Zofenopril versus lisinopril in the treatment of essential hypertension in elderly patients - A randomised, double-blind, multicentre study

Background: Angiotensin-converting enzyme inhibitors have been proposed as first-choice drugs for antihypertensive therapy in elderly subjects because of their demonstrated efficacy and safety. However, no information is currently available on the use of zofenopril in elderly hypertensive patients. Objective: To assess the efficacy and safety of zofenopril (30 or 60mg once daily) compared with lisinopril (10 or 20mg once daily). Patients and methods: Patients aged >= 65 years with mild to moderate essential hypertension (sitting diastolic blood pressure [DBP] >= 90mm Hg and <= 1 10mm Hg) were included in the study. They were randomised to receive either zofenopril 30mg or lisinopril 10mg. Blood pressure and heart rate were measured at baseline and after 4 and 12 weeks of treatment. Patients underwent electrocardiography and evaluation of laboratory parameters at baseline and after 12 weeks. Ambulatory blood pressure monitoring (ABPM) was also performed at baseline and after 12 weeks. After 4 weeks drug doses were doubled in patients whose sitting DBP was >= 90mm Hg. The primary endpoint was to achieve sitting DBP values < 90mm Hg or a reduction of sitting DBP > 10mm Hg after 12 weeks of treatment. Results: 181 patients were randomised to treatment and 164 patients completed the study. Thirty-three patients were included in the analysis of 24-hour blood pressure monitoring. The percentage of patients with normalised sitting DBP (< 90mm Hg) and the rate of treatment responders (reduction of sitting DBP >= 10mm Hg) were not significantly different between the two treatment groups (normalised: zofenopril 81.3% vs lisinopril 76.7%; responders: zofenopril 74.7% vs lisinopril 77.8%). At the end of the treatment sitting DBP was not significantly different between the two treatment groups (zofenopril 82.2 +/- 6.6mm Hg vs lisinopril 82.0 +/- 7.8mm Hg). Eight percent of patients experienced adverse events in the zofenopril group and 9% in the lisinopril group. A small percentage of adverse events (4%) was related to treatment and reported in the zofenopril group. Conclusions: In elderly hypertensive patients, treatment with zofenopril was effective and well tolerated. Efficacy and safety were comparable with those of lisinopril.