Latest & greatest articles for simvastatin

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Top results for simvastatin

21. The Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for SLCO1B1 and Simvastatin-induced Myopathy

The Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for SLCO1B1 and Simvastatin-induced Myopathy CPIC UPdate nature publishing group Simvastatin is among the most commonly used prescription medications for cholesterol reduction. A single coding single- nucleotide polymorphism, rs4149056T>C, in SLCO1B1 increases systemic exposure to simvastatin and the risk of muscle toxicity. We summarize evidence from the literature supporting this association and provide therapeutic (...) recommendations for simvastatin based on SLCO1B1 genotype. This article is an update to the 2012 Clinical Pharmacogenetics Implementation Consortium guideline for SLCO1B1 and simvastatin-induced myopathy. This update to the 2012 guideline 1 provides information that enables the interpretation of SLCO1B1 genotype tests so that the results can be used to guide dosing of simvastatin. Detailed guidelines for the use of simvastatin are beyond the scope of this article. Although polymorphisms in SLCO1B1 affect

2014 Clinical Pharmacogenetics Implementation Consortium

22. Ezetimibe and simvastatin (Inegy) for reduction of cardiovascular risk in coronary heart disease

Ezetimibe and simvastatin (Inegy) for reduction of cardiovascular risk in coronary heart disease Ezetimibe and simvastatin (Inegy) for reduction of cardiovascular risk in coronary heart disease Ezetimibe and simvastatin (Inegy) for reduction of cardiovascular risk in coronary heart disease NIHR HSC Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database (...) . Citation NIHR HSC. Ezetimibe and simvastatin (Inegy) for reduction of cardiovascular risk in coronary heart disease. Birmingham: NIHR Horizon Scanning Centre (NIHR HSC). Horizon Scanning Review. 2013 Final publication URL Indexing Status Subject indexing assigned by CRD MeSH Azetidines; Coronary Diseases; Drug Combinations; Simvastatin Language Published English Country of organisation England English summary An English language summary is available. Address for correspondence The NIHR Horizon Scanning

2013 Health Technology Assessment (HTA) Database.

23. Cholib - fenofibrate / simvastatin

Cholib - fenofibrate / simvastatin 27 June 2013 EMA/CHMP/308856/2013 Committee for Medicinal Products for Human Use (CHMP) Assessment report Cholib International non-proprietary name: fenofibrate / simvastatine Procedure No. EMEA/H/C/002559/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile (...) -density lipoprotein cholesterol HMGCoA 3-Hydroxy-3-Methylglutaryl Coenzyme A HR Hazard Ratio LDL-C Low-density lipoprotein cholesterol LLOQ Lower Limit of Quantification Lp(a) Lipoprotein (a) LXR Liver X Receptor MI Myocardial Infarction NCEP National Cholesterol Education Program PPAR Peroxysome proliferator activated receptor PK Pharmacokinetic PTY Patient Treatment Year(s) SVA Simvastatin acid SV Simvastatin T2DM Type 2 Diabetes Mellitus TG Triglycerides Tmax Time to peak concentration TSH Thyroid

2013 European Medicines Agency - EPARs

24. Cost-effectiveness of rosuvastatin in comparison with generic atorvastatin and simvastatin in a Swedish population at high risk of cardiovascular events Full Text available with Trip Pro

Cost-effectiveness of rosuvastatin in comparison with generic atorvastatin and simvastatin in a Swedish population at high risk of cardiovascular events Cost-effectiveness of rosuvastatin in comparison with generic atorvastatin and simvastatin in a Swedish population at high risk of cardiovascular events Cost-effectiveness of rosuvastatin in comparison with generic atorvastatin and simvastatin in a Swedish population at high risk of cardiovascular events Gandhi SK, Jensen MM, Fox KM, Smolen L (...) concluded that rosuvastatin was cost-effective, over a lifetime, compared with generic simvastatin or atorvastatin. The lack of detailed reporting and the highlighted limitations to this study mean that the authors’ conclusions should be considered with caution. Type of economic evaluation Cost-effectiveness analysis, cost-utility analysis Study objective This study evaluated the long-term cost-effectiveness of alternative statin therapies in Swedish patients with a high risk of cardiovascular events

2012 NHS Economic Evaluation Database.

25. Economic evaluation of ezetimibe combined with simvastatin for the treatment of primary hypercholesterolaemia

Economic evaluation of ezetimibe combined with simvastatin for the treatment of primary hypercholesterolaemia 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.

