Indoprofen in the treatment of osteoarthritis. Results of a phase IV multiclinic study in 1629 patients.
This paper contains a detailed account of the results obtained in 1629 patients with osteoarthritis treated with indoprofen, a recently introduced non-steroidal anti-inflammatory drug. Several traditional objective variables were selected for evaluation of efficacy, and they were shown to be highly correlated. After four weeks' treatment with doses of indoprofen ranging in the great majority of cases from two to four 200 mg tablets daily, highly significant improvement of pain was observed along with amelioration of joint motion as measured with a new arthrogoniometer specially developed for the trial. On a 5 point semiquantitative scale, pain severity decreased on the average ofrom 2.31 (0.03 S.E.M.) to 0.66 (0.02); knee flexion increased on the average from 71.8 (2 . 00) degrees to 93.0 (1.74) (p less than 0.001). These results have confirmed on a much larger scale the conclusions of phase 2 studies. The multiclinic trial disclosed more adverse reactions than those found in phase 3 studies, thus confirming that phase 4 studies are more suitable for supplying information on the acceptance of drugs by practising physicians. The risk/benefit ratio turned out to be very favourable on account of the acceptable frequency of adverse reactions which were mainly confined to the gastrointestinal tract and forced withdrawal in only 6.0% of patients. Untoward clinical events were validated with a new algorithm: their relationship with the drug was in 51.5% probable and 35.6% definite. The results of this study have confirmed the usefulness of indoprofen in the treatment of osteoarthritis.
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D007216:Indoprofen / Q000627:therapeutic use*; D007558:Italy; D008297:Male; D010003:Osteoarthritis / Q000188:drug therapy*; D010666:Phenylpropionates / Q000627:therapeutic use*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D010666:Phenylpropionates; D007216:Indoprofen