Evaluating the bioequivalence of clopidogrel generic formulations

References

• Mehta SR, Yusuf S, Peters RJ, et al. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet 2001;358:527-33
   PubMed Web of Science ®Google Scholar
• Steinhubl SR, Berger PB, Mann JT III, et al. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial. JAMA 2002;288:2411-20
   PubMed Web of Science ®Google Scholar
• Chen ZM, Jiang LX, Chen YP, et al. Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial. Lancet 2005;366:1607-21
   PubMed Web of Science ®Google Scholar
• 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;352:1179-89
   PubMed Web of Science ®Google Scholar
• Yusuf S, Zhao F, Mehta SR, et al. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med 2001;345:494-502
   PubMed Web of Science ®Google Scholar
• Agrawal H, Kaul N, Paradkar AR, Mahadik KR. Stability indicating HPTLC determination of clopidogrel bisulphate as bulk drug and in pharmaceutical dosage form. Talanta 2003;61:581-9
   PubMed Web of Science ®Google Scholar
• Zupancic V, Smrkolj M, Benkic P, et al. Preformulation investigation of some clopidogrel addition salts. Acta Chim Slov 2010;57:376-85
   PubMed Web of Science ®Google Scholar
• Tsoumani ME, Kalantzi KI, Goudevenos IA, Tselepis AD. Clopidogrel generic formulations in the era of new antiplatelets: a systematic review. Curr Vasc Pharmacol 2014;12:766-77
   PubMed Web of Science ®Google Scholar
• Davies G. Changing the salt, changing the drug. Pharm J 2001;266:322-3
   Google Scholar
• Di Girolamo G, Czerniuk P, Bertuola R, Keller GA. Bioequivalence of two tablet formulations of clopidogrel in healthy Argentinian volunteers: a single-dose, randomized-sequence, open-label crossover study. Clin Ther 2010;32:161-70
   PubMed Web of Science ®Google Scholar
• Khosravi AR, Pourmoghadas M, Ostovan M, et al. The impact of generic form of clopidogrel on cardiovascular events in patients with coronary artery stent: results of the OPCES study. J Res Med Sci 2011;16:640-50
   Web of Science ®Google Scholar
• Suh JW, Seung KB, Gwak CH, et al. Comparison of antiplatelet effect and tolerability of clopidogrel resinate with clopidogrel bisulfate in patients with coronary heart disease (CHD) or CHD-equivalent risks: a phase IV, prospective, double-dummy, parallel-group, 4-week noninferiority trial. Clin Ther 2011;33:1057-68
   PubMed Web of Science ®Google Scholar
• Borsiczky B, Sarszegi Z, Konyi A, et al. The effect of clopidogrel besylate and clopidogrel hydrogensulfate on platelet aggregation in patients with coronary artery disease: a retrospective study. Thromb Res 2012;129:700-3
   PubMed Web of Science ®Google Scholar
• Ashraf T, Ahmed M, Talpur MS, et al. Competency profile of locally manufactured clopidogrel Lowplat and foreign manufactured clopidogrel Plavix in patients of suspected ischemic heart disease (CLAP-IHD). J Pak Med Assoc 2005;55:443-8
   PubMedGoogle Scholar
• Park JB, Koo BK, Choi WG, et al. Comparison of antiplatelet efficacy and tolerability of clopidogrel napadisilate with clopidogrel bisulfate in coronary artery disease patients after percutaneous coronary intervention: a prospective, multicenter, randomized, open-label, phase IV, noninferiority trial. Clin Ther 2013;35:28-37 e4
   PubMed Web of Science ®Google Scholar
• Caldeira D, Fernandes RM, Costa J, et al. Branded versus generic clopidogrel in cardiovascular diseases: a systematic review. J Cardiovasc Pharmacol 2013;61:277-82
   PubMed Web of Science ®Google Scholar
• Marcucci R, Paniccia R, Gori AM, et al. Bioequivalence in the real world is a complex challenge: the case of clopidogrel. J Am Coll Cardiol 2013;61:594-5
   PubMed Web of Science ®Google Scholar
• Kovacic JC, Mehran R, Sweeny J, et al. Clustering of acute and subacute stent thrombosis related to the introduction of generic clopidogrel. J Cardiovasc Pharmacol Ther 2014;19:201-8
