Fifty phase III-IV trials were included; these involved 16,590 patients treated with lacidipine, 1,810 treated with other active drugs, and 451 patients treated with placebo. Thirty-two trials were controlled trials with comparison treatment (11 with a crossover design) and 18 were open studies of lacidipine treatment. Most of the patients (60%) were treated for 12 to 26 weeks and were aged from 45 to 64 years; 14% of the patients were treated for at least 48 weeks. Thirty-two per cent of the patients were aged 65 years or older.
In all studies, the estimated event rate for myocardial infarction was 5.46 per 1,000 person-years; the fatal (all-cause) event rate was 5.27 per 1,000 person-years; and the estimated fatal cardiovascular event rate was 2.93 per 1,000 person-years.
In the lacidipine arm of the controlled studies, the mean systolic and diastolic blood-pressure fell from 166 and 102 mmHg, respectively, to 144 and 85 mmHg. The heart rate fell from 75.6 to 74.1 beats/minute.
The overall incidence in the comparative studies of one or more adverse events was 30.3% for lacidipine, 43.8% for other calcium antagonists, 18.7% for diuretics, 48.7% for beta-receptor blockers, 10.4% for angiotensin-converting enzyme inhibitors, and 15.7% for placebo. The reported adverse affects included headaches, flushing, pedal oedema, and palpitations.