The Risk of Major NSAID Toxicity with Celecoxib, Ibuprofen, or Naproxen: A Secondary Analysis of the PRECISION Trial.
- Solomon DH Brigham and Women's Hospital, Boston, Mass. Electronic address: dsolomon@partners.org.
- Husni ME Cleveland Clinic, Cleveland, Ohio.
- Libby PA Brigham and Women's Hospital, Boston, Mass.
- Yeomans ND Western Sydney University, Sydney, NSW, Australia; University of Melbourne, Melbourne, Australia.
- Lincoff AM Cleveland Clinic, Cleveland, Ohio.
- Lϋscher TF University of Zurich, Zurich, Switzerland.
- Menon V Cleveland Clinic, Cleveland, Ohio.
- Brennan DM Cleveland Clinic, Cleveland, Ohio.
- Wisniewski LM Cleveland Clinic, Cleveland, Ohio.
- Nissen SE Cleveland Clinic, Cleveland, Ohio.
- Borer JS SUNY Downstate Medical Center, Brooklyn, NY.
- 2017-07-31
Published in:
- The American journal of medicine. - 2017
Cox-2 selective inhibitor
Drug toxicity
NSAID
Nonsteroidal anti-inflammatory drug
Randomized controlled trial
Anti-Inflammatory Agents, Non-Steroidal
Arthritis, Rheumatoid
Celecoxib
Cyclooxygenase 2 Inhibitors
Double-Blind Method
Female
Humans
Ibuprofen
Male
Middle Aged
Naproxen
Osteoarthritis
English
BACKGROUND
The relative safety of long-term use of nonsteroidal anti-inflammatory drugs is unclear. Patients and providers are interested in an integrated view of risk . We examined the risk of major nonsteroidal anti-inflammatory drug toxicity in the PRECISION trial.
METHODS
We conducted a post hoc analysis of a double-blind, randomized, controlled, multicenter trial enrolling 24,081 patients with osteoarthritis or rheumatoid arthritis at moderate or high cardiovascular risk. Patients were randomized to receive celecoxib 100 to 200 mg twice daily, ibuprofen 600 to 800 mg thrice daily, or naproxen 375 to 500 mg twice daily. All patients were provided with a proton pump inhibitor. The outcome was major nonsteroidal anti-inflammatory drug toxicity, including time to first occurrence of major adverse cardiovascular events, important gastrointestinal events, renal events, and all-cause mortality.
RESULTS
During follow-up, 4.1% of subjects sustained any major toxicity in the celecoxib arm, 4.8% in the naproxen arm, and 5.3% in the ibuprofen arm. Analyses adjusted for aspirin use and geographic region found that subjects in the naproxen arm had a 20% (95% CI 4-39) higher risk of major toxicity than celecoxib users and that 38% (95% CI 19-59) higher risk. These risks translate into numbers needed to harm of 135 (95% CI, 72-971) for naproxen and 82 (95% CI, 53-173) for ibuprofen, both compared with celecoxib.
CONCLUSIONS
Among patients with symptomatic arthritis who had moderate to high risk of cardiovascular events, approximately 1 in 20 experienced a major toxicity over 1 to 2 years. Patients using naproxen or ibuprofen experienced significantly higher risk of major toxicity than those using celecoxib.
The relative safety of long-term use of nonsteroidal anti-inflammatory drugs is unclear. Patients and providers are interested in an integrated view of risk . We examined the risk of major nonsteroidal anti-inflammatory drug toxicity in the PRECISION trial.
METHODS
We conducted a post hoc analysis of a double-blind, randomized, controlled, multicenter trial enrolling 24,081 patients with osteoarthritis or rheumatoid arthritis at moderate or high cardiovascular risk. Patients were randomized to receive celecoxib 100 to 200 mg twice daily, ibuprofen 600 to 800 mg thrice daily, or naproxen 375 to 500 mg twice daily. All patients were provided with a proton pump inhibitor. The outcome was major nonsteroidal anti-inflammatory drug toxicity, including time to first occurrence of major adverse cardiovascular events, important gastrointestinal events, renal events, and all-cause mortality.
RESULTS
During follow-up, 4.1% of subjects sustained any major toxicity in the celecoxib arm, 4.8% in the naproxen arm, and 5.3% in the ibuprofen arm. Analyses adjusted for aspirin use and geographic region found that subjects in the naproxen arm had a 20% (95% CI 4-39) higher risk of major toxicity than celecoxib users and that 38% (95% CI 19-59) higher risk. These risks translate into numbers needed to harm of 135 (95% CI, 72-971) for naproxen and 82 (95% CI, 53-173) for ibuprofen, both compared with celecoxib.
CONCLUSIONS
Among patients with symptomatic arthritis who had moderate to high risk of cardiovascular events, approximately 1 in 20 experienced a major toxicity over 1 to 2 years. Patients using naproxen or ibuprofen experienced significantly higher risk of major toxicity than those using celecoxib.
- Language
-
- English
- Open access status
- bronze
- Identifiers
-
- DOI 10.1016/j.amjmed.2017.06.028
- PMID 28756267
- Persistent URL
- https://sonar.ch/global/documents/258298
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