Safety

PRECISION1

Celebrex GI Safety

CONDOR2

Celebrex GI Safety

GI Reasons3

Celebrex GI Safety

Abbreviations: GI: gastrointestinal; PPI: proton pump inhibitor; ns-NSAID: non selective non steroidal anti inflammatory drug; BID: twice a day; QD: once per day.

References:
1.Nissen SE, Yeomans ND, Solomon DH, et al. Cardiovascular safety of celecoxib, naproxen, or ibuprofen for arthritis. N Engl J Med. 2016;375:2519-29
2.Chan FK, Lanas A, Scheiman J, Berger MF, Nguyen H, Goldstein JL. Celecoxib versus omeprazole and diclofenac in patients with osteoarthritis and rheumatoid arthritis (CONDOR): a randomised trial. Lancet. 2010 Jul 17;376(9736):173-9.
3.Cryer B, Li C, Simon LS, Singh G, Stillman MJ, Berger MF. GI-REASONS: a novel 6-month, prospective, randomized, open-label, blinded endpoint (PROBE) trial. Am J Gastroenterol. 2013 Mar;108(3):392-400.

CELEBREX® demonstrated a CV Safety profile similar to that of Naproxen and Ibuprofen1

Celebrex CV Safety

Abbreviations: CV: cardiovascular; CI: confidence interval; HR: hazard ratio; BID: twice a day; TID: three times a day; PRECISION: Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen or Naproxen.

References:
1.Nissen SE, Yeomans ND, Solomon DH, et al. Cardiovascular safety of celecoxib, naproxen, or ibuprofen for arthritis. N Engl J Med. 2016;375:2519-29.
2.Shah P. Intention-to-treat and per-protocol analysis. CMAJ. 2011;183(6):696.

Significantly Lower Incidence of Renal Events as Compared to Ibuprofen and a Similar Incidence to Naproxen1

Celebrex Renal Safety

Renal outcomes were one of the tertiary outcomes evaluated in the PRECISION trial
Occurrence of clinically significant renal events, defined as development of any of the following:

  • Verified serum creatinine level of ≥2.0 mg/dL and an increase of verified serum creatinine level of ≥0.7 mg/dL from baseline
  • Hospitalization for acute renal failure
  • Initiation of hemodialysis or peritoneal dialysis

Abbreviations: CV: cardiovascular; PRECISION: Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen or Naproxen; HR: hazard ratio; CI: confidence interval.

Reference:
1. Nissen SE, Yeomans ND, Solomon DH, et al. Cardiovascular safety of celecoxib, naproxen, or ibuprofen for arthritis. N Engl J Med. 2016;375:2519-29.

Celecoxib demonstrated a Hepatic Safety profile comparable to ns-NSAIDs1

Celebrex Hepatic Safety

Events included all investigator-reported events (as per the World Health Organization Adverse Reactions Terminology [WHOART] dictionary [1998]) of any hepatic or biliary-related categories.
†p=0.21 vs Celecoxib (any dose).
‡p<0.0001 vs Celecoxib (any dose).
§p=0.06 vs Celecoxib (any dose).
¶p=0.03 vs Celecoxib (any dose).

Abbreviations: ns-NSAIDs: non-selective non-steroidal anti-inflammatory drug.

Reference:
1.Soni P, Shell B, Cawkwell G, et al. The hepatic safety and tolerability of the cyclooxygenase-2 selective NSAID celecoxib: pooled analysis of 41 randomized controlled trials. Curr Med Res Opin. 2009;25(8):1841-51.

Please click on Prescribing Information link to view safety and adverse events information of Celebrex®.

For the use only of registered medical practitioners or a hospital or a laboratory.

PP-CEL-IND-0080 02/06/2021