Treatment of Secondary Hyperparathyroidism in CKD Patients on Dialysis with Cinacalcet

Indications and Recommendations

The FDA approves cinacalcet specifically for patients with CKD stage 5D (dialysis) who have secondary hyperparathyroidism, with benefits primarily limited to prevention of surgical parathyroidectomy and avoidance of hypercalcemia 1, 3
The Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guidelines are not supported by current evidence, which suggests that people with CKD on dialysis and elevated PTH levels should not necessarily receive calcimimetics to decrease serum PTH levels 2, 4

Cinacalcet provides small reductions in the risk of surgical parathyroidectomy (RR 0.49 [95% CI, 0.40-0.59]) but has little or no effect on all-cause mortality (RR 0.97 [95% CI, 0.89-1.05]) 5, 6
Cinacalcet reduces the risk of hypercalcemia (RR 0.23 [95% CI, 0.05-0.97]) 7
Cinacalcet decreases serum PTH (mean difference -281 ng/L [95% CI, -326 to -236]) and calcium concentrations (mean difference -0.22 mmol/L [95% CI, -0.25 to -0.19]) 5

The most common adverse effects of cinacalcet are gastrointestinal, including nausea (RR 2.05 [95% CI, 1.54-2.75]), vomiting (RR 1.95 [95% CI, 1.74-2.18]), and diarrhea (RR 1.15 [95% CI, 1.02-1.29]) 7, 5
Cinacalcet significantly increases the risk of hypocalcemia (RR 7.38 [95% CI, 5.43-10.03]) 7, 5

On average, treating 1,000 people with CKD stage 5D with cinacalcet for 1 year has no effect on survival, prevents about 3 patients from requiring parathyroidectomy, but leads to approximately 60 cases of hypocalcemia and 150 cases of nausea 8
The American College of Physicians may consider cinacalcet for preventing parathyroidectomy in the small number of patients for whom surgery is contraindicated due to risks outweighing benefits 2, 6

Routine use of cinacalcet therapy in people with CKD does not appear warranted based on current evidence 2, 8
Cinacalcet has uncertain effects on cardiovascular mortality (RR 0.67 [95% CI, 0.16-2.87]) 5
Treatment effects on fracture risk are possible but remain imprecise and of lower quality evidence 3, 6
Data for cinacalcet therapy are largely limited to adults with CKD stage 5D, with insufficient evidence for other CKD stages 2
Due to relative absence of trials in peritoneal dialysis patients, treatment estimates for this specific group are less certain 2