News Release

Generic anti-inflammatory causes significantly fewer GI complications than branded medications

Peer-Reviewed Publication

UT Southwestern Medical Center

DALLAS – Nov. 11, 2004 – People in search of pain relief who take the generic anti-inflammatory etodolac suffer 60 percent fewer gastrointestinal complications than those who take similar drugs, according to researchers at UT Southwestern Medical Center at Dallas and the Dallas Veterans Affairs Medical Center.

Use of the drug etodolac instead of drugs like Celebrex or Bextra could save the Veterans health-care system alone about $40 million annually.

"Since etodolac is available as a generic medicine, as much as an 80 percent cost savings can be achieved if patients were to use it rather than branded medications such as Celebrex or Bextra," said Dr. Byron Cryer, associate professor of internal medicine at UT Southwestern, a VA physician and senior author of the study published in the November issue of Gastroenterology. "In the 13 years of etodolac's use in the United States, there have been no reports of increases in cardiovascular events associated with this drug either." Etodolac is a non-steroidal anti-inflammatory drug (NSAID) in the same class as Celebrex. It was first released in the United States in 1991 as a pain reliever and arthritis treatment but has since gone off patent and is generically available.

In the study, Dr. Cryer and his colleagues at UT Southwestern and the Dallas VA evaluated more than 16,000 patients who, over a three-year period from 1999-2001, used either etodolac or naproxen, an over-the-counter pain reliever. Earlier studies indicated etodolac might be safer in the gastrointestinal tract, but none had evaluated its potential effects to reduce gastrointestinal ulcer complications such as bleeding.

When compared to naproxen, etodolac reduced rates of complication by more than 60 percent. This resulted in fewer hospitalizations for bleeding or perforated ulcers in patients taking NSAIDs. Further, the decrease in ulcer complications with etodolac was as great as or greater than those seen in earlier studies with Celebrex or Vioxx.

As a result, the Pharmacy Benefits Management Strategic Healthcare Group for the Veterans Health Care Administration has recommended that all patients in their system currently on Vioxx be considered for conversion to etodolac.

"Once several other large health-care plans become aware of the safety data with etodolac and its cost-saving potential, many others may soon follow the lead of the VA," said Dr. Cryer, associate dean for minority affairs at UT Southwestern.

Other contributors to the Gastroenterology study were Dr. Salahuddin Kazi, associate professor of internal medicine, and Dr. George Sarosi Jr., assistant professor of GI/endocrine surgery, at UT Southwestern; and Dr. Rick Weideman, Dr. Kevin Kelly, Dr. Anh Cung, Dr. Kevin Roberts, Dr. Herbert Smith and Dr. Bertis Little of the Dallas Veterans Affairs Medical Center. Research was supported by the Dallas VA.

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