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


CONCLUSIONS
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.


BACKGROUND
Clinical Trial Registry-India CTRI/2010/091/000114.
MGM New Bombay Hospital, Navi Mumbai, Maharashtra, India.
Uday
U
Jadhav
Poona Hospital & Research Centre, Pune, Maharashtra, India.
Jagdish
J
Hiremath
Criti Care Multi Specialty Hospital & Research Centre, Mumbai, Maharashtra, India.
Deepak J
DJ
Namjoshi
Specialty Clinics A, New Delhi, India.
Vinod K
VK
Gujral
Institute of Medicine Science, Banaras Hindu University, Varanasi, Uttar Pradesh, India.
Kamlakar K
KK
Tripathi
Owaisi Hospital & Research Centre, Deccan College of Medical Sciences, Hyderabad, Andhra Pradesh, India.
Mohammad
M
Siraj
Bangalore Diabetes Centre, Medisys Clinisearch India Pvt. Ltd, Bangalore, Karnataka, India.
Paramesh
P
Shamanna
Université Paris Descartes, Assistance Publique, Hôpitaux de Paris, Hôtel-Dieu Centre de Diagnostic et de Thérapeutique, Paris, France.
Michel
M
Safar
D000328:Adult; D017311:Amlodipine / Q000008:administration & dosage / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects*; D003692:Delayed-Action Preparations / Q000737:chemistry; D004338:Drug Combinations; D000075222:Essential Hypertension; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D007190:Indapamide / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged
D000959:Antihypertensive Agents; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D017311:Amlodipine; D007190:Indapamide