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Sacubitril/valsartan (TBC) Sacubitril/valsartan | CADTH.ca Find the information you need Sacubitril/valsartan Sacubitril/valsartan Last Updated: August 4, 2015 Result type: Reports Project Number: SR0447-000 Product Line: Generic Name: Sacubitril/valsartan Brand Name: Entresto Manufacturer: Novartis Pharmaceuticals Canada Inc. Indications: Heart failure, NYHA class II or III Submission Type: New Project Status: Complete Date Recommendation Issued: March 18, 2016 Recommendation Type: List
Entresto - sacubitril / valsartan 24 September 2015 EMA/671279/2015 Committee for Medicinal Products for Human Use (CHMP) Assessment report Entresto International non-proprietary name: SACUBITRIL / VALSARTAN Procedure No. EMEA/H/C/004062/0000 Note Assessment report as adopted by the CHMP with all information of commercially confidential nature deleted. 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (...) titration Ki Equilibrium dissociation constant for an enzyme inhibitor KIM-1 Kidney injury molecule-1 Assessment report EMA/671279/2015 Page 6/115 LBQ657 ctive metabolite of sacubitril, a neprilysin inhibitor LC-MS/MS Liquid chromatography – tandem mass spectrometry LCZ696 sacubitril/valsartan LCZ696-ABA LCZ696 sodium salt hydrate, crystal modification A LD50 Lethal dose, 50% LOQ Limit of quantification LSM Least square mean LVEF Left-ventricular ejection fraction MA Marketing Authorisation MAH
Entresto (sacubitril / valsartan) - To treat heart failure ENTRESTO (sacubitril/valsartan) Tablets U.S. Department of Health and Human Services Search FDA Submit search ENTRESTO (sacubitril/valsartan) Tablets ENTRESTO Company: Novartis Pharmaceuticals Corp. Application No.: 207620 Approval Date: 07/07/2015 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF) (PDF
Valsartan USE OF ANGIOTENSIN II RECEPTOR ANTAGONISTS IN PREGNANCY 0344 892 0909 USE OF ANGIOTENSIN II RECEPTOR ANTAGONISTS IN PREGNANCY (Date of issue: October 2015 , Version: 2 ) This is a UKTIS monograph for use by health care professionals. For case-specific advice please contact UKTIS on 0344 892 0909. To report an exposure please download and complete a . Please encourage all women to complete an . A corresponding patient information leaflet on is available at . Summary Angiotensin-II (...) receptor antagonists (azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, and valsartan) are typically used in the treatment of hypertension where angiotensin converting enzyme (ACE) inhibitors have not been tolerated, but may also be used in the management of heart failure and diabetic nephropathy. There are limited data on the use of angiotensin-II receptor antagonists (A2RAs) in human pregnancy, however effects are expected to be similar to those of the ACE inhibitors
Efficacy and safety of nebivolol and valsartan as fixed-dose combination in hypertension: a randomised, multicentre study. The fixed-dose combination of any two antihypertensive drugs from different drug classes is typically more effective in reducing blood pressure than a dose increase of component monotherapy. We assessed the efficacy and safety of a fixed-dose combination of a vasodilating β blocker (nebivolol) and an angiotensin II receptor blocker (valsartan) in adults with hypertension.We (...) did an 8-week, phase 3, multicentre, randomised, double-blind, placebo-controlled, parallel-group trial at 401 US sites. Participants (age ≥18 years) with hypertension but with blood pressure less than 180/110 mm Hg were randomly assigned (2:2:2:2:2:2:2:1) by a 24-h interactive web response system in blocks of 15 to 4 weeks of double-blind treatment with nebivolol and valsartan fixed-dose combination (5 and 80 mg/day, 5 and 160 mg/day, or 10 and 160 mg/day), nebivolol (5 mg/day or 20 mg/day
2014LancetControlled trial quality: predicted high
Effect of valsartan on systemic right ventricular function: a double-blind, randomized, placebo-controlled pilot trial The role of angiotensin II receptor blockers in patients with a systemic right ventricle has not been elucidated.We conducted a multicenter, double-blind, parallel, randomized controlled trial of angiotensin II receptor blocker valsartan 160 mg twice daily compared with placebo in patients with a systemic right ventricle caused by congenitally or surgically corrected (...) transposition of the great arteries. The primary end point was change in right ventricular ejection fraction during 3-year follow-up, determined by cardiovascular magnetic resonance imaging or, in patients with contraindication for magnetic resonance imaging, multirow detector computed tomography. Secondary end points were change in right ventricular volumes and mass, Vo(2)peak, and quality of life. Primary analyses were performed on an intention-to-treat basis. A total of 88 patients (valsartan, n=44