2012 NHS Economic Evaluation Database.

26. Simvastatin: updated advice on drug interactions

Simvastatin: updated advice on drug interactions Simvastatin: updated advice on drug interactions - GOV.UK GOV.UK uses cookies to make the site simpler. or Search Simvastatin: updated advice on drug interactions Updated contraindications and maximum dose recommendations when taken with a number of other medicines. Published 11 December 2014 From: Therapeutic area: , Article date: August 2012 We have previously communicated on the increased risk of myopathy associated with use of high-dose (...) simvastatin (80 mg daily) – see . Considering the risk of myopathy associated with simvastatin, recent analysis of clinical trial data, spontaneously reported cases and drug- drug interaction studies has resulted in further changes to the simvastatin prescribing information. The changes include contraindications to concomitant use with certain medicines and maximum dose recommendations when simvastatin is taken with a number of other medicines, as these interactions may increase plasma concentrations

2012 MHRA Drug Safety Update

27. Simvastatin: dose limitations with concomitant amlodipine or diltiazem

Simvastatin: dose limitations with concomitant amlodipine or diltiazem Simvastatin: dose limitations with concomitant amlodipine or diltiazem - GOV.UK GOV.UK uses cookies to make the site simpler. or Search Simvastatin: dose limitations with concomitant amlodipine or diltiazem The maximum recommended dose for simvastatin in conjunction with amlodipine and diltiazem is now 20 mg/day. Published 11 December 2014 From: Therapeutic area: , Contents Article date: October 2012 Pharmacokinetic data (...) Simvastatin is metabolised through the CYP3A4 pathway. Concomitant use of CYP3A4 inhibitors has the potential to increase exposure to simvastatin . Both amlodipine and diltiazem are substrates and inhibitors of CYP3A4 and therefore increase the plasma concentration (AUC0-24h) and maximum plasma concentration (Cmax) of simvastatin when they are co-administered. Studies have found that after 10 days of amlodipine (10 mg), the AUC0-24h of simvastatin and simvastatic acid following a single dose

2012 MHRA Drug Safety Update

28. Weighing the Benefits of High-Dose Simvastatin against the Risk of Myopathy. Full Text available with Trip Pro

Weighing the Benefits of High-Dose Simvastatin against the Risk of Myopathy. 21675881 2011 08 05 2013 11 21 1533-4406 365 4 2011 Jul 28 The New England journal of medicine N. Engl. J. Med. Weighing the benefits of high-dose simvastatin against the risk of myopathy. 285-7 10.1056/NEJMp1106689 Egan Amy A Division of Metabolism and Endocrinology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA. Colman Eric E eng (...) Journal Article 2011 06 15 United States N Engl J Med 0255562 0028-4793 0 Anticholesteremic Agents AGG2FN16EV Simvastatin EC 2.7.3.2 Creatine Kinase AIM IM Anticholesteremic Agents administration & dosage adverse effects Creatine Kinase blood Drug Approval Drug Interactions Drug Labeling Dyslipidemias drug therapy Humans Muscular Diseases chemically induced Risk Simvastatin administration & dosage adverse effects United States United States Food and Drug Administration 2011 6 17 6 0 2011 6 17 6 0 2011

2011 NEJM

29. FDA issues new dosing limitations for Simvastatin

FDA issues new dosing limitations for Simvastatin Breaking News: FDA issues new dosing limitations for Simvastatin – Clinical Correlations Search Breaking News: FDA issues new dosing limitations for Simvastatin June 10, 2011 1 min read By Saleem Ali, MD The FDA has issued new warnings regarding the use of high dose Simvastatin. The FDA is now recommending that the 80mg dose only be used in patients who have been taking that dosage for at least 12 months with no signs of toxicity. Patients who (...) are currently on simvastatin and require more than 40 mg. should be considered for alternative lipid lowering therapy. The FDA is issuing this warning because recent data has shown that the 80 mg. dose has a significantly higher risk of rhabdomyolsysis and muscle injury than lower doses. Leading to this alert was a preliminary analysis of the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial. The purpose of this randomized controlled trial was to determine

