Blood pressure control with a single-pill combination of indapamide sustained-release and amlodipine in patients with hypertension: the EFFICIENT study.
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ABSTRACT: OBJECTIVE:Despite antihypertensive treatment, most hypertensive patients still have high blood pressure (BP), notably high systolic blood pressure (SBP). The EFFICIENT study examines the efficacy and acceptability of a single-pill combination of sustained-release (SR) indapamide, a thiazide-like diuretic, and amlodipine, a calcium channel blocker (CCB), in the management of hypertension. METHODS:Patients who were previously uncontrolled on CCB monotherapy (BP?140/90 mm Hg) or were previously untreated with grade 2 or 3 essential hypertension (BP?160/100 mm Hg) received a single-pill combination tablet containing indapamide SR 1.5 mg and amlodipine 5 mg daily for 45 days, in this multicenter prospective phase 4 study. The primary outcome was mean change in BP from baseline; percentage of patients achieving BP control (BP<140/90 mm Hg) was a secondary endpoint. SBP reduction (?SBP) versus diastolic BP reduction (?DBP) was evaluated (?SBP/?DBP) from baseline to day 45. Safety and tolerability were also assessed. RESULTS:Mean baseline BP of 196 patients (mean age 52.3 years) was 160.2/97.9 mm Hg. After 45 days, mean SBP decreased by 28.5 mm Hg (95% CI, 26.4 to 30.6), while diastolic BP decreased by 15.6 mm Hg (95% CI, 14.5 to 16.7). BP control (<140/90 mm Hg) was achieved in 85% patients. ?SBP/?DBP was 1.82 in the overall population. Few patients (n?=?3 [2%]) reported side effects, and most (n?=?194 [99%]) adhered to treatment. CONCLUSION:In patients who were previously uncontrolled on CCB monotherapy or untreated with grade 2 or 3 hypertension, single-pill combination indapamide SR/amlodipine reduced BP effectively--especially SBP--over 45 days, and was safe and well tolerated. TRIAL REGISTRATION:Clinical Trial Registry-India CTRI/2010/091/000114.
SUBMITTER: Jadhav U
PROVIDER: S-EPMC3979648 | biostudies-literature | 2014
REPOSITORIES: biostudies-literature
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