Delving into the Latest Updates on Satavaptan with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Aquilda, SR-121463F (hydrochloride hydrate)

+ [4]

Target

AVPR2

Mechanism

AVPR2 antagonists(Vasopressin V2 receptor antagonists)

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesDigestive System Disorders+ [2]

Active Indication-

Inactive Indication

AscitesHeart FailureHepatic ascites+ [3]

Originator Organization

Sanofi

Active Organization-

Inactive Organization

Sanofi

Sanofi SA

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC33H45N3O8S

InChIKeyQKXJWFOKVQWEDZ-VCCCEUOBSA-N

CAS Registry185913-78-4

Long term safety and tolerability of satavaptan in patients with cirrhosis of the liver that have been previously randomized and completed treatment in any of the phase III studies: EFC4492; EFC4493 or EFC6682: a double blind parallel group study comparing satavaptan at 5 to 10 mg daily versus placebo - PASCCAL-2

Start Date16 Aug 2007

Sponsor / Collaborator

Sanofi-Aventis Recherche et Développement SA

EUCTR2006-005422-23-BE

/ Not yet recruitingNot Applicable

An open-label, multicenter study evaluating the long-term safety of satavaptan (SR121463B) and maintenance of normonatremia in patients with dilutional hyponatremia who have previously been treated in studies LTS5066, EFC4489 or SFY5904.

Start Date15 May 2007

Sponsor / Collaborator

Sanofi-Aventis Recherche et Développement SA

100 Clinical Results associated with Satavaptan

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100 Translational Medicine associated with Satavaptan

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100 Patents (Medical) associated with Satavaptan

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96

Literatures (Medical) associated with Satavaptan

01 Jan 2023·Clinical epidemiology

Non-Selective Beta-Blockers and Risk of Sepsis in Patients with Cirrhosis and Ascites: Results from a Large Observational Study.

Article

Author: Watson, Hugh ; Jepsen, Peter ; Vilstrup, Hendrik ; Jensen, Morten Daniel

Background and AimsPrevious studies have not been able to determine whether non-selective beta-blockers (NSBB) reduce the risk of sepsis in cirrhosis. We aimed to examine this question with data from 1198 patients with cirrhosis and ascites included in clinical studies of satavaptan, a vasopressin receptor antagonist with no effect on infection risk.MethodsRisk of sepsis was estimated for NSBB users vs nonusers. Patients were examined every four weeks, or in relation to hospitalization, for the one-year duration of the trials. We computed the cumulative risk of sepsis for patients who did vs did not use NSBB at baseline. We used Cox regression to compare hazard rates of sepsis between current users and nonusers, accounting for changes in NSBB use over time. We adjusted for patient sex and age, MELD-Na score, albumin, use of antibiotics, use of proton pump inhibitors, cirrhosis etiology, history of variceal bleeding or SBP, severity of ascites and HE, HCC, other cancers, and diabetes, while stratifying on geographical region.ResultsOf the 1198 patients, 54% used NSBB at some time. There were 56 sepsis episodes. The 1-year risk of sepsis was reduced to 5.7% (95% confidence interval [CI] 2.8-8.6) in baseline NSBB users vs 11.6% (95% CI 7.0-15.9) in baseline nonusers. The hazard ratio of sepsis for current NSBB users vs current nonusers was reduced to 0.5 (95% CI 0.3-0.8) and after adjustment to 0.7 (95% CI 0.4-1.3).ConclusionNSBB use may reduce the risk of sepsis in patients with cirrhosis and ascites, but the precision of the estimate was limited by the number of episodes of sepsis.

01 Nov 2022·Hepatology Communications

Development and validation of the Cirrhotic Ascites Severity model—A patient‐reported outcome‐based model to predict 1‐year mortality

Article

Author: Vilstrup, Hendrik ; Gantzel, Rasmus Hvidbjerg ; Grønbæk, Henning ; Aagaard, Niels Kristian ; Jepsen, Peter ; Watson, Hugh

AbstractAscites formation is a sign of decompensation of cirrhosis and heralds a poor prognosis. The widely used standard binary classification of ascites as diuretic‐responsive or refractory does not cover the spectrum of ascites and has limited prognostic information. We developed the Cirrhotic Ascites Severity (CIRAS) model to predict 1‐year mortality among 465 patients randomized to placebo in the satavaptan trials investigating treatment of cirrhotic ascites. We used multivariable logistic regression to derive the CIRAS model based on these variables: ascites discomfort score (≤50 or >50), plasma sodium (≥140, 133–139, 125–132, or <125 mmoL/L), and a composite of ascites accumulation and diuretic treatment. We validated the prediction model in 697 trial participants randomized to satavaptan treatment. The 1‐year all‐cause mortality was 19.6%. The area under the receiver operator curve was higher for the CIRAS model than for the standard ascites classification into refractory and diuretic‐responsive in both the development cohort (0.68 [95% confidence interval (CI): 0.62–0.75] vs. 0.62 [0.57–0.68]), and the validation cohort (0.68 [0.64–0.72] vs. 0.55 [0.51–0.60]). The CIRAS model had similar discrimination to the Child‐Pugh score and nearly as good as the Model for End‐Stage Liver Disease (MELD), MELD‐Na, and MELD 3.0. Conclusions: The CIRAS model based on simple ascites‐relevant data is an easily applicable and patient‐centered way to describe the severity and prognosis of all ascites grades. It carries more prognostic information than today's label of “refractory ascites” and forms the basis for earlier and better clinical decisions related to ascites management.

