Real-world effectiveness and safety of single-pill combination of amlodipine/valsartan or amlodipine/valsartan/hydrochlorothiazide in patients with hypertension from the Philippines

Jorge A. Sison, De La Salle Medical and Health Sciences Institute
Shari G. Francisco, Novartis Healthcare Philippines, Inc

Abstract

© 2014 Philippine College of Physicians. All rights reserved. Objective: The EXforge Clinical evaluation of amlodIpine and valsarTan in hypertEnsion (EXCITE) study was designed to evaluate the real-world effectiveness and safety of amlodipine/valsartan (Aml/Val) and amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCTZ) single-pill combination (SPC) in patients with hypertension.Methods: This 26-week observational, multicenter, prospective, open-label study included patients a g e d ≥18 years of age with established diagnosis of hypertension. The change in mean sitting systolic BP (msSBP), diastolic BP (msDBP) from baseline to Week 26, proportion of patients achieving BP goal (msSBP/msDBP <130/80 mmHg and <140/90 mmHg for patients with and without diabetes, respectively) at endpoint, and safety were monitored. Here, we report the data of patients from the Philippines.Results: Of the total 1,054 patients in the full analysis set (Aml/Val, n= 928; Aml/Val/HCTZ, n = 126), 923 (87.6%) patients completed the study. The baseline BP was 158.5/96.5 and 167.0/99.5 mmHg in the Aml/Val and Aml/Val/HCTZ groups, respectively. Significant reductions in msSBP and msDBP from baseline to week 26 were observed with both Aml/Val (-31.9/-16.8 mmHg) and Aml?Val/HCTZ (-36.1/-19.2 mmHg). Adverse events were reported by 8.8% of the patients.Conclusion: The Aml/Val and Aml/Val/HCTZ SPCs were effective in controlling BP and were generally well tolerated in patients with hypertension from the Philippines.