   PubMed Web of Science ®Google Scholar
• Kim SH, Sung JH, Shin J, et al. Assessment of the efficacy and tolerability of clopidogrel napadisilate in Korean patients with coronary stenting: a multicenter, prospective, open-label, randomized trial. Curr Med Res Opin 2015;31:449-57
   PubMed Web of Science ®Google Scholar
• Kim YI, Kim KS, Suh KH, et al. New clopidogrel napadisilate salt and its solid dispersion with improved stability and bioequivalence to the commercial clopidogrel bisulphate salt in beagle dogs. Int J Pharm 2011;415:129-39
   PubMed Web of Science ®Google Scholar
• Jeong YH, Bliden KP, Antonino MJ, et al. Usefulness of the VerifyNow P2Y12 assay to evaluate the antiplatelet effects of ticagrelor and clopidogrel therapies. Am Heart J 2012;164:35-42
   PubMed Web of Science ®Google Scholar
• Price MJ, Nayak KR, Barker CM, et al. Predictors of heightened platelet reactivity despite dual-antiplatelet therapy in patients undergoing percutaneous coronary intervention. Am J Cardiol 2009;103:1339-43
   PubMed Web of Science ®Google Scholar
• Tidjane MA, Voisin S, Lhermusier T, et al. More on: adenosine diphosphate-inducible platelet reactivity shows a pronounced age dependency in the initial phase of antiplatelet therapy with clopidogrel. J Thromb Haemost 2011;9:614-16
   PubMed Web of Science ®Google Scholar
• Bertrand ME, Rupprecht HJ, Urban P, Gershlick AH. Double-blind study of the safety of clopidogrel with and without a loading dose in combination with aspirin compared with ticlopidine in combination with aspirin after coronary stenting: the clopidogrel aspirin stent international cooperative study (CLASSICS). Circulation 2000;102:624-9
   PubMed Web of Science ®Google Scholar
• Kwok CS, Rao SV, Myint PK, et al. Major bleeding after percutaneous coronary intervention and risk of subsequent mortality: a systematic review and meta-analysis. Open Heart 2014;1:e000021
   PubMedGoogle Scholar
• Isshiki T, Kimura T, Ueno T, et al. Clopidogrel trial in patients with elective percutaneous coronary intervention for stable angina and old myocardial infarction (CLEAN). Int Heart J 2012;53:91-101
   PubMed Web of Science ®Google Scholar
• Fox KA, Mehta SR, Peters R, et al. Benefits and risks of the combination of clopidogrel and aspirin in patients undergoing surgical revascularization for non-st-elevation acute coronary syndrome: the Clopidogrel in Unstable angina to prevent Recurrent ischemic Events (CURE) trial. Circulation 2004;110:1202-8
   PubMed Web of Science ®Google Scholar
• Ntalas IV, Kalantzi KI, Tsoumani ME, et al. Generic clopidogrel besylate in the secondary prevention of atherothrombotic events: a 6-month follow-up of a randomised clinical trial. Curr Vasc Pharmacol 2015; accepted for publication
   Google Scholar
• Windecker S, Kolh P, Alfonso F, et al. 2014 ESC/EACTS guidelines on myocardial revascularization: the Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J 2014;35:2541-619
   PubMed Web of Science ®Google Scholar
• Wijns W, Kolh P, Danchin N, et al. Guidelines on myocardial revascularization. Eur Heart J 2010;31:2501-55
   PubMed Web of Science ®Google Scholar
• Mauri L, Kereiakes DJ, Yeh RW, et al. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med 2014;371:2155-66
   PubMed Web of Science ®Google Scholar
• Gilard M, Barragan P, Noryani AA, et al. 6- versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin: the randomized, multicenter ITALIC trial. J Am Coll Cardiol 2015;65:777-86
   PubMed Web of Science ®Google Scholar
• Sadanandan S, Singh IM. Clopidogrel: the data, the experience, and the controversies. Am J Cardiovasc Drugs 2012;12:361-74
   PubMed Web of Science ®Google Scholar
• Hassan AE, Zacharatos H, Suri MF, Qureshi AI. Drug evaluation of clopidogrel in patients with ischemic stroke. Expert Opin Pharmacother 2007;8:2825-38
   PubMed Web of Science ®Google Scholar