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Cinacalcet failed to reduce risk for mortality, CV events in hyperparathyroidism
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Cinacalcet did not significantly reduce the risk for death or major CV events, as compared with placebo, in patients who were undergoing dialysis with moderate-to-severe secondary hyperparathyroidism, according to a study recently published in The New England Journal of Medicine.
In this multicenter, prospective, randomized, placebo-controlled trial, researchers compared cinacalcet (Sensipar, Amgen) with placebo in 3,883 adults with moderate-to-severe secondary hyperparathyroidism undergoing dialysis. All patients were eligible to receive conventional therapy. Conventional therapy included phosphate binders, vitamin D sterols or both.
The primary analysis was conducted on the basis of the intention-to-treat principle. Patients were followed for up to 64 months, with median study-drug exposure durations of 21.2 months in the cinacalcet group and 17.5 months in the placebo group. Time until death, MI, hospitalization for unstable angina, HF or a peripheral vascular event comprised the primary composite endpoint.
The primary endpoint occurred in 938 of 1,948 patients (48.2%) in the cinacalcet group and 952 of 1,935 patients (49.2%) in the placebo group (relative HR=0.93; 95% CI, 0.85-1.02). Researchers found that hypocalcemia and gastrointestinal adverse events were significantly more frequent in patients assigned cinacalcet.
“The trial results must be interpreted in context. Patients undergoing dialysis are frequently frail and chronically ill. In the United States, mortality (20.7% per year) and morbidity (median, 2 hospitalizations and 12 hospital days per year) are extraordinarily high for such patients, who commonly have cardiopulmonary, gastrointestinal, musculoskeletal, and neurocognitive symptoms, along with a median pill burden of 19 per day. Thus, recruitment for and retention in clinical trials is particularly challenging,” the researchers wrote in the discussion.
Disclosure: The study was supported by Amgen.
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