Upacicalcet may be effective in adults with secondary hyperparathyroidism on hemodialysis
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Key takeaways:
- In the study, 67% of patients receiving upacicalcet achieved target parathyroid hormone concentrations.
- Overall, 2% of patients had serum corrected calcium concentrations below 7.5 mg/dL.
Upacicalcet, an injectable calcimimetic, may be an effective and safe therapy for adults with secondary hyperparathyroidism on hemodialysis, according to a recently published study.
“Secondary hyperparathyroidism is a major pathognomonic condition representative of chronic kidney disease–mineral and bone disorders ... and can lead to vascular calcification and osteitis fibrosa,” Takashi Shigematsu, MD, PhD, of the division of nephrology at the Rinku General Medical Center in Osaka, Japan, and colleagues wrote.
Researchers conducted a phase 3, double-blind, placebo-controlled trial between January and December 2019 at 41 sites in Japan. A total of 153 patients receiving hemodialysis at least three times per week, and with serum-intact parathyroid hormone (PTH) concentrations greater than 240 pg/mL and corrected calcium concentrations of at least 8.4 mg/dL, were included. Patients were randomly assigned to upacicalcet or a placebo after each session for 24 weeks. Overall, 103 patients received upacicalcet and 50 patients received the placebo. The primary outcome was the percentage of patients achieving the target mean serum intact PTH levels between 60 pg/mL and 240 pg/mL during weeks 22 to 24 of the trial.
Findings showed that 67% of patients in the upacicalcet group achieved the target mean serum intact PTH concentrations during the evaluation period vs. 8% in the placebo group.
Additionally, upacicalcet decreased levels of other markers of bone disease, including fibroblast growth factor-23, bone-specific alkaline phosphatase, total type 1 procollagen-N-propeptide and tartrate-resistant acid phosphatase-5b, according to the study.
Adverse events were reported in 85% of patients in the upacicalcet group and 72% in the placebo group. The incidence of upper gastrointestinal adverse events, such as nausea and vomiting, was similar between the two groups, the researchers noted. A total of 2% of patients in the upacicalcet group experienced serum corrected calcium concentrations below 7.5 mg/dL, compared with none in the placebo group.
In summarizing the results, the authors wrote, “[Upacicalcet] is effective and can be a safe calcimimetic agent for the management of secondary hyperparathyroidism.”
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