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Sensipar (Cinacalcet Hydrochloride) - Summary

 
 



SENSIPAR SUMMARY

Absorption and Distribution

Sensipar™ (cinacalcet hydrochloride) is a calcimimetic agent that increases the sensitivity of the calcium-sensing receptor to activation by extracellular calcium.

Sensipar™ is indicated for the treatment of secondary hyperparathyroidism in patients with Chronic Kidney Disease on dialysis.

Sensipar™ is indicated for the treatment of hypercalcemia in patients with parathyroid carcinoma.


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NEWS HIGHLIGHTS

Published Studies Related to Sensipar (Cinacalcet)

A novel dose regimen of cinacalcet in the treatment of severe hyperparathyroidism in hemodialysis patients. [2011.05]
During the recent years, cinacalcet has markedly improved the management of hyperparathyroidism in patients on hemodialysis. However, to the best of our knowledge, there are no specific studies addressing the dose regimen of cinacalcet... Our results indicate that cinacalcet twice weekly is reasonably safe and effective in suppressing high PTH levels in hemodialysis patients, with fewer side effects.

The ADVANCE study: a randomized study to evaluate the effects of cinacalcet plus low-dose vitamin D on vascular calcification in patients on hemodialysis. [2011.04]
BACKGROUND: This prospective, randomized, controlled trial compared the progression of vascular and cardiac valve calcification in 360 prevalent adult hemodialysis patients with secondary hyperparathyroidism treated with either cinacalcet plus low-dose vitamin D sterols or flexible doses of vitamin D sterols alone... CONCLUSIONS: In hemodialysis patients with moderate to severe secondary hyperparathyroidism, cinacalcet plus low-dose vitamin D sterols may attenuate vascular and cardiac valve calcification.

Cinacalcet HCl reduces hypercalcemia in primary hyperparathyroidism across a wide spectrum of disease severity. [2011.01]
CONTEXT: Primary hyperparathyroidism (PHPT) is characterized by elevated serum calcium (Ca) and increased PTH concentrations. OBJECTIVE: The objective of the investigation was to establish the efficacy of cinacalcet in reducing serum Ca in patients with PHPT across a wide spectrum of disease severity... CONCLUSIONS: Cinacalcet is equally effective in the medical management of PHPT patients across a broad spectrum of disease severity, and overall cinacalcet is well tolerated.

Economic analysis of cinacalcet in combination with low-dose vitamin D versus flexible-dose vitamin D in treating secondary hyperparathyroidism in hemodialysis patients. [2010.12]
BACKGROUND: The ACHIEVE (Optimizing the Treatment of Secondary Hyperparathyroidism: A Comparison of Sensipar and Low Dose Vitamin D vs Escalating Doses of Vitamin D Alone) trial evaluated the efficacy of treatment with cinacalcet plus low-dose activated vitamin D analogues (Cinacalcet-D) compared with vitamin D analogues alone (Flex-D) in attaining KDOQI (Kidney Disease Outcomes Quality Initiative) targets for secondary hyperparathyroidism (SHPT). The economic implications of these treatment regimens have not been explored... CONCLUSIONS: Cinacalcet combined with vitamin D analogues was no more effective than vitamin D analogues in achieving the primary ACHIEVE end point and incurred greater costs. This conclusion was not tempered substantially by the cost of vitamin D analogues or oral phosphate binders. Whether the additional costs of cinacalcet are warranted will require longer term models to determine whether changes in serum levels of mineral metabolic markers translate into lower morbidity, mortality, and downstream costs. Copyright (c) 2010 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Study design and subject baseline characteristics in the ADVANCE Study: effects of cinacalcet on vascular calcification in haemodialysis patients. [2010.06]
BACKGROUND: The ADVANCE (A Randomized Study to Evaluate the Effects of Cinacalcet plus Low-Dose Vitamin D on Vascular Calcification in Subjects with Chronic Kidney Disease Receiving Haemodialysis) Study objective is to assess the effect of cinacalcet plus low-dose active vitamin D versus flexible dosing of active vitamin D on progression of coronary artery calcification (CAC) in haemodialysis patients. We report the ADVANCE Study design and baseline subject characteristics... CONCLUSIONS: Subjects enrolled in ADVANCE have extensive CAC at baseline. The ADVANCE Study should help determine whether cinacalcet attenuates progression of vascular calcification.

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Clinical Trials Related to Sensipar (Cinacalcet)

Efficacy and Safety Study of Cinacalcet for the Treatment of Hypercalcemia in Subjects With PHPT Unable to Undergo Parathyroidectomy [Recruiting]
This phase 3, randomized, double-blind, placebo-controlled study is designed to demonstrate the efficacy and to assess the safety of cinacalcet for the reduction of hypercalcemia in subjects with primary HPT for whom parathyroidectomy is indicated on the basis of an elevated corrected total serum calcium, but who are unable to undergo parathyroidectomy. The reasons a subject would be unable to undergo parathyroidectomy include failed parathyroidectomy, medical contraindication to surgery, or because together with their primary physician they decided it was inappropriate. The study will consist of a 30-day screening phase, a 12-week placebo-controlled dose-titration phase, and a 16 week placebo-controlled efficacy assessment phase (EAP). Subjects who complete 28 weeks on study will continue into an open-label safety extension phase for 24 weeks of investigational cinacalcet treatment.

Pediatric Chronic Kidney Disease Safety and Efficacy [Recruiting]
The purpose of this study is to show that adding cinacalcet to the current treatment of Secondary Hyperparathyroidism in children currently receiving dialysis will lower the parathyroid hormone in a larger number of subjects compared to a program that does not include cinacalcet.

Evaluation of a Cincalcet Suppression Test [Recruiting]
The aim of the study is to compare the results of a parathyroid hormone (PTH)suppression test using a single oral tablet of cinacalcet in two groups of subjects: 1- a group of healthy adults in whom the results of the test with cinacalcet will be compared with those of the standardized PTH suppression test with intravenous calcium loading; 2- a group of patients with proven primary hyperparathyroidism in whom the results of the test with cinacalcet will be compared with those obtained during the same test, in healthy controls.

Cinacalcet in Paediatric Secondary Hyperparathyroidism (SHPT) Due to Chronic Kidney Disease (CKD) [Recruiting]
Twelve-month, multicenter, intra-subject controlled (retrospective-prospective), open-label, active-treatment study to evaluate the dose-response and pharmacokinetics (PK) of cinacalcet HCl for the treatment of Secondary Hyperparathyroidism (SHPT) in paediatric subjects with chronic kidney disease (CKD) on dialysis, followed by 12-month study extension.

Safety & Tolerability of Cinacalcet in Pediatric Subjects With Chronic Kidney Disease & Secondary Hyperparathyroidism [Recruiting]
This is a multicenter, 26-week, single-arm, open-label, safety study. Subjects will remain on study for 26 weeks or until time of kidney transplantation, whichever comes first. All subjects, in addition to receiving cinacalcet, will receive standard of care, which may include vitamin D sterols (25 OH vitamin D and/or 1-25 OH vitamin D and its analogs).

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Reports of Suspected Sensipar (Cinacalcet) Side Effects

Hospitalisation (19)Death (16)Enteral Nutrition (14)Blood Parathyroid Hormone Increased (13)Nausea (12)Gastrointestinal Tube Insertion (10)Dyspnoea (9)Convulsion (9)Blood Calcium Decreased (8)Tremor (8)more >>


Page last updated: 2011-12-09

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