Abstract: PO0358
Indirect Comparison of Treatments for Secondary Hyperparathyroidism Through a Network Meta-Analysis
Session Information
- Biochemical Aspects of Mineral and Bone Disease
October 22, 2020 | Location: On-Demand
Abstract Time: 10:00 AM - 12:00 PM
Category: Bone and Mineral Metabolism
- 402 Bone and Mineral Metabolism: Clinical
Authors
- Gunnarsson, Joel, Quantify Research AB, Stockholm, Sweden
- Lauppe, Rosa, Quantify Research AB, Stockholm, Sweden
- Csomor, Philipp, Vifor Pharma Ltd, Glattbrugg, Zurich, Switzerland
- Grava, Astride, Vifor Pharma Ltd, Glattbrugg, Zurich, Switzerland
- Soro, Marco, Vifor Pharma Ltd, Glattbrugg, Zurich, Switzerland
Background
Secondary hyperparathyroidism (SHPT) is a complication of chronic kidney disease (CKD) affecting mineral and bone metabolism and characterized by excessive parathyroid hormone (PTH) production and parathyroid hyperplasia. Currently the only 2 treatments indicated for the treatment of SHPT in non-dialysis CKD (ND CKD) are paricalcitol (PCT) and more recently extended release calcifediol (ERC). The objective of this analysis was to compare the efficacy and safety of ERC and PCT by assessing their effect on biomarkers PTH, calcium and phosphate.
Methods
A systematic literature research (SLR) was performed in PubMed to identify randomized control trials (RCTs) to be included in a Network Meta-Analysis (NMA). In all articles, the comparator groups were consisting of placebo. A quality assessment was done with the GRADE method. The treatment effects of ERC and PCT were compared using random effects in a frequentist setting, and a sensitivity analysis with Bayesian approach was performed using random effects model. Comparisons were made between the overall treatment effects of the drugs.
Results
Nine RCTs comprising a total of 1426 patients were included in the analyses. Compared to placebo, treatment with both PCT and ERC lowered levels of PTH in a statistically significant manner. No statistically significant differences in PTH reduction were found between PCT and ERC. Treatment with PCT significantly increased calcium levels compared to placebo (effect size: 0.30 mg/dl, 95 % CI: 0.21 to 0.40 mg/dl), while the estimated effect of ERC on calcium (effect size: 0.10 mg/dl) was not significant (95 % CI: -0.03 to 0.23 mg/dl). The calculated difference of effects between treatment with PCT and ERC shows that PCT significantly raises levels of calcium by 0.2 mg/dl (95 % CI: -0.37 to -0.04 mg/dl). No differences in effects on phosphate were observed. Sensitivity analyses using a Bayesian approach confirmed the general pattern of similar PTH reductions and larger increases in calcium from PCT observed in the analyses.
Conclusion
This NMA showed that ERC is non inferior in lowering PTH levels vs PCT. ERC displayed avoidance of clinically relevant increases in serum phosphorus and calcium, offering a new, effective and well tolerated treatment option for the early management of SHPT in patients with ND CKD.
Funding
- Commercial Support –