 29:1 Page 4 of 10 to compare changes in office BP readings over 6  months received at least a high school education (81.2%), and between the normotensive and hypertensive groups. Time had a family history of hypertension (81.3%). Three was introduced as the repeated effect, and a compound patients (18.8%) had a body mass index above 25  kg/m . symmetry covariance matrix handled dependencies in the All patients had taken angiotensin II receptor blockers, data. Explanatory factors included the two BP status groups except one patient taking a calcium channel blocker. On (normotensive and hypertensive groups), time, and the average, participants had adequate health literacy and interaction between the BP status groups and time. reported no clinically significant depressive symptoms. To compare the sample characteristics between the The average ± SD score of self-care adherence for normotensive and hypertensive groups, the Mann– hypertension at baseline was 47.0 ± 8.1, with possible Whitney U-test (an alternative nonparametric test to scores ranging from 18 to 72. The self-care activities that an independent t-test), chi-square test, or Fisher exact were the least adherent were reading food labels to check test was used as appropriate. The linear mixed model for salt content, drinking in moderation, checking food with repeated measures was used to compare changes labels for saturated fat or trans fat, and monitoring BP in adherence to self-care activities for hypertension over at home, in that order. In that order, the most adherent 6  months. In addition to comparing the characteristics self-care activities were regular office visits, smoking ces - between patients who dropped out of the study and those sation, and reducing calories from fat. who did not, the Mann–Whitney U-test, chi-square test, or Fisher exact test was used as appropriate. A P-value Change in blood pressure of ≤ 0.10 was considered statistically significant for all Patients were followed over 6  months (mean, 151  days; analyses because of the study’s exploratory nature. Sta- range, 5–195 days). The probability of normotensive sta - tistical analyses were performed using SAS ver. 9.4 (SAS tus was 1.00 at 30 days, 0.85 at 90 days, 0.51 at 180 days, Institute Inc., Cary, NC, USA). and 0.28 at 195  days. A relatively large decrease in the probability of normotensive status was found between Results 150 and 195 days after the baseline, with the likelihood of Baseline sample characteristics normotensive status of 0.77 and 0.28 at each time point A total of 16 patients with hypertension participated in (Fig.  2). Over 6  months, of the eight patients (50%) met this study. At 1, 3, and 6  months, 15, 12, and 12 patients the criteria for successful discontinuation of the antihy- remained in this study (Fig. 1). The mean ± standard devi- pertensive medication (i.e., normotensive group). ation (SD) age was 41 years (range, 26–55 years) (Table 1). The average ± SD systolic and diastolic BPs at baseline The majority of the patients were female (62.5%), had were 125.4 ± 8.6 and 82.9 ± 10.5  mmHg , respectively. Fig. 1 Study enrollment and hypertension status flow chart L ee and Lee Clinical Hypertension (2023) 29:1 Page 5 of 10 Table 1 Baseline sample characteristics Characteristic Total (n = 16) Normotensive (n = 8) Hypertensive (n = 8) P-value Age (yr) 41.4 ± 9.3 42.0 ± 11.9 40.8 ± 6.6 0.598 Female sex 10 (62.5) 5 (62.5) 5 (62.5) > 0.999 Lived with someone 13 (81.3) 7 (87.5) 6 (75.0) > 0.999 Below high school education 3 (18.8) 2 (25.0) 1 (12.5) > 0.999 Employed 9 (56.3) 5 (62.5) 4 (50.0) > 0.999 Body mass index (kg/m ) 23.7 ± 2.8 23.5 ± 2.1 23.9 ± 3.5 0.753 Family history of high BP 13 (81.3) 7 (87.5) 6 (75.0) > 0.999 Systolic BP at baseline 125.5 ± 8.6 122.8 ± 9.1 128.1 ± 7.6 0.155 Diastolic BP at baseline 83.0 ± 10.5 78.9 ± 11.7 87.0 ± 7.8 0.141 Time since hypertension diagnosis (mo) 68.6 ± 46.0 68.6 ± 50.7 68.6 ± 44.3 0.916 Antihypertensive medications Angiotensin II receptor blocker 15 (93.8) 8 (100) 7 (87.5) 0.182 Calcium channel blocker 1 (6.3) 0 1 (12.5) > 0.999 Total cholesterol 192.9 ± 26.1 186.3 ± 12.8 197.2 ± 32.2 0.443 Triglycerides 97.5 ± 39.5 74.6 ± 11.5 120.4 ± 45.0 0.021 Low‑ density lipoprotein 109.1 ± 22.1 110.5 ± 14.7 107.7 ± 29.2 0.749 High‑ density lipoprotein 57.2 ± 12.4 62.0 ± 13.1 52.4 ± 10.6 0.159 Psychological factor Anxiety 0.5 ± 0.5 0.6 ± 0.6 0.4 ± 0.4 0.489 Depressive symptoms 2.1 ± 2.5 2.4 ± 2.4 1.9 ± 2.7 0.386 Health literacy 4.3 ± 1.6 4.5 ± 1.9 4.1 ± 1.5 0.513 Hypertension self‑ care At baseline 47.0 ± 8.1 47.8 ± 7.4 46.3 ± 9.2 0.713 a) At 1 month (n = 13) 52.9 ± 8.5 53.2 ± 7.6 52.8 ± 9.6 0.768 At 3 months (n = 12) 50.3 ± 9.2 49.3 ± 6.6 50.9 ± 10.6 0.734 At 6 months (n = 12) 51.3 ± 5.6 51.8 ± 6.2 51.0 ± 5.8 0.864 Data are presented as mean ± standard deviation or number (%) BP blood pressure a ) At 1 month, two patients took their BP without completing the questionnaire Fig. 2 Survival plots of 16 participants’ normotensive status over 6 months. Blue areas indicate 95% confidence intervals Lee and Lee Clinical Hypertension (2023) 29:1 Page 6 of 10 were likelier to have lower triglyceride levels than those The mean ± SD changes of systolic and diastolic BP in the hypertensive group (P = 0.028). After excluding the levels from 6  months to baseline were 13.3 ± 8.8 and patients who withdrew from the study, the sample char- 10.1 ± 7.5 mmHg , respectively. acteristics at baseline were compared between patients in Regarding the changes in the mean systolic BP by BP normotensive and hypertensive groups, and there were status groups, there were no time and group interaction no differences between the two groups. effects (P = 0.160). However, there were significant main Regarding changes in self-care adherence between the effects of time and groups (both P < 0.05), indicating sub- normotensive and hypertensive groups, there was a sig- stantial increases in the average systolic BP over time nificant main effect of time, but not the main effect of regardless of the group and significant differences in the group and the interaction effect between time and group. average systolic BP between normotensive and hyperten- In other words, there was an increase in self-care adher- sive groups (Fig.  3). The mean diastolic BP was different ence over 6 months for both groups (P = 0.06). between the normotensive and hypertensive groups, and a nonsignificant time and group interaction effect was Patient experiences related to discontinuing found. However, significant main products of time and antihypertensive medications group were found in diastolic BP (both P < 0.05) (Fig. 3). Four patients in the normotensive (one male and one female) and hypertensive groups (one male and one female) Comparison of sample characteristics and changes were interviewed. All the patients expressed that they were in self-care adherence between the blood pressure status satisfied with an opportunity to stop their antihypertensive groups medications because they believed that others stigmatized There were no significant differences in demographic, young to middle-aged adults taking antihypertensive medi- clinical, and psychological status, except for triglycer- cations. However, they all reported feeling anxious because ide levels (Table  1). Patients in the normotensive group Fig. 3 Changes in (A) systolic and (B) diastolic blood pressure over 6 months using 12 patients who completed the 6‑month follow‑up L ee and Lee Clinical Hypertension (2023) 29:1 Page 7 of 10 they were worried about elevated BP after discontinuing systolic and diastolic BP readings at their last follow-up their medication. One female patient said: “I am still anx- visit were 127.8 ± 5.5 and 85.0 ± 3.4 mmHg, respectively. ious … so I always have the antihypertensive medication Regarding the reasons for withdrawing from the study with me.” and