Risks of clinically significant upper gastrointestinal events with etodolac and naproxen: A historical cohort analysis

Rick A. Weideman, Kevin C. Kelly, Salahuddin Kazi, Anh Cung, Kevin W. Roberts, Herbert J. Smith, George A. Sarosi, Bertis B. Little, Byron Cryer

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

Background & Aims: Etodolac is a generic nonsteroidal anti-inflammatory drug (NSAID). Previous in vitro studies have shown that etodolac is a selective inhibitor of cyclooxygenase (COX)-2 with selectivity in between that of other COX-2 inhibitors such as celecoxib and rofecoxib. However, there are no outcomes data assessing clinically significant upper gastrointestinal (CSUGI) events with etodolac. Methods: A historical cohort study was performed at the Dallas Veterans Affairs Medical Center in which 16,286 veteran patients (5596 patient-years) received etodolac or naproxen during a 3-year period without concurrent use of other ulcerogenic drugs other than low-dose aspirin. The primary outcome was the CSUGI event rate of the etodolac and naproxen groups without concomitant low-dose aspirin. Results: The incidence of CSUGI events was. 78% and. 24% for naproxen and etodolac, respectively. In the NSAID-naive subset, the incidence of CSUGI events was. 99% and. 24% for naproxen and etodolac, respectively. Compared with naproxen, etodolac was associated with a reduction in upper gastrointestinal events, corresponding to an odds ratio of. 39 (95% confidence interval,. 20-.76; P =. 006). Concomitantly used low-dose aspirin increased event rates with naproxen 2-fold and etodolac 9-fold. Hence, there was no significant difference in gastrointestinal event rates between etodolac and naproxen when low-dose aspirin was taken concomitantly. Conclusions: Etodolac is a generic COX-2 selective inhibitor that reduces CSUGI events compared with the nonselective NSAID naproxen. However, concomitant use of low-dose aspirin negates the gastrointestinal safety advantages of etodolac.

Original languageEnglish (US)
Pages (from-to)1322-1328
Number of pages7
JournalGastroenterology
Volume127
Issue number5
DOIs
StatePublished - Nov 2004

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Etodolac
Naproxen
Cohort Studies
Aspirin
Cyclooxygenase 2 Inhibitors
Anti-Inflammatory Agents
Celecoxib
Veterans
Pharmaceutical Preparations
Incidence

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Risks of clinically significant upper gastrointestinal events with etodolac and naproxen : A historical cohort analysis. / Weideman, Rick A.; Kelly, Kevin C.; Kazi, Salahuddin; Cung, Anh; Roberts, Kevin W.; Smith, Herbert J.; Sarosi, George A.; Little, Bertis B.; Cryer, Byron.

In: Gastroenterology, Vol. 127, No. 5, 11.2004, p. 1322-1328.

Research output: Contribution to journalArticle

Weideman, Rick A. ; Kelly, Kevin C. ; Kazi, Salahuddin ; Cung, Anh ; Roberts, Kevin W. ; Smith, Herbert J. ; Sarosi, George A. ; Little, Bertis B. ; Cryer, Byron. / Risks of clinically significant upper gastrointestinal events with etodolac and naproxen : A historical cohort analysis. In: Gastroenterology. 2004 ; Vol. 127, No. 5. pp. 1322-1328.
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abstract = "Background & Aims: Etodolac is a generic nonsteroidal anti-inflammatory drug (NSAID). Previous in vitro studies have shown that etodolac is a selective inhibitor of cyclooxygenase (COX)-2 with selectivity in between that of other COX-2 inhibitors such as celecoxib and rofecoxib. However, there are no outcomes data assessing clinically significant upper gastrointestinal (CSUGI) events with etodolac. Methods: A historical cohort study was performed at the Dallas Veterans Affairs Medical Center in which 16,286 veteran patients (5596 patient-years) received etodolac or naproxen during a 3-year period without concurrent use of other ulcerogenic drugs other than low-dose aspirin. The primary outcome was the CSUGI event rate of the etodolac and naproxen groups without concomitant low-dose aspirin. Results: The incidence of CSUGI events was. 78{\%} and. 24{\%} for naproxen and etodolac, respectively. In the NSAID-naive subset, the incidence of CSUGI events was. 99{\%} and. 24{\%} for naproxen and etodolac, respectively. Compared with naproxen, etodolac was associated with a reduction in upper gastrointestinal events, corresponding to an odds ratio of. 39 (95{\%} confidence interval,. 20-.76; P =. 006). Concomitantly used low-dose aspirin increased event rates with naproxen 2-fold and etodolac 9-fold. Hence, there was no significant difference in gastrointestinal event rates between etodolac and naproxen when low-dose aspirin was taken concomitantly. Conclusions: Etodolac is a generic COX-2 selective inhibitor that reduces CSUGI events compared with the nonselective NSAID naproxen. However, concomitant use of low-dose aspirin negates the gastrointestinal safety advantages of etodolac.",
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T1 - Risks of clinically significant upper gastrointestinal events with etodolac and naproxen