2011 Clinical Correlations

30. Effects on 11-year mortality and morbidity of lowering LDL cholesterol with simvastatin for about 5 years in 20,536 high-risk individuals: a randomised controlled trial. Full Text available with Trip Pro

Effects on 11-year mortality and morbidity of lowering LDL cholesterol with simvastatin for about 5 years in 20,536 high-risk individuals: a randomised controlled trial. Findings of large randomised trials have shown that lowering LDL cholesterol with statins reduces vascular morbidity and mortality rapidly, but limited evidence exists about the long-term efficacy and safety of statin treatment. The aim of the extended follow-up of the Heart Protection Study (HPS) is to assess long-term (...) efficacy and safety of lowering LDL cholesterol with statins, and here we report cause-specific mortality and major morbidity in the in-trial and post-trial periods.20,536 patients at high risk of vascular and non-vascular outcomes were allocated either 40 mg simvastatin daily or placebo, using minimised randomisation. Mean in-trial follow-up was 5·3 years (SD 1·2), and post-trial follow-up of surviving patients yielded a mean total duration of 11·0 years (SD 0·6). The primary outcome of the long-term

2011 Lancet Controlled trial quality: predicted high

31. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Full Text available with Trip Pro

The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lowering LDL cholesterol with statin regimens reduces the risk of myocardial infarction, ischaemic stroke, and the need for coronary revascularisation in people without kidney disease, but its effects in people with moderate-to-severe kidney disease are uncertain. The SHARP trial aimed to assess the efficacy (...) and safety of the combination of simvastatin plus ezetimibe in such patients.This randomised double-blind trial included 9270 patients with chronic kidney disease (3023 on dialysis and 6247 not) with no known history of myocardial infarction or coronary revascularisation. Patients were randomly assigned to simvastatin 20 mg plus ezetimibe 10 mg daily versus matching placebo. The key prespecified outcome was first major atherosclerotic event (non-fatal myocardial infarction or coronary death, non

2011 Lancet Controlled trial quality: predicted high

32. SHARP: Study of Heart & Renal Protection - The Effects of Lowering LDL Cholesterol with Simvastatin plus Ezetimibe in Patients with Chronic Kidney Disease

SHARP: Study of Heart & Renal Protection - The Effects of Lowering LDL Cholesterol with Simvastatin plus Ezetimibe in Patients with Chronic Kidney Disease SHARP: Study of Heart & Renal Protection 1-2 The Effects of Lowering LDL Cholesterol with Simvastatin plus Ezetimibe in Patients with Chronic Kidney Disease TRIAL BACKGROUND • Prevalence of CKD is steadily climbing in Canada. CVD is the leading cause of death in CKD ~10-30 fold higher than general population . • In late-stage CKD GFR 150umol (...) in other trials of combination therapy in a variety of populations ENHANCE, SEAS, ARBITER 6-HALTS suggests ezetimibe did not contribute o Uncertainty: clinical effect of simvastatin 20mg or 40mg alone, or any other statin, in this population • Did not report use of any medications including erythropoietin stimulating agents, phosphate binders, iron therapy which may also impact long-term CV risk • Uncertain if benefit across all subgroups of CKD dialysis vs. non-dialysis – underpowered o Kidney

2011 RxFiles

33. Safety and efficacy of ezetimibe/simvastatin combination versus atorvastatin alone in adults >/=65 years of age with hypercholesterolemia and with or at moderately high/high risk for coronary heart disease (the VYTELD study) (Abstract)

