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Jerry Nedelman, Roland Fisch, Ke Hu, Ines Paule, Jocelyn Zhou
BACKGROUND AND OBJECTIVE: Pasireotide (SOM230, Signifor(®)) is a somatostatin analog approved in a subcutaneous formulation for the treatment of Cushing's disease. This analysis characterizes the population pharmacokinetics (PopPK) of subcutaneous pasireotide jointly in healthy volunteers (HVs) and Cushing's disease patients (CDPs), evaluating the effects of age, body size, and population on pasireotide pharmacokinetics. METHODS: The analysis dataset included five phase I studies and one each from phase II and phase III...
October 14, 2017: Clinical Pharmacokinetics
Kjell Öberg, Steven W J Lamberts
Acromegaly is a hormonal disorder that arises when the pituitary gland secretes excess growth hormone (GH), which in turn stimulates a concomitant increase in serum insulin-like growth factor 1 (IGF-1) levels. Gastroenteropancreatic neuroendocrine tumours (GEP-NET) constitute a heterogeneous group of tumours that can secrete serotonin and a variety of peptide hormones that may cause characteristic symptoms known as carcinoid syndrome or other symptoms and hormonal hypersecretion syndromes depending on the tumour's site of origin...
December 2016: Endocrine-related Cancer
Susan L Samson
Pasireotide (Signifor(®)) long-acting release (LAR) is a next-generation somatostatin receptor ligand (SRL) approved for treatment of patients with acromegaly who have had an inadequate response to surgery or for whom surgery is not an option. Pasireotide LAR has been shown to be more effective than other SRLs in providing biochemical control in patients with acromegaly. However, hyperglycemia-related adverse events were more frequent in patients treated with pasireotide LAR than in those treated with other SRLs...
September 2016: Drugs
L Trementino, G Michetti, A Angeletti, G Marcelli, C Concettoni, C Cardinaletti, B Polenta, M Boscaro, G Arnaldi
Pasireotide is the first pituitary-directed drug approved for treating patients with Cushing's disease (CD). Our 10-year experience with pasireotide in CD is reported here. Twenty patients with de novo, persistent, or recurrent CD after pituitary surgery were treated with pasireotide from December 2003 to December 2014. Twelve patients were treated with pasireotide in randomized trials and 8 patients with pasireotide sc (Signifor(®); Novartis AG, Basel, Switzerland) in clinical practice. The mean treatment duration was 20...
May 2016: Hormone and Metabolic Research, Hormon- und Stoffwechselforschung, Hormones et Métabolisme
(no author information available yet)
In a trial including 198 patients in whom several lines of treatments had failed, pasireotide normalised IGF-1 and GH levels and sometimes reduced the size of the pituitary adenoma, but often at a cost of developing diabetes.
February 2016: Prescrire International
Daniel Cuevas-Ramos, Maria Fleseriu
Morbidity and mortality rates in patients with active acromegaly are higher than the general population. Adequate biochemical control restores mortality to normal rates. Now, medical therapy has an increasingly important role in the treatment of patients with acromegaly. Somatostatin receptor ligands (SRLs) are considered the standard medical therapy, either after surgery or as a first-line therapy when surgery is deemed ineffective or is contraindicated. Overall, octreotide and lanreotide are first-generation SRLs and are effective in ~20%-70% of patients...
2016: Drug Design, Development and Therapy
Kate McKeage
Pasireotide (Signifor(®), Signifor(®) LAR) is a somatostatin analogue recently approved for the treatment of acromegaly. Unlike the first-generation agents, octreotide and lanreotide, which bind preferentially to somatostatin receptor (SSTR)-2, pasireotide binds to multiple SSTRs. This article reviews the clinical use and summarizes the pharmacological properties of intramuscular pasireotide in the treatment of acromegaly. The efficacy of pasireotide 40 mg every 28 days was superior to that of intramuscular octreotide 20 mg every 28 days with regard to biochemical control in a 12-month, phase III trial in medically naive patients...
June 2015: Drugs
H L Truong, D Nellesen, W H Ludlam, M P Neary
OBJECTIVES: Cushing's disease (CD) is a rare condition with a prevalence of roughly 39 cases per million in the general population. Healthcare costs are substantial for CD patients with either untreated or inadequately controlled disease. This study assesses the 3-year budget impact of pasireotide on a US managed care health plan following pasireotide (Signifor) availability. METHODS: Two scenarios were evaluated to understand the differences in costs associated with the introduction of pasireotide...
April 2014: Journal of Medical Economics
(no author information available yet)
No abstract text is available yet for this article.
May 13, 2013: Medical Letter on Drugs and Therapeutics
Kate McKeage
Pasireotide (Signifor(®)) is a new subcutaneous somatostatin analogue that acts via somatostatin receptors to inhibit the secretion of corticotropin from the pituitary adenoma in patients with Cushing's disease. Pasireotide has a receptor binding profile that is distinct from that of other somatostatin analogues, binding with high affinity to somatostatin receptor subtype 5, which is strongly over expressed in corticotroph adenoma cells. Pasireotide is the first pituitary-directed agent to be approved for use in Cushing's disease...
May 2013: Drugs
F Pecori Giraldi, L Pagliardini, M F Cassarino, F Martucci, A Sesta, L Castelli, E Montanari, H A Schmid, F Cavagnini
SOM230 (pasireotide, Signifor), a recently developed somatostatin analog, has been tested in ACTH-secreting pituitary tumors with promising results. No study has yet evaluated whether this analog also directly affects adrenal steroid production. The aim of the current study was to evaluate whether SOM230 modulates corticosteroid secretion by normal adrenals in vitro. Primary cultures from normal human and rat adrenals were incubated with 10-100 nM SOM230 with and without 10nM ACTH. Dose-response studies with 1 nM-1 μM SOM230 were performed on rat adrenals...
September 1, 2012: General and Comparative Endocrinology
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