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Yash R Somnay, Eric Weinlander, David F Schneider, Rebecca S Sippel, Herbert Chen
INTRODUCTION: Tertiary hyperparathyroidism (3HPTH) patients who undergo parathyroidectomy (PTX) are often managed with calcium lowering medications such as cinacalcet (Sensipar) before surgery. Here, we assess how cinacalcet treatment influences intraoperative parathyroid hormone (IOPTH) kinetics and surgical findings in 3HPTH patients undergoing PTX. METHODS: We reviewed retrospectively 113 patients 3HPTH who underwent PTX, 14 of whom were taking cinacalcet and 112 who were not taking the drug...
December 2014: Surgery
Desmond Padhi, Robert Harris, John T Sullivan
BACKGROUND AND OBJECTIVES: Secondary hyperparathyroidism is a common consequence of chronic kidney disease. Cinacalcet (Sensipar(®)) is often prescribed in combination to reduce elevated levels of parathyroid hormone, calcium and phosphorus. The objective of this study was to assess the effects of concomitantly administered therapies of calcium carbonate (CaCO(3); TUMS(®)), sevelamer hydrochloride (HCl; Renagel(®)) and pantoprazole sodium (Protonix(®)) on the pharmacokinetics and safety of cinacalcet in healthy subjects...
August 2014: Clinical Drug Investigation
Qian Zhang, Ming Li, Li You, Haiming Li, Li Ni, Yong Gu, Chuanming Hao, Jing Chen
PURPOSE: Secondary hyperparathyroidism (SHPT) is one of the most common abnormalities of mineral metabolism in patients with chronic kidney disease. We performed a meta-analysis to determine the effect and safety of cinacalcet in SHPT patients receiving dialysis. METHODS: The meta-analysis was performed to determine the effect and safety of cinacalcet in SHPT patients receiving dialysis by using the search terms 'cinacalcet' or 'mimpara' or 'sensipar' or 'calcimimetic' or 'R586' on MEDLINE and EMBASE (January 1990 to February 2012)...
2012: PloS One
Aaron S Kesselheim, Jessica A Myers, Daniel H Solomon, Wolfgang C Winkelmayer, Raisa Levin, Jerry Avorn
INTRODUCTION: The Orphan Drug Act encourages drug development for rare conditions. However, some orphan drugs become top sellers for unclear reasons. We sought to evaluate the extent and cost of approved and unapproved uses of orphan drugs with the highest unit sales. METHODS: We assessed prescription patterns for four top-selling orphan drugs: lidocaine patch (Lidoderm) approved for post-herpetic neuralgia, modafinil (Provigil) approved for narcolepsy, cinacalcet (Sensipar) approved for hypercalcemia of parathyroid carcinoma, and imatinib (Gleevec) approved for chronic myelogenous leukemia and gastrointestinal stromal tumor...
2012: PloS One
Gerald Miller, James Davis, Edward Shatzen, Matthew Colloton, David Martin, Charles M Henley
BACKGROUND: Secondary hyperparathyroidism (sHPT) represents an adaptive response to progressively impaired control of calcium, phosphorus and vitamin D in chronic kidney disease (CKD). It is characterized by parathyroid hyperplasia and excessive synthesis and secretion of parathyroid hormone (PTH). Parathyroid hyperplasia in uremic rats can be prevented by calcium-sensing receptor (CaSR) activation with the calcimimetic cinacalcet (Sensipar®/Mimpara®); however, it is unknown, how long the effects of cinacalcet persist after withdrawal of treatment or if cinacalcet is efficacious in uremic rats with established sHPT...
June 2012: Nephrology, Dialysis, Transplantation
James Norman, Jose Lopez, Doug Politz
BACKGROUND: Cinacalcet (Sensipar) has been shown to decrease calcium levels in patients with primary hyperparathyroidism (PHPT); however, few other endpoints have been studied and long-term effects are not known. METHODS: At the discretion of a referring doctor, 70 patients began Cinacalcet as an alternative to surgery for PHPT. Patients were followed as long as the drug was tolerated at which time all underwent parathyroidectomy. RESULTS: Before treatment, serum calcium levels averaged 11...
