Coronary artery diseaseImpact of Adding Ezetimibe to Statin to Achieve Low-Density Lipoprotein Cholesterol Goal (from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation [COURAGE] Trial)
Section snippets
Methods
The methods used in COURAGE (ClinicalTrials.gov identifier NCT00007657) have been reported previously.1, 2, 3 The study protocol was approved by the human rights committee at the coordinating center and by local institutional review boards. An independent data and safety monitoring board monitored the trial. Data management and analyses were performed solely by the data coordinating center and overseen by the trial's executive committee, which had full access to the data and analyses and
Results
Figure 1 shows patient flow during the trial. Patients who never took statins or ezetimibe before or during the trial tended to be older, were less likely to smoke, and had lower diastolic blood pressures (Table 1). In addition, those patients who were not prescribed ezetimibe during the trial had lower median LDL cholesterol at baseline.
Table 2 lists baseline and on-trial lipid and lipoprotein values and frequency of lipid medication use during the trial. Values for the 2 treatment groups were
Discussion
After titrating statin therapy to the maximum tolerated dose, the addition of ezetimibe was a highly effective strategy to get patients to LDL cholesterol goal. The addition of ezetimibe increased the percentage of those who achieved the 60 to 85 mg/dl goal from 40% to 72% and increased the percentage of those who achieved the <70 mg/dl goal from 23% to 53%. This observation is in contrast with LDL cholesterol goal attainment in patients with coronary disease in real-world practice, in which
Acknowledgment
We wish to thank Joanne E Tomassini, PhD, of Merck Sharp & Dohme Corporation for editorial assistance and creating figures for this report.
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Efficacy and Tolerability of a Fixed-Dose Combination of Rosuvastatin and Ezetimibe Compared with a Fixed-Dose Combination of Simvastatin and Ezetimibe in Brazilian Patients with Primary Hypercholesterolemia or Mixed Dyslipidemia: A Multicenter, Randomized Trial
2020, Current Therapeutic Research - Clinical and ExperimentalCitation Excerpt :The rosuvastatin + ezetimibe combination in the doses that were used in this study also allowed more patients to reach LDL-C level targets. Several studies have demonstrated that the addition of ezetimibe to treatment with statins provides important synergistic decrease in LDLC concentrations.22–32 In a previous study that included participants with coronary heart disease or type 2 diabetes, the addition of ezetimibe 10 mg to run-in therapy with simvastatin 20 mg proved to be a more effective strategy than doubling the simvastatin dose to 40 mg/d, resulting in more intense reduction of LDL-C, total cholesterol, and total cholesterol to HDL-C ratio, as well as significantly increasing the likelihood of achieving LDL-C levels <100 mg/dL, regardless of the level of LDL-C at the beginning of treatment.33
Combination therapy in dyslipidemia: Where are we now?
2014, AtherosclerosisCitation Excerpt :An alternate approach would involve addition of a concomitant lipid-lowering therapy with a complementary mechanism of action to statins. Consequently, several studies have shown this approach (e.g. statin with a fibrate, niacin, or ezetimibe) provided improvements in surrogate markers for CVD, including changes in lipid profile [20–24], reduction of high-sensitivity C-reactive protein (hs-CRP) level [22], and slowing of carotid intima-media thickening (CIMT) [25–28]. However, the evidence for statin combination therapy in improving cardiovascular outcomes in dyslipidemic patients remains inconclusive.
Treatment of dyslipidemia: The problem of reaching the goal
2014, AtherosclerosisPrevalence of dyslipidaemia in patients treated with lipid-lowering agents in China: Results of the DYSlipidemia International Study (DYSIS)
2014, AtherosclerosisCitation Excerpt :They estimated that 25% of patients would require more than two lipid-lowering drugs at maximal doses to attain this goal. Furthermore, It has previously been noted that an algorithm-based statin uptitration/ezetimibe combination regimen was useful to increase LDL-C lowering where statin monotherapy had not achieved target lipid values [24,25]. In the present study, the median daily doses of atorvastatin 10–20 mg or simvastatin 20–40 mg, which were lower than those used in western clinical outcome studies, reflects the usual prescribing practice in China.
This work was supported by the Cooperative Studies Program of the US Department of Veterans Affairs Office of Research and Development (Veterans Affairs Cooperative Studies Program No. 424), Washington, District of Columbia, in collaboration with the Canadian Institutes of Health Research, Ottawa, Ontario, Canada, and by unrestricted research grants from Merck Sharp & Dohme Corporation, Whitehouse Station, New Jersey; Pfizer, Inc., New York, New York; Bristol-Myers Squibb, New York, New York; Fujisawa, Tokyo, Japan; Kos Pharmaceuticals, Cranbury, New Jersey; Datascope, Fairfield, New Jersey; AstraZeneca, Wilmington, Delaware; Key Pharmaceutical, Summit, New Jersey; Sanofi-Aventis, Paris, France; First Horizon, Alpharetta, Georgia; and GE Healthcare, Milwaukee, Wisconsin. All industrial funding in support of the trial was directed through the Department of Veterans Affairs.
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