deciding to resume their antihypertensive medi- All patients in the normotensive group made lifestyle cations, one patient reported that his family was firmly changes throughout the 6  months. They reported that against withdrawing antihypertensive medication. Two their BP had been under control, and their symptoms participants told significant concerns about their fluctu - (e.g., fatigue) were improved. These positive experiences ating BP despite adhering to the recommended lifestyle. motivated them to maintain their lifestyle modifications, The remaining patient felt she was not yet psychologi - which resulted in enhancing their confidence in main - cally prepared to stop the medication. taining appropriate BP levels without medications. One Of the four patients, two patients (one male and one female patient said she kept a detailed diary to record her female) were interviewed. After stopping their medica- daily BP readings and events that may have affected her tions, both patients had higher BP, which made their fam- BP. The log helped her identify major contributing fac - ilies worried. The parent of one male patient requested a tors to a rise in BP and helped her develop strategies to second opinion from her primary care physician about avoid or relieve the factors. Support from their family and her son’s decision to stop taking the antihypertensive physician also helped motivate them to change their life- medication. The physician had an unfavorable opinion. style. A male patient said, “My physician gave me positive A female patient’s spouse suggested that taking antihy- feedback on my BP readings with encouragement, which pertensive medication was acceptable and expected for assured me that I do not need to take the medication any- individuals in their fifties. He reasoned that taking medi - more. This confidence makes me keep doing my lifestyle cations with stable BP readings was better than not tak- modifications.” ing medications with fluctuating BP readings. Patients in the hypertensive group did not make any par- ticular changes in their lifestyle. One male patient said he had been following the recommended lifestyle already, so Discussion he did not find anything further to change. In contrast, one Our study revealed that the participants’ BP was elevated female patient, a homemaker, experienced difficulty exer - after discontinuing the antihypertensive medications cising and eating healthy due to the coronavirus disease over 6  months. A notable reoccurrence of hyperten- 2019 outbreak and the stress she experienced from it. Both sion was developed 5  months after medication with- patients felt stressed or anxious when they found their ele- drawal. However, only a limited portion (less than 30%) vated BP readings. Although the female patient believed of patients remained in normotensive status at the end that not adhering to exercise and diet contributed to her of the follow-up period. In the patient interview, most rise in BP, she was not confident about making changes patients expressed ambivalent feelings toward stopping since she did not enjoy exercising and eating salads daily medication (thrilled vs. worrying). Increase in psycho- to cut down on calories. The male patient did not mention logical distress (e.g., anxiety) was the primary reason for much about social support from his family. However, the withdrawal from this study although BP of the patients female patient received negative feedback from her family, who withdrew from the study was under control. Our saying, “Why are you so bothered? Just take the antihyper- results suggest that clinicians must carefully select tensive medication.” patients who could potentially benefit from an attempt to discontinue the antihypertensive medication. Moreo- Comparison in sample characteristics between patients ver, continuous emotional support might be important to who remained in the study and those who did keep patients off-medication. not and their reasons for withdrawal Antihypertensive medications are assumed to be a life- The retention rate of this study was 75%, with four long treatment. However, a prolonged prescription of patients dropping out of the study. There were no sig - cardiovascular medications has been challenged because nificant differences in the baseline sample characteristics, the length of time investigated in clinical trials on cardio- including the baseline systolic and diastolic BP readings vascular drugs is often limited [21]. Yuan et al. [22] found between patients who remained in the research and those that the maximum duration of the randomized controlled who dropped out. However, patients who remained in trials for beta-blockers (e.g., carvedilol) ranged from 360 the study appeared to be younger and less anxious than to 365 days. In reality, patients had been on those medi- those who withdrew from the study (40  years old vs. cations longer than 365  days [22]. u Th s, there is a need 47  years old, 0.42 vs. 0.79), although the relationships for studies on drug withdrawal as well as the long-term did not reach statistical significance. The four patients’ effects of antihypertensive medications. Lee and Lee Clinical Hypertension (2023) 29:1 Page 8 of 10 We found that 50% of the patients remained normoten- were lower than those of previous studies conducted on sive 180 days after drug withdrawal, similar to 38% in the Asian patients with hypertension, including older Korean systematic review by van der Wardt et al. [23]. However, patients [15, 26]. the proportion of patients in the normotensive group in The middle-range theory of self-care for chronic illness our study was higher than the proportion reported in the suggests that various factors affect self-care in patients study by Sasamura et al. [13] in which similar thresholds with chronic disease, including skills, motivation, confi - for normotensive status were used (0% and 18% of the dence, and support from others [27]. Our interview also patients who previously took nifedipine and candesartan, showed consistent findings that social support from fam - respectively). This difference may be due to the inclu - ily and clinicians affected their motivation to engage in sion criteria; most studies, including our study, included self-care activities. In addition, one patient in the nor- patients whose BP had been well-controlled [19], while motensive group discussed skill development in the the study by Sasamura et  al. [13] enrolled the patients interview. She reported using a detailed diary to identify who had not been treated for BP for 1  year and with a the primary source of BP changes in her daily life and family history of hypertension. develop strategies to minimize exposure to that source. Most participants in our study had elevated BP after Although the theory did not probe misperceptions about discontinuing antihypertensive medication, which is con- factors influencing self-care for chronic, one patient sistent with previous studies [11, 13, 24]. BPs in our sam- in the hypertensive group reported that his self-care ple continuously rose over 6  months. However, in other activities were “ideal.” Previous studies have shown that studies [11, 25] where the samples were older (mean patients’ perceptions of their adherence to self-care activ- age, 55–81  years) with a higher baseline BPs (systolic ities often differ from their actual engagement [28–30]. BP, 140.4–148.8  mmHg) compared to that of our study, For example, 18.7% of community-dwelling adults over- patients’ BP was elevated 10 to 12  weeks after antihy- estimated their vegetable consumption [29]. The findings pertensive medication withdrawal but was maintained from our study and others highlight the need for strate- thereafter. gies for patients who discontinue their antihypertensive Researchers have studied whether demographic and medications