Thirty-two published studies and 33 unpublished studies were included, with a total of 9,903 participants.
There were a total of 169 major clinical adverse events reported, 1.5% in isradipine arms, 2.1% in active control arms and 1.3% in placebo controls. There were a total of 1435 withdrawals reported, 45.4% in Isradipine arms, 3.8% in Isradipine sustained-release arms, 35.3% in active controls and 16.5% in placebo controls.
Results of primary meta-analysis: Odds Ratios (95% CI).
Total withdrawals:
Isradipine sustained-release vs. Placebo0.52 (0.31 - 0.86).
Isradipine vs. Placebo 0.87 (0.65 - 1.16).
Isradipine vs. Active control 0.87 (0.71-1.07).
Major adverse events:
Isradipine sustained-release vs. Placebo 0.80 (0.26 - 2.46).
Isradipine vs. Placebo 0.52 (0.21 - 1.29).
Isradipine vs. Active control 0.99 (0.67 - 1.46).
Angina:
Isradipine sustained-release vs. Placebo 0.77 (0.23 - 2.61).
Isradipine vs. Placebo 0.58 (0.22 - 1.51).
Isradipine vs. Active control 0.95 (0.60 - 1.51).
Results of sensitivity analysis did not show any statistical difference between odds ratios calculated in the primary meta-analysis (all studies) and any of the sub-groups (published studies, unpublished studies, parallel designed studies and crossover designed studies). Results of logistic regression analysis showed that the length of exposure was the only significant covariate in all regression models examining total withdrawals and major adverse events.