Safety and efficacy of ezetimibe/simvastatin combination versus atorvastatin alone in adults >/=65 years of age with hypercholesterolemia and with or at moderately high/high risk for coronary heart disease (the VYTELD study) Higher than 80% of coronary heart disease-related mortality occurs in patients ≥65 years of age. Guidelines recommend low-density lipoprotein (LDL) cholesterol targets for these at-risk patients; however, few clinical studies have evaluated lipid-lowering strategies (...) specifically in older adults. This multicenter, 12-week, randomized, double-blind, parallel-group trial evaluated the efficacy and safety of the usual starting dose of ezetimibe/simvastatin (10/20 mg) versus atorvastatin 10 or 20 mg and the next higher dose of ezetimibe/simvastatin (10/40 mg) versus atorvastatin 40 mg in 1,289 hypercholesterolemic patients ≥65 years of age with or without cardiovascular disease. Patients randomized to ezetimibe/simvastatin had greater percent decreases in LDL cholesterol

2010 EvidenceUpdates Controlled trial quality: uncertain

34. Simvastatin in the treatment of asthma: lack of steroid-sparing effect Full Text available with Trip Pro

Simvastatin in the treatment of asthma: lack of steroid-sparing effect Statins have anti-inflammatory actions which in theory are potentially beneficial in asthma. Small trials have failed to show a significant benefit, but a systematic study to evaluate the steroid-sparing effect of statin treatment has not been carried out.A randomised, placebo-controlled, crossover trial was conducted of simvastatin 40 mg at night with simultaneous stepwise reduction of fluticasone propionate dose until loss (...) of control occurred, followed by an increase until regain of control ('minimum' dose required) in 51 patients with asthma and sputum eosinophils (steroid-free) ≥ 2%.43 patients completed the study. There was no significant difference in 'minimum' inhaled corticosteroid (ICS) dose requirement between simvastatin and placebo: (median (IQR) 50 μg daily (0-250) vs 100 μg daily (0-250), p=0.931). 'Minimum' dose distribution was similar (p=0.269). The fluticasone dose at which loss of control occurred did

2010 EvidenceUpdates Controlled trial quality: uncertain

35. Incremental cholesterol reduction with ezetimibe/simvastatin, atorvastatin and rosuvastatin in UK General Practice (IN-PRACTICE): randomised controlled trial of achievement of Joint British Societies (JBS-2) cholesterol targets Full Text available with Trip Pro

Incremental cholesterol reduction with ezetimibe/simvastatin, atorvastatin and rosuvastatin in UK General Practice (IN-PRACTICE): randomised controlled trial of achievement of Joint British Societies (JBS-2) cholesterol targets The aim of this study was to compare ezetimibe/simvastatin combination therapy with intensified statin monotherapy as alternative treatment strategies to achieve the Joint British Societies (JBS)-2 and National Institute for Health and Clinical Excellence low-density (...) -lipoprotein cholesterol (LDL-C) target of < 2 mmol/l for secondary prevention or JBS-2 LDL-C target of < 2 mmol/l for primary prevention in high-risk patients who have failed to reach target with simvastatin 40 mg.This is a prospective, double-blind study conducted in 34 UK primary care centres; 1748 patients with established cardiovascular disease (CVD), diabetes or high risk of CVD who had been taking simvastatin 40 mg for > or = 6 weeks were screened and 786 (45%) with fasting LDL-C > or = 2.0 mmol/l

2010 EvidenceUpdates Controlled trial quality: predicted high

36. Simvastatin as a treatment for pulmonary hypertension trial Full Text available with Trip Pro

Simvastatin as a treatment for pulmonary hypertension trial In animal models of pulmonary hypertension, simvastatin has been shown to reduce pulmonary artery pressure and induce regression of associated right ventricular (RV) hypertrophy.To assess the therapeutic value of simvastatin in patients with pulmonary arterial hypertension (PAH).Forty-two patients with PAH were randomized to receive either simvastatin (80 mg/d) or placebo in addition to current care for 6 months, and thereafter offered (...) open-label simvastatin. The primary outcome was change in RV mass, assessed by cardiac magnetic resonance (CMR).At 6 months, RV mass decreased by 5.2 +/- 11 g in the statin group (P = 0.045) and increased 3.9 +/- 14 g in the placebo group. The treatment effect was -9.1 g (P = 0.028). N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels decreased significantly in the statin group (-75 +/- 167 fmol/ml; P = 0.02) but not the placebo group (49 +/- 224 fmol/ml; P = 0.43; overall treatment effect

