Trimetazidine Modified Release in the Treatment of Stable Angina : TRIUMPH StudyTRImetazidine MR in Patients with Stable Angina: Unique Metabolic PatH.

OBJECTIVE

To assess the clinical efficacy, safety and effects on quality of life of trimetazidine modified release (MR) in patients with stable angina.

METHODS

This large, open-label, uncontrolled study was conducted in 906 patients with stable angina in the Russian Federation. Patients were treated for 8 weeks with trimetazidine MR (35mg tablet, twice a day) in addition to their conventional therapy.

RESULTS

Overall 846 patients (516 men and 330 women) aged 58.7 +/- 9 years completed the study. During the 8-week treatment period the number of angina attacks per week decreased continuously and significantly from 11.2 +/- 0.4 to 3.6 +/- 0.2 (p < 0.0001). Concurrently, the number of short-acting nitrate tablets taken per week decreased from 11.9 +/- 0.8 to 3.4 +/- 0.2 (p < 0.0001). Patients' quality of life, assessed on the Seattle Angina Questionnaire, showed a significant improvement (p < 0.0001) for all five items evaluated: physical limitation increased from 50.7 +/- 0.7 to 61.0 +/- 0.6, angina stability improved from 57.6 +/- 0.9 to 92.5 +/- 0.7, angina frequency extended from 33.3 +/- 0.7 to 55.6 +/- 0.8, treatment satisfaction increased from 62.3 +/- 0.7 to 77.4 +/- 0.5, and disease perception improved from 36.7 +/- 0.6 to 55.5 +/- 0.7. Adverse events were reported in 2.4% of patients (22/906) during the 8 weeks of treatment. No serious adverse events were reported.

CONCLUSION

The results of this study suggest an improvement in clinical efficacy and in quality of life and a good tolerance of trimetazidine MR administered at a dose of 35mg twice a day for 8 weeks in patients with stable angina.