by improving their skills and motivation, clinical information is associated with normotensive seeking social support, and helping them identify their status and consistently found that monotherapy of anti- actual levels of self-care activities. hypertensive medications and lower baseline BP were Four of the 16 patients enrolled in our study with- predictors of normotensive status [23]. However, we did drew from the study even though their BP levels were not find significant differences in baseline systolic and not considered hypertensive. The most common reason diastolic BP between the normotensive and hypertensive for withdrawal from the study was psychological distress groups (123/79  mmHg vs. 128/87  mmHg, respectively). (e.g., anxiety). Although anxiety levels were not statisti- This may be due to the small sample size in our study to cally different between patients who remained in the detect the differences. research and those who did not, anxiety was somewhat Beyond the demographic and clinical factors poten- lower in patients who remained in the study compared tially associated with hypertensive status, we first tested to those who did not. A similar finding was observed in the psychological aspects and adherence to self-care previous studies [7, 24]; Buranakitjaroen et al. [24] found activities for hypertension to the best of our ability. How- that about 10% of the patients who stopped their antihy- ever, we did not find significant differences in these fac - pertensive medications self-medicated by supplementing tors between the normotensive and hypertensive groups. their antihypertensive medications due to anxiety or feel- Surprisingly, patients’ levels of self-care were not asso- ing unwell. Clinicians need to pay attention to patients’ ciated with BP status. However, improving self-care psychological status when deprescribing antihyperten- activities is critical to maintaining BP when patients with sive medication, which is one of the principles suggested hypertension are not on their antihypertensive medica- by Coe et al. [31]. One patient reported that the family’s tions. One possible reason for this non-significant rela - concern about medication withdrawal was a primary rea- tionship is that the changes patients made in self-care son to withdraw from the study. As social support from activities were not substantial enough to see benefits family members is essential to behavior changes [27], it after discontinuing medications. Patients in both groups can be beneficial to involve family members when dis - were more likely to engage in their self-care activities cussing the possibility of the medication withdrawal. over the 6 months after stopping their medications even There are limitations to be noted in our study. Our though their mean score of self-care activities was not study included a limited number of patients recruited optimal (47.0 at baseline and 51.3 at 6  months, out of from one tertiary medical center, which limits the inter- possible scores of 18–72). The mean scores in our sample nal and external validity of our findings. However, this L ee and Lee Clinical Hypertension (2023) 29:1 Page 9 of 10 Author details study was a pilot study to calculate the effect size and Department of Internal Medicine, Seoul National University Hospital, examine the feasibility of a future large-scale study. The Seoul, Republic of Korea. Research Institute of Nursing Science, Center retention rate of our study was 75%, which is smaller than for Human‑Caring Nurse Leaders for the Future by Brain Korea 21 (BK 21) Four Project, Seoul National University College of Nursing, Seoul, Republic of Korea. that of previous studies [13, 24]. However, we performed linear mixed modeling to use all available data for each Received: 29 June 2022 Accepted: 13 September 2022 patient. The treatment periods for taking antihyperten - sive medication were not collected so that it was not possible to examine the relationship between treatment periods and BP control. References 1. Kim HC, Lee H, Lee HH, Seo E, Kim E, Han J, et al. Korea hypertension fact sheet 2021: analysis of nationwide population‑based data with special Conclusions focus on hypertension in women. Clin Hypertens. 2022;28:1. Our study showed that a small portion of the young and 2. Kim HC, Cho SMJ, Lee H, Lee HH, Baek J, Heo JE, et al. Korea hyperten‑ sion fact sheet 2020: analysis of nationwide population‑based data. Clin middle-aged adults with hypertension maintained nor- Hypertens. 2021;27:8. motensive status after discontinuing their antihyperten- 3. Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison sive medication over 6  months. Although we could not Himmelfarb C, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ ASPC/NMA/PCNA Guideline for the prevention, detection, evaluation, identify factors associated with success in maintaining and management of high blood pressure in adults: a report of the BP over 6 months, our results imply that careful selection American College of Cardiology/American Heart Association Task Force of eligible patients can increase the success of the with- on Clinical Practice Guidelines. J Am Coll Cardiol. 2018;71:e127‑248. 4. Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, et al. drawal of antihypertensive medications. The primary rea - 2018 ESC/ESH Guidelines for the management of arterial hypertension. son for withdrawal from our study was fear of stopping Eur Heart J. 2018;39:3021–104. medications, which highlights the importance of consid- 5. Lee HY, Shin J, Kim GH, Park S, Ihm SH, Kim HC, et al. 2018 Korean Society of Hypertension Guidelines for the management of hypertension: part ering patients’ psychological status. Thus, clinicians need II‑ diagnosis and treatment of hypertension. Clin Hypertens. 2019;25:20. to spend sufficient time with patients to plan the with - 6. Abegaz TM, Shehab A, Gebreyohannes EA, Bhagavathula AS, Elnour AA. drawal process (e.g., providing information on dealing Nonadherence to antihypertensive drugs: a systematic review and meta‑ analysis. Medicine (Baltimore). 2017;96:e5641. with potential withdrawal symptoms and fear) so patients 7. Durand H, Casey M, Glynn LG, Hayes P, Murphy AW, Molloy GJ. A qualita‑ are prepared to stop their medications. tive comparison of high and low adherers with apparent treatment‑ resistant hypertension. Psychol Health Med. 2020;25:64–77. 8. Kang J, Jeong YJ. Psychological resistance to drug therapy in patients Abbreviations with hypertension: a qualitative thematic analysis. Korean J Adult Nurs. BP: Blood pressure; SD: Standard deviation; STAR CAST: Short treatment with 2020;32:124–33. the angiotensin receptor blocker candesartan surveyed by telemedicine. 9. Gascon JJ, Sanchez‑ Ortuno M, Llor B, Skidmore D, Saturno PJ. Treatment Compliance in Hypertension Study Group. Why hypertensive patients Acknowledgements do not comply with the treatment: results from a qualitative study. Fam Not applicable Pract. 2004;21:125–30. 10. Hultgren F, Jonasson G, Billhult A. From resistance to rescue: patients’ Authors’ contributions shifting attitudes to antihypertensives: a qualitative study. Scand J Prim HYL: conceptualization, methodology, writing‑reviewing and editing; KSL: Health Care. 2014;32:163–9. conceptualization, methodology, validation, formal analysis, investigation, data 11. Luymes CH, Poortvliet RK, van Geloven N, de Waal MW, Drewes YM, Blom JW, curation, writing original draft, project administration, funding acquisition. The et al. Deprescribing preventive cardiovascular medication in patients with authors read and approved the final manuscript. predicted low cardiovascular disease risk in general practice: the ECSTATIC study: a cluster randomised noninf ‑ eriority trial. BMC Med. 2018;16:5. Funding 12. Sasamura H, Nakaya H, Julius S, Takebayashi T, Sato Y, Uno H, et al. The This work was supported by the Korean Society of Hypertension (2018). short treatment with the angiotensin receptor blocker candesartan surveyed by telemedicine (STAR CAST ) study: rationale and study design. Availability of data and materials Hypertens Res. 2008;31:1843–9. The data supporting this study’s findings are available from the corresponding 13. Sasamura H, Nakaya H, Julius S, Tomotsugu N, Sato Y, Takahashi F, et al. author upon reasonable request. Feasibility of regression of hypertension using contemporary antihyper‑ tensive agents. Am J Hypertens. 