The most commonly reported side effects were nausea, vomiting, and diarrhea1
Results are pooled from three phase 3, 6-month, multicenter, randomized, double-blind, placebo-controlled clinical studies comparing Sensipar® with placebo in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (HPT) on dialysis with intact parathyroid hormone (iPTH) ≥ 300 pg/mL and serum calcium (Ca) ≥ 8.4 mg/dL (N = 1136). Patients in both treatment arms could be treated with vitamin D sterols and/or phosphate binders. Sensipar® dose was titrated sequentially every 4 weeks unless iPTH ≤ 200 pg/mL, Ca < 7.8 mg/dL, or an adverse event precluded a dose increase. If Ca < 8.4 mg/dL or symptomatic hypocalcemia developed, calcium supplement and/or phosphate binder dose could be increased. If these measures were insufficient, vitamin D dose could be increased. Mean baseline iPTH values in the Sensipar® group and placebo group were 733 pg/mL and 683 pg/mL, respectively. The primary endpoint of the studies was the proportion of patients achieving parathyroid hormone (PTH) level ≤ 250 pg/mL during the efficacy assessment phase. Patients were followed for a total of 26 weeks and were eligible for a 6-month extension, totaling 12 months of therapy.1
- 1. Sensipar® (cinacalcet) prescribing information, Amgen.