01 Jul 2022·Digestive Diseases and Sciences

Risk Factors for Hepatic Hydrothorax in Cirrhosis Patients with Ascites – A Clinical Cohort Study

Article

Author: Jepsen, Peter ; Watson, Hugh ; Deleuran, Thomas ; Vilstrup, Hendrik

BACKGROUNDThe risk factors for hepatic hydrothorax are unknown.METHODSWe used data from three randomized trials of satavaptan treatment in patients with cirrhosis and ascites followed for up to 1 year. We excluded patients with previous hepatic hydrothorax or other causes for pleural effusion. The candidate risk factors were age, sex, heart rate, mean arterial pressure, diuretic-resistant ascites, a recurrent need for paracentesis, diabetes, hepatic encephalopathy, International Normalized Ratio, creatinine, bilirubin, albumin, sodium, platelet count, use of non-selective beta-blockers (NSBBs), spironolactone, furosemide, proton pump inhibitors, and insulin. We identified risk factors using a Fine and Gray regression model and backward selection. We reported subdistribution hazard ratios (sHR) for hepatic hydrothorax. Death without hepatic hydrothorax was a competing risk.RESULTSOur study included 942 patients, of whom 41 developed hepatic hydrothorax and 65 died without having developed it. A recurrent need for paracentesis (sHR: 2.55, 95% CI: 1.28-5.08), bilirubin (sHR: 1.18 per 10 µmol/l increase, 95% CI: 1.09-1.28), diabetes (sHR: 2.49, 95% CI: 1.30-4.77) and non-use of non-selective beta-blockers (sHR: 2.27, 95% CI: 1.13-4.53) were risk factors for hepatic hydrothorax. Development of hepatic hydrothorax was associated with a high mortality-hazard ratio of 4.35 (95% CI: 2.76-6.97).CONCLUSIONSIn patients with cirrhosis and ascites, risk factors for hepatic hydrothorax were a recurrent need for paracentesis, a high bilirubin, diabetes and non-use of NSBBs. Among these patients with cirrhosis and ascites, development of hepatic hydrothorax increased mortality fourfold.

100 Deals associated with Satavaptan

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Satavaptan	-	DB14923

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hyponatremia	Phase 3	NL	Sanofi	01 May 2004
Hyponatremia	Phase 3	US	Sanofi	01 May 2004
Hyponatremia	Phase 3	DE	Sanofi	01 May 2004
Hyponatremia	Phase 3	HU	Sanofi	01 May 2004
Hyponatremia	Phase 3	HU	Sanofi	01 May 2004
Hyponatremia	Phase 3	ES	Sanofi	01 May 2004
Hyponatremia	Phase 3	US	Sanofi	01 May 2004
Hyponatremia	Phase 3	NL	Sanofi	01 May 2004
Hyponatremia	Phase 1	DE	Sanofi	01 May 2004
Hyponatremia	Phase 1	ES	Sanofi	01 May 2004

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00274326 (Pubmed \| Eur J Heart Fail)	Phase 3	Hyponatremia	118	Placebo	tglannozlo(ssqptimkqt) = Higher rates of adverse events occurred with the 50 mg/day dose, including rapid correction of hyponatraemia csndbaathg (lwzcccetda )	-	01 Mar 2011
				Satavaptan 25 mg/day
NCT00501384 (Pubmed \| J Hepatol)	Phase 2	Fibrosis	151	Satavaptan 5mg	tdtvulpmqb(cywnhdvjfw) = yharboizgk sironiwvap (fauzwxsvzq )	-	01 Aug 2010
				Satavaptan 12.5mg	tdtvulpmqb(cywnhdvjfw) = qytikyqsni sironiwvap (fauzwxsvzq )
NCT00501722 (Pubmed \| Hepatology)	Phase 2	Fibrosis \| Hyponatremia	110	Satavaptan 5 mg	(bpdgrbhvvy) = Thirst was significantly more common in patients treated with satavaptan compared to those treated with placebo zxqglepnul (ukywarsras )	-	01 Jul 2008
				Satavaptan 12.5 mg