Cost-effectiveness analysis of valsartan versus losartan and the effect of switching Cost-effectiveness analysis of valsartan versus losartan and the effect of switching Cost-effectiveness analysis of valsartan versus losartan and the effect of switching Baker TM, Goh J, Johnston A, Falvey H, Brede Y, Brown RE Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results (...) and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary The objective was to evaluate the cost-effectiveness of valsartan, compared with losartan, and the impact of switching patients from valsartan to generic losartan, to lower blood pressure and prevent cardiovascular disease. The authors concluded that valsartan appeared to be cost-effective, compared with switching to generic losartan. Overall the quality of the study was adequate
Valsartan (Diovan®) Valsartan (Diovan®) Valsartan (Diovan®) All Wales Medicines Strategy Group (AWMSG) Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation All Wales Medicines Strategy Group (AWMSG). Valsartan (Diovan®) Penarth: All Wales Therapeutics and Toxicology Centre (AWTTC), secretariat of the All Wales Medicines Strategy Group (AWMSG). AWMSG Secretariat (...) Assessment Report Advice No. 0211. 2011 Authors' conclusions Valsartan (Diovan®) tablets are not recommended for use within NHS Wales for the treatment of hypertension in children and adolescents 6 to 18 years of age. The submission contained insufficient evidence for AWMSG to recommend its use. Final publication URL Indexing Status Subject indexing assigned by CRD MeSH Antihypertensive Agentss; Hypertension; Valine Language Published English Country of organisation Wales English summary An English
Comparison of continuous positive airway pressure and valsartan in hypertensive patients with sleep apnea Randomized controlled trials (RCTs) have shown that continuous positive airway pressure (CPAP) treatment of obstructive sleep apnea (OSA) reduces blood pressure (BP). CPAP treatment has never been compared with antihypertensive medications in an RCT.To assess the respective efficacy of CPAP and valsartan in reducing BP in hypertensive patients with OSA never treated for either condition.In (...) this 8-week randomized controlled crossover trial, 23 hypertensive patients (office systolic BP/diastolic BP: 155 ± 14/102 ± 11 mm Hg) with OSA (age, 57 ± 8 yr; body mass index, 28 ± 5 kg/m(2); apnea-hypopnea index, 29 ± 18/h) were randomized first to either CPAP or valsartan (160 mg). The second 8-week period consisted of the alternative treatment (crossover) after a 4-week washout period.Office BP and 24-hour BP were measured before and at the end of the two active treatment periods. Twenty-four
Combination therapy with amlodipine/valsartan in essential hypertension: a 52-week, randomised, open-label, extension study A majority of hypertensive patients require > or = 2 agents to achieve target blood pressure (BP).This 52-week, multicentre, open-label, randomised extension trial to a previously reported double-blind, placebo-controlled study evaluated the safety and efficacy of amlodipine/valsartan (Aml/Val) combination. Patients who successfully completed the core study without serious
Effect of valsartan on the incidence of diabetes and cardiovascular events. It is not known whether drugs that block the renin-angiotensin system reduce the risk of diabetes and cardiovascular events in patients with impaired glucose tolerance.In this double-blind, randomized clinical trial with a 2-by-2 factorial design, we assigned 9306 patients with impaired glucose tolerance and established cardiovascular disease or cardiovascular risk factors to receive valsartan (up to 160 mg daily (...) ) or placebo (and nateglinide or placebo) in addition to lifestyle modification. We then followed the patients for a median of 5.0 years for the development of diabetes (6.5 years for vital status). We studied the effects of valsartan on the occurrence of three coprimary outcomes: the development of diabetes; an extended composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure, arterial revascularization, or hospitalization
A systematic review and meta-analysis of telmisartan vs valsartan in the management of essential hypertension Untitled Document The CRD Databases will not be available from 08:00 BST on Friday 4th October until 08:00 BST on Monday 7th October for essential maintenance. We apologise for any inconvenience.
