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Safety and tolerability of paricalcitol in patients with chronic kidney disease.

Expert opinion on drug safety (2013-04-30)
Christopher A Dyer

Secondary hyperparathyroidism (SHPT) is a complication of chronic kidney disease (CKD). Beyond skeletal complications, uncontrolled SHPT is associated with cardiovascular mortality. Vitamin D receptor activators (VDRAs) are a mainstay of therapy for SHPT; however, use is limited by hypercalcemia, though less so with calcitriol analogs such as paricalcitol and there is emerging experience with oral formulations for non-SHPT indications. The role of VDRAs in the treatment of SHPT becomes a complex question as alternative strategies have developed. This review summarizes trials that established the safety and efficacy of paricalcitol for SHPT. Comparative experience with paricalcitol as against other VDRAs will be reviewed as will the experience with paricalcitol in non-dialysis CKD and comparative experience with non-VDRA-based therapy. VDRA therapy is considered first-line therapy for treatment of SHPT. Paricalcitol has demonstrated superiority to calcitriol with respect to parathyroid hormone suppression and calcium-phosphorus balance. Oral formulations of paricalcitol appear to be similarly effective for SHPT. While there is evidence to suggest adjunctive antiproteinuria benefit with the use of VDRAs, efficacy of these agents to slow the progression of CKD or to reduce cardiovascular risk has not yet been demonstrated.

Product Number
Product Description

Paricalcitol, United States Pharmacopeia (USP) Reference Standard

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