Nonsteroidal anti-inflammatory drugs (NSAIDs) have been the most popular treatment for arthritis - despite their association with gastrointestinal (GI) complications, including bleeding ulcers and death. When selective cyclooxygenase 2 inhibitors (coxibs) were introduced a decade ago, they were widely hailed as a gastroprotective shield for NSAID users.
Eventually, they were incorporated into the treatment guidelines of both the American College of Rheumatology and the Arthritis Foundation for patients at increased risk of GI complications.. Two gastroprotective strategies for patients prescribed NSAIDs were recommended--either coprescription of a non-selective NSAID with an acid-reducing medication or selection of a COX-2 inhibitor NSAID. Then, clinical studies began to uncover evidence that COX-2 inhibitors and other non-selective NSAIDs may increase the risk of heart attack and stroke. Spurred by these findings and other safety concerns, 2 of the 3 FDA-approved coxibs - rofecoxib, known to consumers as Vioxx, and valdecoxib, known to consumers as Bextra - were withdrawn from the market. Questions regarding the appropriate use of COX-2 inhibitors for arthritis patients - and broader questions regarding prescribing patterns of novel drugs soon after FDA approval - remain.
For answers, a study published in the August 2006 issue of Arthritis Care & Research examines the prescribing patterns of COX-2 inhibitors and other gastroprotective agents for arthritis patients with varying levels of GI risk. Using the Consortium of Rheumatology Researchers of North America (CORRONA) registry, a team of CORRONA investigators evaluated data on 2,690 rheumatoid arthritis (RA) patients treated between March 1, 2004 and September 30, 2004 - the last day rofecoxib was legally sold in the U.S.
Of the patient sample, 1,833 (68.1 percent) were prescribed NSAID agents, 538 (20 percent) were prescribed aspirin , and 319 (11.9 percent) were prescribed an NSAID and aspirin. In contrast to multiple earlier epidemiologic studies that observed that a minority of NSAID users were prescribed gastroprotection, the majority (75.3%) of the 1,833 patients prescribed NSAIDs in the study were prescribed a gastroprotective strategy; the most frequently prescribed gastroprotective strategy was COX-2 inhibitors (65.8%).