Ezetimibe, Simvastatin Drug Combination: A pharmaceutical preparation of ezetimibe and simvastatin that is used in the treatment of HYPERCHOLESTEROLEMIA and HYPERLIPIDEMIAS.
ID Source | ID |
---|---|
PubMed CID | 9832423 |
MeSH ID | M0474124 |
Synonym |
---|
vytorin |
inegy |
ezetimibe-simvastatin combination |
ezetimibe, simvastatin drug combination |
ezetimibe/simvastatin |
ezetimibe and simvastatin |
mk 0653a |
simvastatin and ezetimibe |
butanoic acid, 2,2-dimethyl-, (1s,3r,7s,8s,8ar)-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-(2-((2r,4r)-tetrahydro-4-hydroxy-6-oxo-2h-pyran-2-yl)ethyl)-1-naphthalenyl ester, mixt. with (3r,4s)-1-(4-fluorophenyl)-3-((3s)-3-(4-fluorophenyl)-3-hydroxypropyl)-4-(4- |
444313-53-5 |
DTXSID80196177 |
PNAMDJVUJCJOIX-IUNFJCKHSA-N |
[(1s,3r,7s,8s,8ar)-8-[2-[(2r,4r)-4-hydroxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] 2,2-dimethylbutanoate;(3r,4s)-1-(4-fluorophenyl)-3-[(3s)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one |
Excerpt | Reference | Relevance |
---|---|---|
" The pharmacokinetic parameters for ezetimibe and simvastatin were assessed by determining total ezetimibe, free ezetimibe, simvastatin and simvastatin acid concentrations using a validated liquid chromatography-tandem mass spectrometry method." | ( Pharmacokinetics and safety of ezetimibe/simvastatin combination tablet: an open-label, single-dose study in healthy Chinese subjects. Chen, WL; Chu, NN; Li, XN; Xu, HR, 2012) | 0.38 |
"The pharmacokinetic parameters (mean ± SD) for total ezetimibe and free ezetimibe following a single dose were: maximum plasma drug concentration (C(max)) 81." | ( Pharmacokinetics and safety of ezetimibe/simvastatin combination tablet: an open-label, single-dose study in healthy Chinese subjects. Chen, WL; Chu, NN; Li, XN; Xu, HR, 2012) | 0.38 |
" Ezetimibe is absorbed in small intestine, reaching peak plasma concentrations in 4-12 h, with a plasma half-life of 22 h." | ( Pharmacokinetic drug evaluation of ezetimibe + simvastatin for the treatment of hypercholesterolemia. Bove, M; Cicero, AFG; Fogacci, F, 2017) | 0.46 |
Excerpt | Reference | Relevance |
---|---|---|
"Low aqueous solubility is often a limiting aspect to the bioavailability of poorly soluble, but highly permeable drugs (class II compounds according to the Biopharmaceutics Classification System - BCS) administered in single drug products or as fixed dose combinations." | ( New formulation approaches to improve solubility and drug release from fixed dose combinations: case examples pioglitazone/glimepiride and ezetimibe/simvastatin. Dressman, JB; Klein, S; Taupitz, T, 2013) | 0.39 |
Excerpt | Relevance | Reference |
---|---|---|
" By blocking both synthesis and absorption of cholesterol, the fixed combination exerts a cholesterol-lowering effect as important as, or even greater than, that observed with the highest dosage of simvastatin and other statins, with a good tolerance profile." | ( [Drug of the month. Ezetimibe/simvastatin tablet (Inegy)]. Radermecker, RP; Scheen, AJ, 2007) | 0.34 |
"5 mg/dl) mainly regardless of previous statin therapy (rosuvastatin, atorvastatin, simvastatin, pravastatin, fluvastatin, and lovastatin) and dosing (pooled median values)." | ( [Achievement of blood lipid target levels with Ezetimibe/Simvastatin in patients with atherosclerosis and/or diabetes mellitus--an Austrian observational study]. Slany, J, 2009) | 0.35 |
"Two spectrophotometric methods are presented for the simultaneous determination of ezetimibe/simvastatin and ezetimibe/atorvastatin binary mixtures in combined pharmaceutical dosage forms without prior separation." | ( Enhanced spectrophotometric determination of two antihyperlipidemic mixtures containing ezetimibe in pharmaceutical preparations. Barary, MA; El-Kimary, EI; Hassan, EM; Maher, HM; Youssef, RM, 2011) | 0.37 |
" The justifications and benefits of combination therapy are far-reaching, including but not limited to addressing unmet medical needs such as cancer, malaria, and HIV/AIDS, improved clinical efficacy and safety with reduced dosage of a single medication, understanding the underlying science of the disease, alleviating pharmaco-economic impacts, and better drug life-cycle management." | ( A case study of single-pill combination therapy: the ezetimibe/simvastatin combination for treatment of hyperlipidemia. Chen, DY; Huang, X, 2012) | 0.38 |
" Dosing was designed to produce comparable low-density lipoprotein cholesterol reductions, while enabling assessment of potential simvastatin-associated pleiotropic effects." | ( High-dose simvastatin exhibits enhanced lipid-lowering effects relative to simvastatin/ezetimibe combination therapy. D'Alexandri, FL; Fiehn, O; Grapov, D; Haeggström, JZ; Hyötyläinen, T; Newman, JW; Orešič, M; Pedersen, TL; Pernow, J; Settergren, M; Snowden, SG; Wheelock, CE, 2014) | 0.4 |
" The guideline identifies four cohorts of patients with proven benefits from statin therapy and streamlines the dosing and monitoring recommendations based on evidence from published, randomized controlled trials." | ( Implementation of the 2013 American College of Cardiology/American Heart Association Blood Cholesterol Guideline Including Data From the Improved Reduction of Outcomes: Vytorin Efficacy International Trial. Dinkler, J; Watson, K; Ziaeian, B, 2015) | 0.42 |
Timeframe | Studies, This Drug (%) | All Drugs % |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 42 (28.57) | 29.6817 |
2010's | 90 (61.22) | 24.3611 |
2020's | 15 (10.20) | 2.80 |
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023] |
According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be moderate demand-to-supply ratio for research on this compound.
