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| |  COX-2 Controversy May Be Linked to Rise in Bleeding Complications: Presented at ACR By Ed Susman BOSTON, MA -- November 12, 2007 -- Researchers charged that overreaction to possible heart-related side effects of COX-2 inhibitor drugs has led to a widening of the so-called "gastroprotection gap" and greater hospitalization of patients for bleeding complications. They presented their findings here on November 9 at the 71st annual meeting of the American College of Rheumatology (ACR). "We had just about closed the gastroprotection gap - the bleeding and illness caused by like nonsteroidal anti-inflammatory drugs [NSAIDS] with safer medications such as the COX-2s and proton pump inhibitors - when all hell broke loose," said Gurkirpal Singh, MD, Adjunct Clinical Professor of Medicine, Stanford University School of Medicine, and Chief Science Officer, Institute of Clinical Outcomes Research and Education, Palo Alto, California. From 1999 -- when the COX-2s came on the market -- until 2004, the problem of treating pain with drugs that often caused fatal or severely morbid bleeding had just about vanished, Dr. Singh said. In fact, it decreased from 79.1% of NSAID prescriptions in 1999 to 13.9% in 2004. "Then came the COX-2 stories and the removal of Vioxx [rofecoxib] from the market and the use of COX-2 inhibition dropped almost 50% and the gastroprotection gap rose to 34.8% -- a 21% increase that was statistically significant [P <.0001]," said Dr. Singh. "The gastroprotection gap is back," he added. "It is a disaster for patients with rheumatoid arthritis." From 357.4 bleeding complications per 100,000 prescriptions in 2004, there were 433.7 per 100,000 in 2005. Dr. Singh and colleagues studied MediCal records for California to compile the statistics. "This is an ecological study. It does not show cause and effect. It just tells what happened. There may be other interpretations of why the bleeding rate increased the way it did. I think the only one that makes sense is the reduction in use of COX-2 inhibitors which we believe have been more protective of patients who need chronic pain medication for conditions such as arthritis." The study did not receive industry support.
[Presentation title: A New Safety Warning: Decreased Gastroprotection Is Associated With an Increase of Serious Ulcer Complications in Elderly Users of NSAIDs. Abstract 668]
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