Therapeutic value of a cardioprotective agent in patients with severe ischaemic cardiomyopathy

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Abstract
Trimetazidine (TMZ) has been shown to have anti-ischaemic properties improving exercise tolerance without haemodynamic efects. A 6-month double-blindplacebo-controlledstudy was carried out in 20patients, mean age 59 ± 6 years, to examine the benefit of adding 60 mg of TMZ vsplacebo to the classical therapy, excluding those previously treated with calcium-antagonists, conversion enzyme inhibitors, vasodilators and antiplatelet agents. All patients had severe ischaemic cardiomyopathy, confirmed by coronary angiography; six were in N YHA class IV; 14 in N YHA class III; four had mild recurrent angina pectoris. The assessment included clinical and biological evaluation, electrocardiography (ECG) ,24-h ECG monitoring, cardiac volwne evaluation with chest X-ray, left ventricular fractional shortening by echocardiography, left ventricular ejection, fraction by radionuclide angiography. Baseline characteristics were similar inplacebo(1 I patients) and TMZ(ninepatients) groups. Eighteen patients (nine in eachgroup) were followed up for 6 months. In eight patients of the placebo group, treatment had to be modified (addition of calcium antagonists: four patients, conversion enzyme inhibitors: two patients; digitalics: one patient; diuretics: one patient). In the TMZ group, digitalic therapy was withdrawn in one patient and added in one patient ( P < 0.01). At 6 months, all TMZ group patients were free from angina; dyspnoea was improved in all TMZ patients and in only one placebo patient (P < 0.001). Ejection fraction, increased by 9.3% in the TMZ group and decreased by 15.6% in the placebo group (P < 0.018), CV decreased by 7% with TMZ, increased by 4% with placebo. (P = 0.034). TMZ seemsto improve clinical status; ejection fraction and cardiac volume without adverse effects in patients with severe ischaemic cardiomyopathy