2013;26:1381–8. 14. Han HR, Lee H, Commodore‑Mensah Y, Kim M. Development and valida‑ Declarations tion of the Hypertension Self‑ Care Profile: a practical tool to measure hypertension self‑ care. J Cardiovasc Nurs. 2014;29:E11‑20. Ethics approval and consent to participate 15. An N, Jun Y, Song Y. Psychometric properties of the hypertension self‑ care This project is approved by the Institutional Review Board of Seoul National behavior scale for elders with hypertension in Korea. J Korean Acad University Hospital (No. H‑1902–132‑1015). A written signed informed consent Fundam Nurs. 2017;24:1–8. was obtained from each patient who received a thorough explanation of the 16. Weiss BD, Mays MZ, Martz W, Castro KM, DeWalt DA, Pignone MP, et al. study and voluntarily agreed to participate. Quick assessment of literacy in primary care: the newest vital sign. Ann Fam Med. 2005;3:514–22. Consent for publication 17. Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self‑report Not applicable. version of PRIME‑MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. Competing interests 1999;282:1737–44. The authors declare that they have no competing interests. Lee and Lee Clinical Hypertension (2023) 29:1 Page 10 of 10 18. Han C, Jo SA, Kwak JH, Pae CU, Steffens D, Jo I, et al. Validation of the Patient Health Questionnaire‑9 Korean version in the elderly population: the Ansan Geriatric study. Compr Psychiatry. 2008;49:218–23. 19. Derogatis LR, Melisaratos N. The brief symptom inventory: an introduc‑ tory report. Psychol Med. 1983;13:595–605. 20. Hoe M, Lee S. Examining psychometric properties of the brief symptom inventory (BSI‑18) in Korean people with mental disorders. Korean J Soc Welf. 2014;66:253–76. 21. Rossello X, Pocock SJ, Julian DG. Long‑term use of cardiovascular drugs: challenges for research and for patient care. J Am Coll Cardiol. 2015;66:1273–85. 22. Yuan C, Ryan PB, Ta CN, Kim JH, Li Z, Weng C. From clinical trials to clinical practice: how long are drugs tested and then used by patients? J Am Med Inform Assoc. 2021;28:2456–60. 23. van der Wardt V, Harrison JK, Welsh T, Conroy S, Gladman J. Withdrawal of antihypertensive medication: a systematic review. J Hypertens. 2017;35:1742–9. 24. Buranakitjaroen P, Phoojaroenchanachai M, Thongma P, Wimon‑ sophonkitti R. Eec ff t of antihypertensive medication withdrawal in well‑ controlled treated hypertensive patients: preliminary results. J Med Assoc Thai. 2016;99:133–41. 25. Moonen JE, Foster‑Dingley JC, de Ruijter W, van der Grond J, Bertens AS, van Buchem MA, et al. Eec ff t of discontinuation of antihypertensive treatment in elderly people on cognitive functioning: the DANTE Study Leiden: a randomized clinical trial. JAMA Intern Med. 2015;175:1622–30. 26. Yatim HM, Wong YY, Lim SH, Hassali MA, Hong YH, Dali AF, et al. Evalu‑ ation of a group‑based hypertension self‑management education programme among hypertensive community dwellers. Eur J Integr Med. 2018;24:79–84. 27. Riegel B, Jaarsma T, Stromberg A. A middle‑range theory of self‑ care of chronic illness. ANS Adv Nurs Sci. 2012;35:194–204. 28. De Keyzer W, Dofková M, Lillegaard IT, De Maeyer M, Andersen LF, Ruprich J, et al. Reporting accuracy of population dietary sodium intake using duplicate 24 h dietary recalls and a salt questionnaire. Br J Nutr. 2015;113:488–97. 29. Dijkstra SC, Neter JE, Brouwer IA, Huisman M, Visser M. Misperception of self‑reported adherence to the fruit, vegetable and fish guidelines in older Dutch adults. Appetite. 2014;82:166–72. 30. El Alili M, Vrijens B, Demonceau J, Evers SM, Hiligsmann M. A scoping review of studies comparing the medication event monitoring system (MEMS) with alternative methods for measuring medication adherence. Br J Clin Pharmacol. 2016;82:268–79. 31. Coe A, Kaylor‑Hughes C, Fletcher S, Murray E, Gunn J. Deprescribing intervention activities mapped to guiding principles for use in general practice: a scoping review. BMJ Open. 2021;11:e052547. Publisher’s Note Springer Nature remains neutral with regard to jurisdictional claims in pub‑ lished maps and institutional affiliations. Re Read ady y to to submit y submit your our re researc search h ? Choose BMC and benefit fr ? 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Withdrawal of antihypertensive medication in young to middle-aged adults: a prospective, single-group, intervention study

Lee, Hae-Young; Lee, Kyoung Suk
Clinical Hypertension , Volume 29 (1) – Jan 2, 2023
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Copyright © The Author(s) 2022
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10.1186/s40885-022-00225-2
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Abstract

Background: Although antihypertensive drug therapy is commonly believed to be a life‑long therapy, several recent guidelines have suggested that antihypertensive medications can be gradually reduced or discontinued for some patients whose blood pressure (BP) is well‑ controlled for an extended period. Thus, this pilot study aimed to describe the success rate of antihypertensive drug discontinuation over 6 months among young and middle‑aged patients with hypertension. Methods: This was a prospective, single‑ group, intervention study. Patients were eligible for inclusion if their car‑ diologist judged them to be appropriate candidates for this study, their BP had been controlled both in the office (< 140/90 mmHg) and 24‑h ambulatory BP monitoring (< 135/85 mmHg) for at least 6 months with a single tablet dose of antihypertensive medication. A total of 16 patients withdrew their antihypertensive medications at baseline after they received the education, and were followed up over 6 months. After the follow‑ups, six patients participated in the in‑ depth interview. Results: The likelihood of remaining normotensive at 30, 90, 180, and 195 days was 1.00, 0.85, 0.51, and 0.28, respec‑ tively. There were also no significant differences in baseline characteristics and self‑ care activities over time between normotensive (n = 8) and hypertensive groups (n = 8). In the interview, most patients expressed ambivalent feelings toward stopping medications. Psychological distress (e.g., anxiety) was the primary reason for withdrawal from this study although the patients’ BP was under control. Conclusions: We found that only a limited portion of antihypertensive patients could stop their medication suc‑ cessively over 6 months. Although we could not identify factors associated with success in maintaining BP over 6 months, we believe that careful selection of eligible patients may increase success in stopping antihypertensive medications. Also, continuous emotional support might be essential in maintaining patients’ off‑medication. Keywords: Hypertension, Antihypertensive agents, Deprescriptions Background Hypertension is a prevalent chronic condition that sig- nificantly contributes to cardiovascular disease and premature death [1, 2]. Lifestyle modifications and anti - hypertensive medication are the major components of *Correspondence: kyounglee@snu.ac.kr hypertension management [3–5]. According to the 2018 Research Institute of Nursing Science, Center for Human‑Caring Nurse guidelines of the Korean Hypertension Society [5], drug Leaders for the Future by Brain Korea 21 (BK 21) Four Project, Seoul National University College of Nursing, Seoul, Republic of Korea treatment is initiated when the systolic/diastolic blood Full list of author information is available at the end of the article pressure (BP) is ≥ 140/90  mmHg, along with lifestyle © The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http:// creat iveco mmons. org/ licen ses/ by/4. 