The Committee identified a need for long-term clinical studies that are designed to evaluate the effects of cinacalcet on clinical outcomes (in particular, fracture and cardiovascular events) in people with ESRD. Studies to establish the multivariate relationship between biochemical disruption in secondary hyperparathyroidism and these clinical outcomes are also recommended.
The Committee also noted that more research is needed on the effects of cinacalcet in people with ESRD with particular clinical needs, specifically people with refractory secondary (or tertiary) hyperparathyroidism, people awaiting kidney transplants from living donors, people with calciphylaxis, people with recurrent hyperparathyroidism after parathyroidectomy, and people in whom surgical parathyroidectomy is contraindicated.