Objective: To evaluate the effects of add-on treatment with trimetazidine, single dose and long-term, on clinical and objective parameters of ischemia in patients with stable angina pectoris receiving standard antianginal therapy.
Design: One-month single-blind, placebo-controlled study.
Patients: 40 patients with stable angina pectoris.
Interventions: Patients received 1-month treatment with either trimetazidine 20 mg (n = 20) or placebo (n = 20) 3 times daily in addition to standard antianginal therapy.
Main outcome measures: All patients underwent bicycle stress tests at baseline and at 1 month to assess exercise tolerance. Patients receiving trimetazidine also underwent a stress test 2 hours after administration of a 60 mg single dose. Influence of trimetazidine on stress-induced left ventricular function was assessed in 11 patients, with dobutamine stress echocardiography performed at baseline and at 1 month. Clinical efficacy was evaluated in terms of mean weekly number of anginal episodes and weekly nitroglycerin (glyceryl trinitrate) tablet consumption during the study.
Results: Trimetazidine significantly improved most stress test parameters, after a single dose and after 1 month of treatment; the rate-pressure product remained unchanged. Dobutamine tests showed significant (p < 0.05) increases from baseline values in time to onset of anginal pain and threshold dobutamine dose (13.5 +/- 0.7 versus 10.2 +/- 0.8 min, and 43.6 +/- 2.8 versus 35.4 +/- 3.4 microg/kg/min, respectively). The severity of anginal pain and mean weekly number of anginal episodes was reduced significantly (p < 0.05) from baseline values after 1 months' treatment with trimetazidine (1.3 +/- 0.6 versus 2.3 +/- 0.3, and 6.6 +/- 1.4 versus 10.1 +/- 1.3, respectively). After 1 month, weekly consumption of nitroglycerin tablets was decreased by 3.1 from baseline values in the trimetazidine group but increased by 0.3 in the placebo-treated group. No patient withdrew due to treatment-related adverse effects.
Conclusion: This study confirms the antianginal and anti-ischemic efficacy of single dose and long-term treatment with trimetazidine. Treatment with trimetazidine was well tolerated.