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Abstract
Objective:
This study was designed to explore antihypertensive efficacy and safety of a combination of amlodipine (CCB) and valsartan (ARB), in essential hypertensive patients not adequately controlled by amlodipine monotherapy.
Methods:
This was a multi-centre, randomised, double-blind, active-controlled study in patients with essential hypertension. After a washout period followed by a single-blind amlodipine 10 mg run-in period, patients with mean sitting diastolic blood pressure (msDBP) ≥90 mmHg and <110 mmHg were randomised to receive amlodipine/valsartan (10/160 mg o.d.) or amlodipine (10 mg o.d.) for 8 weeks.
Trial registration number:
NCT00171002.
Main outcome measures:
The primary efficacy variable was change from baseline in msDBP at study endpoint. Secondary efficacy variables were change from baseline in mean sitting systolic blood pressure (msSBP), responder rate (msDBP <90 mmHg or ≥10 mmHg reduction from baseline) and DBP control rate (msDBP <90 mmHg).
Results:
Of the 1283 patients enrolled in single-blind period, 944 were randomised to receive amlodipine/valsartan 10/160 mg (n = 473) and amlodipine 10 mg (n = 471). Statistically significant greater reductions (p < 0.0001) from baseline in msSBP/msDBP were observed with combination therapy (12.9/11.4 mmHg) compared to monotherapy (10.0/9.3 mmHg). Responder rate was significantly greater (p = 0.0011) with combination therapy (79.0%) compared to monotherapy (70.1%). The percentage of patients with controlled DBP was also significantly (p < 0.0001) higher with combination therapy (77.8%) compared to monotherapy (66.5%). Incidence of peripheral oedema was slightly higher with amlodipine monotherapy (9.4%) compared to combination therapy (7.6%).
Conclusion:
The combination of amlodipine/valsartan in this 8-week double-blind study provided additional BP control and was well tolerated in patients inadequately controlled with amlodipine monotherapy. Results should be interpreted with the knowledge that study entry criteria may limit application to a wider population.
Transparency
Declaration of funding
This study and the publication support charges for this article were funded by Novartis Pharma AG, Basel.
Declaration of financial/other relationships
R.D.G., M.W. and J.Y. are employees of Novartis Pharmaceuticals Corporation (East Hanover, USA) and own stocks in the company. H.S. has disclosed that he has been the recipient of lecture fees and consulting fees from MSD, Novartis, and sanofi-aventis and that he has been the recipient of lecture fees from AstraZeneca and Pfizer. M.M.V. has disclosed that he has been the recipient of grants from Novartis, AstraZeneca, sanofi-aventis, Daiichi Sankyo, Servier and Boeringer Ingelheim and speaker honoraria and consulting fees from Novartis, Pfizer, sanofi-aventis, AstraZeneca, MSD, Abbott, Servier, Boehringer and Menarini. C.E.M. and J.R. have no relevant financial interests to disclose with respect to the content of this article.
CMRO peer reviewers may receive honoraria from CMRO for their review work. Peer Reviewer 1 has disclosed that he/she has been the recipient of sponsorship and/or research grants from Bayer and Pfizer; that he/she is a consultant/advisor to AstraZeneca, Bayer and Pfizer, and that he/she is on the speakers bureau for AstraZeneca, Bayer and Pfizer. Peer Reviewer 2 has disclosed that he/she is a consultant/advisor to and is on the speakers bureau for Novartis.
Acknowledgements
The authors thank the medical writers Rukkumani Rajagopalan and Vikrant Pallapotu (MSCD India, Novartis) for their assistance with drafting the manuscript and incorporating subsequent revisions. The authors also thank the staff of the centres involved in this work, the clinical trial team for their expert collaboration and the patients who participated in the study.