The efficacy and tolerability of long-term felodipine treatment in hypertension. The Scandinavian Multicenter Group.

The antihypertensive effect of felodipine and hydrochlorothiazide, both given in addition to beta-blockers, were compared in this double-blind multicenter study in 103 patients. To all patients concluding the study (n = 92), felodipine was given openly, and the antihypertensive effect and tolerability was studied for 1 year. Patients with a diastolic blood pressure greater than or equal to 100 mmHg, despite beta-blocker treatment, were randomized to treatment with felodipine 5 mg twice daily (n = 51) or hydrochlorothiazide 25 mg (n = 52) once daily for 4 weeks. The dose was then doubled in all patients for a second 4-week period. During open follow-up, all patients were given felodipine 5-15 mg (starting dose 5 mg) twice daily in addition to the beta-blocker. Hydrochlorothiazide could also be added. Reductions in systolic and diastolic blood pressure were significantly greater with felodipine than with hydrochlorothiazide at both the low and high dose levels. There were significantly more responders (diastolic blood pressure less than or equal to 90 mmHg or fall of greater than or equal to 10 mmHg) in the felodipine group. Felodipine and hydrochlorothiazide were both well tolerated. Hydrochlorothiazide treatment was accompanied by a decrease in serum potassium and an increase in serum uric acid. One year of treatment felodipine therapy resulted in a blood pressure fall from baseline of 34/23 mmHg. The most commonly reported adverse event was ankle edema. No clinically important changes in blood tests were seen during felodipine treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes