COMPARISON OF THE ORIGINAL (PLAVIx) AND GENERIC (CLAPITAx) CLOPIDOGREL ON PLATELET  AGGREGATION: ObSERVATIONAL STUDY

Aim. To compare antiplatelet activeness of the original clopidogrel and its generic, and to evaluate the routine practice of antiplatelet drugs intake by clinically stable patients aiming prevention of atherothrombosis.

Material and methods. Total number of patients that have been taking clopidogrel: 186, of those at outpatient stage 54 on original clopidogrel, the rest 132 on generic. Adenosindiphosphate-induced activeness was measured in two groups (n=57) taking consequently Plavix and Clapitax before replacement of the drug and 14 days after.

Results. At interchange of the drug in group 1 (Clapitax to Plavix) and group 2 (Plavix to Clapitax) the grade of achieved effect remained, and in group 2 it showed additional non-significant decrease. Adverse events related to antiplatelet therapy were not registered. At in-patient stage, 117 patients had an interchange of the drug (incl. several times) of original clopidogrel to its various generics (n=65), and vice versa (n=52), that was related to a range of
routine reasons, of those patient and relatives preferences, specifics of drug supply in a clinic.

Conclusion. The found equal residual reactivity of the platelets after Clapitax and Plavix intake in two groups witness on therapeutical equivalence of the drugs.

1. Yusuf S, Mehta SR, Zhao F, et al. on Behalf of the CURE (Clopidogrel in Unstable angina to prevent Recurrent Events) Trial Investigators. Early and Late Effects of Clopidogrel in Patients With Acute Coronary Syndromes. Circulation. 2003; 107: 966-72. DOI: 10.1161/01.CIR.0000051362.96946.15.

2. Eisenstein EL, Anstrom KJ, Kong DF, et al. Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. JAMA. 2006 Dec 5: E1-E10.

3. Clopidogrel in Unstable angina to prevent Recurrent Events trial (CURE) investigators. Effects of dopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N. Engl.J.Med. 2001; 345: 494-8.

4. Price MJ, Angiolillo DJ, Teirstein PS, et al. Platelet reactivity and cardiovascular outcomes after percutaneous coronary interventions. A time-dependent analysis of the Gauging Responsiveness with a Verify Now P2Y12 Assay: Impact on Thrombosis and Safety (GRAVITAS) trial. 2011 Sep 6; 124 (10):1132-7. DOI: 10.1161/CIRCULATIONAHA.111.029165.

5. The Task Force for the Diagnosis and Treatment of Non-ST-Segment Elevation Acute Coronary Syndromes of the European Society of Cardiology. Guidelines for the diagnosis and treatment of non-ST segment elevation acute coronary syndromes. Eur Heart J 2007; 28: 1598-660. DOI: 10.1093/eurheartj/ehm161.

6. Palmerini T, Barozzi C, Tomasi L, et al. A randomised study comparing the antiplatelet and antiinflammatory effect of clopidogrel 150 mg/day versus 75 mg/day in patients with ST– segment elevation acute myocardial infarction and poor responsiveness to clopidogrel: results from the DOUBLE study. Thromb Res. 2010; 125 (4): 309-14. DOI: 10.1016/j. thromres.2009.06.016.

7. Cannon CP, Harrington RA, James S, et al. Comparison of ticagrelor with clopidogrel in patients with a planned invasive strategy for acute coronary syndromes (PLATO): a randomised double-blind study. Lancet. 2010; 375 (9711): 283-93. DOI: 10.1016/S0140-6736(09)62191-7.

8. Held C, Asenblad N, Bassand JP, et al. Ticagrelor versus clopidogrel in patients with acute coronary syndromes undergoing coronary artery bypass surgery: results from the PLATO (Platelet Inhibition and Patient Outcomes) trial. J. Am. Coll. Cardiol. 2011; 57(6):672-84. DOI: 10.1016/j.jacc.2010.10.029.

9. James SK, Roe MT, Cannon CP, et al. PLATO Study Group. Ticagrelor versus clopidogrel in patients with acute coronary syndromes intended for non-invasive management: substudy from prospective e randomized PLATelet inhibition and patient Outcomes (PLATO) trial. BMJ. 2011; 342: d3527. DOI: 10.1136/bmj.d3527.

10. Lindholm D, Varenhorst C, Cannon CP et al. Ticagrelor vs. clopidogrel in patients with nonST-elevation acute coronary syndrome with or without revascularization: results from the PLATO trial. Eur.Heart J. 2014; 35 (31): 2083-93. DOI: 10.1093/eurheartj/ehu160.

11. Montalescot G, van’t Hof AW, Lapostolle F, et al. ATLANTIC Investigators. Prehospital ticagrelor in ST-elevation myocardial infarction. N. Engl. J. Med. 2014; 371: 1016-27.

12. Tavlueva EV, Yarkovskaya AP, Penskaya TY, et al. Hypoaggregatory effect in patients with myocardial infarction with an elevation of the ST segment with the replacement of clopidogrel with ticagrelor. Atherothrombosis. 2016; 2: 54-60. (In Russ.) Тавлуева Е. В., Ярковская А. П., Алексеенко А. В., и др. Гипоагрегационный эффект у больных инфарктом миокарда с подъёмом сегмента ST при замене клопидогрела на тикагрелор. Атеротромбоз, 2016; 2: 54-60. DOI: 10.21518/2307-1109-2016-2-54-60.