Separating hype from facts on new arthritis painkiller
The drug is touted as safer for the gastrointestinal system, but that remains to be proved
The Oregonian
Wednesday February 24, 1999
By Oz Hopkins Koglin of The Oregonian staff
Arthritis sufferers, get out your hype detectors.
This week, the makers of the first of a long-awaited class
of arthritis painkillers launched a nationwide sales and
advertising campaign promoting the new drug to doctors
and patients.
Celebrex the first of a class called the Cox-2 inhibitors, is
about to take off, but it may not live up to prior billing.
The drug had been touted as a "super aspirin" that reduces
pain better than conventional drugs while causing little or no
damage to the gastrointestinal system.
But doctors say it is not necessarily better than
anti-inflammatory drugs already on the market and only
time will tell how easy Celebrex will be on the
gastrointestinal tract.
"Early on Celebrex was labeled by the media as a super
aspirin, and that is a misnomer," said Dr. Peter Bonafede,
medical director of Providence Arthritis Center. "If we look
at the studies, it is no better than other antiinflammatories."
In the long run, however, researchers expect the Cox-2
inhibitors will prove to be safer, he said.
So while arthritis experts greet Celebrex with interest and
hope, they suspect that the new prescription drug is more
like conventional anti-inflammatory medicines than many
patients expect.
Moreover, the Food and Drug Administration cautions that
thousands more patients need to take the drug before
researchers know if Celebrex actually causes fewer
serious gastrointestinal side effects than conventional
arthritis medications.
So until additional studies are done, the FDA has directed
that labeling for Celebrex include the standard warning
about the risks associated with nonsteroidal
anti-inflammatory drugs, including risk of gastrointestinal
tract ulcers, bleeding and perforation.
An estimated 13 million Americans regularly take
non-steroidal anti-inflammatory drugs, NSAIDs, such as
aspirin and ibuprofen, for various types of arthritis. Each
year about 107,000 people are hospitalized with serious
NSAID-induced gastrointestinal tract problems, and an
estimated 16,500 NSAID-related deaths occur each year.
Bonafede participated in trials of a rival Cox-2 drug, Merck
& Col's Vioxx, which is in the FDA approval pipeline.
However, he has prescribed Celebrex for about two dozen
patients and is participating in long-term studies to
determine whether patients taking the drug develop
problems, such as bleeding ulcers over time.
So far his Celebrex patients have no problems with the drug
or side effects. To the contrary. "What I'm hearing is pretty
much what I expected, and that is some patients are doing
better and some are finding they are doing about as well as
on other anti-inflammatories," Bonafede said.
Drug makes quiet arrival
Last December, the FDA approved Searle Corp.'s
Celebrex specifically for the signs and symptoms of
osteoarthritis and adult rheumatoid arthritis, and the drug
was quietly put on the market in early January. Despite
very little promotion, doctors wrote more than 142,000
Celebrex prescriptions in the first three weeks, leading
marketing experts to predict Celebrex will be this year's
second fastest-selling new drug, second only to the
antiimpotence drug Viagra.
Despite the mixed response some patients have had to the
drug, Brian Little, 41, of Camas, Wash., who was among
the first to use Celebrex, says he felt phenomenally better
four hours after his first dose.
"The change was unbelievable," Little said. "It took pain
and the depressed feeling away, and I have been pretty
much functioning well. The bottoms of my feet still hurt
when I walk, but I'm not limping, and the shoulder pain is
gone."
The first signs of the disease appeared one night in August
when Little, a papermaking machine operator, was finishing
his swing shift. The muscles in his forearms, around his
knees and legs became so sore he could hardly walk. His
wife, Ann, had to pick him up from work early and drive
him home.
"I felt like a 90-year-old hobbling man," Little said.
Decline sets in
That was the beginning of further physical decline and a
series of medical tests while he desperately searched the
Internet for a diagnosis. In October he was referred to
Bonafede, who told him he had rheumatoid arthritis.
Non-steroidal anti-inflammatory drugs gave him some
relief, but not enough to resume normal activities, Little
said. "I tried herbs, lotions, changes in diet, spent hundreds
of dollars trying to see if I could get some relief."
He had heard about Celebrex on a television news program
and the Internet, so when it became available he talked
with Bonafede about trying the drug.
Little has had no stomach problems, but he has only taken
the new drug for two weeks.
Almost 40 million Americans have arthritis, which
encompasses about 100 acute and chronic conditions that
affect areas around joints. Osteoarthritis affects more than
21 million Americans and is the most common form of
arthritis. It usually begins in midlife and develops slowly
through the years, causing a breakdown of joint tissue,
leading to pain and stiffness.
Rheumatoid arthritis is an autoimmune disorder and the
most disabling form of arthritis. It affects approximately 2.1
million Americans, typically between 25 and 50 years of
age.
Conventional anti-inflammatory drugs inhibit an enzyme in
the body called Cox-1, which releases substances called
prostaglandins that protect the stomach and kidneys, and
Cox-2, which releases prostaglandins involved in causing
arthritis pain and inflammation. Celebrex was designed by
advanced molecular technology to target only the Cox-2
enzyme, thereby inhibiting the "bad" Cox enzyme and
leaving the "good" one alone. Celebrex is available in 100
mg and 200 mg capsules.
Dr. Elizabeth A. Tindall, a Portland rheumatologist who
participated in the national trials of Celebrex, predicts that
there will eventually be a number of first and second
generation Cox-2 inhibitors on the market. She is director of
clinical research at Portland Medical Associates.
She confirmed that in clinical trials the incidence of ulcers
was no greater with Celebrex than with conventional
non-steroidal anti-inflammatory drugs. However, she said,
"Patients who have a history of NSAIDs-related ulcers
should consider using Celebrex or another Cox-2 drug
because patients who have developed ulcers are at
significantly increased risk for developing another ulcer,
perforations or bleeding."
The Arthritis Foundation reminds the public there is no
evidence the Cox-2 drugs provide aspirin's protection
against heart attack and stroke, so patients using aspirin
should discuss that matter with their doctor.
You can reach Oz Hopkins Koglin at 503-221-8376 or
by e-mail at ozkoglin@news.oregonian.com.
oregonlive.com |
