ABSTRACT
In a double blind, randomized, parallel group study, 197 patients with osteoarthritis (OA) received nabumetone (1000 mg/day) or indomethacin (75 mg/day) for 6 weeks and doses could be doubled. Doubling the dose resulted in a 100 or 67% increase in pain relief with nabumetone or indomethacin, respectively. Significantly more patients experienced at least 1 severe adverse event with indomethacin than with nabumetone. With nabumetone, the incidence of adverse events did not increase with dose. However, with the increase in dose, the incidence of all adverse events and gastrointestinal events increased in indomethacin treated patients. Nabumetone was as effective as indomethacin for the treatment of OA. However, significantly fewer nabumetone treated patients experienced severe adverse events and the frequency of events did not increase with dose.
Subject(s)
Butanones/therapeutic use , Indomethacin/therapeutic use , Osteoarthritis/drug therapy , Adult , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Butanones/administration & dosage , Butanones/adverse effects , Dose-Response Relationship, Drug , Family Practice/methods , Female , Humans , Indomethacin/administration & dosage , Indomethacin/adverse effects , Male , Middle Aged , Nabumetone , Osteoarthritis/physiopathology , Treatment OutcomeABSTRACT
We have performed a detailed pharmacokinetic study of the plasma concentrations of the major active metabolite of nabumetone, 6-methoxy-2-naphthylacetic acid (6 MNA), attained after a single dose and during chronic administration comparing the results of a group of young healthy volunteers with those of a group of elderly arthritic patients. The latter had higher peak plasma concentrations of 6 MNA and slower rates of elimination but there is no tendency for the drug to accumulate unpredictably in the old. Disease activity also influences plasma concentration, those with more active disease, and lower serum albumin concentrations had lower AUC values.
