Ketanserin compared to nifedipine and methyldopa in patients aged above 50 years: two international multicentre studies. For the International Study Group.

The antihypertensive properties and adverse reactions of ketanserin, nifedipine and methyldopa were compared in hypertensive patients aged above 50 years in two international studies. After a placebo run-in period, patients received for 3 months, either ketanserin or nifedipine retard in study 1, and either ketanserin or methyldopa in study 2. After 1 month of monotherapy, a diuretic was added if necessary. Study 1 had 117 subjects, with 119 in study 2. The changes in systolic and diastolic blood pressure were similar for ketanserin and nifedipine although more patients switched to combination therapy in the ketanserin group. The overall response rate was comparable with ketanserin and nifedipine (96% for both drugs). The decrease in diastolic blood pressure was significantly greater in the ketanserin group compared to methyldopa and more patients responded to ketanserin (82%) than to methyldopa (65%). No rebound hypertension was observed on discontinuation of therapy with any of the drugs. The total incidence of adverse reactions in monotherapy was lower with ketanserin than with nifedipine (34 and 47%) and similar for ketanserin and methyldopa (40 and 45%). For ketanserin no consistent adverse reaction pattern was seen.

RCT Entities:   Population Interventions Outcomes