Felodipine extended release versus conventional diuretic therapy for the treatment of systolic hypertension in elderly patients. The National Trial Group

Abstract

Objective: To compare 8 weeks of monotherapy using either felodipine extended release (ER) or a conventional diuretic therapy, triamterene/hydrochlorothiazide (HCTZ), in elderly patients with systolic hypertension.

Design: Prospective, randomized, single-blind screening, double-blind treatment, parallel group comparison.

Setting: Twenty-nine general and family practice sites across Canada.

Participants: Men and post-menopausal women aged 60 to 85 years, with mild to moderate primary systolic hypertension (systolic blood pressure > 160 mm Hg or blood pressure > 140/ > 90 mm Hg).

Interventions: Daily doses of either felodipine ER (2.5 mg) or triamterene/HCTZ (25/12.5 mg) for 8 weeks. After the first 4 weeks, the patients who responded to the initial dosage (a reduction in systolic blood pressure of at least 15 mm Hg) or whose blood pressure was controlled on the dosage (systolic blood pressure < 140 mm Hg) continued to take the low dose. Among the others, the daily doses were doubled for the final 4 weeks.

Outcome measures: Systolic blood pressure before beginning treatment and at the end of the study, as well as adverse events and results of heart rate measurement, clinical chemistry tests, electrocardiograms and physical examinations before and after therapy.

Results: Sufficient data for analysis were obtained from 216 patients (86 men and 130 women). Mean seated blood pressure was reduced significantly in both the felodipine group (from 168/91 to 151/84 mm Hg) and the diuretic group (from 168/92 to 147/84 mm Hg). The difference in mean reductions in systolic blood pressure between the groups was 2.2 mm Hg (with a 95% confidence interval of-1.7 to 6.0 mm Hg), which was not significant. Clinical chemistry measurements taken before treatment and at the end of the study showed that more patients in the diuretic group developed abnormal values for blood urea nitrogen, uric acid and creatinine. Other changes were unremarkable. The incidence of adverse events was similar in both groups, but more patients in the felodipine group (9) than in the diuretic group (3) discontinued treatment owing to an adverse event.

Conclusions: Felodipine ER (2.5 to 5 mg daily) is as effective in reducing systolic blood pressure as triamterene/HCTZ (25/12.5 mg to 50/25 mg daily). More patients discontinued felodipine treatment than triamterene/HCTZ treatment owing to adverse events. However, patients receiving triamterene/HCTZ tended to have abnormal levels in clinical chemistry tests; these should be monitored.