Pharmaceutical Research

Recent market withdrawal of Vioxx underscores the need to limit new drugs to those who will most benefit from them

The September 2004 market withdrawal of rofecoxib (Vioxx), a selective nonsteroidal antiinflammatory drug (NSAID), signaled concerns about the safety of other cyclooxygenase-2 (COX-2) inhibitors (Bextra and Celebrex) as well. Guidelines recommend prescribing these expensive drugs, typically used for arthritis and back pain, to patients who are at high risk of gastrointestinal (GI) bleeding and other problems from traditional nonselective NSAIDs, such as ibuprofen. However, once COX-2 inhibitors hit the market in 1998, doctors began prescribing them to patients without regard to their risk of GI problems, according to a study supported in part by the Agency for Healthcare Research and Quality (HS11313).

These findings demonstrate the challenge of limiting new drug therapies to patients for whom they are initially targeted and most beneficial, concludes Randall S. Stafford, M.D., Ph.D., of Stanford University. Dr. Stafford and his colleagues analyzed data from the National Ambulatory Medical Care Survey (1999-2002) and the National Hospital Ambulatory Medical Care Survey (1999-2001) to calculate the proportion of patient visits in which COX-2 inhibitors were prescribed. They stratified patients by their risk of adverse GI problems from traditional NSAIDs based on physician-reported health histories as noted in the surveys.

Of the visits in which either a COX-2 inhibitor or traditional NSAID was prescribed, the frequency of COX-2 inhibitor use increased from 35 percent in 1999 to 55 percent in 2000 to 61 percent in 2001 and 2002. Among the patients with the lowest risk of problems from less costly traditional NSAIDs, the proportion receiving a COX-2 inhibitor nearly tripled from 12 percent in 1999 to 35 percent in 2002. The researchers caution that such nonselective prescribing of new drugs, so-called "therapeutic creep," may undermine their cost-effectiveness in actual practice.

Details are in "National trends in cyclooxygenase-2 inhibitor use since market release," by Carolanne Dai, B.Sc., M.Sc., Dr. Stafford, and G. Caleb Alexander, M.D., M.S., in the January 24, 2005, Archives of Internal Medicine 165, pp. 171-177.

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