An Overview of the Long Term Safety Experience of Nabumetone

Summary

Safety data have been gathered in US clinical trials of nabumetone on 1912 patients from August 1981 to May 1988. Dosing in the double-blind trials was 100mg at bedtime, but in open-label trials patients could increase the dosage of nabumetone to 1500 or 2000mg if required. Adverse experiences reported in the double-blind and open-label studies that were considered related to nabumetone treatment, or of unknown origin, occurred most commonly in two body systems: the body as a whole, and the digestive system. Incidence rates greater than 10% for adverse experiences categorised by preferred term occurred in the ‘body as a whole’ category for abdominal pain, and in the digestive system for diarrhoea and dyspepsia. Dosage increases to 2000mg appeared to cause a dose-related increase in diarrhoea. In the long term studies, gastrointestinal ulcers have been confirmed in 13 (0.7%) patients. Hepatic and renal function was well preserved in patients treated with nabumetone. Overall, only 7 nabumetone-treated patients (0.4%) showed a marked elevation in both ALT (SGPT) and AST (SGOT). Two nabumetonetreated patients showed marked elevations in renal parameters, serum creatinine and blood urea nitrogen. Overall, nabumetone was well tolerated, and the adverse experience profile was clinically acceptable and presented no unusual or unexpected patterns.