Latest & greatest articles for valsartan

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Top results for valsartan

41. Effect of 8-Week Combination Therapy with an Extended-Release α1-Blocker (Bunazosin or Doxazosin) in Inadequate Responders to an Angiotensin II Antagonist (Valsartan) in Patients with Stage 1 or 2 Essential Hypertension. (Abstract)

Effect of 8-Week Combination Therapy with an Extended-Release α1-Blocker (Bunazosin or Doxazosin) in Inadequate Responders to an Angiotensin II Antagonist (Valsartan) in Patients with Stage 1 or 2 Essential Hypertension. Given the favorable impact of α1-blockers on lipid and glucose metabolism, this study was designed to compare the efficacy of two extended-release α1-blockers (bunazosin and doxazosin) as an add-on treatment in subjects with stage 1 or 2 essential hypertension which (...) was inadequately controlled by valsartan 80 mg/day.After a 5-week treatment of valsartan monotherapy, subjects with inadequately controlled hypertension were randomized to receive either extended-release bunazosin (n = 47) or doxazosin (n = 46) after breakfast for 8 weeks. Office sitting blood pressure (BP), 24-hour ambulatory BP, and metabolic profiles were measured at baseline, start of study drug, and study end.In the intention-to-treat population (n = 93), the average daily doses of bunazosin

2016 Zhonghua Minguo xin zang xue hui za zhi = Acta Cardiologica Sinica Controlled trial quality: uncertain

42. Amlodipine / Valsartan Mylan - hypertension

Amlodipine / Valsartan Mylan - hypertension 28 January 2016 EMA/CHMP/182030/2016 Committee for Medicinal Products for Human Use (CHMP) Assessment report Amlodipine/Valsartan Mylan International non-proprietary name: amlodipine / valsartan Procedure No. EMEA/H/C/004037/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone (...) /National Formulary UV Ultraviolet light Assessment report EMA/CHMP/182030/2016 Page 4/31 1. Background information on the procedure 1.1. Submission of the dossier The applicant MYLAN S.A.S. submitted on 20 January 2015 an application for Marketing Authorisation to the European Medicines Agency (EMA) for Amlodipine/Valsartan Mylan, through the centralised procedure under Article 3 (3) of Regulation (EC) No. 726/2004 – ‘Generic of a Centrally authorised product’. The eligibility to the centralised

2016 European Medicines Agency - EPARs

43. 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

44. LCZ696 (Sacubitril/ Valsartan) ENTRESTO Summary and Practical Tips

LCZ696 (Sacubitril/ Valsartan) ENTRESTO Summary and Practical Tips November 2015 LCZ696 (Sacubitril/Valsartan), Entresto TM Summary and Practical Tips Mechanism of action: sacubitril is a neprilysin (endopeptidase) inhibitor: ?vasodilatory peptides ? ?sodium loss, ?hypertrophy/remodeling. Combination with an ARB is necessary as inhibition of neprilysin leads to activation of the renin angiotensin aldosterone system (RAAS). Indication: • Health Canada Indication 1 : heart failure with reduced (...) ejection fraction (HFrEF), NYHA class II-III, in combination with other heart failure (HF) therapies in place of an ACEI or ARB • CCS HF 2014 Guidelines 2 : mild-moderate HF, left ventricular ejection fraction (LVEF) 5.2 mmol/L • History of angioedema Dosing: • Tablet: film-coated, unscored containing both sacubitril and valsartan (dose is sum of agents) • Strengths: 50 mg (24/26mg; white), 100 mg (49/51mg; yellow), 200 mg (97/103mg; pink) o Note: different valsartan salts; Entresto TM valsartan 103mg

2016 RxFiles

45. 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

46. 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

47. 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

48. 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

49. 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

50. 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

51. 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

52. Indirect treatment comparison between fixed-dose-combinations of amlodipine/losartan and amlodipine/valsartan in blood pressure control. (Abstract)

