Clinical therapeutics
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Clinical therapeutics · Jul 1995
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialComparison of the efficacy and safety of oxaprozin and nabumetone in the treatment of patients with osteoarthritis of the knee.
This multicenter, 6-week, double-blind, placebo-controlled, parallel-group study compared the efficacy and safety of oxaprozin 1200 mg once daily with that of nabumetone 1000 mg once daily in patients with moderate-to-severe osteoarthritis (OA) of the knee. To be eligible, patients had to experience a flare of OA within 2 weeks of discontinuing their usual OA medication (nonsteroidal anti-inflammatory drug or analgesic). Eligible patients were assessed at baseline and then randomized to receive oxaprozin (n = 109), nabumetone (n = 110), or placebo (n = 109). ⋯ Four of these patients had reversible elevations of aspartate aminotransferase and alanine aminotransferase greater than three times the upper limit of normal range (P < 0.05); two of these patients were taking other medications known to induce liver enzyme abnormalities. The study showed that oxaprozin 1200 mg once daily was statistically significantly more efficacious than nabumetone 1000 mg once daily for the treatment of patients with moderate-to-severe OA of the knee. Both drugs were clinically well tolerated.
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The safety of naproxen sodium for over-the-counter use was evaluated based on 48 randomized, double-blind, placebo-controlled clinical trials that evaluated naproxen/naproxen sodium (NAP) for indications appropriate to, and under, conditions common to, nonprescription analgesics. Of the 48 studies, 27 were single-dose studies and 21 were multiple-dose studies of 1 to 10 days' duration; 19 studies included ibuprofen and 9 included acetaminophen. A total of 4138 patients received naproxen or naproxen sodium (3589 patients received naproxen 187.5 to 400 mg and 549 received naproxen sodium 220 to 440 mg), 2423 received placebo, 1574 received ibuprofen (200 or 400 mg), and 671 received acetaminophen (500 to 1000 mg). ⋯ Across all 48 studies, 83% of both the NAP- and placebo-treated patients reported no adverse events. The incidence rates were similar between NAP and placebo, with headache (4.8% NAP, 6.4% placebo), nausea (3.4% NAP, 3.1% placebo), and somnolence (2.7% NAP, 1.9% placebo) the most commonly reported events. Rates of adverse events with NAP, ibuprofen, and acetaminophen were similar.