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Single-Pill Combination of Perindopril/Indapamide/Amlodipine in Patients with Uncontrolled Hypertension: A Randomized Controlled Trial

INTRODUCTION: Patients with hypertension often require a combination of three antihypertensive agents to achieve blood pressure control, but very few single-pill triple combinations are available. The aim of this study was to determine whether a single-pill triple combination of perindopril, indapam...

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Autores principales: Nedogoda, Sergey V., Stojanov, Vesna J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5446818/
https://www.ncbi.nlm.nih.gov/pubmed/28181192
http://dx.doi.org/10.1007/s40119-017-0085-7
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author Nedogoda, Sergey V.
Stojanov, Vesna J.
author_facet Nedogoda, Sergey V.
Stojanov, Vesna J.
author_sort Nedogoda, Sergey V.
collection PubMed
description INTRODUCTION: Patients with hypertension often require a combination of three antihypertensive agents to achieve blood pressure control, but very few single-pill triple combinations are available. The aim of this study was to determine whether a single-pill triple combination of perindopril, indapamide, and amlodipine was as effective as a dual-pill combination of perindopril/indapamide plus separate amlodipine at reducing blood pressure in patients with uncontrolled, essential hypertension. METHODS: This international, multicenter, open-label, randomized controlled trial was conducted in men or women aged ≥18 years old with confirmed essential hypertension (SBP ≥140 and <160 mmHg and DBP ≥90 and <100 mmHg), uncontrolled on maximal dose antihypertensive monotherapy or with a single dose of dual therapy. Patients were randomly assigned to: single-pill triple combination of perindopril 5 mg/indapamide 1.25 mg/amlodipine 5 mg (Per/Ind/Aml) or dual-pill combination perindopril 5 mg/indapamide 1.25 mg + amlodipine 5 mg (Per/Ind + Aml) once daily for 12 weeks. The primary endpoint was change in office supine SBP and DBP from baseline to week 12. The proportion of responders defined as those with normalized BP (SBP <140 mmHg and DBP <90 mmHg), and/or decrease of SBP ≥20 mmHg, and/or decrease of DBP ≥10 mmHg at week 12 (W12) compared with baseline was also assessed. Secondary efficacy endpoints included change in office supine SBP and DBP, response, and BP control at weeks 4 and 8. The tolerability of the treatments was also assessed. RESULTS: A total of 148 patients were randomized: 75 to Per/Ind/Aml and 73 to Per/Ind + Aml. Mean supine SBP and DBP were 149.1 ± 4.7 and 94.1 ± 3.1 mmHg, respectively, with no relevant between-group difference. At week 12, both triple-therapy regimens were associated with clinically significant reductions in SBP compared with baseline (−21.5 ± 11.7 and −20.0 ± 12.9 mmHg, respectively). Reductions in office supine DBP were also clinically significant (−15.3 ± 7.8 and −14.8 ± 9.0 mmHg, respectively). The proportion of treatment responders was high in both groups: 89.2 and 87.1%, respectively. The reduction in office supine SBP/DBP was already evident at week 4 and maintained for the duration of the study in both groups. The majority of patients were treatment responders at week 4 (89.2 and 82.9%, respectively) and had achieved BP control (87.8 vs. 78.6%, respectively), which was maintained until week 12 in both treatment groups. Both treatments were well tolerated with no between-group differences. CONCLUSIONS: In adult patients with uncontrolled essential hypertension on treatment, single-pill triple-combination therapy with Per/Ind/Aml is as effective as the same dose dual-pill combination of Per/Ind + Aml. Both treatments were associated with clinically significant BP reductions compared with baseline and were well tolerated. Clinical trials number: http://www.controlled-trials.com ISRCTN: 16442558. Funding: Les Laboratoires Servier. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s40119-017-0085-7) contains supplementary material, which is available to authorized users.
