Blood pressure control with a single-pill combination of indapamide sustained-release and amlodipine in patients with hypertension: the EFFICIENT study
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...
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| Published in: | PloS one Vol. 9; no. 4; p. e92955 |
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| Format: | Journal Article |
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01-04-2014
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| Abstract | 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.
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.
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.
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.
Clinical Trial Registry-India CTRI/2010/091/000114. |
|---|---|
| AbstractList | Trial Registration: Clinical Trial Registry--India CTRI/2010/091/000114 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 [greater than or equal to] 140/90 mm Hg) or were previously untreated with grade 2 or 3 essential hypertension (BP [greater than or equal to] 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 ([DELTA]SBP) versus diastolic BP reduction ([DELTA]DBP) was evaluated ([DELTA]SBP/[DELTA]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. [DELTA]SBP/[DELTA]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 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 OBJECTIVEDespite 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. METHODSPatients 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. RESULTSMean 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. CONCLUSIONIn 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 REGISTRATIONClinical Trial Registry-India CTRI/2010/091/000114. 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. 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. 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. 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. 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. Clinical Trial Registry-India CTRI/2010/091/000114. 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 |
| Audience | Academic |
| Author | Gujral, Vinod K Namjoshi, Deepak J Siraj, Mohammad Safar, Michel Jadhav, Uday Tripathi, Kamlakar K Hiremath, Jagdish Shamanna, Paramesh |
| AuthorAffiliation | 7 Bangalore Diabetes Centre, Medisys Clinisearch India Pvt. Ltd, Bangalore, Karnataka, India 6 Owaisi Hospital & Research Centre, Deccan College of Medical Sciences, Hyderabad, Andhra Pradesh, India 2 Poona Hospital & Research Centre, Pune, Maharashtra, India 3 Criti Care Multi Specialty Hospital & Research Centre, Mumbai, Maharashtra, India 8 Université Paris Descartes, Assistance Publique, Hôpitaux de Paris, Hôtel-Dieu Centre de Diagnostic et de Thérapeutique, Paris, France 5 Institute of Medicine Science, Banaras Hindu University, Varanasi, Uttar Pradesh, India 1 MGM New Bombay Hospital, Navi Mumbai, Maharashtra, India University of Milan, Italy 4 Specialty Clinics A, New Delhi, India |
| AuthorAffiliation_xml | – name: 3 Criti Care Multi Specialty Hospital & Research Centre, Mumbai, Maharashtra, India – name: 5 Institute of Medicine Science, Banaras Hindu University, Varanasi, Uttar Pradesh, India – name: University of Milan, Italy – name: 4 Specialty Clinics A, New Delhi, India – name: 7 Bangalore Diabetes Centre, Medisys Clinisearch India Pvt. Ltd, Bangalore, Karnataka, India – name: 8 Université Paris Descartes, Assistance Publique, Hôpitaux de Paris, Hôtel-Dieu Centre de Diagnostic et de Thérapeutique, Paris, France – name: 1 MGM New Bombay Hospital, Navi Mumbai, Maharashtra, India – name: 2 Poona Hospital & Research Centre, Pune, Maharashtra, India – name: 6 Owaisi Hospital & Research Centre, Deccan College of Medical Sciences, Hyderabad, Andhra Pradesh, India |
| Author_xml | – sequence: 1 givenname: Uday surname: Jadhav fullname: Jadhav, Uday organization: MGM New Bombay Hospital, Navi Mumbai, Maharashtra, India – sequence: 2 givenname: Jagdish surname: Hiremath fullname: Hiremath, Jagdish organization: Poona Hospital & Research Centre, Pune, Maharashtra, India – sequence: 3 givenname: Deepak J surname: Namjoshi fullname: Namjoshi, Deepak J organization: Criti Care Multi Specialty Hospital & Research Centre, Mumbai, Maharashtra, India – sequence: 4 givenname: Vinod K surname: Gujral fullname: Gujral, Vinod K organization: Specialty Clinics A, New Delhi, India – sequence: 5 givenname: Kamlakar K surname: Tripathi fullname: Tripathi, Kamlakar K organization: Institute of Medicine Science, Banaras Hindu University, Varanasi, Uttar Pradesh, India – sequence: 6 givenname: Mohammad surname: Siraj fullname: Siraj, Mohammad organization: Owaisi Hospital & Research Centre, Deccan College of Medical Sciences, Hyderabad, Andhra Pradesh, India – sequence: 7 givenname: Paramesh surname: Shamanna fullname: Shamanna, Paramesh organization: Bangalore Diabetes Centre, Medisys Clinisearch India Pvt. Ltd, Bangalore, Karnataka, India – sequence: 8 givenname: Michel surname: Safar fullname: Safar, Michel organization: Université Paris Descartes, Assistance Publique, Hôpitaux de Paris, Hôtel-Dieu Centre de Diagnostic et de Thérapeutique, Paris, France |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/24714044$$D View this record in MEDLINE/PubMed |
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| Copyright | COPYRIGHT 2014 Public Library of Science 2014 Jadhav et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. 2014 Jadhav et al 2014 Jadhav et al |
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| DOI | 10.1371/journal.pone.0092955 |
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| DocumentTitleAlternate | EFFICIENT: Indapamide SR/Amlodipine in Hypertension |
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| Editor | Norata, Giuseppe Danilo |
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| Notes | ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 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. Conceived and designed the experiments: UJ JH DJN VKG KKT M. Siraj PS M. Safar. Performed the experiments: UJ JH DJN VKG KKT M. Siraj PS. Analyzed the data: UJ JH DJN VKG KKT M. Siraj PS M. Safar. Contributed reagents/materials/analysis tools: UJ JH DJN VKG KKT M. Siraj PS M. Safar. Wrote the paper: UJ JH DJN VKG KKT M. Siraj PS M. Safar. |
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| Snippet | Despite antihypertensive treatment, most hypertensive patients still have high blood pressure (BP), notably high systolic blood pressure (SBP). The EFFICIENT... Objective: Despite antihypertensive treatment, most hypertensive patients still have high blood pressure (BP), notably high systolic blood pressure (SBP). The... Trial Registration: Clinical Trial Registry--India CTRI/2010/091/000114 Objective Despite antihypertensive treatment, most hypertensive patients still have high blood pressure (BP), notably high systolic blood pressure (SBP). The... OBJECTIVEDespite antihypertensive treatment, most hypertensive patients still have high blood pressure (BP), notably high systolic blood pressure (SBP). The... OBJECTIVE:Despite antihypertensive treatment, most hypertensive patients still have high blood pressure (BP), notably high systolic blood pressure (SBP). The... Objective Despite antihypertensive treatment, most hypertensive patients still have high blood pressure (BP), notably high systolic blood pressure (SBP). The... |
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| Title | 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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