#VisualAbstract: Effect of Oral Alfacalcidol on Clinical Outcomes in Patients Without Secondary Hyperparathyroidism Receiving Maintenance Hemodialysis
1. In this randomized clinical trial, patients on hemodialysis who received a vitamin D receptor activator (VDRA) did not have better cardiovascular health compared to those with placebo.
2. Patients receiving active vitamin D did not have reduced mortality.
Evidence Rating Level: 1 (Excellent)
Study Rundown:Â Patients with advanced chronic kidney disease (CKD) on hemodialysis are at greater risk for cardiovascular disease, and impaired activation of vitamin D by the kidneys may contribute to this increased risk. Though studies have shown benefits of vitamin D receptor activators (VDRAs) like alfacalcidol for reducing cardiovascular risk, it is not clear if they reduce risk in CKD patients on dialysis. In this open-label, randomized controlled trial, patients on dialysis who received oral alfacalcidol did not have reduced risk of composite cardiac events compared to controls. In addition, there was no difference in mortality between groups. The number of adverse events were similar.
Unfortunately, these results are in line with previous studies such as PRIMO and OPERA that showed that oral paricalcitriol did not have cardiovascular benefit. Though the control group was allowed to take VDRAs if mandated by guidelines, suggesting one confounding factor, the investigators attempted to address this issue by selecting patients with intact PTH levels. In addition, post-hoc power analyses suggested the study may have been underpowered to sufficiently detect differences in the primary and secondary outcomes.
Click to read the study in JAMA
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