Efficacy and Tolerability of Fosinopril 10mg and Hydrochlorothiazide 12.5mg Combination in Elderly Patients with Mild to Moderate Hypertension : A French Multicentre Study.

The objective of the study was to evaluate the efficacy and tolerability of the combination of fosinopril l0mg (FOS) and hydrochlorothiazide (HCTZ) 12.5mg versus placebo in the treatment of elderly patients with mild to moderate hypertension. The study included two distinct phases: Phase I was a short-term phase consisting of a 4-week single-blind, placebo lead-in period followed by a randomised, double-blind, parallel group where patients were treated with either a combination tablet of FOS 10mg with HCTZ 12.5mg or placebo given once daily for 8 weeks. A total of 150 patients, ranging from 60 to 91 years of age, were included in this study. Phase II was a long-term extension of phase I and was a 12-month open-label follow-up in which all patients started therapy with FOS l0mg/HCTZ 12.5mg. After 4 weeks of initial therapy, escalation to FOS 20mg/HCTZ 12.5mg was allowed for seated diastolic blood pressure (SeDBP) > 90mm Hg. Clinic visits were scheduled at months 1, 3, 6, 9 and 12. Data from 118 patients were analysed. The mean SeDBP decreased from baseline more in the FOS/HCTZ group (-12.2mm Hg) than in the placebo group (-6.4mm Hg). Similar results were observed for supine diastolic and systolic blood pressure. After 8 weeks of treatment, 58.2% of patients showed normalised (≤ 90mm Hg) SeDBP with Fos/HCTZ vs 30.3% in the placebo group (p < 0.001). The mean decrease from baseline in SeDBP was -14.3mm Hg and -18.4mm Hg at 1 month and 12 months, respectively, demonstrating efficacy of the lower dose combination (10/12.5mg). The mean seated systolic blood pressure (SeSBP) also decreased from baseline and was -24.5mm Hg and -28.5mm Hg at months 1 and 12, respectively. The results for supine blood pressure corroborated the findings for seated blood pressure. Four patients died either during (2) or shortly after (2) long-term therapy, 5 patients discontinued long-term therapy because of adverse events, 14 patients experienced 16 serious adverse events. Cough was the most common adverse effect reported in 10.4% of patients. No symptomatic orthostatic hypotension was reported.Fosinopril 10 or 20mg when administered in combination with hydrochlorothiazide 12.5mg once daily for 12 months was found to be an effective antihypertensive treatment in elderly patients with mild to moderate hypertension.