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Clinical Trial
. 2014 Apr 8;9(4):e92955.
doi: 10.1371/journal.pone.0092955. eCollection 2014.

Blood pressure control with a single-pill combination of indapamide sustained-release and amlodipine in patients with hypertension: the EFFICIENT study

Uday Jadhav  1 , Jagdish Hiremath  2 , Deepak J Namjoshi  3 , Vinod K Gujral  4 , Kamlakar K Tripathi  5 , Mohammad Siraj  6 , Paramesh Shamanna  7 , Michel Safar  8
Affiliations
Clinical Trial

Blood pressure control with a single-pill combination of indapamide sustained-release and amlodipine in patients with hypertension: the EFFICIENT study

Uday Jadhav et al. PLoS One. .

Erratum in

  • PLoS One. 2014;9(5):e98699

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 (ΔSBP) versus diastolic BP reduction (ΔDBP) was evaluated (ΔSBP/ΔDBP) 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. ΔSBP/ΔDBP 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.

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Conflict of interest statement

Competing Interests: The authors have read the journal's policy and have the following conflicts of interest: the authors received honoraria, research grants, or both, from Servier or Serdia Pharmaceuticals (India) Pvt. Ltd. This study was funded by Serdia Pharmaceuticals (India) Pvt. Ltd. Co-author Paramesh Shamanna is employed by Bangalore Diabetes Centre, Medisys Clinisearch India Pvt. Ltd. There are no patents, products in development or marketed products to declare. This does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials.

Figures

Figure 1
Figure 1. Study flowchart.
Figure 2
Figure 2. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) response to single-pill indapamide sustained-release/amlodipine in all hypertensive patients (panel A), patients with grade 2 hypertension (panel B), and patients with grade 3 hypertension (panel C) over 45 days.
ΔSBP and ΔDBP values are at 45 days.
Figure 3
Figure 3. Blood pressure control* with single-pill indapamide sustained-release/amlodipine in hypertensive patients previously uncontrolled on CCB monotherapy and previously untreated hypertensive patients.
*systolic blood pressure <140 mm Hg, diastolic blood pressure <90 mm Hg, or both. CCB, calcium channel blocker.
See this image and copyright information in PMC

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