Further Evidence Supports GI Safety, Upper GI Tolerability Of Celecoxib Compared With NSAIDs

[Guest guest]

DDW: Further Evidence Supports GI Safety, Upper GI

Tolerability Of Celecoxib Compared With NSAIDs

By Bruce

ATLANTA, GA -- May 25, 2001 -- Results presented at this

year's DDW meeting show that celecoxib, a cyclooxigenase-2

selective inhibitor, is better tolerated and associated with

fewer serious upper gastrointestinal adverse events than the

nonsteroidal anti-inflammatory drugs, naproxen or

diclofenac.

Reporting the findings from the SUCCESS I trial, Dr. Jay L.

Goldstein, University of Illinois at Chicago, Chicago,

Illinois, said that they support a growing body of evidence

on the gastrointestinal (GI) safety of the cyclooxigenase-2

(COX-2) selective inhibitors.

For example, both the CLASS study (celecoxib) and the VIGOR

study (rofecoxib) previously demonstrated a significant

reduction in upper GI ulcer complications and improved

tolerability for the agents. However, CLASS failed to reach

statistical significance on its primary end point of

complicated ulcers.

The SUCCESS I trial was a large, 12-week, prospective,

double-blind, randomized trial in 13,274 osteoarthritis (OA)

patients conducted in 39 countries. The study compared the

upper GI safety of celecoxib 200 mg/day (n=4421) and 400

mg/day (n=4429) was compared with naproxen 1000 mg/day

(n=914) and diclofenac 100 mg/day (n=3510).

Dr. Goldstein pointed out that investigators were required

to report all potential, clinically significant upper GI

events and were allowed to follow local standards of care

with regard to work-up and treatment of events. Events were

categorized as upper GI ulcer complications, which included

perforations, gastric outlet obstruction, bleeding (which in

combination are referred to as POBs) or symptomatic upper GI

ulcers.

Compared to the NSAIDs, celecoxib was associated with a

relative risk (RR) reduction of 88 percent (p=0.008) and 52

percent (p=0.049) for ulcer complications and ulcer

complications plus symptomatic ulcers, respectively.

Celecoxib was associated with a 20.4 percent reduction in

all GI adverse events (p<0.001) compared with the NSAIDs. It

also resulted in a 23.7 percent reduction in upper GI

adverse events (p<0.001), including abdominal pain

(reduction of 22.5 percent. p<0.001) dyspepsia (reduction of

18.6, p<0.008), and nausea (reduction of 29.4 percent,

p<0.001), all compared with the NSAIDs. There was also a

23.5 percent reduction in adverse events leading to

withdrawal with the celecoxib (p<0.001) compared with the

NSAIDs.

Summarizing the results, Dr. Goldstein said, " these data

confirm CLASS results that celecoxib is associated with

significantly fewer ulcer complications and symptomatic

upper GI ulcers than conventional NSAIDs. The differences in

event rates between SUCCESS and CLASS may relate to regional

differences in surveillance or clinical practice. "