RESEARCH - GI bleeding rates in patients newly started on COX-2s or nonselective NSAIDs

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J Manag Care Pharm. 2005 Sep;11(7):550-8.

Gastrointestinal bleeding rates among managed care patients newly started on

cox-2 inhibitors or nonselective NSAIDs.

Stockl K, Cyprien L, Chang EY.

Prescription Solutions, Costa Mesa, CA 92626, USA.

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OBJECTIVE: While cyclooxygenase-2 (COX-2) inhibitors were introduced to the

U.S. market with the promise of less gastrointestinal (GI) toxicity than

nonselective nonsteroidal anti-inflammatory drugs (NSAIDs), additional

research is needed to examine this outcome in the naturalistic setting. The

objective of this study was to examine whether use of COX-2 inhibitors is

associated with reduced risk of GI bleed in a managed care population.

METHODS: Adult patients in a multistate managed care organization that were

initiated on a nonselective NSAID between January 1999 and August 2002 were

identified and matched using propensity scoring with patients in the same

managed care organization that were initiated on a COX-2 inhibitor. Matching

variables included age, gender, geographical state, comorbidity index,

corticosteroid use, warfarin use, arthritis indication, and history of

recent GI bleed. Patients were followed until they switched or discontinued

their NSAID or COX-2 inhibitor, disenrolled from the health plan, developed

a GI bleed, or reached the end of the 1-year follow-up period. A GI bleed

was defined as an inpatient hospitalization for GI bleed or at least 2

medical claims with a primary diagnosis for GI bleed. The relative risk (RR)

of GI bleed was calculated using proportional hazards regression. RESULTS:

Overall, 35,007 pairs of COX-2 inhibitor and nonselective NSAID users were

evaluated. Mean age was 63 years, and 65% were female. There were 375 cases

of GI bleed among 19,201 follow-up years for COX-2 users (19.5 cases per

1,000 person-years) versus 228 cases of GI bleed among 12,680 follow-up

years for NSAID users (18.0 cases per 1,000 person-years). The risk of GI

bleed was not significantly different for COX-2 users compared with

nonselective NSAID users (RR 1.07; 95% confidence interval [CI], 0.90-1.26).

Even among high-risk patients, there was no reduction in the risk of a GI

bleed among users of COX-2 inhibitors (RR 0.995; 95% CI, 0.84 -1.19).

CONCLUSION: Overall, within this managed care population, COX-2 inhibitor

users did not have a reduced risk of a GI bleed compared with patients with

similar baseline characteristics using nonselective NSAIDs.

PMID: 16137212

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=pubmed & dopt=Abstra\

ct & list_uids=16137212 & itool=iconabstr & query_hl=9 & itool=pubmed_docsum

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