Postmarketing surveillance study of benazepril in chinese patients with hypertension: An open-label, experimental, epidemiologic study.

BACKGROUND

Benazepril hydrochloride is an angiotensin-converting enzyme inhibitor. Previous clinical trials show that antihypertensive treatment with benazepril provides effective blood pressure (BP) control and is generally well tolerated by patients with hypertension. However, the long-term antihypertensive effects and tolerability of benazepril remain to be established in Chinese patients with hypertension.

OBJECTIVE

The aim of this study was to investigate the long-term efficacy and tolerability of benazepril in Chinese patients with essential hypertension.

METHODS

This 36-month, community-based, open-label, postmarketing surveillance study was conducted in the Nanshi District (Shanghai, China). Chinese patients with essential hypertension were to receive 1 or more benazepril tablets PO QD in the morning for 36 months. Data for BP and pulse pressure (PP) were collected at baseline (month 0) and throughout the surveillance period. The rate of patients achieving BP targets (systolic BP [SBP]/diastolic BP [DBP], <140/<90 mm Hg) was determined, as was the rate of decrease in BP. Subanalyses by sex and age group also were conducted.

RESULTS

A total of 1831 patients (1090 men, 741 women; mean [SD] age, 55.8 [10.1] years [range, 35-88 years]) entered the study. After the 36-month treatment period, 75.7% of patients receiving benazepril as prescribed (1289 patients) had achieved the SBP target, 87.4% achieved the DBP target, and 71.5% achieved both targets. After 36 months of treatment, the mean (SD) decreases in SBP, DBP, and PP were 15.1 (0.4) mm Hg, 11.0 (0.3) mm Hg, and 4.2 (0.4) mm Hg, respectively, among compliers. In general, the rate of BP decrease slowed over time. No serious adverse drug reactions (ADRs) were detected during the 36-month follow-up period. All ADRs except cough (19.9%) occurred at a relatively low incidence rate (<3.0%). The cumulative incidence of benazepril related cough was statistically significantly higher in women than in men (23.6% vs 18.8%, respectively; P = 0.007). Of the 1831 patients studied, 1360 patients (74.3%) persisted in taking benazepril and were considered optimally compliant at 36-month follow-up.

CONCLUSION

In this study of Chinese patients with hypertension, benazepril was associated with prolonged, stable efficacy in lowering BP and relatively low incidence of ADRs.