[The effects of trimetazidine on ergometric parameters in exercise-induced angina. Controlled multicenter double blind versus placebo study].

The antianginal effect of trimetazidine was assessed by a controlled multicentre double-blind versus placebo trial. The study included 32 males, average age 59.5 years, with stable angina of effort. The stability of angina was determined by two exercise stress tests performed at the beginning and at the end of a 15 day pre-selection period under placebo. The patients included in the trial were given 3 tablets a day of either trimetazidine (20 mg per tablet) or of placebo for one month. At the end of the treatment period the patients underwent a third exercise stress test. Comparing the results of exercise testing before and after treatment by a Mann and Whitney test, a statistically significant improvement with trimetazidine was demonstrated with respect to placebo for three parameters: total work increased from 4200 +/- 372 to 5620 +/- 387 Kpm in the trimetazidine group compared to 4191 +/- 399 to 4564 +/- 431 Kpm for placebo (p = 0.012); the duration of exercise increased from 10.2 +/- 0.5 to 12.1 +/- 0.5 minutes with trimetazidine compared to 10.2 +/- 0.5 to 10.7 +/- 0.5 with placebo (p = 0.016); the period to 1 mm ST depression increased from 8.3 +/- 0.6 to 9.8 +/- 0.5 minutes with trimetazidine compared to 8.4 +/- 0.5 to 9.0 +/- 0.7 minutes with placebo (p = 0.034). These results show that signs of ischaemia are delayed by trimetazidine. There were no significant changes in peripheral haemodynamics at rest or on effort. The antianginal action of trimetazidine seems therefore to be unrelated to a chronotropic or vasomotor effect and could be related to a mechanism of cellular regulation.

RCT Entities:   Population Interventions Outcomes