Efficacy and tolerance of trimetazidine, a metabolic antianginal, in combination with a hemodynamic antianginal in stable exertion angina. TRIMPOL I, a multicenter study

Objective: Assess the antianginal and anti-ischemic effect of trimetazidine in patients with stable exercise-induced angina insufficiently controlled with conventional antianginal drugs.

Methods: The study population included patients with coronarographically documented stable exercise-induced angina and no other serious concomitant condition. For inclusion, patients had to have two comparably positive treadmill exercise tests. Conventional antiangina drugs (long-acting nitrate derivatives, beta-blockers or calcium antagonists) were continued as was any other therapy having no effect on the ECG ST segment. The patients were given a 4-week regimen of trimetazidine (20 mg t.i.d.) after the second positive treadmill test and final inclusion. At the end of this period, a final exercise test was performed. The study population included 700 patients (mean age 54 +/- 8.4 years, range 32-71 years, 615 men, 85 women) who completed the entire treatment protocol.

Results: The main findings observed after 4 weeks of treatment with trimetazidine were: significant lengthening of the total duration of exercise (486.6 s versus 443.7 s, p < 0.01)), increase in total work (10.6 METS versus 9.4 METS, p < 0.01), significant lengthening of delay to 1 mm ST depression (389.9 s versus 337.8 s, p < 0.01) and of the delay to onset of angina (450.3 s versus 251.7 s, p < 0.01). The other results were a significant reduction in the number of daily episodes of angina (2.47 versus 3.66, p < 0.01) and a reduction in mean use of complementary trinitrine (1.8 versus 2.94, p < 0.01).

Conclusions: Four weeks of treatment with trimetazidine in combination with conventional antiangina drugs leads to a longer delay to development of 1 mm ST depression (ischemia threshold), significant lengthening of total duration of treadmill exercise, increased total work, and longer delay to angina theshold. Clinically, there was a reduction in the mean number of episodes of angina and a reduction in the use of trinitrine.