Competency profile of locally manufactured clopidogrel Lowplat and foreign manufactured clopidogrel Plavix in patients of suspected ischemic heart disease (CLAP-IHD).
OBJECTIVE
The primary objective of this study was to test the hypothesis that the antiplatelet effects of loading dose of locally manufactured clopidogrel Lowplat referred as drug (B) 600 mg (8 tablets) given once is comparable to the antiplatelet effects of loading dose of foreign manufactured clopidogrel Plavix referred as drug (A) 600 mg (8 tablets) given once in patients with suspected ischemic heart disease.


METHODS
This was a double blind, randomized, cross over, study, to compare the safety and efficacy of study drug (B) versus (A) in adult subjects suffering from suspected ischemic heart disease presented at National Institute of Cardiovascular Disease (NICVD), Karachi.


RESULTS
Mean platelet aggregation inhibition by drug (B) was 60.7% (p<0.001), while with drug (A) it was 57.8% (p<0.001), using 20 micromol/L ADP, which is statistically significant and comparable. Clopidogrel 600 mg as loading dose was well tolerated.


CONCLUSIONS
Both drugs were equally effective in reducing the platelet aggregation. CLAP-IHD confirmed that drug (B) and (A) are equally effective and comparable antithrombotics in Pakistani population. The cost benefit of drug (B) should be made beneficial to the patients.
Ashraf
Tariq
T
National Institute of Cardiovascular Diseases, Karachi, Pakistan.
Ahmed
Munir
M
Talpur
M Saeed
MS
Kundi
Asadullah
A
Faruqui
Azhar Masood A
AM
Jaffery
Abdul Hafeez
AH
Fareed
Aslam
A
D000284:Administration, Oral; D000328:Adult; D000077144:Clopidogrel; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D016568:Drugs, Generic / Q000493:pharmacokinetics* / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000188:drug therapy / Q000378:metabolism*; D010154:Pakistan; D010975:Platelet Aggregation Inhibitors / Q000493:pharmacokinetics* / Q000627:therapeutic use; D012189:Retrospective Studies; D013810:Therapeutic Equivalency; D013988:Ticlopidine / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D016896:Treatment Outcome; D014481:United States
D016568:Drugs, Generic; D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine