Hypocalcemia Common After Cinacalcet Initiation
Hypocalcemia developed in 58.3% of study participants within the first 16 weeks and, in most cases, resolved within 14 days with no changes in treatment.
Hypocalcemia commonly ensues after initiation of cinacalcet therapy for secondary hyperparathyroidism (SHPT), new findings suggest.
Jürgen Floege, MD, of RWTH University of Aachen in Germany, and his collaborators performed a post-hoc analysis of the randomized, double-blind, placebo-controlled EVOLVE (EValuation Of Cinacalcet Hydrochloride Therapy to Lower CardioVascular Events) trial. More than half of patients receiving the calcimimetic (58.3%) experienced hypocalcemia within the first 16 weeks, compared with just 14.9% of those receiving placebo. Severe hypocalcemia (total serum calcium below 7.5 mg/dL) developed in 18.4% and 4.4%, respectively.
Severe hypocalcemia correlated with higher body mass index, higher baseline serum parathyroid hormone levels, lower corrected total serum calcium, and higher serum alkaline phosphatase. The condition was more likely to develop among patients from Latin America and Russia than those from the United States. Hypocalcemia generally did not produce symptoms. The median cinacalcet dose before the first hypocalcemia episode was 54 to 58 mg daily.
In most cases, hypocalcemia resolved within 14 days without changes in therapy. For the remainder, the most common adjustment was an increase in the dose of active vitamin D.
Amgen, which produces cinacalcet (Sensipar), funded the study.
Floege J, Tsirtsonis K, Iles J, et al. Incidence, predictors, and therapeutic consequences of hypocalcemia in patients treated with cinacalcet: The EVOLVE Trial. Presented at Kidney Week 2017 in New Orleans (Oct. 31-Nov. 5). Abstract: TH-PO1035.