EFFICACY AND SAFETY OF SEVELAMER CARBONATE VERSUS CALCIUM ACETATE IN PATIENTS WITH CHRONIC RENAL DISEASE ON DIALYSIS

摘要

Purpose: Powdered sevelamer carbonate is a new phosphate binder with unproven therapeutic benefit in Indian population. Hence, we aimed to compare its efficacy and safety with calcium acetate in patients with Chronic Renal Disease on hemodialysis. Methods : This was a randomized, prospective, cross over and open labeled study, conducted in the Department of Nephrology, Christian Medical College and Hospital, Ludhiana. Fifty patients were included in data analysis and were randomization into two groups, A & B. Group A patients first received powdered sevelamer carbonate for 4 weeks (n= 25) followed by 1 week of washout and calcium acetate for the next 4 weeks (n=25). Group B: vice-versa. Serum phosphorus, calcium, C-reactive protein (CRP), total cholesterol, triglycerides (TGs) and low density lipoprotein (LDL) levels were performed before and after each drug was administered. Results : Mean baseline serum phosphorus and calcium phosphorus product in group A, reduced from 6.59 ± 0.31mg/dl & 53.18 ± 2.5mg 2 /dl 2 to 5.26± 0.33mg/dl & 44.76mg 2 /dl 2 respectively. In group B these reduced from 6.42±0.33 mg/dl & 52.06±2.5 mg 2 /dl 2 to 5.44±0.3 mg/dl & 44.5mg 2 /dl 2 respectively. The reduction in these values in both groups was statistically significant ( p <0.05). Reductions in serum CRP, total cholesterol, triglycerides and low density lipoprotein (LDL) levels were not statistically significant in either group. Conclusion : Powdered sevelamer carbonate and calcium acetate are equally efficacious with no serious adverse effects. Both the drugs were well tolerated. Hence, powdered sevelamer carbonate can be a useful alternate to calcium based binders in Indian patients.