0/. The Creative Commons Public Domain Dedication waiver (http:// creat iveco mmons. org/ publi cdoma in/ zero/1. 0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Lee and Lee Clinical Hypertension (2023) 29:1 Page 2 of 10 modifications. Although antihypertensive medications over 6  months for young to middle-aged patients with are very effective in BP lowering, some patients refuse hypertension; (2) to compare the changes in BP between it or are nonadherent to the treatment. According to a the normotensive group (i.e., those who successfully dis- recent meta-analysis, the overall nonadherence rate to continued their medications) and the hypertensive group antihypertensive medications was 45.2% [6]. The com - over 6 months; and (3) compare the baseline sample char- mon reasons for refusal or nonadherence to taking anti- acteristics and changes in adherence to self-care activities hypertensive drugs are related to concerns about the side for hypertension between the normotensive and hyper- effects of the medications, social stigma, and the burden tensive groups. The secondary aims of this study were of taking drugs for the rest of their lives once they start to describe the retention rate and the reasons for study medications for hypertension [7–10]. One of the most withdrawal and compare the characteristics of patients frequently asked questions from the patients who need who remained in the study and those who dropped out. drug treatment is whether they should take antihyperten- sive medication indefinitely once it is started is. Methods Although antihypertensive drug therapy is commonly Study design and participants believed to be a life-long therapy, several recent guide- This study was a prospective single-group interventional lines [4, 5] have suggested that antihypertensive medica- study and was approved by the Institutional Review tions can be gradually reduced or withdrawn for some Board of the Seoul National University Hospital (No. patients whose BP is well-controlled for an extended H-1902–132-1015). Patients were recruited from a car- period. However, the level of evidence for this recom- diology clinic in Seoul National University Hospital, a mendation is very weak. A recent experimental study tertiary academic medical center in Republic of Korea. suggested that when antihypertensive medications were Patients were eligible for inclusion if their cardiologist stopped from the patients at low-cardiovascular disease judged them to be appropriate candidates for this study, risk, BP control at the 2-year follow-up was not inferior their BP had been controlled in normotensive range to standard care [11]. However, the investigators did (< 140/90 mmHg) for at least 6 months with a single tab- not explore the characteristics of patients who success- let dose of antihypertensive medication; the value of their fully stopped antihypertensive medications. In addition, 24-h ambulatory BP monitoring within 1  month before in this study, it was optional for patients in the inter- the study enrollment was 135/85  mmHg or below; they vention group to consult with their clinicians regarding were between 20 to 60 years old. Patients with secondary their medication withdrawal. About 35% of the patients hypertension, cardiovascular complications (e.g., myo- in the intervention group did not attempt to have their cardial infarction), or renal dysfunction were excluded. medications withdrawn. However, the reasons were not investigated further in that study [11]. This result implies Outcome that some patients with low-cardiovascular disease risk The outcome of this study was the success rate of anti - continued taking their antihypertensive medications hypertensive medication withdrawal, which was assessed even though they were eligible to discontinue them. from the cumulative time-related curve over 6 months. If Another study showed far more pessimistic results. The patients met one or more of the following criteria, they short treatment with the angiotensin receptor blocker were considered unsuccessful in discontinuing their anti- candesartan surveyed by telemedicine (STAR CAST) hypertensive medications, and were categorized in the Study investigated whether treatment with candesartan hypertensive group: (1) office systolic BP of 140  mmHg or nifedipine-controlled release resulted in a sustained above or diastolic BP of 90 mmHg above on two consecu- regression of hypertension in 244 patients with stage 1 tive visits, (2) office systolic BP of 160  mmHg above or essential hypertension [12]. After 1 year of treatment, the diastolic BP of 100 mmHg above on any one visit, or (3) medications were tapered and discontinued. During the resumed antihypertensive medication. 1-year follow-up, there was a substantial reoccurrence of hypertension; at the study end, only one patient remained Blood pressure measurement normotensive without antihypertensive medication [13]. The automated office BP readings were obtained based u Th s, it is important to explore who can successfully dis - on standard procedures. The first BP readings were continue antihypertensive medications and the charac- obtained in both arms, and then patients were instructed teristics of patients who do not want to stop medications to use the arm with a higher BP monitoring throughout despite a low risk for cardiovascular disease. It is also the study. Patients had a series of three BP readings at essential to explore their reasons for such a decision. least 2 minutes apart after resting for at least 5 minutes. The primary aims of this pilot study were to (1) describe A mean of three consecutive automated office BP read - the success rate of antihypertensive drug discontinuation ings was recorded. L ee and Lee Clinical Hypertension (2023) 29:1 Page 3 of 10 Factors related to the success of antihypertensive nurses using the standard clinical procedures (e.g., medication discontinuation removing heavy clothes and shoes). Body mass index Adherence to self‑care activities for hypertension was calculated by weight in kilograms divided by height Adherence to self-care activities for hypertension is in meters. A medical record review for each participant based on the behavior subdomain of the Hypertension was performed to collect the laboratory data (e.g., lipid Self-Care Profile Behavior Scale [14]. The behavior sub - panel). domain consists of 20 items related to recommended lifestyle modifications (e.g., low fat and low sodium Study procedures diet, exercise, smoking cessation, and stress manage- After obtaining ethical approval from the Institutional ment), taking medications as directed, and attending all Review Board at the study site, eligible patients were clinic appointments. Each item is rated on a 1 to 4 Lik- referred to the researchers by their cardiologists. A writ- ert scale, and total scores can range from 20 to 80, with ten signed informed consent was obtained from each higher scores indicating better adherence to self-care patient who received a thorough explanation of the study activities. Because two items related to taking medica- and voluntarily agreed to participate. tions were irrelevant for this study, we used the remain- At baseline, automated office BP was taken using the ing 18 items, with the total scores ranging from 18 to standard procedure, and patients completed the ques- 72. The psychometric validity of the Korean version was tionnaires (e.g., sociodemographic information and supported [15]. health literacy). They also received verbal education, a booklet