| This Compound (23.93) All Compounds (24.57) |
Publication Type | This drug (%) | All Drugs (%) |
---|---|---|
Trials | 61 (39.87%) | 5.53% |
Reviews | 18 (11.76%) | 6.00% |
Case Studies | 5 (3.27%) | 4.05% |
Observational | 5 (3.27%) | 0.25% |
Other | 64 (41.83%) | 84.16% |
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023] |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
A Multicenter, Randomized, Parallel-Groups, Double-Blind Placebo-Controlled Study Comparing the Efficacy, Safety, and Tolerability of Administration of Ezetimibe/Simvastatin Tablet 10/20 mg Versus Doubling the Dose of Simvastatin 20 mg [Simvastatin 40 mg] [NCT00423579] | Phase 4 | 120 participants (Actual) | Interventional | 2006-07-01 | Completed | ||
"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Factorial Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet in Patients With Primary Hypercholesterolemia" [NCT00092651] | Phase 3 | 1,398 participants (Actual) | Interventional | 2002-09-30 | Completed | ||
Lipid-lowering Regimes Improve Oxidative Stress, Tryptophan Degradation in Hypercholesterolemia Chronic Kidney Disease Patients [NCT03543774] | Phase 4 | 30 participants (Anticipated) | Interventional | 2018-06-15 | Recruiting | ||
A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin Monotherapy in High-Risk Subjects Presenting With Acute Coronary Syndrome (IMProved Reduction of Outcomes: [NCT00202878] | Phase 3 | 18,144 participants (Actual) | Interventional | 2005-10-17 | Completed | ||
Efficacy of Ezetimibe/Simvastatin 10/20 mg and MK0524A (1-2 g/Day) in Patients With Mixed Hyperlipidemia and Two or More Risk Factors to Cardiovascular Disease. [NCT00738985] | Phase 4 | 0 participants (Actual) | Interventional | 2009-11-30 | Withdrawn(stopped due to The study was cancelled due to budget limitations) | ||
Ezetimibe/Simvastatin and Rosuvastatin for Oxidative Stress and Mitochondrial Function in Diabetic Polyneuropathy: a Randomized, Double Blinded, Placebo Controlled Clinical Trial [NCT02129231] | Phase 2 | 74 participants (Actual) | Interventional | 2012-02-29 | Completed | ||
Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 in Patients With Metabolic Syndrome [NCT00988364] | Phase 4 | 30 participants (Actual) | Interventional | 2007-03-31 | Completed | ||
Additive Effect of Ezetimibe Upon Simvastatin Treatment on Systemic Inflammatory Activity and Endothelial Function During Myocardial Infarction [NCT00905905] | Phase 4 | 40 participants (Anticipated) | Interventional | 2009-05-31 | Completed | ||
Post - Marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients [NCT00909389] | 4,748 participants (Actual) | Observational | 2006-11-30 | Completed | |||
Efficacy and Safety of Simvastatin-ezetimibe Combination Therapy in Reduction of Progression of Atherosclerosis Among Patients With Systemic Lupus Erythematosus: A Randomized Single-Blind Trial [NCT02548936] | Early Phase 1 | 30 participants (Actual) | Interventional | 2015-04-30 | Enrolling by invitation | ||
Comparative Efficacy of a Vytorin 10/80 Tablet Split Into 4 (Estimated Dose Ezetimibe 2.5 + Simvastatin 20) Versus Simvastatin 20 Milligrams on LDL Cholesterol [NCT00762164] | Phase 4 | 34 participants (Actual) | Interventional | 2007-03-31 | Completed | ||
To Study the Effect of Vytorin on Intracellular Lipid and Inflammation in Obese Subjects [NCT01420328] | Phase 3 | 20 participants (Anticipated) | Interventional | 2011-05-31 | Active, not recruiting | ||
SCH 465981: Assessment of Bi-Directional Interaction Between Components of Vytorin® (Ezetimibe and Simvastatin) and Niaspan® (Niacin Extended-Release Tablets) in Healthy Subjects [NCT00652431] | Phase 1 | 18 participants (Actual) | Interventional | 2007-05-31 | Completed | ||
