EFFECTS OF DEFLAZACORT VERSUS PREDNISONE ON BONE MASS, BODY-COMPOSITION, AND LIPID PROFILE - A RANDOMIZED, DOUBLE-BLIND-STUDY IN KIDNEY-TRANSPLANT PATIENTS

To compare the effects of deflazacort (DEFLA) vs. prednisone (PRED) on bone mineral density (BMD), body composition, and lipids, 24 patients with end-stage renal disease were randomized in a double blind design and followed 78 weeks after kidney transplantation. BMD and body comp osition were assessed using dual energy x-ray absorptiometry. Seventee n patients completed the study. Glucocorticosteroid doses, cyclosporin e levels, rejection episodes, and drop-out rates were similar in both groups. Lumbar BMD decreased more in PRED than in DEFLA (P < 0.05), th e difference being particularly marked after 24 weeks (9.1 +/- 1.8% vs . 3.0 +/- 2.4%, respectively). Hip BMD decreased from baseline in both groups (P < 0.01), without intergroup differences. Whole body BMD dec reased from baseline in PRED (P < 0.001), but not in DEFLA. Lean body mass decreased by approximately 2.5 kg in both groups after 6-12 weeks (P < 0.001), then remained stable. Fat mass increased more (P < 0.01) in PRED than in DEFLA (7.1 +/- 1.8 vs. 3.5 +/- 1.4 kg). Larger increa ses in total cholesterol (P < 0.03), low density lipoprotein cholester ol (P < 0.01), lipoprotein B2 (P < 0.03), and triglycerides (P = 0.054 ) were observed in FRED than in DEFLA. In conclusion, using DEFLA inst ead of PRED in kidney transplant patients is associated with decreased loss of total skeleton and lumbar spine BMD, but does not alter bone loss at the upper femur. DEFLA also helps to prevent fat accumulation and worsening of the lipid profile.