Trimetazidine added to combined hemodynamic antianginal therapy in patients with type 2 diabetes: a randomized crossover trial.
BACKGROUND
In nondiabetic patients with stable angina, combined treatment with hemodynamic agents and trimetazidine is well-tolerated and effective in controlling ischemia. This study aims to evaluate the antiischemic and metabolic effects of trimetazidine in patients with type 2 diabetes mellitus, not eligible for revascularization, who remained symptomatic despite the use of at least 2 antianginal agents.


METHODS
A randomized, double-blind, crossover clinical trial was used. Ten patients were randomized to receive trimetazidine (20 mg, 3 times a day) or placebo for 6-week periods. At baseline and at the end of each 6-week intervention period, clinical and biochemical evaluations, exercise testing, 24-hour ambulatory blood pressure, and Holter monitoring were performed.


RESULTS
During trimetazidine therapy, patients had significant improvement on angina functional class (P < .05), with decrease in the number of weekly angina episodes (1.5 +/- 0.8 vs 0.4 +/- 0.7, P < .01), and in sublingual nitrate doses (1.4 +/- 0.7 mg vs 0.1 +/- 0.3 mg, P < .001). Time to 1-mm ST-segment depression during exercise test was increased after trimetazidine use (229 +/- 126 seconds at baseline, 276 +/- 101 seconds after placebo, and 348 +/- 145 seconds after trimetazidine, P < .001). No differences were observed between treatment periods on mean 24-hour blood pressure, heart rate, and rate-pressure product evaluated concomitantly with ambulatory blood pressure and Holter monitoring. Glycemic and lipid profiles were similar after trimetazidine and placebo use.


CONCLUSIONS
In patients with diabetes who remain symptomatic, the addition of trimetazidine improves symptoms and exercise responses without hemodynamic or metabolic changes. The present data suggest that trimetazidine may be an effective adjunct therapy for these patients, but further investigation is needed to confirm these findings.
Ribeiro
Letícia Weiss
LW
Cardiology Division, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Ribeiro
Jorge P
JP
Stein
Ricardo
R
Leitão
Cristiane
C
Polanczyk
Carísi Anne
CA
D000787:Angina Pectoris / Q000209:etiology / Q000517:prevention & control*; D018660:Blood Pressure Monitoring, Ambulatory; D018592:Cross-Over Studies; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy*; D004334:Drug Administration Schedule; D015716:Electrocardiography, Ambulatory; D005080:Exercise Test; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D014292:Trimetazidine / Q000008:administration & dosage*
D014292:Trimetazidine