11/12 15:43 New arthritis drug avoids usual side effects -study
By Mark Egan
LOS ANGELES, Nov. 12 (Reuters) - The makers of a new anti-inflammatory
drug said Thursday its treatment was as effective in treating arthritis as popular
drugs like Advil and aspirin while avoiding side effects like ulcers and bleeding.
Monsanto Co.'s <MTC.N> G.D. Searle drug unit said trials of its drug
Celebrex, known generically as celecoxib, revealed it was equally effective in
treating both the most common and severe forms of arthritis while avoiding the
common side effects of traditional treatments.
Earlier this week, Monsanto rival Merck & Co. <MRK.N> announced results
from trials of a similar drug that can provide arthritis relief without the side
effects of traditional medications.
Monsanto said its phase III trials, usually the last step before seeking regulatory
approval for a drug, showed Celebrex was as effective as the popular drug
naproxen in treating osteoarthritis and as effective as diclofenac in treating
rheumatoid arthritis.
The trials also revealed patients taking the traditional drugs were much more
likely to suffer from stomach or intestinal ulcers and bleeding than patients
taking Celebrex.
Osteoarthritis is the most common form of arthritis affecting about 20 million
Americans. It is caused by the wearing down of cartilage in the joints and often
results in patients needing hip or knee replacement surgery. Rheumatoid
arthritis, the most severe form of the disease, affects about 2.5 million
Americans and can cripple its victims.
"I am thrilled. I've been in this area of research for about 15 years and we have
constantly worked on the issue of how can we get drugs to treat arthritis with a
safety profile that keeps the patient from harm," Searle vice president of clinical
research Dr. Steven Geis told Reuters.
"Now we have found out that (Celebrex) is that answer. It has all the
advantages of (traditional drugs) but doesn't have that gastrointestinal toxicity,"
he said.
In a 1,000 patient trial, which compared Celebrex with naproxen, patients were
tested before the study began to ensure they had no ulcers. At the end of the
12-week trial patients were again tested for ulcers. Among those taking the
traditional drug naproxen 26 percent had ulcers compared to just 4 percent for
those taking either Celebrex or a placebo.
"This test shows Celebrex had a much superior safety profile compared to
naproxen," Geis said.
Celebrex is is part of a new class of drugs knows as Cox-2 inhibitors. The drug
fights pain and inflammation by blocking the so-called Cox-2 enzyme.
Commonly available drugs like naproxen, diclofenac, Motrin, Advil and aspirin
also inhibit the Cox-2 enzyme, but often cause ulcers and other gastrointestinal
side effects by also blocking the Cox-1 enzyme which protects the stomach
lining.
Doctors estimate that about 76,000 people are admitted to hospitals annually as
a result of side effects from anti-inflammatory drugs with about 7,600 deaths
each year attributed to the drugs. Researchers claim those problems could be
largely eradicated with the use of Cox-2 inhibitors.
Results of the trials were presented at the American College of Rheumatology's
annual meeting in San Diego.
Merck released similar findings on its Cox-2 inhibitor drug, Vioxx, earlier in the
week at the San Diego meeting. The two drugs are both expected to be
approved by regulators some time in the new year.
Searle had originally planned to market its drug under the name Celebra but
recently changed the brand name to Celebrex to avoid possible confusion with
another unrelated drug.
moneynet.com@NEWS-P2&Index=1&HeadlineURL=../News/NewsHeadlines.asp&DISABLE_FORM=&NAVSVC=News\Company |
