Combination lipid lowering therapy with rosuvastatin and ezetimibe in dyslipidemic patients with stable coronary artery disease and metabolic syndrome
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Ezetimibe
Dyslipidemia
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Rosuvastatin Calcium
Introduction: Statins are powerful lipid-lowering agents which reduce cardiovascular (CV)–related morbidity and mortality. However, a large proportion of patients cannot attain the target low-density lipoprotein cholesterol (LDL-C) levels, despite receiving maximally tolerated doses of high-intensity statins. Also, adherence to treatment may be reduced due to statin-induced myopathy or other side effects. For these reasons, guidelines recommend adding the cholesterol absorption inhibitor ezetimibe.Areas covered: Authors discuss the main pharmacological characteristics of rosuvastatin and ezetimibe, their lipid-lowering and pleiotropic effects, as well as the clinical effects of the fixed dose combination of these drugs when used to treat dyslipidemia.Expert opinion: The rosuvastatin/ezetimibe combination is safe and effective in patients with hypercholesterolemia or dyslipidemia with or without diabetes and with or without cardiovascular disease. This drug combination enabled higher proportions of patients to achieve recommended LDL-C goals than rosuvastatin monotherapy or the simvastatin/ezetimibe combination, without additional adverse events. Despite the lack of additional CV outcomes data and comparisons with atorvastatin/ezetimibe, rosuvastatin/ezetimibe appears as a potent and generally well-tolerated drug combination eligible for the management of hypercholesterolemia and dyslipidemia in adults. Recently, the 40 mg rosuvastatin/10 mg ezetimibe fixed combination was approved and is also evaluated.
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Objective To evaluate the efficacy and safety of domestic-made rosuvastatin in low body weight female patients with dyslipidemia.Methods 40 low body weight female patients with dyslipidemia toke rosuvastatin 5mg orally once daily for 3 months.The efficacy and safety of this treatment were evaluated after 3 months of treatment by evaluating the changes and compliance rate of TC,LDL-C.Results Comparing with the baseline,the TC and LDL-C decreased after 3 months treatment,which received a significant difference.The compliance rate of TC,LDL-C were 44.6 % and 56.3 % respectively.There were no significant differences when comparing the concentration of TG and HDL-C before and after rosuvastatin treatment.No serious adverse events related to the medication were observed.Conclusion Rosuvastatin may improve the lipid profile of dyslipidemia female patients with low body.
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A novel UV spectrophotometric method has been developed for the simultaneous estimation of ezetimibe and rosuvastatin in combined dosage form. Method is based on simultaneous equations method. The wavelengths selected for analysis were λmax of ezetimibe: 231.2 nm and λmax of rosuvastatin: 242 nm. Beer’s law was obeyed in the concentration range 2-40 µg mL-1 for ezetimibe and rosuvastatin, with correlation coefficient (r2) greater than 0.990. Validation of the developed method was as per ICH guidelines. The % assays of ezetimibe and rosuvastatin in tablet formulation complied with acceptance criteria. The developed method thus serves as a powerful quality control tool for simultaneous analysis of the drugs in bulk and in formulation by UV spectroscopy.
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The percentage of change from baseline in low−density lipoprotein cholesterol（LDL−C）after the addition of ezetimibe 10 mg to rosuvastatin 2.5 mg was compared with uptitration torosuvastatin 5 mg. The subjects enrolled in the study were thirty−four out−patients（fourteenmales and twenty females, mean age：64.3 years）with hyperlipidemia who had never beentreated, but after being given rosuvastatin 2.5 mg for six months as initial therapy, had failedto reach the goals of LDL−C levels set by the Japan Atherosclerosis Society Guidelines forPrevention of Atherosclerotic Cardiovascular Diseases 2007 edition（LDL−C levels droppedfrom196.6±27.2 to 129.5±28.0 mg／dL（−34％））. The subjects were randomly assigned intoone of the two groups：rosuvastatin 2.5 mg plus ezetimibe 10 mg or uptitration to rosuvastatin5 mg. After 6 months of treatment, rosuvastatin 2.5 mg plus ezetimibe 10 mg significantlyreduced LDL−C by −31.2％ compared with rosuvastatin 5 mg by −17.5％（p＜0.01）. Also,LDL−C reductions from the baselines showed a significant difference（54.7％ versus 46.7％, p＜0.05）. No specific adverse events were found in either group. In conclusion, these resultsshowed that adding ezetimibe to rosuvastatin 2.5 mg was significantly more effective thanuptitrating to rosuvastatin 2.5 mg at lowering LDL−C.（Jpn Pharmacol Ther 2010；38：305−11）KEY WORDS Rosuvastatin, Increase of statin, Ezetimibe, Combination of ezetimibe
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Ezetimibe
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Ezetimibe
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Derivative spectroscopy offers a useful approach for the analysis of drugs in multi-component mixtures. In this study, a first-derivative spectroscopic method was used for simultaneous determination of ezetimibe and rosuvastatin using the zero-crossing technique. The measurements were carried out at wavelengths of 290 and 245.6 nm for ezetimibe and rosuvastatin, respectively. The method was found to be linear (r2 > 0.9994) in the range of 5- 40 µg/mL for ezetimibe at 290 nm. The linear correlation was obtained (r2 > 0.9935) in the range of 5- 80 µg/mL for rosuvastatin at 245.6 nm. The limit of determination was 0.43 and 0.69 µg/mL for ezetimibe and rosuvastatin, respectively. The limit of quantification was 1.44 and 2.89 µg/mL for ezetimibe and rosuvastatin, respectively. The method was successfully applied for simultaneous determination of ezetimibe and rosuvastatin in drug mixture.
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Introduction: Reducing low-density lipoprotein cholesterol (LDL-C) with lipid-lowering therapies has been associated with a decrease in the frequency of cardiovascular events.Areas covered: A systematic search was conducted on PubMed (MEDLINE), using the MeSH terms [Rosuvastatin] + [Ezetimibe] + [Dyslipidemia] + [treatment]. Original data from clinical trials, prospective and retrospective studies and more useful reviews were selected.Expert opinion: While statins continue to be the cornerstone of dyslipidemia management, many patients do not attain LDL-C targets with high-intensity statins alone. Rosuvastatin is a high-intensity statin with a low risk of adverse effects and drug-drug interactions and proven benefits in the prevention of cardiovascular disease. Rosuvastatin and ezetimibe have complementary mechanisms of action that enhance their ability to reduce LDL-C levels. Various studies have shown that the combination of rosuvastatin 10-40 mg and ezetimibe 10 mg enables considerable reductions in LDL-C (up to 60-75%) with a good safety profile in a broad spectrum of patients with hypercholesterolemia, including those at high risk and those with atherosclerotic cardiovascular disease. In addition, a fixed-dose combination of rosuvastatin and ezetimibe may improve adherence to medication. In this review, the available evidence on the combination of rosuvastatin and ezetimibe is updated.
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