highlighting the importance of home BP moni- Health literacy toring at least twice daily, and recommended lifestyle Health literacy was measured with the Newest Vital modifications. They were also provided a contact num - Sign [16]. Patients are asked six questions about the ber. Patients were instructed to stop their BP medications "nutrition facts" label from a pint of ice cream. The after the baseline data collection of this study, which was number of correct responses is summed to produce a informed to their cardiologist. total score ranging from 0 to 6. Scores below four indi- Patients were followed up 1, 3, and 6  months after cate limited to possibly limited health literacy. the baseline. Three automated office BP readings were taken. They also completed the questionnaire about their adherence to self-care activities for hypertension at each Depressive symptoms visit. Reasons for withdrawal from the study were also The nine-item Patient Health Questionnaire was used collected. to measure the levels of depressive symptoms [17]. After the 6-month follow-up, participants were invited Patients were asked to rate their depressed moods over to participate in a semistructured, in-depth interview to 2  weeks on a 4-point Likert scale (0–3). The sum of elicit information about their experience with antihyper- each item yields a total score, with higher scores indi- tensive drug discontinuation (e.g., what changes did you cating higher levels of depressive symptoms. A total make after drug discontinuation?). The interviews were score of 10 or greater indicates clinically significant conducted in person in a private space and lasted 20 to depressive symptoms [17]. The validity of the Korean 50 min. Audio-recorded interviews were transcribed ver- version was supported in a previous study [18]. batim. The transcribed interviews were summarized to describe the experience of discontinuing antihyperten- Anxiety sive medications and the reasons for withdrawal from the The anxiety subscale of the Brief Symptom Inven - study, if applicable. Six patients participated in the inter- tory-18 was used to measure anxiety [19]. This subscale views; two in the normotensive group, two in the hyper- consists of six items based on a 5-point Likert scale tensive group, and two who withdrew from the study. (0–4). Total scores were the average of the scores of the six items, with higher scores indicating a higher level of anxiety. The psychometric soundness of the Korean Statistical analyses version of the Brief Symptom Inventory-18 was sup- To describe the success rate of antihypertensive medication ported in a previous study [20]. discontinuation over 6 months, we used the Kaplan–Meier curve of time to have elevated office BP based on the pre - set criteria (i.e., above 140/90  mmHg on two consecutive Sociodemographic information visits, above 160/100  mmHg on any time visit, or physi- Sociodemographic information (e.g., age, family history cians’ prescription for antihypertensive medications). The of hypertension) was obtained based on self-report. survival probability was summarized at 1, 3, and 6 months. Height and weight were measured by trained research The linear mixed model with repeated measures was used Lee and Lee Clinical Hypertension (2023) 29:1 Page 4 of 10 to compare changes in office BP readings over 6  months received at least a high school education (81.2%), and between the normotensive and hypertensive groups. Time had a family history of hypertension (81.3%). Three was introduced as the repeated effect, and a compound patients (18.8%) had a body mass index above 25  kg/m . symmetry covariance matrix handled dependencies in the All patients had taken angiotensin II receptor blockers, data. Explanatory factors included the two BP status groups except one patient taking a calcium channel blocker. On (normotensive and hypertensive groups), time, and the average, participants had adequate health literacy and interaction between the BP status groups and time. reported no clinically significant depressive symptoms. To compare the sample characteristics between the The average ± SD score of self-care adherence for normotensive and hypertensive groups, the Mann– hypertension at baseline was 47.0 ± 8.1, with possible Whitney U-test (an alternative nonparametric test to scores ranging from 18 to 72. The self-care activities that an independent t-test), chi-square test, or Fisher exact were the least adherent were reading food labels to check test was used as appropriate. The linear mixed model for salt content, drinking in moderation, checking food with repeated measures was used to compare changes labels for saturated fat or trans fat, and monitoring BP in adherence to self-care activities for hypertension over at home, in that order. In that order, the most adherent 6  months. In addition to comparing the characteristics self-care activities were regular office visits, smoking ces - between patients who dropped out of the study and those sation, and reducing calories from fat. who did not, the Mann–Whitney U-test, chi-square test, or Fisher exact test was used as appropriate. A P-value Change in blood pressure of ≤ 0.10 was considered statistically significant for all Patients were followed over 6  months (mean, 151  days; analyses because of the study’s exploratory nature. Sta- range, 5–195 days). The probability of normotensive sta - tistical analyses were performed using SAS ver. 9.4 (SAS tus was 1.00 at 30 days, 0.85 at 90 days, 0.51 at 180 days, Institute Inc., Cary, NC, USA). and 0.28 at 195  days. A relatively large decrease in the probability of normotensive status was found between Results 150 and 195 days after the baseline, with the likelihood of Baseline sample characteristics normotensive status of 0.77 and 0.28 at each time point A total of 16 patients with hypertension participated in (Fig.  2). Over 6  months, of the eight patients (50%) met this study. At 1, 3, and 6  months, 15, 12, and 12 patients the criteria for successful discontinuation of the antihy- remained in this study (Fig. 1). The mean ± standard devi- pertensive medication (i.e., normotensive group). ation (SD) age was 41 years (range, 26–55 years) (Table 1). The average ± SD systolic and diastolic BPs at baseline The majority of the patients were female (62.5%), had were 125.4 ± 8.6 and 82.9 ± 10.5  mmHg , respectively. Fig. 1 Study enrollment and hypertension status flow chart L ee and Lee Clinical Hypertension (2023) 29:1 Page 5 of 10 Table 1 Baseline sample characteristics Characteristic Total (n = 16) Normotensive (n = 8) Hypertensive (n = 8) P-value Age (yr) 41.4 ± 9.3 42.0 ± 11.9 40.8 ± 6.6 0.598 Female sex 10 (62.5) 5 (62.5) 5 (62.5) > 0.999 Lived with someone 13 (81.3) 7 (87.5) 6 (75.0) > 0.999 Below high school education 3 (18.8) 2 (25.0) 1 (12.5) > 0.999 Employed 9 (56.3) 5 (62.5) 4 (50.0) > 0.999 Body mass index (kg/m ) 23.7 ± 2.8 23.5 ± 2.1 23.9 ± 3.5 0.753 Family history of high BP 13 (81.3) 7 (87.5) 6 (75.0) > 0.999 Systolic BP at baseline 125.5 ± 8.6 122.8 ± 9.1 128.1 ± 7.6 0.155 Diastolic BP at baseline 83.0 ± 10.5 78.9 ± 11.7 87.0 ± 7.8 0.141 Time since hypertension diagnosis (mo) 68.6 ± 46.0 68.6 ± 50.7 68.6 ± 44.3 0.916 Antihypertensive medications Angiotensin II receptor blocker 15 (93.8) 8 (100) 7 (87.5) 0.182 Calcium channel blocker 1 (6.3) 0 1 (12.5) > 0.999 Total cholesterol 192.9 ± 26.1 186.3 ± 12.8 197.2 ± 32.2 0.443 Triglycerides 97.5 ± 39.5 74.6 ± 11.5 120.4 ± 45.0 0.021 Low‑ density lipoprotein 109.1 ± 22.1 110.5 ± 14.7 107.7 ± 29.2 0.749 High‑ density lipoprotein 57.2 ± 12.4 62.0 ± 13.1 52.4 ± 10.6 0.159 Psychological factor Anxiety 0.5 ± 0.5 0.6 ± 0.6 0.4 ± 0.4 0.489 Depressive symptoms 2.1 ± 2.5 2.4 ± 2.4 1.9 ± 2.7 0.386 Health literacy 4.3 ± 1.6 4.5 ± 1.9 4.1 ± 1.5 0.513 Hypertension self‑ care At baseline 47.0 ± 8.1 47.8 ± 7.4 46.3 ± 9.2 0.713 a) At 1 month (n = 13) 52.9 ± 8.5 53.2 ± 7.6 52.8 ± 9.6 0.768 At 3 months (n = 12) 50.3 ± 9.2 49.3 ± 6.6 50.9 ± 10.6 0.734 At 6 months (n = 12) 51.3 ± 5.6 51.8 ± 6.2 51.0 ± 5.8 0.864 Data are presented as mean ± standard deviation or number (%) BP blood pressure a ) At 1 month, two patients took their BP without completing the questionnaire Fig. 2 Survival plots of 16 participants’ normotensive status over 6 months. Blue areas indicate 95% confidence intervals Lee and Lee Clinical Hypertension (2023) 29:1 Page 6 of 10 were likelier to have lower triglyceride levels than those The mean ± SD changes of systolic and diastolic BP in the hypertensive group (P = 0.028). After excluding the levels from 6  months to baseline were 13.3 ± 8.8 and patients who withdrew from the study, the sample char- 10.1 ± 7.5 mmHg , respectively. acteristics at baseline were compared between patients in Regarding the changes in the mean systolic BP by BP normotensive and hypertensive groups, and there were status groups, there were no time and group interaction no differences between the two groups. effects (P = 0.160). However, there were significant main Regarding changes in self-care adherence between the effects of time and groups (both P < 0.05), indicating sub- normotensive and hypertensive groups, there was a sig- stantial increases in the average systolic BP over time nificant main effect of time, but not the main effect of regardless of the group and significant differences in the group and the interaction effect between time and group. average systolic BP between normotensive and hyperten- In other words, there was an increase in self-care adher- sive groups (Fig.  3). The mean diastolic BP was different ence over 6 months for both groups (P = 0.06). between the normotensive and hypertensive groups, and a nonsignificant time and group interaction effect was Patient experiences related to discontinuing found. However, significant main products of time and antihypertensive medications group were found in diastolic BP (both P < 0.05) (Fig. 3). Four patients in the normotensive (one male and one female) and hypertensive groups (one male and one female) Comparison of sample characteristics and changes were interviewed. All the patients expressed that they were in self-care adherence between the blood pressure status satisfied with an opportunity to stop their antihypertensive groups medications because they believed that others stigmatized There were no significant differences in demographic, young to middle-aged adults taking antihypertensive medi- clinical, and psychological status, except for triglycer- cations. However, they all reported feeling anxious because ide levels (Table  1). Patients in the normotensive group Fig. 3 Changes in (A) systolic and (B) diastolic blood pressure over 6 months using 12 patients who completed the 6‑month follow‑up L ee and Lee Clinical Hypertension (2023) 29:1 Page 7 of 10 they were worried about elevated BP after discontinuing systolic and diastolic BP readings at their last follow-up their medication. One female patient said: “I am still anx- visit were 127.8 ± 5.5 and 85.0 ± 3.4 mmHg, respectively. ious … so I always have the antihypertensive medication Regarding the reasons for withdrawing from the study with me.” and deciding to resume their antihypertensive medi- All patients in the normotensive group made lifestyle cations, one patient reported that his family was firmly changes throughout the 6  months. They reported that against withdrawing antihypertensive medication. Two their BP had been under control, and their symptoms participants told significant concerns about their fluctu - (e.g., fatigue) were improved. These positive experiences ating BP despite adhering to the recommended lifestyle. motivated them to maintain their lifestyle modifications, The remaining patient felt she was not yet psychologi - which resulted in enhancing their confidence in main - cally prepared to stop the medication. taining appropriate BP levels without medications. One Of the four patients, two patients (one male and one female patient said she kept a detailed diary to record her female) were interviewed. After stopping their medica- daily BP readings and events that may have affected her tions, both patients had higher BP, which made their fam- BP. The log helped her identify major contributing fac - ilies worried. The parent of one male patient requested a tors to a rise in BP and helped her develop strategies to second opinion from her primary care physician about avoid or relieve the factors. Support from their family and her son’s decision to stop taking the antihypertensive physician also helped motivate them to change their life- medication. The physician had an unfavorable opinion. style. A male patient said, “My physician gave me positive A female patient’s spouse suggested that taking antihy- feedback on my BP readings with encouragement, which pertensive medication was acceptable and expected for assured me that I do not need to take the medication any- individuals in their fifties. He reasoned that taking medi - more. This confidence makes me keep doing my lifestyle cations with stable BP readings was better than not tak- modifications.” ing medications with fluctuating BP readings. Patients in the hypertensive group did not make any par- ticular changes in their lifestyle. One male patient said he had been following the recommended lifestyle already, so Discussion he did not find anything further to change. In contrast, one Our study revealed that the participants’ BP was elevated female patient, a homemaker, experienced difficulty exer - after discontinuing the antihypertensive medications cising and eating healthy due to the coronavirus disease over 6  months. A notable reoccurrence of hyperten- 2019 outbreak and the stress she experienced from it. Both sion was developed 5  months after medication with- patients felt stressed or anxious when they found their ele- drawal. However, only a limited portion (less than 30%) vated BP readings. Although the female patient believed of patients remained in normotensive status at the end that not adhering to exercise and diet contributed to her of the follow-up period. In the patient interview, most rise in BP, she was not confident about making changes patients expressed ambivalent feelings toward stopping since she did not enjoy exercising and eating salads daily medication (thrilled vs. worrying). Increase in psycho- to cut down on calories. The male patient did not mention logical distress (e.g., anxiety) was the primary reason for much about social support from his family. However, the withdrawal from this study although BP of the patients female patient received negative feedback from her family, who withdrew from the study was under control. Our saying, “Why are you so bothered? Just take the antihyper- results suggest that clinicians must carefully select tensive medication.” patients who could potentially benefit from an attempt to discontinue the antihypertensive medication. Moreo- Comparison in sample characteristics between patients ver, continuous emotional support might be important to who remained in the study and those who did keep patients off-medication. not and their reasons for withdrawal Antihypertensive medications are assumed to be a life- The retention rate of this study was 75%, with four long treatment. However, a prolonged prescription of patients dropping out of the study. There were no sig - cardiovascular medications has been challenged because nificant differences in the baseline sample characteristics, the length of time investigated in clinical trials on cardio- including the baseline systolic and diastolic BP readings vascular drugs is often limited [21]. Yuan et al. [22] found between patients who remained in the research and those that the maximum duration of the