Evaluation of the efficacy and safety of NSAIDs. A new methodological approach.
When rheumatic patients were questioned concerning the most desired attributes for a nonsteroidal anti-inflammatory drug (NSAID), the majority of replies related to tolerability. For example; low frequency of gastrointestinal side-effects, safety in the elderly, a low frequency of renal side-effects and a superior anti-inflammatory effect than other drugs available, were all regarded as important NSAID properties. This focus on safety issues by patients is probably due to problems experienced in recent years with non-steroidals on the market. In particular, the withdrawal of benoxaprofen was of major concern for both doctors and patients, and this together with other events over the last few years has not really contributed to an improvement of the relationship between rheumatic patients and doctors. The NSAIDs which have experienced problems and resulted in withdrawal from the market are as follows: benoxaprofen (Coxigon), indoprofen (Flosin), indomethacin (Osmosin, Osmogit), isoxicam (Pacyl) and oxyphenbutazone (Tanderil). Additionally, there were restrictions on the usage of phenylbutazone. This has resulted in the major authorities requiring more data concerning safety issues. The following paper will discuss an overview of the methodology which is now used in the development of a NSAID, using data and procedures obtained from the evaluation of tenoxicam.
Fenner
H
H
Clinical Research Department, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects* / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy; D002986:Clinical Trials as Topic; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D007256:Information Systems / Q000592:standards; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy; D010894:Piroxicam / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D012494:Sampling Studies
D000894:Anti-Inflammatory Agents, Non-Steroidal; D010894:Piroxicam; C032801:tenoxicam