Efficacy of a new single-pill combination of a thiazide-like diuretic and a calcium channel blocker (indapamide sustained release/amlodipine) in essential hypertension

Dominiczak, A. F. , de Champvallins, M., Brzozowska-Villatte, R. and Asmar, R. (2019) Efficacy of a new single-pill combination of a thiazide-like diuretic and a calcium channel blocker (indapamide sustained release/amlodipine) in essential hypertension. Journal of Hypertension, 37(11), pp. 2280-2289. (doi: 10.1097/HJH.0000000000002177) (PMID:31246894)

Abstract

Objectives: The current international, 12-week, double-blind, randomized, controlled trial assessed the efficacy and safety of indapamide sustained release/amlodipine single-pill combination (SPC) in mild-to-moderate hypertensive patients. Methods: Following a 4-week run-in period on amlodipine 5 mg, patients (SBP 150–180 mmHg and/or DBP < 110 mmHg) were randomized to indapamide 1.5 mg sustained release/amlodipine 5 mg SPC or amlodipine 5 mg/valsartan 80 mg SPC with conditional uptitration at week 6. Office blood pressure (BP) was assessed at baseline, weeks 6 and 12; ambulatory and home blood pressure monitoring (ABPM/HBPM) at baseline and week 12. Results: Baseline characteristics were similar in both groups (57 years, 51% men, BP 160/92 mmHg). 233 patients were randomized to IndSR/Aml and 232 to amlodipine/valsartan, of whom 48 and 57% were uptitrated, respectively. After 12 weeks, office SBP/DBP decreased similarly with both treatments (−21/−8 vs. −20/−8 mmHg) leading to BP control in 50% and BP response in 70% of patients. Uptitration was effective (P < 0.001) with both regimens, in favour of IndSR/Aml (SBP/DBP −12/−6 vs. −7/−3 mmHg, respectively). ABPM (n = 273) and HBPM (n = 194) confirmed 24-h efficacy of both regimens. In the subgroup of patients with sustained uncontrolled hypertension assessed by ABPM (n = 216), office SBP/DBP decreased by −23/−13 vs. −18/−10 mmHg, respectively (P = 0.016/P = 0.135, post-hoc analysis). Both treatments were generally well tolerated. Conclusion: Both regimens produced effective BP reductions confirmed by ABPM/HBPM. Both treatments were well tolerated, in accordance with the individual agents’ safety profile. Trial registration number: EUDRA CT no. 2012-001690-84.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Dominiczak, Professor Anna
• Authors: Dominiczak, A. F., de Champvallins, M., Brzozowska-Villatte, R., and Asmar, R.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
• Journal Name: Journal of Hypertension
• Publisher: Lippincott, Williams and Wilkins
• ISSN: 0263-6352
• ISSN (Online): 1473-5598
• Copyright Holders: Copyright © 2019 Wolters Kluwer Health, Inc.
• First Published: First published in Journal of Hypertension 37(11):2280-2289
• Publisher Policy: Reproduced in accordance with the copyright policy of the publisher