Preview

Meditsinskiy sovet = Medical Council

Advanced search

Use of clopidogrel generics in patients with acute coronary syndrome: have all issues have been resolved?

https://doi.org/10.21518/2079-701X-2014-12-40-43

Abstract

Effective care in acute coronary syndrome (ACS) is aimed to reduce mortality from cardiovascular causes, reduce mortality and disability of patients of working age, as well as decrease the financial burden. The key aspect of treatment of ACS patients is effective antiplatelet therapy, especially in high-risk patients and patients undergoing percutaneous interventions. Clopidogrel today remains one of the most widely used drugs in the treatment of such patients. Application of generic forms of clopidogrel in clinical practice is quite common. At the same time, there are methodological difficulties in assessing the equivalence of the original and reproduced forms due to the specificity of the pharmacokinetic and pharmacodynamic properties of clopidogrel. The currently available data are not enough for a clear prognosis of administration of generic forms in patients with ACS.

About the Author

AN Yakovlev
V.A. Almazov Federal Medical Research Centre, Ministry of Health of the Russian Federation, St. Petersburg
Russian Federation


References

1. WHO Fact Sheet №310, May 2014. The top 10 causes of death. http://www.who.int/mediacentre/factsheets/fs310/en.

2. Gitt A.K., Betriu A. Antiplatelet therapy in acute coronary syndromes. Eur Heart], 2008, 10 (Suppl. A): A4-A12.

3. Rossini R, Capodanno D, Lettieri C et al. Prevalence, predictors, and long-term prognosis of premature discontinuation of oral antiplatelet therapy after drug eluting stent implantation. Am] Cardiol, 2011, 107 (2): 186-194.

4. Wiviott SD, Braunwald E, McCabe CH et al. Prasugrel versus Clopidogrel in Patients with Acute Coronary Syndromes. N Engl]Med, 2007, 357: 2001-2015.

5. Wallentin L, Becker RC, Budaj A et al. Ticagrelor versus Clopidogrel in Patients with Acute Coronary Syndromes. N Engl] Med, 2009, 361: 1045-1057.

6. Heikkila R., Mantyselka R., Ahonen R. Price, familiarity, and availability determine the choice of drug - a population-based survey five years after generic substitution was introduced in Finland. BMC Clinical Pharmacology, 2011, 11: 20-26.

7. CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). Lancet, 1996, 348: 1329-1339.

8. Budaj A, Yusuf S, Mehta SR et al. Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) Trial Investigators. Benefit of clopidogrel in patients with acute coronary syndromes without ST-segment elevation in various risk groups. Circulation, 2002, 106: 1622-1626.

9. Sabatine MS, Cannon CP, Gibson CM et al. Addition of clopidogrel.to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. N Engl J Med, 2005, 352: 1179-1189.

10. Chen ZM, Jiang LX, Chen YP et al. Addition.of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: randomised placebocontrolled trial. Lancet, 2005, 366: 1607-1621.

11. Kazui M, Nishiya Y, Ishizuka T, et al. Identification of the human cytochrome P450 enzymes involved in the two oxidative steps in the bioactivation of clopidogrel to its pharmacologically active metabolite. Drug Metab Dispos, 2010, 38: 92-99.

12. Bates ER, Lau WC, Angiolillo DJ. Clopidogrel-Drug Interactions. J Am Coll Cardiol, 2011, 57: 1251-1263.

13. Harrison AL, Frelinger MI, Furmanb AD et al. Measuring antiplatelet drug effects in the laboratory. Thrombosis Research. 2007, 120: 323-336.

14. Gomez Y, Adams E, Hoogmartens J. Analysis of purity in 19 drug product tablets containing clopidogrel: 18 copies versus the original brand. Journal of Pharmaceutical and Biomedical Analysis, 2004, 34: 341-348.

15. Caldeira D, Fernandes RM, Costa J et al. Branded Versus Generic Clopidogrel in Cardiovascular Diseases: A Systematic Review] CardiovascPharmacol., 2013, 61 (4): 277-282.

16. Bliden KP, Baker BA, Nolin TD et al. Thienopyridine efficacy and cigarette smoking status. Am Heart], 2013, 165: 693-703.

17. Gurbel PA, Bliden KP, Butler K et al. Randomized double-blind assessment of the ONSET and OFFSET of the antiplatelet effects of ticagrelor versus clopidogrel in patients with stable coronary artery disease: the ONSET/OFFSET study Circulation, 2009, 120 (25): 2577-2585.

18. Alexopoulos D, Xanthopoulou I, Gkizas V et al. Randomized assessment of ticagrelor versus prasugrel antiplatelet effects in patients with ST-segment-elevation myocardial infarction. Circ Cardiovasc Interv, 2012, 5 (6): 797-804.

19. van der Meersch A, Dechartres A, Ravaud P. Quality of Reporting of Bioequivalence Trials Comparing Generic to Brand Name Drugs: A Methodological Systematic Review. PLoS ONE, 6 (8): e23611.


Review

For citations:


Yakovlev A. Use of clopidogrel generics in patients with acute coronary syndrome: have all issues have been resolved? Meditsinskiy sovet = Medical Council. 2014;(12):40-43. (In Russ.) https://doi.org/10.21518/2079-701X-2014-12-40-43

Views: 339


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2079-701X (Print)
ISSN 2658-5790 (Online)