Clinical Acceptability Of Trimetazidine Modified-Release 80mg Once Daily Versus Trimetazidine Modified-Release 35mg Twice Daily In Stable Angina Pectoris.

Abstract

IntroductionTrimetazidine (TMZ) is an anti-ischemic metabolic agent that has been shown to be efficacious in angina treatment, both in monotherapy and in combination. A new formulation of TMZ modified-release (MR) 80 mg was developed, which is to be taken once daily (od), instead of twice daily (bid) for the currently available TMZ MR 35 mg, with the aim of simplifying the medication regimen.MethodsThe present study was an international, multicenter, randomized, double-blind, parallel-group phase III study with a 12-week treatment period. The safety of TMZ MR 80 mg once daily was assessed compared to TMZ MR 35 mg twice daily, in patients previously treated successfully by the latter. Emergent adverse events (EAEs), biological parameters, vital signs, 12-lead resting ECG (electrocardiogram) and Canadian Cardiovascular Society (CCS) classification were recorded.ResultsOne-hundred and sixty-five patients previously diagnosed with stable angina pectoris on treatment were randomized to receive either TMZ MR 80 mg od or TMZ MR 35 mg bid. In the TMZ MR 80 mg group, fewer patients had ≥ 1 EAE (17.1 vs. 22.9% in the TMZ MR 35 mg group). Serious EAEs were reported by three patients in each group. No EAE required dose modification, withdrawal, or temporary interruption of study treatments. Vital signs, 12-lead ECG, and laboratory parameters did not change. No worsening in CCS classes was observed with either treatment.ConclusionsTMZ MR 80 mg od and TMZ MR 35 mg bid have similar safety profiles. This new once-daily formulation could improve patient compliance with therapy, thereby enhancing clinical benefit.Trial RegistrationISRCTN registry, ISRCTN 84362208.FundingInstitut de Recherches Internationales Servier and Servier, Moscow, Russian Federation.Plain Language SummaryPlain language summary available for this article.Electronic supplementary materialThe online version of this article (10.1007/s40119-018-0110-5) contains supplementary material, which is available to authorized users.