Anti-Anginal Effectiveness and Tolerability of Trimetazidine Modified Release 80 Mg Once Daily in Stable Angina Patients in Real-World Practice

Abstract

IntroductionTrimetazidine (TMZ) was shown to reduce angina symptoms and increase the exercise capacity in stable angina (SA) patients. A new formulation allowing a once-daily (od) dosage could improve patients’ satisfaction and adherence.MethodsODA was a 3-month, observational, multicenter, prospective Russian study in SA patients with persistent symptoms despite therapy. Angina attack frequency, short-acting nitrate (SAN) consumption, adherence to antianginal medications, and overall efficacy and tolerability of TMZ 80 mg od were assessed in a real-world setting.ResultsA total of 3066 patients were included (mean age 62.8, 48% male). After 3 months, TMZ 80 mg od treatment led to a significant (p < 0.001) decrease in angina attack frequency (from 4.7 ± 3.5 to 0.9 ± 1.3/week) and SAN use (from 4.5 ± 3.9 to 0.7 ± 1.3/week). Overall tolerability and effectiveness were rated as “very good” by the majority of physicians. Medication adherence improved significantly, with good adherence reported by 56% of patients (vs. 24% at baseline, p < 0.0001) and non-adherence by 3% (vs. 36% at baseline, p < 0.0001) at month 3. Patient satisfaction with TMZ od was 9.5 [on a scale of 1 to 10 (very satisfied)]. Patients reported improved physical activity: more patients reported no limitations (15% vs. 1% at baseline p < 0.01), slight limitation (46% vs. 5% at baseline, p < 0.001) or moderate limitation (30% vs. 23%, p < 0.01) and fewer patients reported substantial limitation (8% vs. 52% at baseline, p < 0.001) or very marked reduction (1% vs. 19% at baseline, p < 0.01) at month 3.ConclusionIn this prospective, observational study, TMZ 80 mg od effectively reduced angina attacks and SAN consumption, improved physical activity and adherence and was well tolerated in chronic SA patients.Trial RegistrationISRCTN registry Identifier, ISRCTN97780949.FundingServier.Plain Language SummaryPlain language summary available for this article.

Effectiveness of Trimetazidine in Patients with Stable Angina Pectoris of Various Durations: Results from ODA

“…TMZ od is therefore an important part of antianginal therapy, as it effectively improves angina symptoms and shows a good tolerability profile. Tolerability was not assessed in this analysis, but as reported in the main analysis, there were only 0.3% suspected adverse drug reactions [ 22 ].…”

“…ODA was a 3-month observational, multicenter, prospective study in 3066 stable angina patients with persistent symptoms despite therapy, conducted in Russia from March 2017 to June 2017 in a real-world clinical setting. The methods and main findings of this study have been published previously [ 22 ]. Patients were treated according to current recommendations for coronary artery disease management and their inclusion was exclusively determined by the decision of the physician regarding medical meaningfulness and indication for treatment with TMZ od 80 mg.…”

“…The ODA (anti-anginal effectiveness and tolerability of trimetazidine modified release 80 mg once daily in stable angina patients in real-world practice) study assessed the effectiveness and tolerability of TMZ 80 mg once daily (od) in stable angina patients in a real-life clinical practice setting in Russia and its rationale, design, and main results have been previously published [ 22 ]. In the present analysis of the ODA study, we sought to assess the effect of TMZ 80 od addition to hemodynamic therapy with regard to angina duration focusing on its impact on effectiveness and adherence to treatment in the patients corresponding to the new ESC CCS Guidelines definition of “recently diagnosed” CCS patients, as well as on patients with a diagnosis duration longer than 1 year, corresponding to the group of patients with long-standing diagnosis of CCS.…”

A különféle trimetazidinkészítmények klinikai hatása stabil anginával járó krónikus koszorúér-szindrómában. Frissített módszeres áttekintés és metaanalízis

“…Adatbázisunk összesen 31 közleményt tartalmazott , ebből 2 tanulmány feldolgozása két részletben történt [29,38]: egy orosz vizsgálat betegadatait teljesen logikusan ismét feldolgozták, és elkülönítették benne a korábban trimetazidint már szedő vagy nem szedő betegeket, ami az első közleményből kimaradt [29,30]. Az 1. táblázatban értelemszerűen mindkét vizsgálatot feltüntettük, de csak a módosított tanulmány [30] eredményeivel számoltunk.…”

“…Az 1. táblázatban értelemszerűen mindkét vizsgálatot feltüntettük, de csak a módosított tanulmány [30] eredményeivel számoltunk. Egy lengyel kutatás során először részletesen ismertették a diabeteses betegek eredményeit [37]; a teljes tanulmány később jelent meg [38] [31], kettőbe pedig bekerülhettek korábban trimetazidint már szedők és nem szedők egyaránt [29,39] -ez a vizsgálatban szereplő adatok homogenitását egyértelműen rontotta, de ahogyan korábban említettük, az egyik kutatás korrekciója ebből a szempontból megtörtént [29,30].…”