Efficacy and Tolerability of a Single-Pill Combination of Amlodipine/Valsartan in Asian Hypertensive Patients Not Adequately Controlled with Valsartan Monotherapy

Abstract

This randomized, double-blind study evaluated efficacy of a single-pill combination of amlodipine/valsartan (Aml/Val) in Asian patients with hypertension not responding to Val 80 mg. Patients with mean sitting diastolic blood pressure (DBP) ≥90 − ≤110 mmHg were randomized to Aml/Val 5/80, Val 80, or Val 160 mg for 8 weeks. At week-8 endpoint, significantly greater reductions in BP were seen with Aml/Val 5/80 mg than valsartan monotherapies (p < 0.0001). The BP control was greater with Aml/Val 5/80 (70.5%) than Val (44.1–58.6%) monotherapies. The combination was well tolerated. In conclusion, single-pill combination with Aml/Val provided significant additional BP reduction and control in hypertensive patients not responding to Val 80 mg.

Keywords:

• valsartan
• amlodipine
• Asian
• single-pill
• hypertension

ACKNOWLEDGMENTS

This study was supported and funded by Novartis Pharma AG, Basel, Switzerland. The authors would like to thank Thej Kumar Nallagangula and Ashish Agarwal (both of Novartis) for their assistance with drafting the manuscript. We thank the staff of the centers involved in this work, the clinical trial team for their expert collaboration, and the patients who participated in the study.

Declaration of interest: Jun Huang, Ning-Ling Sun, Yu-Ming Hao, and Jun-Ren Zhu report no conflicts of interest. Yingmei Tu, Valentin Curt, and Ying Zhang are employees of Novartis Pharma AG. The authors alone are responsible for the content and writing of the paper.

Author contributions: Dr. Jun-Ren Zhu and Dr. Jun Huang were involved in the study concept/design, data interpretation, and critical revision of the article. Dr. Ning-Ling Sun, Dr. Yu-Ming Hao, Dr. Yingmei Tu, and Ying Zhang were involved in the study design, data interpretation and critical revision of the article. Dr. Valentin Curt contributed to study concept/design, data analysis/interpretation and drafting, and critical revision of the article.