A randomized, double-blind, study by Pharmacia Corporation’s Serle unit and Pfizer, Inc., the comarketers of Celebrex, recently released long-term data showing that Celebrex has fewer side effects than NSAIDs painkillers.
The study included 8000 patients from different hospitals and clinics over a 13-month time period. Each patient was studied for at least six months. The patient pool encompassed a diversity of ages and disease severities. Approximately 20% of the patients were already taking aspirin for pain relief.
Celebrex patients received 800mg, or quadruple the recommended dose for osteoarthritis, while other patients under NSAIDs took 2400mg of ibuprofen or 150mg of diclofenac.
The study revealed that for the entire group incidents of ulcer and ulcer complications were 3.5% in the NSAIDs users and only 2.0% in the Celebrex users. Excluding the aspirin patients, Celebrex users were one third as likely to develop ulcer complications, and half as likely to develop both ulcers and ulcer complications.
Furthermore, use of NSAIDs was linked to greater blood loss in the gastro-intestinal (GI) tract, while Celebrex patients had no increased risk of stroke, heart attack, or other cardiovascular problems.
``No previous study has examined such a broad range of (gastrointestinal-- GI) side effects -- which encompass events ranging from serious and often devastating GI ulcers and ulcer complications, to silent but medically important damage to the lining of the intestine, to symptoms like abdominal pain,'' claims Harvard Medical School professor Lee Simon.
``I'm incredibly excited about this data set,'' he says. ``These drugs are just basically safer.''
While G.D. Serle & Co’s Celebrex and Merck and Co.’s Vioxx, have been competing to win FDA approval to declare on their labels COX-2 inhibitors are safer than NSAIDs in treating arthritis, the FDA has approved another NSAIDs drug for pain relief, the third arthritis drug approved in the past two years.
Boehringer Ingelheim Pharmaceuticals and Abbott Laboratories’s Mobic is expected in the short term to profit from big sales.
``The fact that there is another drug on the market, you're going to get people trying it,'' claims Glenn Reicin, managing director at Morgan Stanley Dean Witter.
Mobic will also be cheaper than older NSAIDs on the market.
If Celebrex manages to win FDA approval to change their label, however, COX-2 inhibitors may completely overthrow the market for arthritis pain relievers, rendering NSAIDs use obsolete.
