Long-term (over 12 months) study of nabumetone was conducted in patient with RA in a PMS drug evaluation effort. Only a small number of patients dropped out or discontinued nabumetone therapy at an early stage, with the treatment period being less than 3 months in 12 of 162 patients (7.4%), 3-6 months in 14 patients (8.6%) and 6-9 months in 9 patients (5.6%) . Treatment was continued for more than 12 months in 121 patients (74.7%), suggesting that the drug is well-tolerated by most of the patients.
Grip strength, erythrocyte sedimentation rate, number of painful joints, number of swollen joints, duration of morning stiffness and Lansbury's index showed statistically significant improvement from the pre-treatment base line at every evaluation time point.
The global improvement rate (“markedly improved”+“moderately improved”+“slightly improved”) was 56.6%, 64.1%, 63.6% and 64.9% respectively at 3, 6, 9, and 12 months. The improvement rate thus increased till 6 months after starting the treatment. Adverse events occurred in only 12 of 159 patients (7.5%), with GI symptoms, which are major adverse events of non-steroidal anti-inflammatory agents, in only 9 patients (5.6%; 11 episodes) .
Severity of adverse events was rated“mild”or“moderate”and no severe adverse event was reported. Abnormal laboratory findings observed were 4 patients (4 episodes), but all of them cleared after the discontinuation of nabumetone.