Indirect treatment comparison between fixed-dose-combinations of amlodipine/losartan and amlodipine/valsartan in blood pressure control. This study compared blood pressure (BP) changes after 8 weeks of therapy between a fixed-dose combination (FDC) of amlodipine/losartan and amlodipine/valsartan using a network meta-analysis because no trials directly compared amlodipine/losartan with other FDCs.A systematic search identified six randomised controlled trials (amlodipine/losartan-3, amlodipine (...) /valsartan-3) of FDCs and their component monotherapies. Conventional fixed-effects methods were used to conduct the comparisons. The primary and secondary effect measures were the changes in sitting diastolic and systolic blood pressure (sitDBP, sitSBP) at 8 weeks post-randomisation.The estimated amlodipine/valsartan - amlodipine/losartan difference (95% confidence interval) in sitDBP reduction was -1.27 mmHg, (-5.7, 2.2) for lower dosages and -0.45 mmHg, (-3.7, 2.7) for higher dosages; for sitSBP

2014 International journal of clinical practice

53. 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

54. 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

55. Meta-analysis of three observational studies of amlodipine/valsartan in hypertensive patients with additional risk factors. (Abstract)

Meta-analysis of three observational studies of amlodipine/valsartan in hypertensive patients with additional risk factors. In this study, the effectiveness of amlodipine/valsartan single-pill combination was assessed in hypertensive patients with diabetes, metabolic risk or overweight.Data from 12,265 patients treated with amlodipine/valsartan from three studies were analyzed in a meta-analysis. These studies focused on (i) non-diabetic hypertensive patients suffering from abdominal obesity (...) pressure reduction were evident between the study groups. In both age subgroups (< 80 years and ≥ 80 years) blood pressure reduction was comparable. Tolerability was assessed by treating physicians as "very good" (69.3%) and "good" (27.3%).In daily practice, treatment of hypertensive patients with additional risk factors with amlodipine/valsartan single-pill combinations is well tolerated and associated with effective reduction of blood pressure.

2013 Blood pressure

56. Effect of valsartan on systemic right ventricular function: a double-blind, randomized, placebo-controlled pilot trial (Full text)

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 PubMed abstract

57. A meta-analysis of randomized trials of telmisartan vs. valsartan therapy for blood pressure reduction. (Abstract)

A meta-analysis of randomized trials of telmisartan vs. valsartan therapy for blood pressure reduction. A previous meta-analysis of six randomized head-to-head trials suggests that the blood pressure (BP)-lowering capabilities of telmisartan may be comparable to those of valsartan. We performed an updated meta-analysis of telmisartan vs. valsartan therapy for the reduction of BP in hypertensive patients. MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials were searched (...) through August 2012 using web-based search engines (PubMed, OVID). Eligible studies were prospective randomized controlled trials examining telmisartan vs. valsartan therapy and reporting clinic BP as an outcome. For each study, the data regarding changes from baseline to final clinic systolic BP (SBP) and diastolic BP (DBP) in both the telmisartan and valsartan groups were used to generate mean differences (MDs) and 95% confidence intervals (CIs). Of the 62 potentially relevant articles initially

2013 Hypertension research : official journal of the Japanese Society of Hypertension

58. Cost-effectiveness analysis of valsartan versus losartan and the effect of switching (Full text)

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. PubMed abstract

59. 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.

60. Real-world effectiveness of valsartan on hypertension and total cardiovascular risk: review and implications of a translational research program. (Full text)

Real-world effectiveness of valsartan on hypertension and total cardiovascular risk: review and implications of a translational research program. The pharmacological efficacy of various monotherapy, single pill, and combination therapies of the angiotensin II receptor blocker valsartan have been established, mainly through randomized controlled trials that used similar methodological and statistical platforms and thus enabled synthesis of evidence. The real world effectiveness of valsartan has (...) been studied extensively, but the relative lack of scientific and technical congruence of these studies render synthesis virtually impossible. To date, all have focused on blood pressure outcomes, despite evidence-based calls to grade antihypertensive treatment to patients' total cardiovascular risk. We review a T3 translational research program of seven studies involving valsartan monotherapy as well as single and separate pill combinations, and the determinants and effect on blood pressure

2011 Vascular health and risk management PubMed abstract