2010 EvidenceUpdates Controlled trial quality: uncertain

37. Intensive lowering of LDL cholesterol with 80 mg versus 20 mg simvastatin daily in 12,064 survivors of myocardial infarction: a double-blind randomised trial. Full Text available with Trip Pro

Intensive lowering of LDL cholesterol with 80 mg versus 20 mg simvastatin daily in 12,064 survivors of myocardial infarction: a double-blind randomised trial. Lowering of LDL cholesterol reduces major vascular events, but whether more intensive therapy safely produces extra benefits is uncertain. We aimed to establish efficacy and safety of more intensive statin treatment in patients at high cardiovascular risk.We undertook a double-blind randomised trial in 12,064 men and women aged 18-80 (...) years with a history of myocardial infarction. Participants were either currently on or had clear indication for statin therapy, and had a total cholesterol concentration of at least 3·5 mmol/L if already on a statin or 4·5 mmol/L if not. Randomisation to either 80 mg or 20 mg simvastatin daily was done centrally using a minimisation algorithm. Participants were assessed at 2, 4, 8, and 12 months after randomisation and then every 6 months until final follow-up. The primary endpoint was major

2010 Lancet Controlled trial quality: predicted high

38. Projected cost-effectiveness of ezetimibe/simvastatin compared with doubling the statin dose in the United Kingdom: findings from the INFORCE study Full Text available with Trip Pro

Projected cost-effectiveness of ezetimibe/simvastatin compared with doubling the statin dose in the United Kingdom: findings from the INFORCE study Projected cost-effectiveness of ezetimibe/simvastatin compared with doubling the statin dose in the United Kingdom: findings from the INFORCE study Projected cost-effectiveness of ezetimibe/simvastatin compared with doubling the statin dose in the United Kingdom: findings from the INFORCE study Reckless J, Davies G, Tunceli K, Hu XH, Brudi P 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 switching to a combination of ezetimibe and simvastatin, compared with doubling the statin dose, for patients with acute coronary syndrome, who had

2010 NHS Economic Evaluation Database.

39. Simvastatin: increased risk of myopathy at high dose (80 mg)

Simvastatin: increased risk of myopathy at high dose (80 mg) Simvastatin: increased risk of myopathy at high dose (80 mg) - GOV.UK GOV.UK uses cookies to make the site simpler. or Search Simvastatin: increased risk of myopathy at high dose (80 mg) There is an increased risk of myopathy associated with high-dose (80 mg) simvastatin. The 80-mg dose should be considered only in patients with severe hypercholesterolaemia and high risk of cardiovascular complications who have not achieved (...) their treatment goals on lower doses, when the benefits are expected to outweigh the potential risks Published 11 December 2014 From: Therapeutic area: Contents Article date: May 2010 The simvastatin (Zocor) product information (Summary of Product Characteristics and Patient Information Leaflet) has been updated to include warnings about increased risk of myopathy in patients receiving the highest licensed dose (80 mg). Similar changes are being implemented to the product information for combination products

2010 MHRA Drug Safety Update

40. Lipid-altering efficacy and safety of ezetimibe/simvastatin versus atorvastatin in patients with hypercholesterolemia and the metabolic syndrome (from the VYMET study) (Abstract)

Lipid-altering efficacy and safety of ezetimibe/simvastatin versus atorvastatin in patients with hypercholesterolemia and the metabolic syndrome (from the VYMET study) Patients with the metabolic syndrome are at an increased risk of cardiovascular disease and might require intensive lipid therapy. Many patients remain at the starting dose of lipid therapy and might not be titrated up to a higher dose. The present double-blind, randomized, 6-week study assessed the lipid-lowering efficacy (...) of ezetimibe/simvastatin 10/20 mg versus atorvastatin 10 or 20 mg, and ezetimibe/simvastatin 10/40 mg versus atorvastatin 40 mg in 1,128 patients with hypercholesterolemia and the metabolic syndrome. The primary end point was the percentage of change from baseline in low-density lipoprotein (LDL) cholesterol. Additional end points included changes in other lipids, lipoprotein ratios, high-sensitivity C-reactive protein, and attainment of prespecified lipid levels. Significantly greater improvements

2009 EvidenceUpdates Controlled trial quality: uncertain