Efficacy and tolerability of fosinopril 10 mg 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 10 mg (FOS) and hydrochlorothiazide (HCTZ) 12.5 mg 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 10 mg with HCTZ 12.5 mg 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 10 mg/HCTZ 12.5 mg. After 4 weeks of initial therapy, escalation to FOS 20 mg/HCTZ 12.5 mg was allowed for seated diastolic blood pressure (SeDBP) > 90 mm 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 (-12.2 mm Hg) than in the placebo group (-6.4 mm Hg). Similar results were observed for supine diastolic and systolic blood pressure. After 8 weeks of treatment, 58.2% of patients showed normalised (≤ 90 mm Hg) SeDBP with Fos/HCTZ vs 30.3% in the placebo group (p < 0.001). The mean decrease from baseline in SeDBP was -14.3 mm Hg and -18.4 mm Hg at 1 month and 12 months, respectively, demonstrating efficacy of the lower dose combination (10/12.5 mg). The mean seated systolic blood pressure (SeSBP) also decreased from baseline and was -24.5 mm Hg and -28.5 mm 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 20 mg when administered in combination with hydrochlorothiazide 12.5 mg once daily for 12 months was found to be an effective antihypertensive treatment in elderly patients with mild to moderate hypertension.