Safety of CELEBREX

Study Descriptions

Data on file, Pfizer Inc. The Celecoxib Long-term Arthritis Safety Study (CLASS) was a double-blind, randomized, controlled trial to prospectively evaluate the effects of CELEBREX at 2 to 4 times the maximum therapeutic dose vs therapeutic doses of nonselective NSAIDs (ibuprofen and diclofenac) on measures of GI toxicity. Patients were randomly assigned CELEBREX 400 mg BID, ibuprofen 800 mg TID, or diclofenac 75 mg BID for at least 6 months, and no more than 52 weeks (in the diclofenac protocol) or 65 weeks (in the ibuprofen protocol). Median treatment duration was ≈9 months for the CELEBREX and diclofenac groups and ≈6 months for the ibuprofen group. Primary end point: ulcer complication, defined as perforation, gastric outlet obstruction, and bleeding. Twenty-two percent of patients were taking low-dose aspirin for CV prophylaxis.

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Singh et al. Successive Celecoxib Efficacy and Safety Study-1 (SUCCESS-1) was a multicenter, double-blind, randomized, comparison study to evaluate the overall efficacy, safety, and tolerability of CELEBREX and nonselective NSAIDs in 13,274 OA patients. OA patients were randomized for 12 weeks to CELEBREX 100 mg BID (n=4393), CELEBREX 200 mg BID (n=4407), naproxen 500 mg BID (n=905), or diclofenac 50 mg BID (n=3489), which was used rather than naproxen in countries outside the United States and Canada. Primary safety analysis was adjudication of serious upper GI events, as well as an overall evaluation of investigator-reported adverse events. Primary efficacy analysis was comparison of patient's assessment of arthritis pain on a Visual Analog Scale (VAS), patient's Global Assessment of Arthritis, and Western Ontario and McMaster Universities Osteoarthritis index.

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Nissen et al. The PRECISION trial was a double-blind, randomized, controlled trial of cardiovascular safety in OA and RA patients with or at high risk for cardiovascular disease comparing celecoxib with naproxen and ibuprofen. Patients were randomized to a starting dose of 100 mg twice daily of celecoxib, 600 mg three times daily of ibuprofen, or 375 mg twice daily of naproxen, with the option of escalating the dose as needed for pain management. Based on labeled doses, OA patients randomized to celecoxib could not dose escalate. The primary endpoint, the Antiplatelet Trialists' Collaboration (APTC) composite, was an independently adjudicated composite of cardiovascular death (including hemorrhagic death), non-fatal myocardial infarction, and non-fatal stroke with 80% power to evaluate non-inferiority. All patients were prescribed open-label esomeprazole (20-40 mg) for gastroprotection. Treatment randomization was stratified by baseline low-dose aspirin use. Additionally, there was a 4-month sub-study assessing the effects of the 3 drugs on blood pressure as measured by ambulatory monitoring.

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Solomon et al. APC (Adenoma Prevention with Celecoxib) was a multicenter, randomized, clinically controlled study evaluating the efficacy and safety of CELEBREX 200 mg BID, CELEBREX 400 mg BID, and placebo in reducing the occurrence of adenomatous polyps in the colon and rectum 1 year and 3 years after endoscopic polypectomy. PreSAP (Prevention of Spontaneous Adenomatous Polyps) was a multicenter, randomized, clinically controlled study evaluating the efficacy and safety of CELEBREX 400 mg QD and placebo in reducing the occurrence of adenomatous polyps in the colon and rectum 1 year and 3 years after endoscopic polypectomy. Both APC and PreSAP participants were considered at high risk for colorectal adenoma recurrence. CV adverse events were adjudicated by an independent cardiovascular safety committee commissioned by the study's Data Safety Monitoring Board. Seventy-seven percent of patients completed 37 months of follow-up in APC. Fifty-four percent of patients completed 37 months of follow-up in PreSAP. CELEBREX 200 mg BID is 2x the approved OA dose. CELEBREX 400 mg BID is 4x the approved OA dose.

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Whelton et al. The Celecoxib Long-term Arthritis Safety Study (CLASS) was a double-blind, randomized, controlled trial to prospectively evaluate the effects of CELEBREX at 2 to 4 times the maximum therapeutic dose vs therapeutic doses of nonselective NSAIDs (ibuprofen and diclofenac) on measures of GI toxicity. Patients were randomly assigned CELEBREX 400 mg BID, ibuprofen 800 mg TID, or diclofenac 75 mg BID for at least 6 months, and no more than 52 weeks (in the diclofenac protocol) or 65 weeks (in the ibuprofen protocol). Median treatment duration was ≈9 months for the CELEBREX and diclofenac groups and ≈6 months for the ibuprofen group. Primary end point: ulcer complication, defined as perforation, gastric outlet obstruction, and bleeding. Approximately 39% of patients had a history of hypertension. Twenty-two percent of patients were taking low-dose aspirin for CV prophylaxis.

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*Eligibility required. Terms and conditions apply. Full terms and conditions can be found at CELEBREX.com/savings-terms. This Savings Offer will be accepted only at participating pharmacies. This Savings Offer is not health insurance. No membership fees. Maximum savings of $1,750 per offer. This Savings Offer is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, or other federal or state healthcare programs. This Savings Offer is not valid for prescriptions that are eligible to be reimbursed in whole by private insurance plans or other health or pharmacy benefit programs. Pfizer reserves the right to revoke, rescind, or amend this offer without notice. For help with the CELEBREX Savings Offer, call 1-855-612-1956, visit CELEBREX.com, or write: Pfizer Inc., 235 E 42nd Street, New York, NY 10017.

References:
  1. Data on file. Pfizer Inc., New York, NY.
  2. Singh G, Fort JG, Goldstein JL, et al; for SUCCESS-I Investigators. Celecoxib versus naproxen and diclofenac in osteoarthritis patients: SUCCESS-I study. Am J Med. 2006;119(3):255-266.
  3. Nissen SE, Neville D, Yeomans H, et al. Cardiovascular safety of celecoxib, naproxen, or ibuprofen for arthritis. N Engl J Med. 2016;375(26):2519-2529.
  4. Solomon SD, Pfeffer MA, McMurray JJV, et al; for the APC and PreSAP Trial Investigators. Effect of celecoxib on cardiovascular events and blood pressure in two trials for the prevention of colorectal adenomas. Circulation. 2006;114(10):1028-1035.
  5. Whelton A, Lefkowith JL, West CR, Verburg KM. Cardiorenal effects of celecoxib as compared with the nonsteroidal anti-inflammatory drugs diclofenac and ibuprofen. Kidney Int. 2006;70(8):1495-1502.

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