Treatment of High-Risk patients with ezetimibe plus simvastatin Co-Administration versus simvastatin alone to attain National Cholesterol Education Program Adult Treatment Panel III Low-Density lipoprotein cholesterol goals
Theodore FeldmanMichael J. KorenWilliam InsullJames M. McKenneyHelmut G. SchrottAndrew LewinSukrut ShahMichelle SidisinMeehyung ChoDebra KushYale Mitchel
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Objective To study the effect of combined simvastatin and ezetimibe on atherosclerosis in ApoE-/- mice on a high-fat diet. Methods Thirty-six male ApoE-/-mice aged 8 weeks were randomly divided into model group, simvastatin treatment group and combined simvastatin and ezetimibe treatment group(12 in each group). Animals in simvastatin treatment group were treated with intragastric simvastatin(20 mg/kg), those in combined simvastatin and ezetimibe treatment group were treated with intragastric simvastatin(20 mg/kg) and ezetimibe(10 mg/kg), and those in model group received PBS buffer, once a day for 8 weeks. Aorta tissue sample taken from the animals were stained with oil red O to measure the area of their plaques. Results The serum TG, TC and LDL-C levels were significantly lower in simvastatin treatment group and combined simvastatin and ezetimibe treatment group than in model group(P0.01). The serum TG and LDL-C levels were significantly lower in combined simvastatin and ezetimibe treatment group than in simvastatin treatment group(P0.01) whereas the HDL-C/ LDL-C ratio was significantly higher in combined simvastatin and ezetimibe treatment group than in model group and simvastatin treatment group(P0.01). The area of plaques was significantly smaller in simvastatin treatment group and combined simvastatin and ezetimibe treatment group than in model group(P0.01). Conclusion Combined simvastatin and ezetimibe inhibits atherosclerosis in ApoE-/- mice more significantly than simvastatin alone.
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OBJECTIVE To observe the therapeutic effectiveness and safty of ezetimibe combined with Simvastatin on patients with hypercholesteremia.METHODS Hypercholesteremia patients were divided into three groups,A(Ezetimibe) group,B(Simvastatin) group,C(combination) group,which were treated with correspond methods.Twelve weeks later patients' plasma level of TC,HDL-C,LDL-C and Apo-B were detected,and the results were analysed.RESULTS:①There was significant difference on of patients in group C be-tween pretherapy and post-treatment(P0.05,P0.01).The difference of average change rates also had statistical significance be-tween patients in three groups(P0.Ol).②There was no relationship between the change level of TC,HDL-C,LDL-C,Apo-B and Simvastatin dosage,in patients of C group.In respect of lowering LDL-C level,Ezetimibe and simvastatin(10 mg/d) was better than Simvastatin(large dosage).The total effective rate of patients in group C was 69.8%,which were higher than that in group A and B(P0.01).The side effects rates had no difference between three groups statistically(P0.05).CONCLUSION The effect of combina-tion of ezetimibe and simvastatin is better than that ezetimibe and simvastatin alone,in regulating cholesterol metabolism,and combination of Ezetimibe and Simvastatin is safe.
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Treatments with ezetimibe/simvastatin (combined or alone) have been indicated as very promising approaches to strongly reduce cholesterol levels in hyperlipidemic patients.We will discuss the efficacy and safety of ezetimibe/simvastatin and their potential to reduce atheroprogression. The molecular mechanisms underlying the possible benefits in atherosclerosis and its complications will also be described.Combined therapy with ezetimibe/simvastatin has been shown to improve lipid profile inducing a very rapid reduction of low-density lipoprotein cholesterol levels in clinical trials. In the near future, potential clinical benefits could be observed in the IMPROVE-IT or SHARP trials. Although clinical studies are needed to further confirm safety of ezetimibe/simvastatin therapy, the greater efficacy in lipid-lowering was not associated with the increase of adverse events. Also the possible association between ezetimibe and cancer, which was observed in the SEAS trial, was not confirmed by further studies and meta-analyses. At present, ezetimibe should be considered an effective lipid-lowering agent that can be used in conjunction with simvastatin at the beginning of therapy, or included in the treatment of patients who do not achieve their low-density lipoprotein cholesterol goal with statins alone.
