Real-life Effectiveness and Safety of Amlodipine/Valsartan Single-pill Combination in Patients with Hypertension in Egypt: Results from the EXCITE Study

Abstract

Background: EXCITE (clinical experience of amlodipine and valsartan in hypertension) evaluated the real-world effectiveness and safety of single-pill combinations (SPCs) of amlodipine/valsartan (Aml/Val) and amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCTZ) in patients with hypertension from the Middle East and Asia. Objective: The objective of this study was to report the results of EXCITE study from Egypt, where all patients were prescribed Aml/Val. Methods: This was a 26-week, observational, multicenter, prospective, non-interventional, open-label study. Effectiveness was assessed as change in the mean sitting systolic/diastolic blood pressure (msSBP/msDBP) from baseline and the proportion of patients achieving the therapeutic blood pressure (BP) goal (<140/90; <130/80 mmHg in patients with diabetes mellitus) and BP response (SBP <140 mmHg or reduction of ≥20 mmHg; DBP <90 mmHg or reduction of ≥10 mmHg). Safety was monitored by recording the incidence of adverse events (AEs) and serious AEs (SAEs). Results: A total of 2566 patients (mean age, 52.6 years; mean duration of hypertension, 7.9 years) were prescribed Aml/Val, of whom 2439 (95.1 %) completed the study. At week 26, Aml/Val SPC significantly (p < 0.0001) reduced msSBP/msDBP by −34.5/−19.4 mmHg from baseline (BP: 164.3/100.5 mmHg). Therapeutic goal, SBP response, and DBP response was achieved by 49.3, 91.1, and 91.4 % of patients, respectively. AEs were reported in 12.5 % of patients, with the most common including peripheral edema (1.8 %), bronchitis (1.1 %), and gastritis (0.8 %), and SAEs in 0.5 % of patients. Two deaths were reported during the study, none of which were considered to be study drug related by the investigators. Conclusion: Aml/Val SPC provided clinically significant BP reductions and was generally well tolerated in patients with hypertension from Egypt.