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spelling pubmed-54468182017-06-13 Single-Pill Combination of Perindopril/Indapamide/Amlodipine in Patients with Uncontrolled Hypertension: A Randomized Controlled Trial Nedogoda, Sergey V. Stojanov, Vesna J. Cardiol Ther Original Research INTRODUCTION: Patients with hypertension often require a combination of three antihypertensive agents to achieve blood pressure control, but very few single-pill triple combinations are available. The aim of this study was to determine whether a single-pill triple combination of perindopril, indapamide, and amlodipine was as effective as a dual-pill combination of perindopril/indapamide plus separate amlodipine at reducing blood pressure in patients with uncontrolled, essential hypertension. METHODS: This international, multicenter, open-label, randomized controlled trial was conducted in men or women aged ≥18 years old with confirmed essential hypertension (SBP ≥140 and <160 mmHg and DBP ≥90 and <100 mmHg), uncontrolled on maximal dose antihypertensive monotherapy or with a single dose of dual therapy. Patients were randomly assigned to: single-pill triple combination of perindopril 5 mg/indapamide 1.25 mg/amlodipine 5 mg (Per/Ind/Aml) or dual-pill combination perindopril 5 mg/indapamide 1.25 mg + amlodipine 5 mg (Per/Ind + Aml) once daily for 12 weeks. The primary endpoint was change in office supine SBP and DBP from baseline to week 12. The proportion of responders defined as those with normalized BP (SBP <140 mmHg and DBP <90 mmHg), and/or decrease of SBP ≥20 mmHg, and/or decrease of DBP ≥10 mmHg at week 12 (W12) compared with baseline was also assessed. Secondary efficacy endpoints included change in office supine SBP and DBP, response, and BP control at weeks 4 and 8. The tolerability of the treatments was also assessed. RESULTS: A total of 148 patients were randomized: 75 to Per/Ind/Aml and 73 to Per/Ind + Aml. Mean supine SBP and DBP were 149.1 ± 4.7 and 94.1 ± 3.1 mmHg, respectively, with no relevant between-group difference. At week 12, both triple-therapy regimens were associated with clinically significant reductions in SBP compared with baseline (−21.5 ± 11.7 and −20.0 ± 12.9 mmHg, respectively). Reductions in office supine DBP were also clinically significant (−15.3 ± 7.8 and −14.8 ± 9.0 mmHg, respectively). The proportion of treatment responders was high in both groups: 89.2 and 87.1%, respectively. The reduction in office supine SBP/DBP was already evident at week 4 and maintained for the duration of the study in both groups. The majority of patients were treatment responders at week 4 (89.2 and 82.9%, respectively) and had achieved BP control (87.8 vs. 78.6%, respectively), which was maintained until week 12 in both treatment groups. Both treatments were well tolerated with no between-group differences. CONCLUSIONS: In adult patients with uncontrolled essential hypertension on treatment, single-pill triple-combination therapy with Per/Ind/Aml is as effective as the same dose dual-pill combination of Per/Ind + Aml. Both treatments were associated with clinically significant BP reductions compared with baseline and were well tolerated. Clinical trials number: http://www.controlled-trials.com ISRCTN: 16442558. Funding: Les Laboratoires Servier. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s40119-017-0085-7) contains supplementary material, which is available to authorized users. Springer Healthcare 2017-02-08 2017-06 /pmc/articles/PMC5446818/ /pubmed/28181192 http://dx.doi.org/10.1007/s40119-017-0085-7 Text en © The Author(s) 2017 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Research
Nedogoda, Sergey V.
Stojanov, Vesna J.
Single-Pill Combination of Perindopril/Indapamide/Amlodipine in Patients with Uncontrolled Hypertension: A Randomized Controlled Trial
title Single-Pill Combination of Perindopril/Indapamide/Amlodipine in Patients with Uncontrolled Hypertension: A Randomized Controlled Trial
title_full Single-Pill Combination of Perindopril/Indapamide/Amlodipine in Patients with Uncontrolled Hypertension: A Randomized Controlled Trial
title_fullStr Single-Pill Combination of Perindopril/Indapamide/Amlodipine in Patients with Uncontrolled Hypertension: A Randomized Controlled Trial
title_full_unstemmed Single-Pill Combination of Perindopril/Indapamide/Amlodipine in Patients with Uncontrolled Hypertension: A Randomized Controlled Trial
title_short Single-Pill Combination of Perindopril/Indapamide/Amlodipine in Patients with Uncontrolled Hypertension: A Randomized Controlled Trial
title_sort single-pill combination of perindopril/indapamide/amlodipine in patients with uncontrolled hypertension: a randomized controlled trial
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5446818/
https://www.ncbi.nlm.nih.gov/pubmed/28181192
http://dx.doi.org/10.1007/s40119-017-0085-7
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