No permanent reduction in bone mineral density during treatment of polymyalgia rheumatica and temporal arteritis using low dose corticosteroids.

The objective of the study was to examine bone mineral density (BMD) in patients with polymyalgia rheumatica (PMR) or temporal arteritis (TA) currently or previously treated with prednisolone. BMD (using single or dual x-ray absorptiometry) was measured in radius, spine, and hip in 26 currently and 28 previously prednisolone treated patients with PMR (n = 38) or TA (n = 16). The prednisolone treated patients were compared to 30 newly diagnosed PMR (n = 26) or TA patients (n=4) examined prior to start of prednisolone, and 70 healthy controls. No statistically significant differences were found between the groups regarding age, height, weight, and gender. For current users of prednisolone, the mean daily dose was 6.5 mg, the mean cumulative dose 7.7 grams, and for previous users 5.6 mg and 6.6 grams, respectively. No statistically significant differences in BMD at the different measurement sites were found between prednisolone treated patients and the two control groups. Similarly, no significant differences in BMD were found between current and previous users of prednisolone and between the prednisolone treated PMR and TA patients. In conclusion, BMD is not substantially reduced in PMR and TA patients currently or previously treated with mean low dose prednisolone. However, a tendency to a lower BMD was found in PMR/TA patients currently treated with prednisolone and in the prednisolone treated TA patients.

Conversion of patients with rheumatoid arthritis from the conventional to a microemulsion formulation of cyclosporine: a double blind comparison to screen for differences in safety, efficacy, and pharmacokinetics.

OBJECTIVE: To assess whether patients with rheumatoid arthritis (RA) may be converted, on a milligram-to-milligram basis, from conventional cyclosporin A (CyA, Sandimmun) to the microemulsion formulation (Neoral) with maintenance of longterm safety, and to compare cyclosporin A (CyA) pharmacokinetics between formulations. METHODS: In this double blind, multicenter, parallel group study, 51 patients receiving stable conventional CyA maintenance treatment were randomized to continue conventional CyA (n = 27) or to convert to CyA microemulsion (n = 24) and were monitored for 52 weeks. Trough blood CyA levels were measured before and at intervals after conversion. CyA steady-state area under the curve was assessed one week before and 2 and 6 weeks after randomization in 15 patients in each treatment arm. CyA trough levels and pharmacokinetic results remained unknown to investigators throughout the study. CyA doses were titrated as necessary on the basis of clinical evaluation and disease activity assessments. RESULTS: Initial mean daily doses were 3.5 mg/kg/day (conventional CyA) and 3.3 mg/kg/day (CyA microemulsion) and did not change significantly during the study. The mean bioavailability of CyA from the microemulsion formulation was 23% higher than from conventional CyA. Replicate assessments indicated a more reproducible pharmacokinetic profile with CyA microemulsion. The overall incidence and nature of adverse events and changes in vital signs and laboratory variables were similar in both groups. No clinically relevant differences in efficacy were found between treatments. No loss of efficacy and no tolerability problems occurred after conversion from conventional to microemulsion CyA. CONCLUSION: Existing CyA dosing guidelines, formulated for conventional CyA, are suitable for longterm CyA microemulsion therapy of patients with RA. These results indicate the pharmacokinetic advantages of the microemulsion formulation.