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Related Experiment Videos

Cinacalcet hydrochloride.

Julia A Barman Balfour1, Lesley J Scott

  • 1Adis International Limited, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, Auckland 1311, New Zealand. demail@adis.co.nz

Drugs
|January 6, 2005
PubMed
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Cinacalcet hydrochloride (HCl) effectively lowers parathyroid hormone (PTH) in dialysis patients with secondary hyperparathyroidism. This calcimimetic agent also reduces calcium and phosphorus levels, demonstrating broad efficacy across diverse patient populations.

Area of Science:

  • Nephrology
  • Endocrinology
  • Pharmacology

Background:

  • Secondary hyperparathyroidism (HPT) is a common complication in chronic kidney disease (CKD) patients on dialysis.
  • Elevated parathyroid hormone (PTH) levels contribute to significant morbidity and mortality in these patients.
  • Current treatments for secondary HPT have limitations, necessitating novel therapeutic approaches.

Purpose of the Study:

  • To evaluate the efficacy and safety of oral cinacalcet hydrochloride (HCl), a novel calcimimetic agent, in managing secondary HPT in CKD patients on dialysis.
  • To assess the impact of cinacalcet HCl on PTH, serum calcium, and phosphorus levels.
  • To investigate the effectiveness of cinacalcet HCl in patients with parathyroid carcinoma.

Main Methods:

  • Three pivotal phase III, randomized, double-blind, multicenter trials involving 1136 CKD patients on dialysis with uncontrolled secondary HPT.

Related Experiment Videos

  • Patients received oral cinacalcet HCl (30-180 mg/day) or placebo for 26 weeks.
  • An open-label, multicenter, dose-titration trial assessed cinacalcet HCl (60-360 mg/day) in patients with parathyroid carcinoma.

    • Main Results:

    • A significantly higher proportion of cinacalcet HCl recipients achieved target PTH levels (< or =250 pg/mL) compared to placebo.
    • Cinacalcet HCl treatment led to simultaneous reductions in serum calcium, phosphorus, and calcium-phosphorous product levels.
    • The drug demonstrated efficacy across a broad range of CKD patients, irrespective of disease severity, dialysis modality, or concurrent medications.
    • In parathyroid carcinoma patients, cinacalcet HCl reduced elevated serum calcium levels in 71% of participants.

    Conclusions:

    • Oral cinacalcet HCl is an effective therapeutic agent for secondary HPT in CKD patients on dialysis.
    • Cinacalcet HCl offers a novel mechanism of action by modulating the calcium-sensing receptor (CaR).
    • The drug is generally well-tolerated, with most adverse events being mild to moderate in severity.