A General Practice Assessment of Alrheumat(R)(Ketoprofen) in the Treatment of Rheumatic Conditions

General practice trials: a reappraisal in the light of the findings of a general practice study of Oruvail®

“…A close similarity was found between the results on therapeutic efficacy in the present study and those emerging from three earlier large scale general practice studies of ketoprofen 5 , 6 , 7 . The reported successful therapeutic outcomes in these studies all fall into a narrow range, between 78.5 and 82.2 per cent.…”

“…The 95 per cent confidence limits (18 ± 8.484) obtained from this study in a larger sample of 15,228 patients suggest an incidence of gastrointestinal haemorrhage within the limits of 0.06 to 0.17 per cent or, roughly, between 0.5 and 2 per 1,000 patients per three month course of treatment. No intestinal perforations occurred during this study, neither did they occur during the series reviewed by Fossgreen 8 or in the three large scale studies reported by Goulton et al 5 , Baker et al 7 and Mason 6 . It seems reasonable to conclude, therefore, that intestinal perforation can be assumed to be an exceedingly rare event during therapy with ketoprofen, whatever the formulation.…”

Meta‐analysis of dyspepsia and nonsteroidal antiinflammatory drugs

“…We identified in the published literature 55 NSAID verses placebo RCTs providing data on GI adverse events (22-75); 86 NSAID versus NSAID RCTs (sample size Ն 50) (76 -160); 24 cohort studies (not discussed); 56 case control studies (not discussed); and 23 large exposure studies (sample size Ն 1,000) (161)(162)(163)(164)(165)(166)(167)(168)(169)(170)(171)(172)(173)(174)(175)(176)(177)(178)(179). From the FDA data, we identified an additional 37 previously unpublished NSAID verses placebo clinical trials (complete evidence table available by request).…”