Blood Pressure Control with a Single-Pill Combination of Indapamide Sustained-Release and Amlodipine in Patients with Hypertension: The EFFICIENT Study

被引:20
|
作者
Jadhav, Uday [1 ]
Hiremath, Jagdish [2 ]
Namjoshi, Deepak J. [3 ]
Gujral, Vinod K. [4 ]
Tripathi, Kamlakar K. [5 ]
Siraj, Mohammad [6 ]
Shamanna, Paramesh [7 ]
Safar, Michel [8 ]
机构
[1] MGM New Bombay Hosp, Navi Mumbai, Maharashtra, India
[2] Poona Hosp & Res Ctr, Pune, Maharashtra, India
[3] Criti Care Multi Specialty Hosp & Res Ctr, Mumbai, Maharashtra, India
[4] Specialty Clin A, New Delhi, India
[5] Banaras Hindu Univ, Inst Med Sci, Varanasi 221005, Uttar Pradesh, India
[6] Owaisi Hosp & Res Ctr, Deccan Coll Med Sci, Hyderabad, Andhra Pradesh, India
[7] Medisys Clinisearch India Pvt Ltd, Bangalore Diabet Ctr, Bangalore, Karnataka, India
[8] Univ Paris 05, AP HP, Paris, France
来源
PLOS ONE | 2014年 / 9卷 / 04期
关键词
ANTIHYPERTENSIVE AGENTS; CARDIOVASCULAR EVENTS; CALCIUM; THERAPY; VALSARTAN/HYDROCHLOROTHIAZIDE; METAANALYSIS; MONOTHERAPY; PREVENTION; MANAGEMENT; REDUCTION;
D O I
10.1371/journal.pone.0092955
中图分类号
O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];
学科分类号
07 ; 0710 ; 09 ;
摘要
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 (triangle SBP) versus diastolic BP reduction (triangle DBP) was evaluated (triangle SBP/triangle 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. triangle SBP/triangle 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
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页数:6
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