New, Pricey Pain Drugs Used Inappropriately: Study

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New, Pricey Pain Drugs Used Inappropriately: Study

Tue Jun 4, 5:35 PM ET

By Pallarito

NEW YORK (Reuters Health) - Many patients are getting the new COX-2

anti-inflammatory drugs although traditional drugs, such as aspirin and

ibuprofen, are just as effective and a much cheaper way to relieve pain,

researchers say.

The research findings suggest that doctors are prescribing the COX-2 drugs

for arthritis, acute pain and other conditions without first having tried

less expensive treatments.

The study, released Tuesday by St. Louis, Missouri-based pharmacy benefits

management company Express Scripts, questions the overall cost-effectiveness

of COX-2 inhibitors, such as Pharmacia's Celebrex (celecoxib) and Bextra

(valdecoxib) and Merck & Co.'s Vioxx (rofecoxib).

The analysis reinforces lingering doubts about the benefit of COX-2 drugs

compared with traditional nonsteroidal anti-inflammatory drugs (NSAIDs),

such as naproxen and ibuprofen. The debate centers on whether COX-2 drugs

provide an added safety benefit for patients at risk of stomach problems,

such as ulcers and bleeding, that can occur with long-term use of

traditional NSAIDs.

Studies have shown that some COX-2 inhibitors have this advantage, while

this has not been shown in others. In the June 1st issue of the British

Medical Journal, researchers conclude that an early study of Celebrex leaves

the false impression that the COX-2 drug has fewer gastrointestinal side

effects than traditional NSAIDs.

Annual spending for COX-2 drugs spiked 38% in 2000, the report indicates.

The increase reflected a huge influx of new patients taking the drugs, said

Fred Teitelbaum, the company's vice president for research and planning.

Spending grew another 15% in 2001.

When they probed deeper, the company discovered that 74% of new users had no

evidence of being at risk of gastrointestinal adverse events.

Furthermore, 29% of new users had a diagnosis of lower back pain, a

condition not yet listed as an approved indication for COX-2 drugs, it said.

No clinical studies have shown COX-2 drugs to be any better than NSAIDs for

lower back pain, according to Dr. , manager for outcomes research

at Express Scripts.

Also, short-term use of COX-2 drugs was greater than expected, suggesting

that these agents are not being reserved for patients requiring long-term

treatment for which gastrointestinal side effects may be an issue.

said the study underscores a " significant opportunity " for health plan

sponsors to encourage a more cost-effective approach. Express Scripts

advocates an approach called step therapy, whereby physicians are encouraged

to start new patients without risk of gastrointestinal side effects on a

generic NSAID before progressing, if necessary, to a COX-2 drug.

Express Scripts estimates that step therapy alone can trim total spending on

NSAIDs by 12%, said Motheral, the company's senior director of

outcomes research.