Thursday, June 28, 2007

Sensipar® no longer indicated for chronic kidney disease patients (stages 3 and 4) not receiving dialysis

From Health Canada:
The following updated information has been provided recently to healthcare professionals to review with their patients when prescribing Sensipar®.

Sensipar® has been authorized in Canada since 2004 for the treatment of secondary hyperparathyroidism (HPT) in patients with chronic kidney disease (CKD). Recently, a study was conducted with the intent of providing further evidence of the efficacy and safety of cinacalcet in patients with secondary HPT and CKD who are not receiving dialysis. The results of this study showed that while cinacalcet effectively lowered PTH, the incidence of serum calcium levels below the lower limit of the normal range (8.4 mg/dL [2.1 mmol/L]) with cinacalcet treatment was higher than that observed in patients with secondary HPT and CKD receiving dialysis. As such, Amgen considers that this study has not provided evidence of a positive risk to benefit profile of use of cinacalcet in patients with secondary HPT and CKD who are not receiving dialysis.
For the public
For health professionals

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