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| |  Cardiovascular Outcomes Appear Similar for Ezetimibe/Simvastatin and Monotherapy Simvastatin or Atorvastatin: Presented at AHA By Bruce Sylvester ORLANDO, Fla -- November 22, 2009 -- A retrospective study of data on high-risk patients suggests that cardiovascular outcomes for those treated with a combination of ezetimibe/simvastatin are similar to those treated with simvastatin or atorvastatin monotherapy. The findings were reported here on November 18 at the American Heart Association (AHA) Scientific Sessions 2009. “In this cohort of patients at high risk for future adverse cardiovascular outcomes, treatment with combination ezetimibe and simvastatin appears to demonstrate no significant difference in clinical results when compared with treatment with equipotent doses of simvastatin or atorvastatin alone,” said presenter Karen Stockl, PharmD, Prescriptions Solutions, Irvine, California. The investigators acquired their data from administrative claims from a health insurance plan that included commercial and Medicare clients. They analysed cohort data retrospectively comparing relative rates of clinical events (hospitalisation for myocardial infarction [MI] or stroke) among patients aged 18 to 84 years with history of MI, stroke, or diabetes who had been treated with ezetimibe/simvastatin versus simvastatin or atorvastatin. Patients were selected during a data “identification period” of August 2004 through March 2006. They were selected based on a new prescription fill for atorvastatin, simvastatin, or ezetimibe/simvastatin during the identification period. Exclusion criteria included prior prescription fill of a statin, ezetimibe/simvastatin, or simvastatin during the pre-period (prior to the index date) of 180 days, or inpatient hospitalisation for MI or stroke during the pre-period. Simvastatin and atorvastatin-treated patients were each matched 1:1 with ezetimibe/simvastatin patients based on simvastatin daily dose equivalent and a propensity score derived from using demographic and cardiovascular risk variables. The investigators used standard statistical tools to adjust for demographics, medical history, and coronary heart disease medication use. The primary outcome was inpatient hospitalisation for MI or stroke. There were 9,983 patients in each cohort. The number of MIs or stroke per 100 person-years was 0.89 for ezetimibe/simvastatin, 0.93 for atorvastatin, and 1.05 for simvastatin, and risk of hospitalisation for MI or stroke was not significantly different for ezetimibe/simvastatin versus atorvastatin, for ezetimibe/simvastatin versus simvastatin alone, or for simvastatin versus atorvastatin. Limitations of the study included the inability to control for cholesterol levels, family medical history, race, obesity, smoking status, and use of aspirin. While noting that the study is highly suggestive, Dr. Stockl concluded that “longer term follow-up studies are needed to determine whether the apparent lack of difference in cardiovascular outcomes between these medicines persists over time.” Funding for this study was supported by Prescription Solutions, Inc. [Presentation title: Cardiovascular Outcomes for Patients Treated With Ezetimibe/Simvastatin Combination Compared With Simvastatin or Atorvastatin Alone. Abstract 5769]
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