What is the clinical evidence from this study?

Study design: RCT. Population: stable angina (n=149). Intervention: Trimetazidine vs. propranolol (40 mg three times daily). Primary outcome: anginal attack rate per week (MD 2, 95% CI -4.4, 0.5).

March 1, 1994Open Access

Trimetazidine: a new concept in the treatment of angina. Comparison with propranolol in patients with stable angina. Trimetazidine European Multicenter Study Group.

Key Result

Trimetazidine had similar efficacy to propranolol in men with stable angina, with no significant difference in anginal attack rate per week (MD 2; 95% CI -4.4 to 0.5).

Study Design

Type

RCT (n=149)

Blinding

Double-blind

Randomization

parallel group

Multicenter

Yes

Structured PICO

Does trimetazidine provide similar anti-anginal efficacy compared to propranolol in men with stable angina?

Population

149 men with stable angina and > 1 mm ST-depression on exercise test, followed for 3 months.

Intervention

Trimetazidine 20 mg three times daily

Comparator

Propranolol 40 mg three times daily

Outcome

Anti-anginal efficacy including anginal attack rate per week, exercise duration, and time to 1 mm ST segment depressionsurrogate

Trimetazidine 20 mg three times daily demonstrated similar anti-anginal efficacy to propranolol 40 mg three times daily in men with stable angina over 3 months.

Main Result

Mean Difference: 2 (95% CI -4.4–0.5)

Abstract

Trimetazidine has a direct anti-ischaemic effect on the myocardium without altering the rate x pressure product or coronary blood flow. 2. The effects of trimetazidine (20 mg three times daily) were compared with those of propranolol (40 mg three times daily) in a double-blind parallel group multicentre study in 149 men with stable angina. 3. Reproducibility of exercise performance was verified during a 3 week run-in placebo washout period. All patients had > 1 mm ST-depression on exercise test. 4. After 3 months, similar anti-anginal efficacy was observed between the trimetazidine (n = 71) and propranolol (n = 78) groups. No significant differences were observed between trimetazidine and propranolol as regards anginal attack rate per week (mean difference P-TMZ: 2; 95% CI: -4.4, 0.5) and exercise duration (mean difference P-TMZ: 0 s; 95% CI: -33, 34) or time to 1 mm ST segment depression (mean difference P-TMZ: 13 s; 95% CI: -24, 51). Heart rate and rate x pressure product at rest and at peak exercise remained unchanged in the trimetazidine group but significantly decreased with propranolol (P < 0.001 in all cases). With both drugs there was a trend to decreased ischaemic episodes in the 46% patients who experienced ambulatory ischaemia on Holter monitoring. Six patients stopped trimetazidine and 12 propranolol. Of these, five in each group were withdrawn because of deterioration in cardiovascular status. 5. The results suggest that trimetazidine and propranolol at the doses studied have similar efficacy in patients with stable angina pectoris.(ABSTRACT TRUNCATED AT 250 WORDS)