A multicenter double-blind comparative study of rilmenidine and clonidine in 333 hypertensive patients.

The efficacy and acceptability of rilmenidine were studied in a double-blind clonidine-controlled multicenter trial; after a 4-week placebo run-in period, patients with supine diastolic blood pressure (BP) between 95 and 115 mm Hg received as monotherapy either rilmenidine or clonidine over 6 weeks. The initial dose (rilmenidine 1 mg/day or clonidine 0.15 mg/day) was doubled (1 mg or 0.15 mg twice a day, respectively) after 2 weeks if diastolic BP remained greater than or equal to 90 mm Hg. Three hundred and thirty-three patients (mean age 57.8 +/- 0.7 years) with a systolic BP of 170.53 +/- 0.92 mm Hg and a diastolic BP of 101.57 +/- 0.30 mm Hg were randomly divided into 2 homogenous groups (rilmenidine, n = 162 and clonidine, n = 171). All patients taking rilmenidine completed the trial. Seventeen patients taking clonidine (10%, p less than 0.01 vs rilmenidine) were withdrawn because of severe side effects. Systolic and diastolic BP were significantly reduced in both groups at every examination (at 2, 4 and 6 weeks). The mean decreases in supine and erect BP were identical in both groups: systolic BP 19 mm Hg and diastolic BP 12 mm Hg after 6 weeks. BP was normalized (systolic BP less than 160 and diastolic BP less than or equal to 90 mm Hg) in 57% of patients taking rilmenidine and 56% of patients taking clonidine (60% of normalized patients had been taking the single dose in both groups).(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes