|Year : 2016 | Volume
| Issue : 1 | Page : 36-40
The association between blood pressure control and well-being in primary care practice: An observational study
Nair Tiny1, Nigel Beckett2
1 Department of Cardiology, PRS Hospital, Trivandrum, Kerala, India
2 Department of Ageing and Health, Guy and St. Thomas NHS Foundation Trust, St. Thomas Hospital, London SE1 7NH, UK
|Date of Web Publication||26-May-2016|
Department of Cardiology, PRS Hospital, Trivandrum, Kerala
Source of Support: None, Conflict of Interest: None
Objective: The objective of this study was to assess the effect of indapamide sustained release (SR) 1.5 mg in the treatment of hypertensive patients, untreated or uncontrolled on monotherapy with different antihypertensive agents, on blood pressure (BP) reduction and well-being. Patients and Methods: In a prospective multicenter study from 32 cities across India, 1545 patients between 40 and 70 years of age with untreated or uncontrolled hypertension (BP >140/90 mmHg) received indapamide SR 1.5 mg once daily as monotherapy, or in addition to the existing treatment for 90 days. The Nottingham general health questionnaire was used to assess the changes in well-being. Results: In 1545 hypertensive patients, with a mean (standard deviation) age of 56.86 years, 64.1% being men. Of those recruited, 29% were treatment naïve and 71% were receiving different antihypertensive medications. In terms of a sense of well-being, a lack of energy was reported in 56.6%, emotional problems in 61.6%, and disturbed sleep in 58.1% of the patients. On an intention to treat basis, 842 patients (54.5%; 95% confidence interval, 52.0–57.0) achieved BP control. The patients who achieved BP control (compared to those who did not) felt more energetic by 6.3% (8.2–4.3, P< 0.0001), emotionally better by 5% (6.3–3.6, P< 0.0001), and had improved sleep by 5.6% (7.4–4.1, P< 0.001). Conclusion: In hypertensive patients, untreated or uncontrolled on monotherapy with any of the major drug classes, the addition of indapamide SR 1.5 mg is effective in reducing BP and in improving their well-being.
Keywords: Diastolic blood pressure, hypertension, indapamide sustained release 1.5 mg, Nottingham health profile questionnaire, systolic blood pressure
|How to cite this article:|
Tiny N, Beckett N. The association between blood pressure control and well-being in primary care practice: An observational study. J Pract Cardiovasc Sci 2016;2:36-40
|How to cite this URL:|
Tiny N, Beckett N. The association between blood pressure control and well-being in primary care practice: An observational study. J Pract Cardiovasc Sci [serial online] 2016 [cited 2021 Sep 24];2:36-40. Available from: https://www.j-pcs.org/text.asp?2016/2/1/36/182984
| Introduction|| |
In urban primary care practice of India, the prevalence of hypertension among adults aged 20 years and over is 20%. Although 70.8% of these patients receive treatment, only 45.9% achieve blood pressure (BP) control. Thus, the majority do not benefit from the potential reduction in cardiovascular risk of 20–35%, associated with BP control. While there are a number of effective drug classes, they all tend to reduce BP to a similar extent. It is therefore recognized that patient's failure to adhere with medication may be an important reason for low BP control rates in the community.
Of the several aspects that influence adherence, the impact of drug treatment on patients' sense of well-being could be important. Data from a hypertension drug trial from India, in the setting of primary care, suggest that in the initial stages of drug treatment, the majority (98%) of patients are free of side effects. Therefore, the preferential use of those drugs that improve a sense of well-being may promote better adherence and BP control.
However, the evidence of an association between the presence of hypertension, the drugs used to treat it, or BP control, with the patient's perception of well-being from observational,, case–control, and randomized trials , is conflicting. Further, there is a lack of such data from the setting of day-to-day practice where the majority of patients with hypertension are treated.
One of the measures that attempts to assess well-being based on the perceived emotional, social, and physical health problems of an individual is The Nottingham health profile questionnaire (NHPQ). It was developed for the use in epidemiological studies of health and disease. The objective of this multicenter prospective, observational study, set in the primary care practice of urban India, is to explore the changes in patients' perception of energy levels, emotional reactions, and sleep using NHPQ, while attempting to improve BP control with additional antihypertensive treatment, and the influence of such changes on control rates.
| Patients and Methods|| |
Selection of study investigators
Of 468 Indian cities with a population of over 1 million in 2007, 32 (7%) patients were randomly selected. Primary care physicians in these cities and the metropolitan cities of Mumbai, Calcutta, Delhi, and Chennai were identified by their membership of the Association of Physicians of India and invited to participate in the study.
