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A double blind multicenter study of sulindac once daily versus sulindac twice daily in osteoarthritis of the knee

A double blind multicenter study of sulindac once daily versus sulindac twice daily in osteoarthritis of the knee

Current Therapeutic Research 41(5): 692-705

Nine investigators participated in a four-week, double-blind, multicenter, controlled study of the safety and efficacy of sulindac administered once daily versus twice daily in the treatment of osteoarthritis of the knee. One hundred seventy four patients who satisfied specified criteria for disease activity after all anti-inflammatory analgesic therapy was discontinued were randomly divided into two groups, one receiving sulindac once daily in the morning with breakfast and he other receiving sulindac twice daily with breakfast and at 9:00 PM with a snack, during a four-week treatment period. The daily dose of sulindac, which was initially 300 mg, was raised to 400 mg if indicated by patient need and tolerability. Sulindac given once daily was at least as effective as sulindac given twice daily in regard to all efficiency parameters. Sulindac given once daily was generally well tolerated and was similar in its adverse reaction profile to sulindac given twice daily. Expected differences in the serum drug concentration profile between the ratio regimen were confirmed in that trough (0-hour) concentrations of sulindac and metabolites were lower and three group postdose concentrations were higher in the once-daily regimen than in the twice-daily regimen. The results of the study support the clinical utility of once-daily therapy with sulindac in the treatment of osteoarthritis.

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