Patient Treatment Considerations

Study Descriptions

Niculescu et al was a pooled analysis of 21 CELEBREX trials (6-52 weeks in duration) from the Pfizer database comparing the GI tolerability of CELEBREX and nonselective NSAIDs in 23,545 patients diagnosed with OA, RA, or ankylosing spondylitis and treated with CELEBREX, naproxen, ibuprofen, or diclofenac. The majority of patients had OA (approximately 86%; n=20,233) and approximately 12% had RA (n=2857). The remaining patients had ankylosing spondylitis. Primary end points were combined incidence of the 5 most common GI AEs (dyspepsia, abdominal pain, diarrhea, nausea, flatulence) and time to discontinuation due to any GI AE. Median exposure=0.2 years overall.

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Renda et al was a randomized, placebo-controlled, double-blind, parallel-group study to address whether CELEBREX or ibuprofen interferes with the inhibition of platelet COX-1 activity by aspirin in 24 patients with OA and stable ischemic heart disease on low-dose aspirin. Stable ischemic heart disease was defined as a stable pattern of effort angina lasting over 6 months, with angiographically documented coronary artery disease. Each patient was given aspirin 100 mg with either CELEBREX 200 mg BID, ibuprofen 600 mg TID, or placebo for 7 consecutive days. Primary end point: evaluation of platelet COX-1 activity ex vivo, as measured by serum TxB2 levels. Secondary end points: platelet aggregation induced by arachidonic acid (AA) and adenosine-diphosphate (ADP). CELEBREX did not interfere with aspirin's ability to inhibit TxB2, while Rx ibuprofen was associated with a significant increase in TxB2 levels (P<.001). CELEBREX did not interfere with aspirin's ability to inhibit platelet aggregation, while Rx ibuprofen was associated with a significant increase in AA-induced platelet aggregation (P<.01) and ADP-induced platelet aggregation (P<.05).

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Catella-Lawson et al was a randomized, crossover study of combinations of single daily doses of 2 treatments for 6 days to determine potential interactions between aspirin 81 mg and some arthritis therapies. Each of 3 study groups had 6 healthy subjects between the ages of 18 and 65 years. One group received a single daily dose of aspirin each morning 2 hours before ibuprofen (400 mg each morning) for 6 days and then, after a washout period of at least 14 days, received the same medications in reverse order; a second group of subjects received aspirin 2 hours before acetaminophen (1000 mg each morning) for 6 days and then the same medications in reverse order after a washout period of at least 14 days; the third group of subjects received aspirin 2 hours before the cyclooxygenase-2 inhibitor rofecoxib (25 mg each morning) for 6 days and then the same medications in reverse order after a washout period of at least 14 days. Primary analysis was the measurement of serum thromboxane B2 24 hours after administration of the first study drug on day 6 of combination therapy to assess the inhibition of platelet cyclooxygenase-1. Secondary analysis was platelet aggregation induced by arachidonic acid, which was measured in platelet-rich plasma ex vivo 24 hours after administration of the first study drug on day 6 of combination therapy.

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Leese et al was a 10-day, single-center, double-blind, randomized, placebo-controlled study to evaluate the effects of CELEBREX 600 mg BID on platelet function compared with naproxen 500 mg BID or placebo in 24 healthy men and women aged 18 to 55 years. Thirty minutes prior to treatment administration, blood samples were collected for baseline measurements. On day 1, subjects received a single dose of treatment. On day 3 through day 9, subjects received the same dose (12 hours apart), followed by a single dose on day 10. Blood samples for evaluation were taken on day 1 at 30 minutes before and 8 hours after dosing, and on day 10 at 30 minutes before and 4, 6, and 8 hours after dosing. Posttreatment change from baseline for platelet aggregation, bleeding time, and serum concentrations of TxB2 were primary variables assessed as measures of platelet function. CELEBREX 600 mg BID is 6 times the recommended OA dose.

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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. 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. Niculescu L, Li C, Huang J, Mallen S. Pooled analysis of GI tolerability of 21 randomized controlled trials of celecoxib and nonselective NSAIDs. Curr Med Res Opin. 2009;25(3):729-740.
  2. Data on file. Pfizer Inc, New York, NY.
  3. Renda G, Tacconelli S, Capone ML, et al. Celecoxib, ibuprofen, and the antiplatelet effect of aspirin in patients with osteoarthritis and ischemic heart disease. Clin Pharmacol Ther. 2006;80(3):264-274.
  4. Catella-Lawson F, Reilly MP, Kapoor SC, et al. Cyclooxygenase inhibitors and the antiplatelet effects of aspirin. N Engl J Med. 2001;345(25):1809-1817.
  5. Leese PT, Hubbard RC, Karim A, Isakson PC, Yu SS, Geis GS. Effects of celecoxib, a novel cyclooxygenase-2 inhibitor, on platelet function in healthy adults: a randomized, controlled trial. J Clin Pharmacol. 2000;40(2):124-132.

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