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A double blind multicenter study of sulindac once daily versus sulindac twice daily in rheumatoid arthritis



A double blind multicenter study of sulindac once daily versus sulindac twice daily in rheumatoid arthritis



Current Therapeutic Research 41(5): 679-691



Ten investigators participated in a four-week, double-blind, multicenter, controlled study of the safety and efficacy of sulindac once daily versus sulindac twice daily in the treatment of rheumatoid arthritis. One hundred eighty-one patients who satisfied specified criteria for disease activity after all anti-inflammatory and analgesic therapy was discontinued were randomly divided into two groups, one receiving sulindac once daily at 9:00 PM with a snack and the 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 subsequently raised to 400 mg, if indicated by patient need and tolerability. Except for morning stiffness at week 4 when therapy-related withdrawals were excluded, sulindac given once daily was as effective as sulindac given twice daily, in all the evaluated measures of efficacy including signs, symptoms, and global responses at two and four weeks. Sulindac given once daily was generally well tolerated and was similar in its adverse reaction profile to sulindac given twice daily. The results of this study support the clinical utility of once-daily therapy with sulindac in the treatment of rheumatoid arthritis.

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