Elderly hypertensive patients (older than 70 years, with a diastolic blood pressure [BP] between 95 and 114 mm Hg) were entered into a study after a 2-week wash-out period and randomized to 2 parallel groups: rilmenidine (n = 28) and methyldopa (n = 30). The initial dose (rilmenidine, 1 mg once daily A.M. or methyldopa, 250 mg twice daily) was doubled (1 mg twice daily or 500 mg twice daily, respectively) on day 21 if supine diastolic BP remained greater than 90 mm Hg. After a 6-week treatment period (days 0 to 42, with weekly examinations), the effects of treatment withdrawal (day 42) were evaluated twice daily (days 43 to 45), with a final examination on day 49. Most of the 58 patients (70%) (aged 81.5 +/- 0.8 years) with a mean diastolic BP of 100.2 +/- 0.7 mm Hg remained treated with the initial dose in both groups. Efficacy in both groups was identical on day 42: decrease in systolic and diastolic BP of approximately 18 mm Hg, with 85% of patients having BP levels normalized (supine diastolic BP less than or equal to 90 mm Hg). Compared with the reference period, no increase in adverse effects was noted apart from a moderate dryness of mouth in 15% of patients in both groups; no orthostatic hypotension was observed.(ABSTRACT TRUNCATED AT 250 WORDS)