A double-blind multicenter trial compared
rilmenidine with placebo in the treatment of 126 patients with mild to moderate
hypertension after a 4-week placebo run-in period. Patients with mild
hypertension (study 1) with mean supine diastolic blood pressure (BP) between 95 and 104 mm Hg received either
rilmenidine 1 mg/day (n = 31) or placebo (n = 35) for 4 weeks. In study 2, patients with moderate
hypertension (mean supine diastolic BP between 105 and 115 mm Hg) received either
rilmenidine 1 mg twice a day (
n = 30) or placebo twice a day (
n = 30) for 4 weeks. All 61 patients taking
rilmenidine completed the study; 8 of the 65 patients taking placebo were withdrawn because of an increase in BP.
Rilmenidine significantly reduced mean systolic and diastolic BP compared with placebo in both studies. BP was normalized (systolic less than 160 mm Hg and diastolic less than or equal to 90 mm Hg in 61% of the patients taking
rilmenidine as opposed to 23% of those taking placebo (p less than 0.001). There was no significant difference in the incidence of either dry mouth or daytime drowsiness between
rilmenidine, 1 mg/day, and placebo. Dry mouth was significantly more frequent with
rilmenidine, 2 mg/day, than with placebo, but this difference was transient and no longer significant at the end of the study. No unexpected adverse effects occurred.
Rilmenidine as single
therapy appears to be effective and well accepted in the management of mild to moderate
hypertension, in particular at the 1-mg/day dose, which normalized 84% of mild hypertensive patients and did not induce any significant adverse effects compared with placebo.