Antihypertensive effect of felodipine combined with beta-blockade. A comparison between 2 and 3 daily dosages.

24 hypertensive patients, who were not satisfactorily controlled (diastolic blood pressure greater than 95 mm Hg) with beta-blockers alone were randomised to 2 treatment groups where felodipine was administered for 2 weeks in a total daily dose of 15 mg divided in 2 or 3 doses. Following a 2-week placebo washout period, the patients were switched to the alternative dose regimen in a double-blind crossover manner. Blood pressure was measured with standard techniques and was also non-invasively monitored for 24 hours at the end of each dose regimen period and at the end of the intermediate placebo period. Mean arterial blood pressure at the end of the placebo run-in period was 169/105 mm Hg. Felodipine 5 mg thrice daily reduced blood pressure by 20/9 mm Hg and felodipine 7.5 mg twice daily by 17/9 mm Hg (p less than 0.05). The difference between the 2 dose regimens was not statistically significant. When 24-hour blood pressure measurements for the 2 dose regimens were compared, there were no statistically significant differences. Both regimens reduced the 24-hour blood pressure significantly compared with placebo. Two patients were withdrawn during the study, 1 before felodipine treatment started and the other due to diarrhoea and flushing related to felodipine. Otherwise felodipine was generally well tolerated.

RCT Entities:   Population Interventions Outcomes