[Antihypertensive effect of a new form of nifedipine compared to a beta-blocker during chronic administration]

The aim of this study was to test the efficacy of a 20 mg tablet preparation of nifedipine alone in twice daily dosage, in the treatment of moderate hypertension (95 greater than or equal to DBP less than or equal to 115 mmHg). Efficacy was defined as the ability to maintain treatment for 6 months with a fall in DBP of a least 5 mmHg after the first month, and with a DBP 100 mmHg from the second month. One hundred and seventy seven patients were recruited from november 1981 to december 1982, 55% during the first three months of the trial. There were 95 men (54%) and 82 women, with a mean age of 55.6 +/- 10 years. The DBP ranged from 96 to 111 mmHg in 80% of cases. The patients were randomly allocated in lots of 6, to three groups: placebo (58 patients), nifedipine (57 patients) and acebutolol (61 patients). The comparability of 21 parameters amongst these 3 groups was verified. After 1 month of placebo, 25 patients did not meet the criteria of inclusion and were excluded from the study. During this phase, 19 patients (10.5%) complained of at least one side effect. Of the 152 patients who received active treatment, 34 (22.4%) were "wrongly included", 17 did not complete the test period for undefined reasons and were considered to have been "lost to follow-up", and 6 patients "deviated" from the protocol. These 3 groups were taken into account in the statistical analysis of the graphs of non-failure.