Hepatic and renal tolerability of long-term naproxen treatment in patients with rheumatoid arthritis.

Clinical and laboratory assessments of hepatic and renal function in rheumatoid arthritis (RA) patients who received naproxen for up to 6 months during two randomized, double-blind studies comparing naproxen 375 mg twice daily (n = 286) with naproxen 750 mg twice daily (n = 300) were analyzed. Patient groups were segregated by dosage, duration of treatment, and age at entry (less than 65 years v greater than or equal to 65 years), and laboratory measurements of SGOT, SGPT, serum creatinine (Scr), and BUN were examined. Records of individual patients with clinically meaningful abnormalities in laboratory tests or adverse events of hepatic or renal origin were examined in detail. Over the duration of these studies, there were no clinically meaningful changes in mean laboratory values or differences in occurrences of abnormal values among the different patient groups. In both dosage groups, pretreatment incidences of clinically meaningful abnormalities in laboratory tests were similar to those in serial observations during treatment. Six patients who received naproxen 375 mg twice daily and four patients who received naproxen 750 mg twice daily had a hepatic or renal clinical event or distinctly abnormal laboratory value, but only three of these withdrew because of these problems. Occasional transient abnormalities of conventional laboratory tests of hepatic and renal function occurred in some patients during naproxen treatment. Such abnormalities called for careful patient monitoring but generally did not warrant immediate drug withdrawal.

RCT Entities:   Population Interventions Outcomes