The influence of molsidomine on infarct size: an acute post-infarction pilot study with 303 patients.

In a multicenter, randomized and double-blind study, the efficiency of molsidomine on infarct size has been examined in 303 patients suffering from a first myocardial infarction and compared with a placebo. According to previous enzyme studies, and in order to detect a 20% reduction infarct size with conventional levels of risk, alpha = 0.05 and beta = 0.20, the recommended sample size was 264 patients. Thirty-three patients initially selected were excluded for protocol violation and, among the 270 patients definitively included, 133 were allocated to molsidomine and 137 to placebo, without any difference concerning age, delay of treatment, infarct location, and initial blood pressure. Test drugs were both initiated within the 6 first hours and administered orally at decreasing doses for 10 days: 16 mg on the first day, 12 mg on the second day, and 6 mg daily from the third to the tenth days. There was not a significant difference between the molsidomine and placebo groups regarding the enzyme evaluation of infarct size, neither for CK dosage (101.72 +/- 74.76 gram equivalents vs. 92.71 +/- 65.91 gram equivalents, NS) nor for its MB fraction (67.34 +/- 50.07 gram equivalents vs. 63.50 +/- 43.01 gram equivalents, NS). Moreover, changes in the Q- or R-wave sum during the 10 days of follow-up were strictly identical. However, in-hospital mortality was lower in the molsidomine group than in the placebo group (4.5% vs. 8.0%), but this reduction was not statistically significant. During the study, there were few side effects, mainly headaches, without withdrawal of the treatment.