"This is one study, one piece of the data puzzle, but it certainly suggests that we may be able to help promote improved patient safety through outreach and education," said Ed Pezalla, MD, national medical director for Aetna Pharmacy Management and co-author of the analysis. "We have notified the FDA of our findings and are making physicians aware of the potential risks of taking these medications together."
Aetna is currently working to create a clinical alert to physicians and pharmacists when these two medications are prescribed concurrently.
Aetna Pharmacy Management's (APM) Pharmacy Outcomes Research team conducted the analysis following a previous report on clopidogrel in the Journal's January 2008 issue, which suggested PPIs can have a negative influence on the antiplatelet action of clopidogrel. Following the publication of this report, the team analyzed Aetna's medical and pharmacy claims information to see if the data showed a difference in MI event rates for Aetna members taking clopidogrel depending on whether they were also taking a PPI.
"Because proton pump inhibitors are prescribed in almost half of all patients receiving clopidogrel, we felt this study was needed to evaluate the significance of the risk when both drugs were simultaneously used," said David Day, MS, RPh, head of Pharmacy Outcomes Research for Aetna and co-author of the analysis. "We're evaluating any additional communication that may be necessary."
Aetna identified 1,010 members less than 65 years old that were continuously eligible for Aetna medical and pharmacy benefits from January 2005 through December 2006 and were newly started on clopidogrel during the month of January 2006. Aetna then associated these members with concurrent pharmacy claims for PPIs, medical claims for hospital admission with diagnoses indicative of MI co-morbidities, and internal measures of severity of illness at the time of first clopidogrel use.
* Those members who received >182 days supply of clopidogrel throughout 2006 without evidence of PPI use were assigned to the control group. Those members who received >182 days supply of clopidogrel throughout 2006 and <182 days supply of PPI were assigned to the low PPI exposure group, and finally, those members who received >182 days supply of clopidogrel throughout 2006 and > 182 days supply of PPI were assigned to the high PPI exposure group.
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