Selection of patients
Each investigator selected consecutive outpatients between 40 and 70 years of either sex, with essential hypertension (Stage 1 hypertension was a systolic BP [SBP]/diastolic BP [DBP] ≥140/90, but <160/100 mmHg; Stage 2, equal to or >160/100, but <180/110 mmHg; and Stage 3, or severe, above 180/110 mmHg) that was either untreated, or inadequately controlled by monotherapy with beta-blockers (BBs), calcium channel blockers (CCBs), angiotensin-converting enzyme inhibitors (ACEI), or angiotensin receptor blockers (ARBs). In addition, patients had to be literate and able to complete the NHPQ. Patients with secondary hypertension, any chronic disease other than diabetes, pregnancy, lactation, or a contraindication to the use of indapamide sustained release (SR) 1.5 mg (Natrilix SR) were excluded from the study.
Study design, assessments, and follow-up
After giving their written informed consent, patients were assessed at baseline [Table 1] for demographic, clinical, prior treatment, and biochemical characteristics. Patients' perception of well-being was assessed by the NHPQ in the dimensions of energy level, emotional reaction, and sleep (where yes/no items are scored using weighted values within a range of 0 = no problems, to 100 = all problems).
Patients were prescribed 1 tablet daily of indapamide SR 1.5 mg (NatrilixSR) in the morning, or in addition to antihypertensive treatment they may have been taking, for the next 90 days. Thiazide-like diuretics such as indapamide SR 1.5 mg have been recommended by the International Hypertension guidelines since long. In fact, BHS-NICE guidelines in 2011 recommended that if a diuretic is needed for hypertension, it should be thiazide-like such as indapamide (1.5 mg modified release or 2.5 mg immediate release once daily) or chlorthalidone (12.5 mg–25 mg once daily). Emerging evidence suggests that not all diuretics are equal and indapamide SR may be a better option to hydrochlorothiazide and chlorthalidone., Treatment of associated disease was allowed at the discretion of the local physician. All medications were required to be purchased by the patients from market as they could not be provided within the study. Patients were followed up and reassessed after 30, 60, and 90 days of treatment. At each follow-up visit, BP was measured and patients were asked open-ended questions about side effects since the previous visit. Well-being was reassessed with NHPQ at the end of the study, and patients were asked whether it was easy or not to adhere with the treatment.
The primary outcomes were the mean changes in BP and NHPQ scores from baseline after receiving the study treatment and the number of patients achieving BP control (SBP <140 and DBP <90 mmHg, including those with diabetes) on an intention to treat basis. Other outcomes were frequency of side effects reported by the patient and adherence with the study treatment. Changes in the NHPQ scores between baseline and 90 days treatment were tested for significance by the paired t-test and between those achieving BP control or not, by independent samples t-test. Significance was defined as P < 0.05.
| Results|| |
In all, 135 physicians from 32 cities, distributed throughout India, recruited 1545 patients with uncontrolled essential hypertension. Baseline characteristics are shown in [Table 1]. The average age of patients was 56.86 years, with 64.1% being men. BP was elevated to Stage 1 in 26.6%, Stage 2 in 48.8%, and Stage 3 in 24.7% of the patients. Of those recruited, 29% were treatment naïve. Of those already on monotherapy but not controlled, 9.1% were on BB, 16.8% CCB, 11.9% ACEI, and 11.8% ARB. Two drug combinations were being taken by 19.2% and three drug combinations by 2.0%. Diabetes was present in 28.7%. In terms of a sense of well-being, a lack of energy was reported in 56.6%, emotional problems in 61.6%, and disturbed sleep in 58.1%.
As shown in [Figure 1], baseline mean (95% confidence interval [CI]) SBP of 164.6 (163.8–165.4) decreased to 133.6 (133.0–134.2) mmHg and baseline DBP from 98.2 (97.8–98.6) to 83.6 (83.3–83.9) mmHg after receiving indapamide SR 1.5 mg for 90 days. This BP response was accompanied by a mean improvement in lack of energy by 34.3% (32.2–36.5, t = 31.5, df = 1544, P < 0.001), emotional problems by 17.1% (16.1–18.6, t = 29.9, df = 1544, P < 0.001), and disturbed sleep by 15.4% (14.1–16.8, t = 22.2, df = 1544, P < 0.001).
|Figure 1: Response of mean blood pressure and well-being* to treatment with indapamide sustained release 1.5 mg.|
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On an intention to treat basis, 842 patients (54.5%; 95% CI, 52.0–57.0) achieved BP control (SBP <140 and DBP < 90 mmHg). Mean (95% CI) improvement in well-being was significantly greater among patients achieving BP control compared to those who did not by 6.3% (8.2–4.3, P < 0.0001) in lack of energy, 5.0% (6.3–3.6, P < 0.0001) in emotional problems, and 5.8% (7.4–4.1, P < 0.001) in disturbed sleep [Figure 2].
|Figure 2: Differences* in well-being between patients who achieve blood pressure control and those who do not.|
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Seventeen (1.1%) patients withdrew during treatment with indapamide SR 1.5 mg. Of these, 6 (0.4%) were due to side effects, 3 (0.2%) due to aggravation of associated disease, and 8 (0.5%) for reasons unrelated to treatment. Further 97 (6.3%) patients were lost to follow-up. The side effects reported by at least 5 patients were weakness in 19, ankle edema in 15, headache in 7, and cough in 5. Adherence with daily medication was reported as being easy by 92.6% of patients.