Effects on Atherosclerosis Regression of Ezetimibe Monotherapy or Ezetimibe Plus Simvastatin Combination Therapy: Evaluation by Fluorodeoxyglucose Positron Emission Tomography [NCT00926055] | 0 participants (Actual) | Interventional | 2011-09-30 | Withdrawn | |||
An Open-label Exploratory Study of the Pharmacokinetic Interaction of CXA-10 Administered to Steady State With Pravastatin and Vytorin® (Simvastatin and Ezetimibe) in Healthy Males [NCT02547402] | Phase 1 | 10 participants (Actual) | Interventional | 2015-12-31 | Completed | ||
A Randomized Trial of the Long-term Clinical Effects of Raising HDL Cholesterol With Extended Release Niacin/Laropiprant [NCT00461630] | Phase 3 | 25,673 participants (Actual) | Interventional | 2007-01-31 | Completed | ||
Rho-kinase in Patients With Atherosclerosis: Effects of Statins A Randomized Clinical Trial Comparing Ezetimibe/Simvastatin and Simvastatin [NCT00560170] | Phase 4 | 40 participants (Actual) | Interventional | 2007-09-30 | Completed | ||
Clinical Trial of Zocor and Vytorin in Adolescents With Type 1 Diabetes [NCT00477204] | Phase 2 | 9 participants (Actual) | Interventional | 2007-05-31 | Completed | ||
A Pilot Study To Evaluate the Efficacy of Vytorin (Simvastatin +Ezetimibe) In the Treatment of Alopecia Areata [NCT01520077] | Phase 1 | 29 participants (Actual) | Interventional | 2011-07-31 | Completed | ||
The Effects of Ezetimibe on Postprandial Hyperlipidemia and Endothelial Dysfunction in Patients With the Metabolic Syndrome. [NCT00189085] | Phase 4 | 20 participants | Interventional | 2004-12-31 | Completed | ||
A Multicenter, Open-label, 6 Week Study to Evaluate the Efficacy and Safety of Algorithm Based Intensive Treatment With Vytorin Versus Standard Treatment of Other Statins in Moderate, Moderately High and High Risk Patients. [NCT01587235] | Phase 4 | 0 participants (Actual) | Interventional | 2013-03-31 | Withdrawn | ||
The Effects of Ezetimibe/Simvastatin Versus Simvastatin Alone on Platelet and Inflammatory Biomarkers in Patients With the Metabolic Syndrome [NCT00819403] | Phase 4 | 15 participants (Actual) | Interventional | 2009-01-31 | Completed | ||
Phase 3, Open-Label, Multi-Center, Double-Blind, Randomized, Parallel Group Study Efficacy and Safety of Fixed Combination Torcetrapib/Atorvastatin, Administered Once Daily (QD) Compared to Fixed Combination Ezetimibe/Simvastatin for 6 Weeks in Subjects W [NCT00267267] | Phase 3 | 1,784 participants | Interventional | 2006-01-31 | Terminated | ||
[NCT01660945] | Phase 4 | 204 participants (Actual) | Interventional | 2011-07-31 | Completed | ||
[NCT01666067] | Phase 4 | 204 participants (Actual) | Interventional | 2011-11-30 | Completed | ||
A Randomized, Double-Blind, Active-Controlled Study of Patients With Primary Hypercholesterolemia and High Cardiovascular Risk and Not Adequately Controlled With Atorvastatin: A Comparison of Switching to a Combination Tablet Ezetimibe/Simvastatin Versus [NCT00782184] | Phase 3 | 250 participants (Actual) | Interventional | 2008-11-30 | Completed | ||
Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) Co-Administered in Patients With Type IIa or Type IIb Hyperlipidemia [NCT00271817] | Phase 3 | 1,220 participants (Actual) | Interventional | 2005-12-31 | Completed | ||
Study of Lipoprotein Subfractions, Inflammation, Oxidative Stress and Endothelial Function After Treatment With Simvastatin and Ezetimibe Administered Alone and in Combination in Hyperlipidemic Patients [NCT02304926] | 42 participants (Actual) | Interventional | 2009-01-31 | Completed | |||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |