What is the treatment for secondary hyperparathyroidism in patients with chronic kidney disease (CKD) using Sensipar (cinacalcet)?

From the Guidelines

Sensipar (cinacalcet) should not be used as a routine treatment for secondary hyperparathyroidism in patients with chronic kidney disease (CKD) due to its limited benefits and potential adverse effects, as evidenced by a cumulative meta-analysis of randomized controlled trials 1. The goal of treatment for secondary hyperparathyroidism in CKD patients is to reduce parathyroid hormone (PTH) levels while maintaining normal calcium and phosphorus levels. However, cinacalcet has been shown to have little or no effect on all-cause mortality and uncertain effects on cardiovascular death, despite its ability to reduce PTH levels and prevent surgical parathyroidectomy 1. Some key points to consider when using cinacalcet in CKD patients include:

• Starting dose: 30 mg once daily, titrated every 2-4 weeks to a maximum of 180 mg daily based on PTH levels
• Monitoring: regular monitoring of serum calcium, phosphorus, and PTH is essential, with dose adjustments made accordingly
• Side effects: common side effects include nausea, vomiting, and hypocalcemia, which should be monitored closely
• Combination therapy: cinacalcet is often used in combination with vitamin D analogs and phosphate binders for comprehensive management of mineral bone disorder in CKD
• Discontinuation: treatment should be temporarily discontinued if serum calcium falls below 8.4 mg/dL until it normalizes, then resumed at a lower dose It is essential to weigh the potential benefits and risks of cinacalcet therapy in individual patients, considering factors such as the severity of CKD, presence of comorbidities, and potential for adverse effects 1.

From the FDA Drug Label

Cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis [see Clinical Studies (14.1)]. The recommended starting oral dose of cinacalcet tablets is 30 mg once daily. Cinacalcet tablets should be titrated no more frequently than every 2 to 4 weeks through sequential doses of 30,60,90,120, and 180 mg once daily to target iPTH levels of 150 to 300 pg/mL.

The treatment for secondary hyperparathyroidism in patients with chronic kidney disease (CKD) using Sensipar (cinacalcet) is to administer the drug orally, starting with a dose of 30 mg once daily, and titrating the dose every 2 to 4 weeks to target intact parathyroid hormone (iPTH) levels of 150 to 300 pg/mL. Key considerations include:

• Monitoring serum calcium and phosphorus levels within 1 week and iPTH levels 1 to 4 weeks after initiation or dose adjustment
• Adjusting the dose to prevent hypocalcemia, with options including supplemental calcium, calcium-based phosphate binders, or vitamin D sterols
• Using cinacalcet tablets alone or in combination with vitamin D sterols and/or phosphate binders 2

From the Research

Treatment of Secondary Hyperparathyroidism with Sensipar (Cinacalcet)

Sensipar, also known as cinacalcet, is a calcimimetic agent used to treat secondary hyperparathyroidism in patients with chronic kidney disease (CKD) [ 3, 4, 5, 6, 7 ].

• Mechanism of Action: Cinacalcet acts on the calcium-sensing receptor to increase its sensitivity to calcium, thereby reducing parathyroid hormone (PTH) secretion [ 3 ].
• Efficacy in Dialysis Patients: Studies have shown that cinacalcet is effective in reducing PTH levels in patients with CKD on dialysis [ 3, 4 ].
• Efficacy in Non-Dialysis Patients: Cinacalcet has also been shown to be effective in reducing PTH levels in patients with CKD not receiving dialysis [ 5, 7 ].
• Common Side Effects: The most common side effects of cinacalcet are nausea, vomiting, and diarrhea, which are usually mild to moderate in severity and transient [ 3, 4, 7 ].
• Pharmacokinetics: Cinacalcet has a terminal elimination half-life of 30-40 hours and steady-state concentrations are achieved within 7 days [ 6 ].
• Dosing and Administration: Cinacalcet is typically administered orally once daily, with a dose range of 30-180 mg [ 3, 5 ].

Key Findings

• A randomized, double-blind, multicenter study found that cinacalcet was more effective than placebo in reducing PTH levels in patients with CKD on dialysis [ 3 ].
• A meta-analysis of six trials found that cinacalcet was effective in reducing PTH levels and achieving biochemical targets in patients with CKD on dialysis [ 4 ].
• A phase 2 study found that cinacalcet was effective in reducing PTH levels in patients with CKD not receiving dialysis [ 5 ].
• A retrospective observational study found that cinacalcet was effective in reducing PTH levels in patients with CKD and secondary hyperparathyroidism not receiving dialysis [ 7 ].