TRIMETAZIDINE AND REDUCTION IN MORTALITY AND HOSPITALIZATION IN PATIENTS WITH ISCHEMIC DILATED CARDIOMYOPATHY A POSTHOC ANALYSIS OF THE VILLA PINI DABRUZZO TRIMETAZIDINE TRIAL

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INTRODUCTION In patients with left ventricular dysfunction or heart failure, treatment with combination neuro-hormonal blockade with ACE inhibition and ß-blockade is a standard evidence-based recommendation. Although considerable progress has been made over the last years, the mortality rate remains high and many patients have side-effects with traditional drugs and continue to experience intractable symptoms. For these reasons, more attention has been given to drugs that modulate energy metabolism and exert a valid protection of cardiac cells against ischemia and reperfusion damage without any hemodynamic effect. Among these drugs, trimetazidine (1-[2,3,4-trimethoxybenzil] piperazine, dihydrocloride) is the prototypal agent of a class of antianginal drugs, that reduces fatty acid oxidation and stimulates glucose utilization by selective inhibition of mitochondrial long-chain 3-ketoacyl CoA thiolase (3-KAT) (Figure 1). The Villa Pini d’Abruzzo trimetazidine trial, was a single centre site (Villa Pini d’Abruzzo Clinic, Centre for Study and Treatment of Congestive Heart Failure, Chieti, Italy), open-label, randomized trial of the metabolic inhibitor trimetazidine in chronic heart failure. METHODS We performed an extension to 48 months and a post-hoc analysis of the Villa Pini d’Abruzzo trimetazidine trial; in this single centre, open-label, randomized trial with the metabolic inhibitor trimetazidine in chronic heart failure, sixty-one patients were randomized to either receive trimetazidine (20mg tid) in addition to their conventional treatment or to continue their usual drug therapy for 4 years. Patients were evaluated at baseline, 6, 12, 18, 24, 32, 36, 42 and 48 months with clinical examination, echocardio-graphy. TRIMETAZIDINE AND REDUCTION IN MORTALITY AND HOSPITALIZATION IN PATIENTS WITH ISCHEMIC DILATED CARDIOMYOPATHY: A POST-HOC ANALYSIS OF THE VILLA PINI D’ABRUZZO TRIMETAZIDINE TRIAL. Pericle Di Napoli MD*, Paolo Di Giovanni MD*, Marta Gaeta MD*, Alfonso Taccardi MD*, Antonio Barsotti MD** *Heart Failure Unit, Villa Pini d'Abruzzo Clinic, Chieti, **Dept. of Internal Medicine (DiMI), University of Genoa, Italy. RESULTS Patients characteristics at enrolment are reported in Table I. Sixty-one patients were included and randomized in the study (trimetazidine group, n=30; control group, n=31). A total of 17 patients died during the follow-up, 5 in trimetazidine group and 12 in control group. After 48 months, trimetazidine significantly reduced all-cause mortality (17% vs 39% control) resulting in a difference of 56% (hazard ratio 0.258, 95% CI 0.097-0.687; P = 0.0047 by the log-rank test). The mean survival time was 42 months (95% CI: 36.43-47.49) in trimetazidine group and 29 months in control group (95% CI: 23.95-34.13). The difference in mortality emerged after 2 years treatment (Figure 2, left). During the follow-up we observed a significant reduction of heart failure hospitalizations (log-rank test P = 0.002, Figure 2, right). The mean survival time from hospitalization was 20.5 months (95% CI: 14.3-26.28) in trimetazidine group, while in control group was 16 months (95% CI: 10.45-19.61).Trimetazidine also improves patient functional status (NYHA class) (Figure 3) and Left Ventricle Ejection Fraction (LVEF p<0.001 at 48 months) (Figure 4). p = 0.002 Hospitalization p = 0.0047 Cumulative survival (%) Total Mortality Pts. free of Hospital. (%) Months Months Months NYHA class Ejection Fraction Months * * * * * * * * * * * * = p<0.001 * = p<0.001 Table 1: Clinical characteristics and echocardiographic measurements at baseline. Group TMZ (n=30) Group C (n=31) Age (yrs): 67 (5.5) 69 (7) Sex: male/female 17/13 18/13 Coronary angiography one-vessel: 15 (50) one vessel: 13 (41.9) two-vessel: 10 (33.3) two-vessel: 12 (38.7) three-vessel: 5 (16.6) three-vessel: 6(19.4) Diabetics 10 (33.3) 11 (35.4) Drug treatment n (%) Diuretics 30 (100) 31 (100) ACE-I/Sartanes 27 (90) 28 (90.3) Digoxin 8 (26.7) 7 (22.6) Nitrates 6 (20) 8 (25.8) Statins 27 (90) 28 (90.3) Aldosterone antag 8 (26.7) 7 (22.6) Beta-blockers 15 (50) 18 (58.1) Calcium antag. 6 (20) 6 (19.4) Aspirin 22 (73.3) 20 (64.5) ICD n (%) 3 (10) 4 (12.9) Echocardiography Left Ventricular volume: End-systolic (mL/m2): 91 (18) 88 (15) End-diastolic (mL/m2): 133 (30) 127 (22) Ejection fraction (%): 30 (6) 31 (8) Mitral insufficiency: n (%) (light to moderate) 17 (56.7%) 16 (51.6%) CONCLUSION Long-term trimetazidine therapy significantly reduces all-cause mortality and heart failure hospitalization in patients with ischemic cardiomyopathy. If confirmed in large scale randomized trials, this treatment could be useful in the management of left ventricle dysfunction and remodeling in patients with ischemic heart disease. TRIMETAZIDINE Figure 2 Figure 3 Figure 4 Figure 1 Control Trimetazidine

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