Clinical Literature

The safety and efficacy of Sensipar® has been demonstrated in multiple clinical studies. Follow the links below to view summaries of these studies.

Combined therapy with cinacalcet and low doses of vitamin D sterols in patients with moderate to severe secondary hyperparathyroidism.

Nephrology Dialysis Transplantation, 2008.

The OPTIMA study: assessing a new cinacalcet (Sensipar®/Mimpara®) treatment algorithm for secondary hyperparathyroidism.

Clinical Journal of the American Society of Nephrology, 2008.

Achieving NKF-K/DOQI™ bone metabolism and disease treatment goals with cinacalcet HCI.

Kidney International, 2005.

Cinacalcet hydrochloride (Sensipar®) in hemodialysis patients on active vitamin D derivatives with controlled PTH and elevated calcium x phosphate.

Clinical Journal of the American Society of Nephrology, 2006.

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Important Safety Information

Significant reductions in calcium may lower the threshold for seizures. Secondary hyperparathyroidism (HPT) patients, particularly those with a history of seizure disorder, should be carefully monitored for the occurrence of low serum calcium or symptoms of hypocalcemia.

In Sensipar® postmarketing use, isolated, idiosyncratic cases of hypotension, worsening heart failure, and/or arrhythmia were reported in patients with impaired cardiac function. The causal relationship to Sensipar® therapy could not be completely excluded and may be mediated by reductions in serum calcium levels.

Sensipar® lowers serum calcium; therefore, it is important that patients have a serum calcium ≥ 8.4 mg/dL when initiating therapy.

Adynamic bone disease may develop if intact parathyroid hormone (iPTH) levels are suppressed below 100 pg/mL.

Patients with moderate to severe hepatic impairment should be monitored throughout treatment with Sensipar®, as cinacalcet exposure assessed by area under the curve (AUC) was higher than in patients with normal hepatic function.

Serum calcium and serum phosphorus should be measured within 1 week and PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Sensipar®. Once the maintenance dose has been established, serum calcium and serum phosphorus should be measured approximately monthly, and PTH every 1 to 3 months.

The most commonly reported side effects were nausea, vomiting, and diarrhea.

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