NSAIDs include over-the-counter and prescription versions of aspirin, ibuprofen and naproxen (Aleve). This family of drugs also includes the recently recalled Vioxx and Bextra, two prescription NSAIDs that target the cox-2 enzyme. A third cox-2 inhibitor, Celebrex, remains on U.S. drug store shelves.
Doctors have long recognized that long-term use of non-cox-2 NSAIDs can raise risks for gastrointestinal bleeding, and guidelines exist to spot patients at especially high risk.
However, many doctors are not giving these patients the medicines that can protect them against bleeding, said study author Dr. Neena S. Abraham, a gastroenterologist at Baylor College of Medicine and physician investigator at the Michael E. DeBakey Veteran's Administration (VA) Medical Center in Houston.
"The VA leads the way in adherence to guidelines and does at least as well, if not better than other groups, but while we know who's at high risk for upper gastrointestinal bleeding, somehow that knowledge is not being put into practice," she said.
The results of the study, which received funding from the American College of Gastroenterology and the Houston VA's Center for Quality of Care and Utilization Studies, appear in Gastroenterology 2005.
NSAIDs are the most commonly prescribed drug in the United States, Abraham said, with millions of Americans use lower-dose OTC versions as well. They are used to treat pain from any number of ailments including headache, arthritis, postoperative pain, muscle and back ache and cancer pain.
Abraham added that upper gastrointestinal bleeding, including ulcers that can perforate the stomach wall, occurs in about 4.5 percent of patients who take NSAIDs over the long term. Internal bleeding is especially dangerous for people over 65, since the death risk linked to such bleeding is 30 times higher in elderly people, Abraham said.
Other patients at high risk for bleeding include those who take a steroid and/or anti-coagulant on top of an NSAID; patients with a past history of upper gastrointestinal bleeding, and patients who take NSAIDs in an amount exceeding the manufacturers' recommended dosage.
These risks are well-known and numerous organizations, including the American College of Gastroenterology, the American College of Rheumatology and the VA Pharmacy Benefits Management Plan, have issued guidelines over the past seven years to recommend preventive therapy for these patients, Abraham said. Guidelines are also being formulated to take into account recent research finding that heart attack risk can increase among NSAID users.
In their study, Abraham and her colleagues looked at more than 300,000 patients treated at 176 VA hospitals throughout the country during 2002. All were prescribed an NSAID for pain relief, and would also be considered at high risk for upper gastrointestinal bleeding.
Among patients with one or more risk factor, only about 27 percent were prescribed a safer NSAID prescription strategy aimed at reducing the risk of bleeding, the researchers found. Among patients with at least two risk factors, close to 40 percent were prescribed a safer NSAID strategy, while about 42 percent of patients with three risk factors received these benefits.
"I'm absolutely surprised by these findings," said Dr. Jeffrey Raskin, chief of gastroenterology at the University of Miami School of Medicine. "The risk factors for this have been identified since 1995, and I think we've educated so many people that it was surprising that physicians were not ordering additional therapy in this high-risk group."
Abraham said gastroenterologists like herself who treat NSAID-related side effects are obviously aware of the importance of preventing bleeding, but doctors in other specialties as well as general practitioners may be less aware.
"It's a common health-care issue for us, but if you're in general practice with, say 100 patients, 10 of whom are on NSAIDs and only one of whom may have had had bleeding -- unless you've had an experience with it -- you might not know," she said. Abraham added that cardiologists, orthopedic doctors, oncologists and rheumatologists may also lack awareness of the importance of prescribing safer NSAID strategies that may reduce the risk of bleeding among high-risk patients.
Additional factors may include disparities in prescription guidelines or financial constraints from insurers on ordering secondary medications, she said.
The authors reported that a number of organizations have published guidelines that recommend slightly different management strategies to reduce the risk of bleeding among high-risk NSAID patients. When the authors re-analyzed their data according to these varying guidelines -- from the American College of Rheumatology, the American College of Gastroenterology, Assessing Care of Vulnerable Elders and the VA Pharmacy Benefits Management Plan -- they found that VA provider adherence to the recommended safer NSAID strategies of these guidelines would have been 28 percent, 26 percent, 29 percent and 33 percent, respectively.
"This is an important study to publish and will provoke a lot of discussion, as it really highlights some of the gaps between official society recommendations and clinical practice," said Dr. Gregory Haber, director of the division of gastroenterology and the Center for Advanced Therapeutic Endoscopy at New York City's Lenox Hill Hospital.
More information
For more on NSAIDs, head to the The Mayo Clinic.
