Comparison of sustained-release with standard tiaprofenic acid in the treatment of rheumatic diseases in general practice.

An open, parallel-group study was carried out to compare the efficacy and tolerance of a sustained-release capsule formulation of tiaprofenic acid at a dosage of 600 mg once daily with standard 300 mg tiaprofenic acid tablets given twice daily. Four hundred and eighty-five general practice patients with rheumatic disease requiring long-term non-steroidal anti-inflammatory drug therapy were included in the analysis. Patients were randomly allocated to receive, in a ratio of 3:1, either 2 X 300 mg sustained-release capsules at night or standard 300 mg tablets twice daily for a treatment period of 3 months. Pain, impairment of function and duration of morning stiffness were assessed at Week 0 (after a 3-day washout period) and at the end of Weeks 4, 8 and 12. Side-effects and compliance were also recorded at the end of Weeks 4, 8 and 12. Eighty-one (16.7%) patients withdrew from the study, with no significant difference in the withdrawal rates for the two treatment groups. Both treatment groups showed significant improvements clinically during tiaprofenic acid treatment; there were no significant differences between the two groups at Weeks 4, 8 or 12, nor were there any significant differences between the two treatment groups in the number of patients reporting side-effects at any of the assessments. In total, 36% of patients reported side-effects during the trial. The results indicate that both formulations are effective, well-tolerated treatments for rheumatic disease in general practice.

RCT Entities:   Population Interventions Outcomes