Comparative clinical and laboratory study of the original and generic platelet P2Y12 inhibitor ticagrelor in patients with stable coronary artery disease
Abstract
Aim . To compare the laboratory (pharmacodynamic) efficacy, plasma concentrations, and safety of the original ticagrelor (OT, Brilinta) and generic ticagrelor (GT, Cardibrilin) at a dose of 60 mg twice daily in patients with stable coronary artery disease (CAD) at high ischemic risk. Material and methods . This prospective, single-center, open-label, randomized study included 50 patients with stable CAD (median age, 73 years [67; 78]; men, 62%) randomized to 2 groups of 25 and receiving B or С as part of dual antiplatelet therapy with acetylsalicylic acid (75 mg/day). Antiplatelet effect was assessed by light transmission aggregometry (LTA-ADP, ADP 5 and 10 μmol/L) at timepoints 0, 1 and 2 (baseline, Day 1, Day 3), VerifyNow P2Y 12 Assay (platelet reactivity units, PRU) and liquid chromatography-tandem mass spectrometry (LC-MS/MS) (plasma concentrations of ticagrelor and metabolite AR-C124910XX). Follow-up was 30 days. Results . The groups were comparable in age, sex and body mass index; the GT group had a higher prevalence of diabetes (52,0% vs 20,0%, p=0,039). Conversely, heart failure with preserved ejection fraction was less frequent (70,0% vs 100%, p=0,022). Both agents produced substantial reduction in platelet aggregation by day 1 (p<0,001 within each group), with no intergroup differences at any time-point (p>0,05). On day 3, PRU did not differ (38,0 [18,0; 45,0] vs 36,0 [18,0; 73,0], p=0,838). No patient showed high platelet reactivity (PRU ≥208). Plasma concentrations of ticagrelor (day 1 p=0,146; day 3 p=0,662) and AR-C124910XX (p=0,491) were comparable. No major adverse cardiovascular events, clinically significant bleeding or rehospitalisations occurred over 30 days. The adverse event profile was comparable (p>0,05). Conclusion . The original (Brilinta 60 mg) and generic (Cardibrilin 60 mg) ticagrelor showed no significant differences in pharmacodynamic parameters, plasma concentrations of ticagrelor and its active metabolite, or clinical outcomes. These data align with regulatory bioequivalence studies and support the therapeutic equivalence and clinical interchangeability of generic ticagrelor in patients with stable CAD at high ischemic risk.