Simultaneous Reduction of Key Secondary Hyperparathyroidism Parameters

In the three 6-month, phase 3, multicenter, randomized, double-blind, placebo-controlled clinical studies in chronic kidney disease (CKD) patients with secondary hyperparathyroidism (HPT) on dialysis (N = 1,136), patients receiving Sensipar® and traditional therapy demonstrated simultaneous reductions of key secondary HPT parameters: parathyroid hormone (PTH), calcium, phosphorus, and calcium-phosphorus product (Ca x P).^1-3Traditional therapy included vitamin D and phosphate binders, if prescribed.³

Sensipar®, in combination with traditional therapy, simultaneously reduced key secondary HPT laboratory parameters^1-3

Adapted from Kammerer et al, Adv Chronic Kidney Dis, 2005.³
*For each point versus control.
Click here for Phase 3 summary description.

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Important Safety Information

Sensipar® treatment should not be initiated if serum calcium is less than the lower limit of the normal range (8.4 mg/dL).

Sensipar® lowers serum calcium; therefore, it is important that patients are carefully monitored for the occurrence of hypocalcemia.

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.

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.

References

Moe SM, Chertow GM, Coburn JW, et al. Achieving NKF-K/DOQI™ bone metabolism and disease treatment goals with cinacalcet HCl. Kidney Int. 2005;67:760-771.
Sensipar® (cinacalcet HCl) prescribing information, Amgen.
Kammerer J, Nolen J, Bradley C, Turner S. Using START (Sensipar® treatment approach to reach K/DOQI™ targets) to optimize Sensipar® use. Adv Chronic Kidney Dis. 2005;12:244. Abstract and poster.

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Simultaneous Reduction of Key Secondary Hyperparathyroidism Parameters

Sensipar®, in combination with traditional therapy, simultaneously reduced key secondary HPT laboratory parameters1-3

Important Safety Information

References

Sensipar®, in combination with traditional therapy, simultaneously reduced key secondary HPT laboratory parameters^1-3