EVALUATION OF THE EFFICACY AND TOLERABILITY OF A FIXED DOSE COMBINATION OF AMLODIPINE AND INDAPAMIDE IN PATIENTS OLDER THAN 55 YEARS

Abstract

Objective: There is very limited real-life data on hypertension management in Bangladeshi population. Considering this fact, this study evaluated the effectiveness of treatment with an indapamide/amlodipine single-pill combination (SPC) in Bangladeshi patients over the age of 55 years, in an OPD setting with uncontrolled systolic hypertension in real-life clinical practice. Methods: This was a 3-month, multicenter, observational, open-label study conducted in 3 divisional cities of Bangladesh among patients with grade I or II hypertension who were either uncontrolled on previous antihypertensive treatment or treatment-naïve. The effectiveness of indapamide/amlodipine SPC was assessed by the change in office systolic blood pressure (SBP) and the rate of target SBP (< 140 mmHg) achievement at 2 weeks, 1 month and 3 months, in four age groups: 55-59 years, 60-69 years, 70-79 years, and 80 years or older. Design and method: The COMBINE study recruited 213 patients, of whom 185 took indapamide/amlodipine 1.5/5 mg SPC fora full three-month course of therapy. Mean age was 62.4±7.4 years, 76 men [41.1%] and 109 women [58.9%]. The absolute decrease of SBP during 3 months of taking indapamide/amlodipine single-pill combination (SPC) was 29.3 mm Hg, DBP - 12.9 mm Hg. After 3 months of treatment significant SBP decreases from baseline were observed in each age group: ? 31.8 mmHg (from 156.7 to 124.9), ? 26.4 mmHg (from 152.7 to 126.3), ? 29.5 mmHg (from 152.8 to 123.3), and ? 25.8 mmHg (from 151.7 to 125.9) in the 55-59, 60-69, 70-79, and 80 years and older age groups, respectively. Leg edema was observed in 3 patients (1.62%), electrolyte imbalance was observed in 4 patients (2.16%) and 1 patients observed sudden fall of blood pressure. Conclusion: This COMBINE study results showed that indapamide/amlodipine SPC was associated with significant and rapid reductions in BP even in a different age range of Bangladeshi patients in routine clinical practice. This study result is consistent with already achieved data of this SPC globally.