T2 - A historical cohort analysis

AU - Weideman, Rick A.

AU - Kelly, Kevin C.

AU - Kazi, Salahuddin

AU - Cung, Anh

AU - Roberts, Kevin W.

AU - Smith, Herbert J.

AU - Sarosi, George A.

AU - Little, Bertis B.

AU - Cryer, Byron

PY - 2004/11

Y1 - 2004/11

N2 - Background & Aims: Etodolac is a generic nonsteroidal anti-inflammatory drug (NSAID). Previous in vitro studies have shown that etodolac is a selective inhibitor of cyclooxygenase (COX)-2 with selectivity in between that of other COX-2 inhibitors such as celecoxib and rofecoxib. However, there are no outcomes data assessing clinically significant upper gastrointestinal (CSUGI) events with etodolac. Methods: A historical cohort study was performed at the Dallas Veterans Affairs Medical Center in which 16,286 veteran patients (5596 patient-years) received etodolac or naproxen during a 3-year period without concurrent use of other ulcerogenic drugs other than low-dose aspirin. The primary outcome was the CSUGI event rate of the etodolac and naproxen groups without concomitant low-dose aspirin. Results: The incidence of CSUGI events was. 78% and. 24% for naproxen and etodolac, respectively. In the NSAID-naive subset, the incidence of CSUGI events was. 99% and. 24% for naproxen and etodolac, respectively. Compared with naproxen, etodolac was associated with a reduction in upper gastrointestinal events, corresponding to an odds ratio of. 39 (95% confidence interval,. 20-.76; P =. 006). Concomitantly used low-dose aspirin increased event rates with naproxen 2-fold and etodolac 9-fold. Hence, there was no significant difference in gastrointestinal event rates between etodolac and naproxen when low-dose aspirin was taken concomitantly. Conclusions: Etodolac is a generic COX-2 selective inhibitor that reduces CSUGI events compared with the nonselective NSAID naproxen. However, concomitant use of low-dose aspirin negates the gastrointestinal safety advantages of etodolac.

AB - Background & Aims: Etodolac is a generic nonsteroidal anti-inflammatory drug (NSAID). Previous in vitro studies have shown that etodolac is a selective inhibitor of cyclooxygenase (COX)-2 with selectivity in between that of other COX-2 inhibitors such as celecoxib and rofecoxib. However, there are no outcomes data assessing clinically significant upper gastrointestinal (CSUGI) events with etodolac. Methods: A historical cohort study was performed at the Dallas Veterans Affairs Medical Center in which 16,286 veteran patients (5596 patient-years) received etodolac or naproxen during a 3-year period without concurrent use of other ulcerogenic drugs other than low-dose aspirin. The primary outcome was the CSUGI event rate of the etodolac and naproxen groups without concomitant low-dose aspirin. Results: The incidence of CSUGI events was. 78% and. 24% for naproxen and etodolac, respectively. In the NSAID-naive subset, the incidence of CSUGI events was. 99% and. 24% for naproxen and etodolac, respectively. Compared with naproxen, etodolac was associated with a reduction in upper gastrointestinal events, corresponding to an odds ratio of. 39 (95% confidence interval,. 20-.76; P =. 006). Concomitantly used low-dose aspirin increased event rates with naproxen 2-fold and etodolac 9-fold. Hence, there was no significant difference in gastrointestinal event rates between etodolac and naproxen when low-dose aspirin was taken concomitantly. Conclusions: Etodolac is a generic COX-2 selective inhibitor that reduces CSUGI events compared with the nonselective NSAID naproxen. However, concomitant use of low-dose aspirin negates the gastrointestinal safety advantages of etodolac.

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