May 2012: Annals of Surgical Oncology
Greg L Plosker
This article provides an overview of the clinical profile of the calcimimetic agent cinacalcet (Mimpara®, Sensipar®) in the treatment of patients with secondary hyperparathyroidism (SHPT) undergoing dialysis for end-stage renal disease (ESRD), followed by a comprehensive review of pharmacoeconomic analyses with cinacalcet in this patient population. Most patients with ESRD undergoing dialysis develop SHPT, which is associated with disturbances in bone mineral metabolism and the development of fractures, cardiovascular disease and other clinical events...
September 2011: PharmacoEconomics
Alice Cavanaugh, Ying Huang, Gerda E Breitwieser
Calcium-sensing receptors (CaSR) are integral to regulation of systemic Ca(2+) homeostasis. Altered expression levels or mutations in CaSR cause Ca(2+) handling diseases. CaSR is regulated by both endogenous allosteric modulators and allosteric drugs, including the first Food and Drug Administration-approved allosteric agonist, Cinacalcet HCl (Sensipar®). Recent studies suggest that allosteric modulators not only alter function of plasma membrane-localized CaSR, but regulate CaSR stability at the endoplasmic reticulum...
March 2012: British Journal of Pharmacology
Theresa I Shireman, Ammar Almehmi, James B Wetmore, John Lu, Mark Pregenzer, L Darryl Quarles
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...
December 2010: American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation
Caryn Tong
No abstract text is available yet for this article.
April 2004: Discovery Medicine
Martin Wilkie, Giuseppe Pontoriero, Fernando Macário, Magdi Yaqoob, Koen Bouman, Johann Braun, Beat von Albertini, Hans Brink, Francisco Maduell, Helmut Graf, João M Frazão, Willem Jan Bos, Vicente Torregrosa, Heikki Saha, Helmut Reichel, Valter J Zani, Dave Carter, Piergiorgio Messa
BACKGROUND/AIMS: The calcimimetic cinacalcet (Mimpara/Sensipar) simultaneously lowers parathyroid hormone (PTH), phosphorus (P) and calcium (Ca) levels in patients with secondary hyperparathyroidism. The OPTIMA study demonstrated that cinacalcet and adjusted doses of vitamin D maximized control of these parameters. This post-hoc analysis of OPTIMA data assessed the impact of reducing or increasing the dose of concomitant vitamin D on PTH, P and Ca in patients receiving cinacalcet. METHODS: Dialysis patients with mean baseline intact PTH (iPTH) 300-800 pg/ml (31...
2009: Nephron. Clinical Practice
Paul E Harrington, Christopher Fotsch
The calcium sensing receptor (CaR) is a G protein-coupled receptor (GPCR) that plays a fundamental role in serum calcium homeostasis. The CaR is expressed on the chief cells of the parathyroid gland and is responsible for controlling the secretion of parathyroid hormone (PTH). PTH acts on several organs including the bone, kidney, and intestine to tightly regulate the concentration of serum calcium. Substances other than calcium that activate the CaR are referred to as calcimimetics. Calcimimetics that bind to the CaR as agonists are referred to as type I...
2007: Current Medicinal Chemistry
Piergiorgio Messa, Fernando Macário, Magdi Yaqoob, Koen Bouman, Johann Braun, Beat von Albertini, Hans Brink, Francisco Maduell, Helmut Graf, João M Frazão, Willem Jan Bos, Vicente Torregrosa, Heikki Saha, Helmut Reichel, Martin Wilkie, Valter J Zani, Bart Molemans, Dave Carter, Francesco Locatelli
BACKGROUND AND OBJECTIVES: Cinacalcet, a novel calcimimetic, targets the calcium-sensing receptor to lower parathyroid hormone (PTH), calcium, and phosphorus levels in dialysis patients with secondary hyperparathyroidism (SHPT). This study compared the efficacy of a cinacalcet-based regimen with unrestricted conventional care (vitamin D and phosphate binders) for achieving the stringent National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) targets for dialysis patients...
January 2008: Clinical Journal of the American Society of Nephrology: CJASN
Yoshiyuki Hanba, Maki Ooura, Shigeo Negi, Takashi Shigematsu
In this part, we reports the experience of treatment by calcimimetics for 3 hemodialyzed patients with refractory secondary hyperparathyroidism. They purchased own expense, and used "Cinacalcet" as calcimimetics (Sensipar(R) 30 mg/tablet, by AMGEN co. Ltd. in USA) . Serum Ca, P, and intact-PTH decreased certainly in 3 cases after cinacalcet therapy. Especially the reduction of intact-PTH is obviously. The any adverse effect did not observed by 30 mg/tablet/day prescription except mild epigastralgia in a case...