At the end of the study, mean (standard deviation) biochemical parameters in mg/dl decreased by 21.0 (35.9) in total cholesterol, 0.6 (16.0) in high-density lipoprotein cholesterol, 13.4 (24.1) in low-density lipoprotein cholesterol, 24.1 (61.7) in total triglycerides, 11.7 (26.9) in fasting plasma glucose, 1.7 (6.9) in serum sodium, 0.1 (1.5) in serum potassium, and 1.7 (5.7) in serum chloride.
| Discussion|| |
This observational study was carried out in the urban primary care setting of India on hypertensive patients, who were treatment naïve or were uncontrolled hypertension, eligible to receive a diuretic. Most were middle-aged males, with Stage 2 or 3 hypertension, who were either untreated or uncontrolled with monotherapy. More than half felt that their well-being was affected because of a lack of energy, emotional problems, or disturbed sleep.
The initiation of antihypertensive treatment with indapamide SR 1.5 mg, or its addition to existing agents, reduced SBP by about 30 and DBP by 15 mmHg. Despite the majority of patients having Stage 2 or 3 hypertension, this was sufficient to bring the BP under control in over half. Side effects were infrequent, and patients found the medication easy to comply with. In addition, treatment significantly improved the well-being in all three domains of energy, emotion, and sleep. Patients who achieved BP control had a significantly better sense of well-being than those who could not.
All commonly used antihypertensive drug classes reduce BP to a similar extent in heterogeneous populations. Most are suitable for once daily administration and have an acceptable side effect profile. Despite these characteristics which promote adherence, the control rate of hypertension among patients receiving treatment in the community is low. This suggests that other factors may be important in influencing this. The purpose of treating hypertension is to reduce cardiovascular risk; however, at the level of BP at which treatment is recommended, few patients have specific symptoms. In consequence, there may be less inclination to comply with antihypertensive medication. Any perceptible improvement in well-being, related to such treatment, may therefore be important in sustaining motivation to continue treatment.
The relationship between BP lowering and its impact on well-being is unclear. In a cross-sectional study on elderly Europeans, presence of hypertension or its control did not alter well being. However, an adverse impact with a CCB was reported in a randomized study on similar patients. In contrast, among patients of all ages, a recent population survey  and a case–control study  suggested that patients with a diagnosis of hypertension had decreased well-being compared to those without it. Although in this study, it was also observed that receiving treatment or achieving control did not improve well-being, the treatment of mild hypertension study reported that patients randomized to diuretics and cardio selective BB appeared to improve their quality of life. These observations suggest that there may be differences between patient groups and between antihypertensive drugs, in relation to the perception of well-being. However, the cross-sectional design of the observational studies does not permit assessment of change in well-being with treatment over time, and the randomized trial evidence is limited to the elderly or those with mild hypertension. In particular, there are little prospective data from day-to-day practice where most patients with hypertension are managed.
This study overcomes some of these difficulties. The prospective design enabled assessment of well-being at the initiation or intensification of treatment and its relationship with BP and BP control over time in a single patient cohort. Since all patients received the same antihypertensive agent, either as initial or add-on treatment, and each served as its own control (i.e., before and after treatment), the influence of confounding variables was reduced. Well-being was assessed by the NHPQ, a widely used, valid, and reliable measure of health. Specifically, it has been shown to be capable of measuring changes in health following different treatments. Patients were drawn from widely distributed centers across India, and the cohort is representative of a heterogeneous hypertensive population managed in the setting of primary care.
There are however several limitations. There was no comparison with a normotensive cohort in assessing the extent of loss in well-being at diagnosis, or in uncontrolled hypertensive patients. The absence of a control treatment does not permit analysis of whether these results are because of lowering BP, the use of indapamide SR 1.5 mg, both of these, or the simple fact that they had greater interaction with the healthcare system. The 90-day study duration limits these results to the short term. The improvement in the well-being could be due to reduction in BP.
| Conclusions|| |
These results among patients managed in the primary care setting suggest that the majority of patients who are newly diagnosed or with uncontrolled hypertension report a perceived loss of well-being. Antihypertensive treatments with indapamide SR 1.5 mg, either in monotherapy or as an add-on therapy, effectively achieved BP control in most patients. It was associated with significantly improved reported scores of well-being, and this association was stronger in those who achieved BP control. Further studies are required to elucidate whether this effect on well-being is sustained over the longer term, and whether it pertains to other antihypertensive agents as well. Such evidence could help improve adherence by the preferential selection of those antihypertensive agents which are associated with an improved patients' sense of well-being.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]