Zemplar (Abbott) shows positive results in Phase IV Hyperparathyroidism study

A Phase IV clinical trial comparing the efficacy of Zemplar, from Abbott, against cinacalcet plus low-dose vitamin D in treating secondary Hyperparathyroidism (SHPT) in patients on kidney dialysis (hemodialysis) shows that more patients treated with intravenous Zemplar achieved their treatment goal, compared to patients treated with cinacalcet plus low-dose vitamin D. The study, IMPACT-SHPT, was an international, multi-centre investigation of 272 patients who were randomly assigned to receive either intravenous or oral Zemplar or cinacalcet plus low-dose vitamin D, either intravenously or orally. Significantly more patients in the Zemplar group achieved the primary end point (57.7%) of a mean iPTH level of 150-300 pg/mL during weeks 21-28 than patients in the cinacalcet group (32.7%; p = 0.016). According to lead author Markus Ketteler, professor of medicine and head, division of nephrology, Klinikum Coburg, more patients in the oral Zemplar group (54.4%) achieved the primary endpoint than patients in the cinacalcet group (43.4%; p = 0.260), but the results did not reach statistical significance. Major adverse cardiac events were more common in the Zemplar group than in the cinacalcet group. The reason for this imbalance is not known. Results have been published online in Nephrology Dialysis Transplantation