randomized controlled who dropped out. However, patients who remained in trials for beta-blockers (e.g., carvedilol) ranged from 360 the study appeared to be younger and less anxious than to 365 days. In reality, patients had been on those medi- those who withdrew from the study (40  years old vs. cations longer than 365  days [22]. u Th s, there is a need 47  years old, 0.42 vs. 0.79), although the relationships for studies on drug withdrawal as well as the long-term did not reach statistical significance. The four patients’ effects of antihypertensive medications. Lee and Lee Clinical Hypertension (2023) 29:1 Page 8 of 10 We found that 50% of the patients remained normoten- were lower than those of previous studies conducted on sive 180 days after drug withdrawal, similar to 38% in the Asian patients with hypertension, including older Korean systematic review by van der Wardt et al. [23]. However, patients [15, 26]. the proportion of patients in the normotensive group in The middle-range theory of self-care for chronic illness our study was higher than the proportion reported in the suggests that various factors affect self-care in patients study by Sasamura et al. [13] in which similar thresholds with chronic disease, including skills, motivation, confi - for normotensive status were used (0% and 18% of the dence, and support from others [27]. Our interview also patients who previously took nifedipine and candesartan, showed consistent findings that social support from fam - respectively). This difference may be due to the inclu - ily and clinicians affected their motivation to engage in sion criteria; most studies, including our study, included self-care activities. In addition, one patient in the nor- patients whose BP had been well-controlled [19], while motensive group discussed skill development in the the study by Sasamura et  al. [13] enrolled the patients interview. She reported using a detailed diary to identify who had not been treated for BP for 1  year and with a the primary source of BP changes in her daily life and family history of hypertension. develop strategies to minimize exposure to that source. Most participants in our study had elevated BP after Although the theory did not probe misperceptions about discontinuing antihypertensive medication, which is con- factors influencing self-care for chronic, one patient sistent with previous studies [11, 13, 24]. BPs in our sam- in the hypertensive group reported that his self-care ple continuously rose over 6  months. However, in other activities were “ideal.” Previous studies have shown that studies [11, 25] where the samples were older (mean patients’ perceptions of their adherence to self-care activ- age, 55–81  years) with a higher baseline BPs (systolic ities often differ from their actual engagement [28–30]. BP, 140.4–148.8  mmHg) compared to that of our study, For example, 18.7% of community-dwelling adults over- patients’ BP was elevated 10 to 12  weeks after antihy- estimated their vegetable consumption [29]. The findings pertensive medication withdrawal but was maintained from our study and others highlight the need for strate- thereafter. gies for patients who discontinue their antihypertensive Researchers have studied whether demographic and medications by improving their skills and motivation, clinical information is associated with normotensive seeking social support, and helping them identify their status and consistently found that monotherapy of anti- actual levels of self-care activities. hypertensive medications and lower baseline BP were Four of the 16 patients enrolled in our study with- predictors of normotensive status [23]. However, we did drew from the study even though their BP levels were not find significant differences in baseline systolic and not considered hypertensive. The most common reason diastolic BP between the normotensive and hypertensive for withdrawal from the study was psychological distress groups (123/79  mmHg vs. 128/87  mmHg, respectively). (e.g., anxiety). Although anxiety levels were not statisti- This may be due to the small sample size in our study to cally different between patients who remained in the detect the differences. research and those who did not, anxiety was somewhat Beyond the demographic and clinical factors poten- lower in patients who remained in the study compared tially associated with hypertensive status, we first tested to those who did not. A similar finding was observed in the psychological aspects and adherence to self-care previous studies [7, 24]; Buranakitjaroen et al. [24] found activities for hypertension to the best of our ability. How- that about 10% of the patients who stopped their antihy- ever, we did not find significant differences in these fac - pertensive medications self-medicated by supplementing tors between the normotensive and hypertensive groups. their antihypertensive medications due to anxiety or feel- Surprisingly, patients’ levels of self-care were not asso- ing unwell. Clinicians need to pay attention to patients’ ciated with BP status. However, improving self-care psychological status when deprescribing antihyperten- activities is critical to maintaining BP when patients with sive medication, which is one of the principles suggested hypertension are not on their antihypertensive medica- by Coe et al. [31]. One patient reported that the family’s tions. One possible reason for this non-significant rela - concern about medication withdrawal was a primary rea- tionship is that the changes patients made in self-care son to withdraw from the study. As social support from activities were not substantial enough to see benefits family members is essential to behavior changes [27], it after discontinuing medications. Patients in both groups can be beneficial to involve family members when dis - were more likely to engage in their self-care activities cussing the possibility of the medication withdrawal. over the 6 months after stopping their medications even There are limitations to be noted in our study. Our though their mean score of self-care activities was not study included a limited number of patients recruited optimal (47.0 at baseline and 51.3 at 6  months, out of from one tertiary medical center, which limits the inter- possible scores of 18–72). The mean scores in our sample nal and external validity of our findings. However, this L ee and Lee Clinical Hypertension (2023) 29:1 Page 9 of 10 Author details study was a pilot study to calculate the effect size and Department of Internal Medicine, Seoul National University Hospital, examine the feasibility of a future large-scale study. The Seoul, Republic of Korea. Research Institute of Nursing Science, Center retention rate of our study was 75%, which is smaller than for Human‑Caring Nurse Leaders for the Future by Brain Korea 21 (BK 21) Four Project, Seoul National University College of Nursing, Seoul, Republic of Korea. that of previous studies [13, 24]. However, we performed linear mixed modeling to use all available data for each Received: 29 June 2022 Accepted: 13 September 2022 patient. The treatment periods for taking antihyperten - sive medication were not collected so that it was not possible to examine the relationship between treatment periods and BP control. References 1. Kim HC, Lee H, Lee HH, Seo E, Kim E, Han J, et al. Korea hypertension fact sheet 2021: analysis of nationwide population‑based data with special Conclusions focus on hypertension in women. Clin Hypertens. 2022;28:1. Our study showed that a small portion of the young and 2. Kim HC, Cho SMJ, Lee H, Lee HH, Baek J, Heo JE, et al. 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Journal

Clinical Hypertension – Springer Journals

Published: Jan 2, 2023

Keywords: Hypertension; Antihypertensive agents; Deprescriptions

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