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| |  Celecoxib Safe and Effective for Sore Throat Pain at 50 and 100 mg Doses: Presented at ACCP By Maggie Schwarz PHILADELPHIA -- September 20, 2008 -- Celecoxib is safe and effective for treatment of pain due to pharyngitis in doses of 50 and 100 mg, according to research presented here at the American College of Clinical Pharmacology (ACCP) 37th Annual Meeting. Bernard P. Schachtel, MD, Schachtel Research Company, Jupiter, Florida, and colleagues assessed the analgesic effects of celecoxib in doses lower than the approved 200 mg for treatment of painful pharyngitis. He reported on the results of the trial in a presentation on September 15. Dr. Schachtel and colleagues performed a single-centre, randomised, double-blind, placebo-controlled, parallel-group trial that enrolled 269 patients. Patients were randomised to 1 of 4 treatment arms: celecoxib 50 mg followed by another 50-mg dose of celecoxib after 6 to 12 hours; celecoxib 100 mg followed by placebo 6 to 12 hours later; celecoxib 100 mg followed by celecoxib 50 mg 6 to 12 hours later; or placebo followed by placebo 6 to 12 hours later. A total of 268 patients completed the study. The primary efficacy endpoint was summed pain intensity difference (SPID) in the 2-hour period immediately after the initial dose. Secondary and tertiary endpoints included pain intensity difference at individual time points and summed over 6, 12, and 24 hours; total pain relief over 2, 6, 12, and 24 hours; pain intensity difference for throat soreness over 2, 6, 12, and 24 hours; and pain intensity difference for difficulty swallowing over 2, 6, 12, and 24 hours. In the primary efficacy analysis, celecoxib 50 mg and 100 mg resulted in a significantly greater reduction in mean pain intensity at 2 hours than placebo (26.4 and 21.0 vs 9.4, respectively; P = .0003). There were also significant differences between celecoxib and placebo in pain intensity difference from 45 minutes onward (P = .005) and through 6 hours (P <= .001). Total pain relief was significantly improved in celecoxib groups versus placebo groups at all time points tested (P < .001). For sore throat relief, there were significant differences between celecoxib regimens and placebo from 1 hour onward (P = .003) and through 6 hours (P <= .001). Thirty-four (12.6%) patients reported 1 or more adverse events, but none were serious or severe, and no deaths were reported in any treatment group. The incidence of adverse events was similar among the 4 treatment groups, with gastrointestinal disorders the most frequent in all treatment groups. All were mild to moderate and included abdominal pain/discomfort/distention, diarrhoea, dyspepsia, nausea, and stomach discomfort. Dr. Schachtel concluded that celecoxib was safe and effective at the 50- and 100-mg doses and may be a suitable treatment option for patients in acute pain.
[Presentation title: Acute Analgesic Efficacy and Tolerability of Low-Dose Celecoxib: Results of a Randomised, Double-Blind, Placebo-Controlled Trial. Abstract 89]
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