Salts of Clopidogrel: Investigation to Ensure Clinical Equivalence: A 12-Month Randomized Clinical Trial

Ntalas, Ioannis; Kalantzi, Kallirroi I; Tsoumani, Maria; Bourdakis, Adamantios; Charmpas, Christos; Christogiannis, Zaharias; Dimoulis, Nikolaos; Draganigos, Antonios; Efthimiadis, I.; Giannakoulas, George; Giatrakos, Ioannis; Giogiakas, Vassilios; Goumas, G.; Hatziathanasiou, Giorgos; Kazakos, Evangelos; Kipouridis, Nikolaos; Konstantinou, Spiros; Milionis, Haralampos; Nikolopoulos, Dimitrios; Peltekis, Leonidas; Prokopakis, Nikolaos; Sinteles, Ioannis; Stroumbis, Christos S.; Terzoudi, Kyriafina; Thoma, Maria; Tsilias, Karmelos; Vakalis, Ioannis; Vardakis, Konstantinos E.; Vasilakopoulos, Vasileios; Vemmos, Konstantinos; Voukelatou, Maria; Xaraktsis, Ioannis; Panagiotakos, Demosthenes B.; Goudevenos, John; Tselepis, Alexandros D.

doi:10.1177/1074248416644343

Cited by 6 publications

(3 citation statements)

References 35 publications

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“…In this work it was revealed that at 12 months of follow-up, the clinical endpoint had occurred in a relatively low number of patients, below 5% of the total number of ACS patients who participated in the study, without any differences between genders, or between those patients living in mainland urban areas or on the islands. As for the all-cause mortality rate, this was low, probably due to the short-term follow-up period, the result of which was in accordance with our previously published study using the same generic clopidogrel formulation [ 16 ]. Furthermore, the use of the generic clopidogrel besylate was quite high (81–90%) in both urban and insular areas.…”

Section: Discussionsupporting

confidence: 90%

“…Therefore, it is important that any efficacy or safety concern arising from the use of generic clopidogrel in CVD patients should be referred to the specific product used. In this regard, our previous studies have demonstrated that the pharmacodynamic potency as well as clinical efficacy and safety profile of the generic clopidogrel used in the present study are similar to those of the original drug [16,[22][23][24]. In the present work, the 12-month composite clinical endpoint remained quite low, with the use of generic clopidogrel being at a high level, while multivariate analysis revealed that original and generic forms of clopidogrel did not present any significant differences in terms of the examined efficacy outcome (Table II).…”

Section: Protective Effect Harmful Effectsupporting

confidence: 65%

“…A number of studies aiming to compare the efficacy and safety of generic versus original clopidogrel in CVD, including ACS patients, have shown conflicting results, with some studies reporting no differences and others suggesting important potential differences [16][17][18][19][20]. A very recent study assessed primary causative adverse events after brand clopidogrel and generic clopidogrel use in the Food and Drug Administration (FDA) Adverse Event Reporting System.…”

Section: Protective Effect Harmful Effectmentioning

confidence: 99%

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The incidence of recurrent cardiovascular events among acute coronary syndrome patients treated with generic or original clopidogrel in relation to their sociodemographic and clinical characteristics. The Aegean study

Patsourakos

Kouvari

Kotidis

et al. 2020

aoms

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Introduction The use of generic drugs is continuously growing; however, there are limited epidemiological data regarding the therapeutic equivalence of each original drug formulation with its generic counterparts. We evaluated the 12-month composite endpoint of recurrent acute myocardial infarction, ischaemic stroke, cardiac deaths, or hospitalisation due to a major bleeding in acute coronary syndrome (ACS) patients treated with original clopidogrel or a generic clopidogrel formulation, in relation to sociodemographic and clinical characteristics. Material and methods Consecutive Greek ACS patients ( n = 1194) hospitalised in the Aegean islands and the Attica region were enrolled. Clopidogrel treatment was recorded either as original clopidogrel hydrogen sulphate (Plavix ® /Iscover ® ) or as a generic clopidogrel besylate formulation (Clovelen ® ). The composite endpoint was recorded at 12-month follow-up. Results The 12-month composite endpoint was 3.9% (4.6% in the Aegean islands and 3.5% in the Attica area, p > 0.05). The respective incidence in men was 4.0% and in women 3.8% ( p > 0.05). Overall, generic and original clopidogrel use was 87% and 13% of patients, respectively. No significant differences were observed between original and generic clopidogrel use and 12-month composite endpoint incidence. Subgroup analysis with gender, region of residence, and clinical and lifestyle factors as strata did not reveal any significant outcomes. Haemorrhage incidence did not exceed 1% in the total sample. Conclusions The use of a generic clopidogrel besylate formulation was quite high in both urban and insular areas of Greece and had similar efficacy and safety profile with the original clopidogrel salt, supporting the routine use of this low-cost generic clopidogrel in the management of cardiovascular disease patients.

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Section: Discussionsupporting

confidence: 90%

Section: Protective Effect Harmful Effectsupporting

confidence: 65%

Section: Protective Effect Harmful Effectmentioning

confidence: 99%

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The incidence of recurrent cardiovascular events among acute coronary syndrome patients treated with generic or original clopidogrel in relation to their sociodemographic and clinical characteristics. The Aegean study

Patsourakos

Kouvari

Kotidis

et al. 2020

aoms

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Comparison of 4 different strategies of DAPT after PCI in ACS real world population from a Northern Italy registry

Rasia¹,

Solinas²,

Marino

et al. 2017

J Thromb Thrombolysis

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Aim of the study was to compare four different strategies of dual antiplatelet therapy (DAPT) in patients with acute coronary syndromes (ACS) treated with PCI. DAPT with Clopidogrel, Ticagrelor and Prasugrel has proved to be effective in patients with ACS treated with percutaneous coronary intervention (PCI) by reducing major adverse cardiovascular outcomes (MACE). However, the effect of the different strategies in a real-world population deserves further verification. A retrospective analysis of 2404 discharged ACS patients treated with PCI was performed, with a median follow-up of 1 year. The study population was stratified in four drug treatment cohorts: ASA + Clopidogrel (A-C), ASA + Plavix (A-PLx), ASA + Ticagrelor (A-T), ASA + Prasugrel (A-P). We assessed the incidence of net adverse cardiovascular events (NACE): all-cause death, myocardial infarction (MI), target vessel revascularization (TVR), stroke and bleeding during follow-up. At 1-year, the use of A-C and A-PLx was associated with the highest cumulative incidence of NACE in comparison with A-T and A-P therapies (respectively 14.8 and 29.6% vs. 9.2 and 6%). This difference was mainly driven by the mortality and TVR outcomes. Considering selection bias and differences in the patients baseline characteristics, the association of A-T and A-P seems to be superior in comparison with a DAPT strategy of A-C and A-PLx in low risk ACS-PCI patients from real world. In our Region the prescription is consistent with guidelines recommendations and Clopidogrel and Plavix are still predominantly used in older patients with more comorbidities, and this could partially explain the inferiority of this association.

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Are Generic Drugs Used in Cardiology as Effective and Safe as their Brand-name Counterparts? A Systematic Review and Meta-analysis

Leclerc

Thibault

Gonella

et al. 2020

Drugs

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Salts of Clopidogrel: Investigation to Ensure Clinical Equivalence: A 12-Month Randomized Clinical Trial

Abstract: The efficacy and safety of CB administered for 12 months for the secondary prevention of atherothrombotic events are similar to that of CHS. (Salts of Clopidogrel: Investigation to ENsure Clinical Equivalence, SCIENCE trial; ClinicalTrials.gov Identifier:NCT02126982).

Cited by 6 publications

References 35 publications

The incidence of recurrent cardiovascular events among acute coronary syndrome patients treated with generic or original clopidogrel in relation to their sociodemographic and clinical characteristics. The Aegean study

The incidence of recurrent cardiovascular events among acute coronary syndrome patients treated with generic or original clopidogrel in relation to their sociodemographic and clinical characteristics. The Aegean study

Comparison of 4 different strategies of DAPT after PCI in ACS real world population from a Northern Italy registry

Are Generic Drugs Used in Cardiology as Effective and Safe as their Brand-name Counterparts? A Systematic Review and Meta-analysis

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