First treatment for serious complications of kidney disease, parathyroid cancer

FDA Consumer, May-June, 2004

Patients who experience debilitating consequences of chronic kidney disease and parathyroid cancer now have a first-of-its-kind treatment option.

Sensipar (cinacalcet) was approved in March 2004 to treat secondary hyper-parathyroidism in patients with chronic kidney disease who are on dialysis. In secondary hyperparathyroidism, elevated levels of parathyroid hormone are associated with changes in calcium and phosphorus metabolism, bone pain, fractures, and an increased risk for cardiovascular death.

The drug also was approved to treat hypercalcemia, an elevation in calcium levels in the blood, that results from a rare cancer of the parathyroid glands. Elevated levels of serum calcium can cause mental confusion, lethargy, dehydration, nausea, vomiting, constipation, and kidney damage.

Nearly all of the more than 300,000 kidney dialysis patients in the United States experience hyperparathyroidism.

Treatment with Sensipar, manufactured by Amgen Inc. of Thousand Oaks, Calif., lowers blood levels of parathyroid hormone as well as the amount of calcium and phosphorus in the blood.