January 2008: Clinical Calcium
J R Sterrett, J Strom, H K Stummvoll, U Bahner, A Disney, S D Soroka, C Corpier, J A Arruda, L E Schwanauer, P S Klassen, K A Olson, G A Block
AIMS: This 1-year double-blind, placebo-controlled, multicenter study evaluated the long-term safety and efficacy of cinacalcet for the treatment of secondary hyperparathyroidism in patients receiving hemodialysis. METHOD: Patients were randomly assigned in a 1:1 ratio to cinacalcet or control treatment groups. The initial dose of cinacalcet (or matching placebo) was 30 mg. Doses were titrated every 3 or 4 weeks based on the intact parathyroid hormone (iPTH) response and safety profile...
July 2007: Clinical Nephrology
Glenn M Chertow, Samuel Blumenthal, Stewart Turner, Michael Roppolo, Leonard Stern, Eric M Chi, John Reed
Active vitamin D derivatives attenuate the severity of secondary hyperparathyroidism but often increase serum calcium (Ca) and phosphorus (P) as a result of enhanced intestinal absorption. The calcimimetic cinacalcet HCl lowers parathyroid hormone (PTH) and tends to decrease Ca x P. A 16-wk, open-label clinical trial was conducted in adult hemodialysis patients who had controlled PTH (biointact PTH [biPTH] 80 to 160 pg/ml) and elevated Ca x P (> 55 mg2/dl2) and were receiving paricalcitol > 6 microg/wk (or an equipotent dose of an alternative active vitamin D derivative)...
March 2006: Clinical Journal of the American Society of Nephrology: CJASN
James A Sloand
No abstract text is available yet for this article.
May 2007: Nephrology Nursing Journal: Journal of the American Nephrology Nurses' Association
Desmond Padhi, Margaret Salfi, Robert Z Harris
Cinacalcet HCl reduces iPTH, serum calcium, serum phosphorus, and the calcium-phosphorus product in patients with chronic kidney disease and secondary hyperparathyroidism who are receiving dialysis, and reduces elevated serum calcium associated with primary hyperparathyroidism and parathyroid carcinoma. Cinacalcet is administered orally, and thus concomitant administration with food may affect its bioavailability. The objective of this study was to examine the effect of fat and caloric intake on cinacalcet exposure...
May 2007: American Journal of Therapeutics
G F M Strippoli, A Tong, S C Palmer, G Elder, J C Craig
BACKGROUND: Calcimimetic agents have recently been evaluated in the treatment of secondary hyperparathyroidism (SHPT) as add-on therapy to calcitriol and vitamin D analogues and dietary phosphate binders. OBJECTIVES: To evaluate the benefits and harms of calcimimetics for the prevention of secondary hyperparathyroid bone disease (including osteitis fibrosa cystica and adynamic bone disease) in dialysis patients with chronic kidney disease (CKD). SEARCH STRATEGY: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and conference proceedings were searched for randomised controlled trials (RCTs) evaluating any calcimimetic against placebo or another agent in pre-dialysis or dialysis patients with CKD...
October 18, 2006: Cochrane Database of Systematic Reviews
Irina Shahapuni, Matthieu Monge, Roxana Oprisiu, Hakim Mazouz, Pierre-François Westeel, Philippe Morinière, Ziad Massy, Gabriel Choukroun, Albert Fournier
Calcimimetics suppress the secretion of parathyroid hormone by sensitizing the parathyroid calcium receptor to serum calcium. Cinacalcet (Sensipar/Mimpara), Amgen Inc., Thousand Oaks, CA), the first-in-class calcimimetic agent approved for treatment of secondary hyperparathyroidism in dialysis patients, is, in association with higher dose of a calcium-based oral phosphate binder, a well-tolerated and effective alternative to standard treatments such as vitamin D derivatives in association with a non-calcium-based oral phosphate binder...
June 2006: Nature Clinical Practice. Nephrology
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