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

Suh, Jung Won; Seung, Ki Bae; Gwak, Chung Hwan; Kim, Kwon Sam; Hong, Soon Jun; Park, Tae Ho; Kim, Sang Hyun; Choi, Young Jin; Joo, Seung Jea; Tahk, Seung Jea; Kim, Hyo Soo

doi:10.1016/j.clinthera.2011.07.001

Cited by 13 publications

(8 citation statements)

References 39 publications

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“…Of the 745 papers initially retrieved (online PRISMA flow diagram), we included 74 randomized trials comparing generic vs brand-name drugs against cardiovascular diseases [ 9 – 13 , 15 – 40 , 42 , 43 , 53 – 56 , 61 – 96 ]: 53 trials evaluated at least one efficacy outcome (overall sample 3051), 32 trials measured mild or moderate adverse events (n = 2407), and 52 reported on serious adverse events (n = 2952). Among the 53 trials including at least one efficacy outcome, we could extract hard outcomes (MACE or death) from 3 trials only, and soft outcomes from 52 trials.…”

Section: Resultsmentioning

confidence: 99%

“…inhibition (E), mAEs (S), sAEs (S) Generic manufacturer No Di Girolamo [ 70 ] 2010 Argentina Clopidogrel Healthy 34 12 h Cross-over 24 (24) sAEs (S) Generic manufacturer No Müller [ 74 ] 2010 Venezuela Clopidogrel Healthy 23 7 days Cross-over 20 (20) Platelet aggr. inhibition (E) Not reported No Shim [ 95 ] 2010 Korea Clopidogrel Healthy 29 1 week Cross-over 29 (29) Bleeding time (E), sAEs (S) Generic manufacturer No Khosravi [ 71 ] 2011 Iran Clopidogrel PCI 59 6 months Parallel-group 442 (224) MACE and death (E) Generic manufacturer IRCT 138712111723N1 Suh [ 96 ] 2011 Korea Clopidogrel CVD 62 4 weeks …”

Section: Resultsmentioning

confidence: 99%

“…Overall, 8 serious possibly drug-related adverse events were reported in 52 studies: 5 events among the 2134 subjects who assumed generics (819 from parallel-group RCTs and 1315 from cross-over RCTs; rate = 2.34 ‰); 3 events among the 2136 subjects who assumed brand-name drugs (815 from parallel-group RCTs and 1321 from cross-over RCTs; rate = 1.40 ‰). All but 1 event were reported by industry-sponsored Asian studies, published after the year 2005, with follow-up longer than 27 days [ 22 , 39 , 92 , 96 ]. No deaths were reported, and all cases made a full recovery.…”

Section: Resultsmentioning

confidence: 99%

“…The only other published meta-analysis to-date on this topic, although rigorously done, only included 50, 23 and 71 subjects in the evaluation of antiplatelet agents, ACE inhibitors and statins, respectively [ 4 ]. Also, most of these subjects had been followed for <2 days, only efficacy outcomes were combined, and many trials have been published later on [ 32 , 54 , 55 , 63 , 64 , 67 – 72 , 74 – 81 , 83 , 84 , 86 – 96 ]. In the present meta-analysis all 53 RCTs evaluating efficacy outcomes found no significant differences between generic and brand-name cardiovascular drugs.…”

Section: Discussionmentioning

confidence: 99%

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Generic versus brand-name drugs used in cardiovascular diseases

et al. 2015

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This meta-analysis aimed to compare the efficacy and adverse events, either serious or mild/moderate, of all generic versus brand-name cardiovascular medicines. We searched randomized trials in MEDLINE, Scopus, EMBASE, Cochrane Controlled Clinical Trial Register, and ClinicalTrials.gov (last update December 1, 2014). Attempts were made to contact the investigators of all potentially eligible trials. Two investigators independently extracted and analyzed soft (including systolic blood pressure, LDL cholesterol, and others) and hard efficacy outcomes (including major cardiovascular adverse events and death), minor/moderate and serious adverse events. We included 74 randomized trials; 53 reported ≥1 efficacy outcome (overall sample 3051), 32 measured mild/moderate adverse events (n = 2407), and 51 evaluated serious adverse events (n = 2892). We included trials assessing ACE inhibitors (n = 12), anticoagulants (n = 5), antiplatelet agents (n = 17), beta-blockers (n = 11), calcium channel blockers (n = 7); diuretics (n = 13); statins (n = 6); and others (n = 3). For both soft and hard efficacy outcomes, 100 % of the trials showed non-significant differences between generic and brand-name drugs. The aggregate effect size was 0.01 (95 % CI −0.05; 0.08) for soft outcomes; −0.06 (−0.71; 0.59) for hard outcomes. All but two trials showed non-significant differences in mild/moderate adverse events, and aggregate effect size was 0.07 (−0.06; 0.20). Comparable results were observed for each drug class and in each stratified meta-analysis. Overall, 8 serious possibly drug-related adverse events were reported: 5/2074 subjects on generics; 3/2076 subjects on brand-name drugs (OR 1.69; 95 % CI 0.40–7.20). This meta-analysis strengthens the evidence for clinical equivalence between brand-name and generic cardiovascular drugs. Physicians could be reassured about prescribing generic cardiovascular drugs, and health care organization about endorsing their wider use.Electronic supplementary materialThe online version of this article (doi:10.1007/s10654-015-0104-8) contains supplementary material, which is available to authorized users.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Generic versus brand-name drugs used in cardiovascular diseases

et al. 2015

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“…Most of the studies performed to date have demonstrated that the pharmacodynamic potency as well as the clinical efficacy and safety profile of generic clopidogrel salt formulations are similar to the original clopidogrel hydrogen sulphate [11][12][13][14][15][16] . In contrast, a pharmacodynamic study of clopidogrel base performed in a relatively large cohort showed that this generic formulation is less *Plavix and Iscover are registered trade names of Bristol-Meyers Squibb/Sanofi-Pharmaceuticals Partnership, Bridgewater, NJ, USA effective in inhibiting adenosine diphosphate (ADP)-induced platelet activation compared with the original clopidogrel hydrogen sulfate 17 .…”

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confidence: 99%