Copalia HCT - amlodipine / valsartan / hydrochlorothiazide European Medicines Agency Evaluation of Medicines for Human Use 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 70 51 E-mail: firstname.lastname@example.org http://www.emea.europa.eu Doc.Ref: EMEA/CHMP/471143/2009 ASSESSMENT REPORT FOR Copalia HCT International Nonproprietary Name: amlodipine besylate / valsartan / hydrochlorothiazide Procedure No. EMEA/H/C/001159 Assessment Report as adopted (...) new fixed combination products. The applicant applied for the following indication: “Treatment of essential hypertension. Copalia HCT is indicated as replacement therapy in patients whose blood pressure is adequately controlled on amlodipine, valsartan and hydrochlorothiazide (HCT) used as individual or combination therapies”. Information on Paediatric requirements Pursuant to Article 7, the application included an EMEA Decision P/14/2009 for the following condition: • Essential hypertension
Valsartan for prevention of recurrent atrial fibrillation. Atrial fibrillation is the most common cardiac arrhythmia, and no current therapy is ideal for control of this condition. Experimental studies suggest that angiotensin II-receptor blockers (ARBs) can influence atrial remodeling, and some clinical studies suggest that they may prevent atrial fibrillation.We conducted a large, randomized, prospective, placebo-controlled, multicenter trial to test whether the ARB valsartan could reduce (...) the recurrence of atrial fibrillation. We enrolled patients who were in sinus rhythm but had had either two or more documented episodes of atrial fibrillation in the previous 6 months or successful cardioversion for atrial fibrillation in the previous 2 weeks. To be eligible, patients also had to have underlying cardiovascular disease, diabetes, or left atrial enlargement. Patients were randomly assigned to receive valsartan or placebo. The two primary end points were the time to a first recurrence of atrial
An economic evaluation of valsartan for post-MI patients in the UK who are not suitable for treatment with ACE inhibitors An economic evaluation of valsartan for post-MI patients in the UK who are not suitable for treatment with ACE inhibitors An economic evaluation of valsartan for post-MI patients in the UK who are not suitable for treatment with ACE inhibitors Taylor M, Scuffham P A, Chaplin S, Papo N L Record Status This is a critical abstract of an economic evaluation that meets (...) the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary This study examined the cost-effectiveness of valsartan for the treatment after myocardial infarction of patients with left ventricular systolic dysfunction, heart failure, or both, who were not suitable for treatment with angiotensin-converting enzyme inhibitors
The cost effectiveness and cost utility of valsartan in chronic heart failure therapy in Italy: a probabilistic Markov model The cost effectiveness and cost utility of valsartan in chronic heart failure therapy in Italy: a probabilistic Markov model The cost effectiveness and cost utility of valsartan in chronic heart failure therapy in Italy: a probabilistic Markov model Pradelli L, Iannazzo S, Zaniolo O Record Status This is a critical abstract of an economic evaluation that meets (...) the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary This study examined the cost-effectiveness of valsartan in patients aged 45 years or older, who had chronic heart failure, with a low (<40%) left ventricular ejection fraction. Valsartan was likely to be an effective and economically attractive addition to therapy
Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): a randomised, open-label, blinded endpoint morbidity-mortality study. Drugs that inhibit the renin-angiotensin-aldosterone system benefit patients at risk for or with existing cardiovascular disease. However, evidence for this effect in Asian populations is scarce. We aimed to investigate whether addition of an angiotensin receptor blocker, valsartan, to conventional cardiovascular (...) treatment was effective in Japanese patients with cardiovascular disease.We initiated a multicentre, prospective, randomised controlled trial of 3081 Japanese patients, aged 20-79 years, (mean 65 [SD 10] years) who were undergoing conventional treatment for hypertension, coronary heart disease, heart failure, or a combination of these disorders. In addition to conventional treatment, patients were assigned either to valsartan (40-160 mg per day) or to other treatment without angiotensin receptor
2007LancetControlled trial quality: predicted high
Efficacy and safety of combined use of aliskiren and valsartan in patients with hypertension: a randomised, double-blind trial. The aim of this study was to assess dual renin system intervention with the maximum recommended doses of aliskiren and valsartan, compared with each drug alone in patients with hypertension.In this double-blind study, 1797 patients with hypertension (mean sitting diastolic blood pressure 95-109 mm Hg and 8-h daytime ambulatory diastolic blood pressure > or =90 mm Hg (...) ) were randomly assigned to receive once-daily aliskiren 150 mg (n=437), valsartan 160 mg (455), a combination of aliskiren 150 mg and valsartan 160 mg (446), or placebo (459) for 4 weeks, followed by forced titration to double the dose to the maximum recommended dose for another 4 weeks. The primary endpoint was change in mean sitting diastolic blood pressure from baseline to week 8 endpoint. Analyses were done by intention to treat. This trial is registered at ClinicalTrials.gov with the number
2007LancetControlled trial quality: predicted high