Two double-blind multicenter trials were performed to compare the antihy pertensive action of ketanserin, at an oral dosage of 20 mg three times daily, with that of placebo over a period of four to six weeks. A subset of patients was treated in a crossover fashion for either four weeks (36 patients) or six weeks (24 patients).
The patients had essential hypertension, with a diastolic blood pressure ≥ 95 mmHg measured in sitting position at the end of a placebo run-in period of at least one week.
In a first trial, 78 of 82 patients completed the four-week study period, where the mean drop of the systolic/diastolic blood pressure was -14/-12 mmHg in the ketanserin group (n = 32) versus — 8/ — 5 mmHg in the placebo group (n=46). This difference is statistically significant (p = 0.05/p < 0.01). In 13 patients who after the initial ketanserin treatment were further treated with placebo in crossover for four weeks, the blood pressure rose slightly (+1/+3 mmHg). In the alternative group (n =23), the blood pressure fell by -10/-7 mmHg after placebo and decreased further by -10/-8 mmHg after ketanserin.
In a second trial, 24 patients completed a two by six week crossover treat ment. In 12 patients assigned to the sequence placebo-ketanserin, there was a drop of the systolic/diastolic blood pressure by — 7/ — 4 mmHg after placebo and an additional drop by — 26/ —10 mmHg after ketanserin. In the other 12 pa tients, who received the sequence ketanserin-placebo, the blood pressure de creased by -21/-15 mmHg during ketanserin and rose again by + 11/+8 mmHg during placebo. In both treatment groups, the antihypertensive action of ketanserin was significantly superior to that of placebo.
The heart rate was not significantly influenced by ketanserin in any of these groups. Orthostatic hypotension was not observed in any of these patients.
It is concluded that ketanserin is a well-tolerated antihypertensive agent, whose blood pressure-lowering effect is significantly superior to that of placebo.
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