Study queries bleed benefit of COX-2 drugs
LONDON (Reuters) - British scientists said on Friday they had found no evidence that prescription painkillers designed to protect against stomach bleeding were safer than older drugs.
Julia Hippisley-Cox, of the University of Nottingham in England, said she had found no proof the painkillers, known as COX-2 inhibitors, were less likely to cause gastrointestinal bleeding than aspirin or other treatments called non-steroidal anti-inflammatory drugs (NSAIDS).
"Overall we found no strong evidence of enhanced safety against gastrointestinal events with any of the new cyclo-oxygenase-2 (COX-2) inhibitors compared to non-selective non-steroidal anti-inflammatory drugs," she said in a report in the British Medical Journal.
In the four-year observational study, Hippisley-Cox and her team studied more than 9,000 patients in Britain who had been diagnosed with a stomach ulcer or bleeding and compared each case with up to 10 control patients.
Forty-five percent of the patients with a stomach ailment had been prescribed an NSAIDS in the previous three years and 10 percent had taken a COX-2 inhibitor. This compared with 33 percent and 6 percent in the control group.
The researchers said the risk of a stomach problem associated with using NSAIDS was lower in patients who were also taking drugs to heal ulcers.
COX-2 inhibitors, which include Vioxx, the arthritis drug made by Merck & Co and Pfizer Inc's Celebrex, have also been shown to raise the risk of blood pressure, stroke and heart disease.
Pfizer said Celebrex was the only treatment found not to significantly increase the risk of gastrointestinal events and had a lower risk of complications compared to Vioxx and NSAIDS.
"Physicians and their patients need balanced and objective information in order to make the best treatment decisions," Dr Gail Cawkwell, the company's senior medical director, said in a statement.
Merck pulled Vioxx off the market last year after it was shown to double the risk of heart attack and stroke among patients taking it for 18 months or longer.
Julia Hippisley-Cox, of the University of Nottingham in England, said she had found no proof the painkillers, known as COX-2 inhibitors, were less likely to cause gastrointestinal bleeding than aspirin or other treatments called non-steroidal anti-inflammatory drugs (NSAIDS).
"Overall we found no strong evidence of enhanced safety against gastrointestinal events with any of the new cyclo-oxygenase-2 (COX-2) inhibitors compared to non-selective non-steroidal anti-inflammatory drugs," she said in a report in the British Medical Journal.
In the four-year observational study, Hippisley-Cox and her team studied more than 9,000 patients in Britain who had been diagnosed with a stomach ulcer or bleeding and compared each case with up to 10 control patients.
Forty-five percent of the patients with a stomach ailment had been prescribed an NSAIDS in the previous three years and 10 percent had taken a COX-2 inhibitor. This compared with 33 percent and 6 percent in the control group.
The researchers said the risk of a stomach problem associated with using NSAIDS was lower in patients who were also taking drugs to heal ulcers.
COX-2 inhibitors, which include Vioxx, the arthritis drug made by Merck & Co and Pfizer Inc's Celebrex, have also been shown to raise the risk of blood pressure, stroke and heart disease.
Pfizer said Celebrex was the only treatment found not to significantly increase the risk of gastrointestinal events and had a lower risk of complications compared to Vioxx and NSAIDS.
"Physicians and their patients need balanced and objective information in order to make the best treatment decisions," Dr Gail Cawkwell, the company's senior medical director, said in a statement.
Merck pulled Vioxx off the market last year after it was shown to double the risk of heart attack and stroke among patients taking it for 18 months or longer.
posted by Chris Placitella at 6:26 AM
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