Latest & greatest articles for valsartan

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Top results for valsartan

41. PARADIGM?HF: Valsartan 160mg po BID + Sacubitril (=LCZ696) versus Enalapril 10mg po BID in Heart Failure

PARADIGM?HF: Valsartan 160mg po BID + Sacubitril (=LCZ696) versus Enalapril 10mg po BID in Heart Failure RXFILES PRELIMINARY TRIAL SUMMARY LYNETTE KOSAR JAN 7 TH , 2015 – WWW.RXFILES.CA Page 1 of 3 PARADIGM-HF: Valsartan 160mg po BID + Sacubitril (=LCZ696) versus Enalapril 10mg po BID in HF 1 Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality & morbidity in HF BOTTOM LINE ? In PARADIGM-HF, clinically stable patients with heart failure (HF) (NYHA class I 5%, class (...) : LCZ696 375±71mg (=valsartan 300±57mg/day), Enalapril 18.9±3.4mg - MEAN SBP AT 8 MONTHS: LCZ696 3.2±0.4mmHg lower (p<0.001), but the authors stated this was not the reason for benefit when it was analyzed as a time-dependent covariate STRENGTHS, LIMITATIONS, & UNCERTAINTIES STRENGTHS: ? Important clinical endpoints (e.g. cardiovascular death, HF hospitalizations) with blinded adjudication of outcomes. ? Only 20 patients lost to follow-up (0.13%). LIMITATIONS: ? No Phase II studies have been conducted

2016 RxFiles

42. Estimating the Long-Term Treatment Benefits of Sacubitril-Valsartan. (Abstract)

Estimating the Long-Term Treatment Benefits of Sacubitril-Valsartan. 26630151 2015 12 22 2015 12 03 1533-4406 373 23 2015 Dec 03 The New England journal of medicine N. Engl. J. Med. Estimating the Long-Term Treatment Benefits of Sacubitril-Valsartan. 2289-90 10.1056/NEJMc1509753 Claggett Brian B Brigham and Women's Hospital, Boston, MA. Packer Milton M McMurray John J V JJ Swedberg Karl K Rouleau Jean J Zile Michael R MR Jhund Pardeep P Lefkowitz Martin M Shi Victor V Solomon Scott D SD (...) PARADIGM-HF Investigators eng Letter United States N Engl J Med 0255562 0028-4793 0 Aminobutyrates 0 Angiotensin Receptor Antagonists 0 Drug Combinations 0 LCZ 696 0 Tetrazoles 80M03YXJ7I Valsartan AIM IM Aged Aged, 80 and over Aminobutyrates therapeutic use Angiotensin Receptor Antagonists therapeutic use Cause of Death Drug Combinations Heart Failure drug therapy mortality Humans Kaplan-Meier Estimate Life Expectancy Middle Aged Tetrazoles therapeutic use Valsartan therapeutic use 2015 12 3 6 0 2015

2015 NEJM

43. Sacubitril/valsartan (TBC)

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

2015 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

44. Sacubitril/valsartan (TBC)

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

2015 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

45. Sacubitril/valsartan (TBC)

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

2015 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

46. CardioMEMS HF System (St. Jude Medical, Inc.) and Sacubitril/Valsartan (Entresto, Novartis AG) for Management of Congestive Heart Failure

CardioMEMS HF System (St. Jude Medical, Inc.) and Sacubitril/Valsartan (Entresto, Novartis AG) for Management of Congestive Heart Failure ©Institute for Clinical and Economic Review, 2015 CardioMEMS™ HF System (St. Jude Medical, Inc.) and Sacubitril/Valsartan (Entresto™, Novartis AG) for Management of Congestive Heart Failure: Effectiveness, Value, and Value-Based Price Benchmarks Final Report December 1, 2015 Completed by: Institute for Clinical and Economic Review ©Institute for Clinical (...) and associated software for monitoring increases in pulmonary artery (PA) pressure (a key indicator of worsening CHF) known as the CardioMEMS™ HF System (St. Jude Medical), and a drug, Entresto™ (Novartis AG), a combination of the angiotensin II receptor blocker (ARB) valsartan and the neprilysin (nep-ri- li-sin) inhibitor sacubitril. The objective of this report is to evaluate the accumulated evidence on these two new interventions, to understand the context around their potential use in clinical practice

2015 California Technology Assessment Forum

47. Entresto (sacubitril / valsartan) - To treat heart failure

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

2015 FDA - Drug Approval Package

48. Entresto - sacubitril / valsartan

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

2015 European Medicines Agency - EPARs

49. Valsartan

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

2014 UK Teratology Information Service

50. Efficacy and safety of nebivolol and valsartan as fixed-dose combination in hypertension: a randomised, multicentre study. (Abstract)

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

2014 Lancet Controlled trial quality: predicted high

51. Effect of valsartan on systemic right ventricular function: a double-blind, randomized, placebo-controlled pilot trial Full Text available with Trip Pro

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

2013 EvidenceUpdates Controlled trial quality: predicted high

52. Cost-effectiveness analysis of valsartan versus losartan and the effect of switching Full Text available with Trip Pro

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

2012 NHS Economic Evaluation Database.

53. Valsartan (Diovan®)

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

2011 Health Technology Assessment (HTA) Database.

54. Comparison of continuous positive airway pressure and valsartan in hypertensive patients with sleep apnea (Abstract)

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

2010 EvidenceUpdates Controlled trial quality: uncertain

55. Combination therapy with amlodipine/valsartan in essential hypertension: a 52-week, randomised, open-label, extension study (Abstract)

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

2010 EvidenceUpdates Controlled trial quality: uncertain

56. A systematic review and meta-analysis of telmisartan vs valsartan in the management of essential hypertension

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.

2010 DARE.

57. Effect of valsartan on the incidence of diabetes and cardiovascular events. Full Text available with Trip Pro

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

2010 NEJM Controlled trial quality: predicted high

58. Valsartan vs. other angiotensin II receptor blockers in the treatment of hypertension: a meta-analytical approach Full Text available with Trip Pro

Valsartan vs. other angiotensin II receptor blockers in the treatment of hypertension: a meta-analytical approach To compare the efficacy of valsartan in systolic (SBP) and diastolic blood pressure (DBP) reduction with other angiotensin II receptor blockers (ARBs) in essential hypertension.Systematic literature search of databases between October 1997 and May 2008. Meta-analysis of short-term, double-blind, parallel group, randomised controlled trials (RCTs) for treatment of adult hypertension (...) (DBP: 90-115 mmHg). Random-effects meta-regression adjusting for baseline blood pressure (BP) was used to analyse the data. Mean change in SBP and DBP was estimated for each individual drug and dose combination.In all, 31 RCTs (n = 13,110 patients) were included in the analysis. Six studies include trial arms with candesartan, six irbesartan, 13 losartan, two olmesartan, five telmisartan and 12 valsartan. The weighted average reduction in mean SBP and DBP for valsartan 160 mg was -15.32 mmHg (95

2009 EvidenceUpdates

59. Copalia HCT - amlodipine / valsartan / hydrochlorothiazide

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: mail@emea.europa.eu 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

2009 European Medicines Agency - EPARs

60. 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 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

2009 NHS Economic Evaluation Database.