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.
Introduction Trimetazidine (TMZ) has been shown to be efficacious for angina treatment. The TMZ 80-mg formulation allows one-daily (od) dosage, which could improve symptom control and adherence. Methods The 3-month, observational, multicenter, prospective ODA (antianginal effectiveness and tolerability of trimetazidine modified release 80 mg Once Daily in stable Angina patients in real-world practice) study assessed TMZ 80 mg od effectiveness in stable angina patients with persistent symptoms despite therapy. Two clinical situations were compared: patients who initiated treatment with TMZ 80 mg od (initiation group) and patients who were previously treated with TMZ 20 mg thrice daily (tid) or TMZ 35 mg MR twice daily (bid) and switched to TMZ 80 mg od (switch group). Number of angina attacks, short-acting nitrate (SAN) consumption, self-reported patient daily activity, Canadian Cardiovascular Society (CCS) class, adherence to antianginal therapy, overall efficacy and tolerability were assessed. Results A significant decrease in weekly number of angina attacks was observed for both the initiation group ( n = 1841 patients) from 4.8 ± 3.5 at baseline to 0.9 ± 1.4 at 3 months (M3) ( P < 0.001), and the switch group ( n = 1216 patients) from 4.4 ± 1.3 at baseline to 0.9 ± 1.3 at M3 ( P < 0.001). Significant reduction in SAN consumption and improvement in CCS class were observed for both groups. Adherence to antianginal therapy improved in both groups at 1 month (M1) and M3. Overall effectiveness of TMZ 80 mg od was rated by physicians as “very good” (68% initiation group, 70% switch group), “good” (31% initiation group, 29% switch group), “moderate” (1%, both groups) or “poor” (< 1%, both groups). Overall tolerability of TMZ 80 mg od was rated by physicians as “very good” (75%), “good” (25%) or “moderate” (< 1%) in both groups. Conclusions TMZ 80 mg od, in association with other antianginal therapy, effectively reduced angina attacks and SAN consumption and improved physical activity and adherence to antianginal therapy both in patients initiating TMZ treatment and those switching from a bid or tid formulation. Trial Registration ISRCTN registry Identifier, ISRCTN97780949. Funding Servier. Plain Language Summary Plain language summary available for this article. Electronic supplementary material The online version of this article (10.1007/s40119-019-0128-3) contains supplementary material, which is available to authorized users.
Introduction Trimetazidine (TMZ) is an antianginal agent that acts directly at the myocardial cell level and which is now available in a once-daily (od) formulation. Methods ODA, a 3-month, observational, multicenter study in Russia, assessed the effectiveness and tolerability of TMZ 80 mg od in patients with stable angina and persisting symptoms, in real-life settings. The present analysis explored the effects of adding TMZ to background antianginal treatment with respect to the duration of stable angina. Results A total of 3032 patients were divided into four groups according to stable angina pectoris duration since diagnosis, ranging from less than 1 year to more than 10 years. A decrease in frequency of angina attacks was observed, including in patients with angina duration < 1 year, in whom the frequency of weekly angina attacks decreased from 3.8 ± 2.9 to 1.4 ± 1.7 at 1 month and 0.6 ± 1.0 at 3 months. Short-acting nitrate consumption and proportion of angina-free patients decreased, and self-reported physical activity and adherence to antianginal therapy improved in all patient groups, including recently diagnosed patients and starting already at month 1. Conclusions Addition of TMZ 80 mg od to antianginal treatment was effective in reducing the frequency of angina attacks and the use of short-acting nitrates, improving Canadian Cardiovascular Society (CCS) class, self-reported physical activity, and adherence to antianginal therapy. These beneficial effects were observed in patient groups with different durations of stable angina, suggesting an opportunity for decreasing angina burden even in recently diagnosed patients. Trial Registration ISRCTN registry Identifier, ISRCTN97780949. Electronic supplementary material The online version of this article (10.1007/s40119-020-00174-7) contains supplementary material, which is available to authorized users.
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