Effect of low-dose manidipine on ambulatory blood pressure in very elderly hypertensives.

To evaluate the effect of manidipine 10 mg on 24-hour ambulatory blood pressure (BP) and heart rate (HR) in very elderly hypertensive patients, 54 patients aged 76-89 years (mean age 81.8 years) with systolic blood pressure (SBP) > 160 mmHg and diastolic blood pressure (DBP) >; 90 mmHg were studied. After a 4-week placebo washout period, patients were randomized to receive manidipine 10 mg or placebo, both administered once daily for 8 weeks. Patients were checked after the initial run-in placebo phase and every 4 weeks thereafter. At each visit casual BP and HR were measured. At the end of the placebo period and after 8 weeks of active treatment, noninvasive 24-hour ambulatory blood pressure measurement (ABPM) was performed. Manidipine significantly lowered casual sitting and standing SBP (P < 0.001) and DBP (P < 0.001) at the trough level. ABPM showed a significant decrease in 24-hour SBP and DBP values (P < 0.001), daytime SBP and DBP (P < 0.001), and night-time SBP (P < 0.001) and DBP (P < 0.005). In addition, ABPM confirmed a consistent antihypertensive activity throughout the 24-hour dosing interval, without effect on the circadian BP profile. The trough/peak ratio was 0.67 for SBP and 0.59 DBP. No statistically significant change in HR was observed. The treatment was well tolerated, and there were no serious side effects. In conclusion, in very elderly hypertensive patients, once-daily administration of manidipine 10 mg was well tolerated and effective in reducing casual as well ambulatory BP.

RCT Entities:   Population Interventions Outcomes