Utilisation review of clopidogrel: are they used under the FDA-approved indications?
BACKGROUND
Clopidogrel has shown benefit in patients with increased risk of cardiovascular diseases. Due to its high acquisition cost and its increased use, this study was conducted to review the use of clopidogrel based on the Food and Drug Administration (FDA)-approved indications and the ST-segment elevation myocardial infarction (STEMI).


METHODS
This was a cross-sectional study conducted at a tertiary-care, university-affiliated hospital in the Northern part of Thailand. Medical records of patients receiving clopidogrel during January 2005 to February 2006 were reviewed. Baseline characteristics of patients along with specific information regarding the use of clopidogrel were collected. Data were analysed using descriptive statistics.


RESULTS
A total of 191 patients were included in this utilisation review (95 and 96 were inpatient and outpatient, respectively). The use of clopidogrel was deemed appropriate in 82.7% of cases including 72.2% for FDA-approved indications and 10.5% for STEMI. Clopidogrel/aspirin combination was indicated in 93 patients; however, 22 patients received clopidogrel monotherapy. On the contrary, 10 patients received clopidogrel/aspirin combination when only clopidogrel monotherapy was indicated. Moreover, 60% of patients who received clopidogrel monotherapy had no history of aspirin intolerance or recurrent events while on aspirin therapy.


CONCLUSIONS
The results showed that the majority of clopidogrel use was deemed appropriate based on FDA-approved indications and for medically justified indication. However, a significant number of patients received clopidogrel instead of aspirin while no aspirin intolerance was documented. Therefore, efforts should be made to promote the appropriate use of this agent to improve patient outcomes.
Niruntraporn
Surachet
S
Faculty of Pharmaceutical Sciences, Department of Pharmacy Practice, Naresuan University, Phitsanulok, Thailand.
Chaiyakunapruk
Nathorn
N
Nathisuwan
Surakit
S
Thamlikitkul
Visanu
V
D054058:Acute Coronary Syndrome / Q000188:drug therapy; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000009:adverse effects / Q000627:therapeutic use; D000077144:Clopidogrel; D003430:Cross-Sectional Studies; D004359:Drug Therapy, Combination; D017723:Drug Utilization Review / Q000379:methods*; D006785:Hospitals, University / Q000706:statistics & numerical data*; D006801:Humans; D007297:Inpatients / Q000706:statistics & numerical data; D008499:Medical Records / Q000706:statistics & numerical data; D008875:Middle Aged; D010045:Outpatients / Q000706:statistics & numerical data; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D012189:Retrospective Studies; D013785:Thailand; D013988:Ticlopidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000592:standards
D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin