Meta-analysis of two double-blind comparative studies with the sustained-release form of etodolac in rheumatoid arthritis.

A meta-analysis was done with the data from two studies that provided the first efficacy and safety results for the new sustained-release (SR) formulation of etodolac versus established nonsteroidal anti-inflammatory drugs in patients with rheumatoid arthritis (RA). The studies were 4-week, double-blind, multicenter, randomized, parallel-group comparisons of etodolac SR 600 mg (102 patients) with either diclofenac SR 100 mg (65 patients) or piroxicam 20 mg (35 patients). The data for etodolac SR were pooled and compared with the pooled data for the comparators. The primary efficacy assessments (weeks 2 and 4) were physician and patient overall evaluation of the patient's condition, number of painful/tender joints, and number of swollen joints. Patients met at least five of the American Rheumatism Association diagnostic criteria and were within Steinbrocker progression stage I, II, or III and functional class I, II, or III. The homogeneity of the treatment groups across studies and the changes from baseline between groups were tested using a Cochran-Mantel-Haenszel test and an analysis of variance including "study," "treatment," and "center within treatment" factors and their interaction. The efficacy analysis was based on the final assessment during therapy (last visit). The patients in the etodolac SR group were older than those in the comparators group (P = 0.032), and there were more patients over 65 years of age in the etodolac SR group than in the comparators group (31% versus 14%, respectively; P = 0.004).(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes