HONOLULU — Even over-the-counter doses of nonselective NSAIDs significantly increase the risk of serious GI complications, Joseph Biskupiak, Ph.D., said at the annual meeting of the American College of Gastroenterology.
Moreover, his study of a large, national outpatient primary care database of electronic medical records showed that this risk is further intensified by concomitant use of low-dose aspirin, added Dr. Biskupiak of the University of Utah College of Pharmacy, Salt Lake City.
“I think there are a couple of take-home messages here for the patient and physician populations. It's that [over-the-counter] NSAIDs are not benign. As physicians, you need to assess patient usage of these medications and inform them of the associated risks. And patients taking these medications need to discuss their use with their physician,” he said.
Dr. Biskupiak reviewed the 3.2-million-patient GE Medical Systems Centricity database and identified 11,957 individuals taking OTC naproxen at 220 mg/day and 38,507 taking OTC ibuprofen at 200 mg/day who were free of medical conditions or therapies that would predispose to GI bleeding. He compared the incidence of GI perforations, ulcers, or bleeding (PUB) during the first 3 months after taking the NSAID—even a single dose—with the rates during the 6- and 12-month periods prior to taking either NSAID.
In the 6 months prior to taking ibuprofen, 55 patients experienced a PUB, as did 100 in the year prior to taking the drug. During the 3 months after starting on ibuprofen, patients were 2.5 times more likely to experience a PUB than in the previous 6 months, and 38% more likely to experience a PUB than in the year prior to taking the NSAID.
Similarly, patients who took naproxen were 2.74 times more likely to develop PUBs than in the 6 months before taking the drug, and 54% more likely than in the year beforehand, he continued.
Concurrent low-dose aspirin was used by 2,328 patients who took naproxen; their risk of developing a PUB was twice that of patients on naproxen alone. The 4,843 patients on low-dose aspirin and ibuprofen were 3.36 times more likely to develop a PUB within 3 months of starting the NSAID than patients taking ibuprofen alone.
Session cochair Dr. David Y. Graham questioned the clinical relevance of Dr. Biskupiak's findings.
“The actual PUB complication rates with [over-the-counter] NSAIDs were maybe 1 in 200 patients per year. In the control group, it would be a little less than that. That's an extraordinarily low number. The question is, is it clinically important?” asked Dr. Graham, professor of medicine at Baylor College of Medicine, Houston.
Dr. Biskupiak's answer was emphatically yes. “Considering that we're talking about an estimated 60 million Americans using OTC pain medications daily—many of whom are unaware that NSAIDs can cause major GI problems—even though 1 in 200 is a very small number, it turns out to be a significant total number of people,” noted Dr. Biskupiak. “And remember: More than 100,000 hospitalizations annually … are attributed to GI complications of NSAID usage.”
His study was funded by Pfizer Inc.
NSAIDs are not benign. Patients taking them need to be informed of the associated risks. DR. BISKUPIAK