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

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.