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Objective To investigate the therapeutic effectiveness and safly of simvastatin combined with ezetimibe on patients with hy-percholesteremia.Methods 71 patients with hypercholesterolemia were divided into the simvatatin group and combination group(simvastatin combined with ezetimibe).which were treated with correspond methods.The therapy lasted for twelve weeks in both two groups.The levels of TC,TG,HDL-C,LDL-C were measured in pre-treatment and post-treatmen.Results After twelve weeks treatment with simvastatin,the lipids of TC、LDL-C、TG were decreased and HDL-C ele-vated remarkably than those at baseline,and with P0.05.When combined with ezetimibe for twelve weeks,the lipid level of TC、LDL-C、TG was reduced than that of merely using simvastatin,and with P0.01 in respect.The side effects rates had no difference between two groups statistically(P0.05).Conclusion The effect of combination of ezetimibe and simvastatin is better than that simvastatin alone,in regulating cholesterol metabolism,and comb-nation of ezetimibe and simvastatin is safe.
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BACKGROUND Arterial stiffness (AS) and highly sensitive CRP (hsCRP) predict risk for cardiovascular events. Statins can improve inflammation and AS. The effect of ezetimibe on AS and hsCRP has not been studied. The aim of this study was to compare the effect of simvastatin with ezetimibe on AS and hsCRP. METHODS Forty hypercholesterolemic patients were studied. Group 1: previously untreated received simvastatin 40mg/d, group 2: previously treated with simvastatin 40mg/d received simvastatin 80mg/d; group 3: previously untreated received ezetimibe 10mg/d; group 4: previously treated with simvastatin 40mg/d received simvastatin 40mg/d and ezetimibe 10mg/d. Augmentation index (AIx, a measure of AS), and hsCRP were measured at baseline and after 3 months. RESULTS The reduction in LDL after treatment was significantly greater in groups 1 and 4 (39% and 37%) compared to groups 2 and 3 (18% and 16%). AIx decreased significantly in group 1 compared to the other groups (−22.1%, −0.4%, −0.3% and 0.4% in groups 1–4, p=0.035). Changes in hsCRP paralleled the changes in AIx: significant decreased in group 1 (−50.8%), compared to group 2 (+3.6%), p=0.002. In groups 3 and 4 hsCRP decreased, but there was no significant difference (−21.3% and −11.3%, p=0.81). CONCLUSIONS Compared to simvastatin, ezetimibe as monotherapy resulted in milder decreases in LDL cholesterol and had no effects on AS or hsCRP. Increasing the dose of simvastatin or the addition of ezetimibe to simvastatin had no beneficial effects on AS or hsCRP. Clinical Pharmacology & Therapeutics (2005) 79, P1–P1; doi: 10.1016/j.clpt.2005.12.003
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Low doses of ezetimibe/simvastatin provide greater improvements in lipid profile than simvastatin or atorvastatin monotherapy. Ezetimibe/simvastatin may be useful in patients who are unable to tolerate high-dose statin therapy. Combination ezetimibe-simvastatin is less expensive than adding ezetimibe to a statin and more convenient than taking two separate medicines.
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A combination of simvastatin and ezetimibe with complementary mechanisms of action is used for treating high levels of cholesterol in the blood. The aim of this study was to develop a rapid and sensitive derivative spectrophotometric method for analysis of these drugs in combined dosage forms. A first order derivative spectrophotometric method was developed for simultaneous determination of simvastatin and ezetimibe using zero‐crossing technique. The measurements were carried out at 219 and 265 nm for simvastatin and ezetimibe respectively. The described method was found to be linear (r 2 >0.999) over the range of 2‐40 μg/mL for simvastatin in the presence of 10 μg/mL ezetimibe at 219 nm and in the range of 1‐20 μg/mL of ezetimibe in the presence of 20 μg/mL of simvastatin at 265 nm. The within‐day and between‐day precision values for both drugs were less than 3% (CV). Also, good recoveries were obtained with both synthetic mixtures and commercial tablets. The proposed method was successfully applied for simultaneous determination of simvastatin and ezetimibe in a pharmaceutical dosage form without any interference from excipients.
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