title: A randomized comparison of platelet reactivity in patients after treatment with various commercial clopidogrel preparations: the CLO-CLO trial.
abstract: BACKGROUND
  The salt linked to the clopidogrel molecule in generic preparations is suspected to affect its clinical efficacy. There is a lack of information about inhibition of platelet reactivity by generic preparations.
  
  
  OBJECTIVE
  To compare the effect of original clopidogrel (clopidogrel bisulphate [Plavix(®)]), generic clopidogrel preparations (clopidogrel hydrochloride [Clopidogrel-Mepha(®)]; clopidogrel besylate [Clopidogrel Sandoz(®)]) and prasugrel (Efient(®)) on platelet reactivity in patients with coronary artery disease.
  
  
  METHODS
  Patients with coronary artery disease treated with stents received, in a random sequence, original clopidogrel bisulphate, clopidogrel hydrochloride and clopidogrel besylate. Platelet function was assessed with the Multiplate analyser after an initial loading dose (600 mg) and at day 10 after each treatment period. Prasugrel was given for another 10 days. An adenosine diphosphate (ADP) test value<46 antiaggregation units (U) was defined as therapeutic platelet inhibition.
  
  
  RESULTS
  Sixty patients (mean age 69 ± 10 years; 50 men) were randomized. Original clopidogrel bisulphate, clopidogrel hydrochloride and clopidogrel besylate provided similar inhibition of platelet reactivity with values of 31 ± 25, 33 ± 28 and 28 ± 23 U, respectively (P not significant). Prasugrel provided better inhibition of platelet function (10 ± 11 vs. 31 ± 25 U for clopidogrel bisulphate; P<0.001). An ADP test value>46 U was measured in 11 patients (18%) with clopidogrel bisulphate, 13 (22%) with clopidogrel besylate and 13 (22%) with clopidogrel hydrochloride compared with only one (2%) with prasugrel.
  
  
  CONCLUSIONS
  Generic clopidogrel preparations provided similar inhibition of platelet reactivity to original clopidogrel bisulphate, although prasugrel was more efficient.
authors.affiliation: Service de Cardiologie, Hôpital Cantonal, Fribourg, Switzerland.
authors.forename: Markus
authors.initials: M
authors.lastname: Oberhänsli
authors.forename: Cédric
authors.initials: C
authors.lastname: Lehner
authors.forename: Serban
authors.initials: S
authors.lastname: Puricel
authors.forename: Sonja
authors.initials: S
authors.lastname: Lehmann
authors.forename: Mario
authors.initials: M
authors.lastname: Togni
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Stauffer
authors.forename: Gérard
authors.initials: G
authors.lastname: Baeriswyl
authors.forename: Jean-Jacques
authors.initials: JJ
authors.lastname: Goy
authors.forename: Stéphane
authors.initials: S
authors.lastname: Cook
mesh_terms: D000244:Adenosine Diphosphate / Q000494:pharmacology; D000368:Aged; D000369:Aged, 80 and over; D000077144:Clopidogrel; D018592:Cross-Over Studies; D016568:Drugs, Generic / Q000493:pharmacokinetics / Q000494:pharmacology* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000601:surgery; D018579:Patient Selection; D062645:Percutaneous Coronary Intervention; D010879:Piperazines / Q000493:pharmacokinetics / Q000494:pharmacology* / Q000627:therapeutic use; D015539:Platelet Activation / Q000187:drug effects*; D010975:Platelet Aggregation Inhibitors / Q000493:pharmacokinetics / Q000494:pharmacology* / Q000627:therapeutic use; D000068799:Prasugrel Hydrochloride; D016037:Single-Blind Method; D015607:Stents; D013810:Therapeutic Equivalency; D013876:Thiophenes / Q000493:pharmacokinetics / Q000494:pharmacology* / Q000627:therapeutic use; D013927:Thrombosis / Q000517:prevention & control; D013988:Ticlopidine / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D016568:Drugs, Generic; D010879:Piperazines; D010975:Platelet Aggregation Inhibitors; D013876:Thiophenes; D000244:Adenosine Diphosphate; D000077144:Clopidogrel; D000068799:Prasugrel Hydrochloride; D013988:Ticlopidine