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A multicenter trial of sulindac in osteoarthritis of the hip
Author(s) -
Calabro John J.,
Andelman Sumner V.,
Caldwell Jacques R.,
Gerber Robert C.,
Hamaty Daniel,
Kaplan Herbert,
Maltz Bertram A.,
Parsons James L.,
Saville Paul,
Tretbar Harold C.,
Ward John R.
Publication year - 1977
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt1977223358
Subject(s) - sulindac , medicine , placebo , osteoarthritis , phenylbutazone , rash , nonsteroidal , anesthesia , alternative medicine , pathology
Sulindac (cis‐5‐fluoro‐2‐methyl‐I‐[ (p‐methyl‐sulfinyl )‐benzylidene J‐indene‐3 ‐acetic acid) is a new nonsteroidal antirheumatic drug recently evaluated in a double‐blind trial of 91 patients with hip osteoarthritis. Consecutive patients with documented flare following previous drug withdrawal were randomly assigned to one of 3 treatment groups: (I) sulindac given twice daily, (2) sulindac given 4 times daily, and (3) placebo. The dosage of sulindac, 100 to 300 mg daily, was adjusted according to patient global response and tolerance at 3‐ to 7‐day intervals over 3 wk. Of 15 efficacy measurements evaluated, there was no difference between sulindac given 2 or 4 times daily, but differences were disclosed between one or both sulindac treatment groups and placebo in II of the 15 efficacy measurements (p < 0.05, < 0.01). The frequency of adverse reactions was of the same order for each treatment group. These included gastrointestinal upset, rash, and dizziness, usually transient and mild to moderate in severity. Serial laboratory studies revealed no evidence of renal, hepatic, or hematopoietic toxicity.