EFFICACY AND TOLERABILITY OF FOSINOPRIL 10MG AND HYDROCHLOROTHIAZIDE 12.5MG COMBINATION IN ELDERLY PATIENTS WITH MILD-TO-MODERATE HYPERTENSION - A FRENCH MULTICENTER STUDY

The objective of the study was to evaluate the efficacy and tolerabili ty of the combination of fosinopril 10mg (FOS) and hydrochlorothiazide (HCTZ) 12.5mg versus placebo in the treatment of elderly patients wit h mild to moderate hypertension. The study included two distinct phase s: Phase I was a short-term phase consisting of a 4-week single-blind, placebo lead-in period followed by a randomised, double-blind, parall el 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 incl uded 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 ther apy with FOS 10mg/HCTZ 12.5mg. After 4 weeks of initial therapy, escal ation to FOS 20mg/HCTZ 12.5mg was allowed for seated diastolic blood p ressure (SeDBP) > 90mm HE. Clinic visits were scheduled at months 1, 3 , 6, 9 and 12. Data from 118 patients were analysed. The mean SeDBP de creased from baseline more in the FOS/HCTZ group (-12.2mm Hg) than in the placebo group (-6.4mm Hg). Similar results were observed for supin e diastolic and systolic blood pressure. After 8 weeks of treatment, 5 8.2% of patients showed normalised (less than or equal to 90mmm Hg) Se DBP 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 mon th and 12 months, respectively, demonstrating efficacy of the lower do se combination (10/12.5mg). The mean seated systolic blood pressure (S eSBP) also decreased from baseline and was -24.5mm Hg and -28.5mm Hy a t months and 1 and 12, respectively. The results for supine blood pres sure corroborated the findings fur seated blood pressure. Four patient s died either during (2) or shortly after (2) long-term therapy, 5 pat ients discontinued long-term therapy because of adverse events, 14 pat ients experienced 16 serious adverse events. Cough was the most common adverse effect reported in 10.4% of patients. No symptomatic orthosta tic hypotension was reported. Fosinopril 10 or 20mg when administered in combination with hydrochlorothiazide 12.5mg once daily for 12 month s was found to be an effective antihypertensive treatment in elderly p atients with mild to moderate hypertension.