A study of the safety of tenoxicam in general practice.

An open, noncomparative study was undertaken to examine the safety of tenoxicam, a new nonsteroidal antiinflammatory drug (NSAID) in general practice. One thousand two hundred and sixty-seven patients with rheumatic conditions were recruited by 392 general practitioners throughout New Zealand. Forty-three point six percent of patients recruited were over 65 years of age, 62.5% had some form of concomitant disease and 76.3% of patients were already receiving NSAIDs. Three hundred and four (23.9%) patients experienced adverse drug reactions, the commonest being gastrointestinal (11.4%), central and peripheral nervous system disorders (2.8%) and skin reactions (2.5%). The profile of adverse drug reactions in those more than 65 was similar to those in patients under 65 years. Of the reactions reported, 14.7% were considered severe. Three peptic ulcers were reported. There were no unexpected adverse drug reactions. Eight hundred and forty-nine patients completed 6 months treatment. Subjective assessments of overall efficacy, pain at night, pain on movement and stiffness made before treatment and at 1, 3 and 6 months posttreatment showed that tenoxicam significantly improved all parameters. The clinical response was maintained throughout the 6 month study period and was not different in patients less than or greater than 65 years.