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| |  DALM: Study Projects Benefit of Ezetimibe in Coronary Heart Disease Patients Not at Low-Density Lipoprotein Goal By Chris Berrie VENICE, ITALY -- October 28, 2004 -- Co-administration of the selective cholesterol absorption inhibitor ezetimibe with statin therapy for patients with coronary heart disease (CHD) who are not achieving low-density lipoprotein cholesterol (LDL-C) target levels is more effective than either conventional statin therapy or aggressive statin titration, according to results of an analysis from a multicentre, retrospective study. As there will be no outcomes data of the combination of ezetimibe with statins until current studies become available after 2007, the only way to project long-term benefits of such combinations is through modeling of patients who are currently on lipid-lowering therapy, said researchers here on October 26th at the XV International Symposium on Drugs Affecting Lipid Metabolism. "This is what led to this project, and the study that we have evaluated is what would happen to patients currently on lipid-lowering therapy in Germany who have not reached their recommended target [level] if they continued their current therapy or if they were titrated up on their statin until they reach goal [levels] or the maximum dose of the statin," said presenter Evo Alemao, RPh, MS, analytical investigator and manager, Outcomes Research, Worldwide Human Health Marketing, Merck & Co. Inc., Whitehouse Station, New Jersey, United States. Despite the still expanding use of lipid-lowering therapy in the fight against CHD, many patients in Germany remain above the LDL-C goal of < 100 mg/dL, he said. Indeed, present data indicate a 76% likelihood (95% CI, 73%-79%) that any single CHD patient on statins will remain above the LDL-C goal. This has resulted in their mean on-treatment LDL-C levels of 130.1 mg/dL (95% CI, 127.3-132.9). The addition of ezetimibe to statin therapy in patients who have failed to reach goal LDL-C levels has been proven to be an alternative to statin titration. Thus, the present study included a model for the potential long-term impact of further reduction of lipid levels by co-administration of ezetimibe 10 mg. The annual risk of fatal and nonfatal CHD events based on the Framingham Risk Equations was combined with the annual risk of death from nonCHD causes based on German mortality data. The Markov model was used to project the long-term impact of lipid change by lipid-lowering therapy on the annual risk of fatal and nonfatal CHD events. This model was applied to 339 CHD patients with a mean age of 63.7 years who failed to reach their LDL-C goals on statin therapy (42.2% on atorvastatin, 31.6% on simvastatin, 10.0% on pravastatin, 8.6% on fluvastatin, 7.7% on lovastatin). The mean lipid parameters of these patients were 150.3 mg/dL LDL-C, 232.4 mg/dL total cholesterol, and 48.3 mg/dL high-density lipoprotein. To determine the projected benefits of alternative lipid-lowering therapy strategies, the researchers evaluated 3 observation levels. The first was based on the evidence that 11% of current statin users in Germany who have not reached LDL-C goal will be titrated to the next statin dose (ST-11). Although this is representative of current practice, the potential benefits were also determined for an assumed 100% statin dose titration for these patients (ST-100). Finally, these were both compared with the projected potential benefits from the model for the co-administration of ezetimibe 10 mg with the existing statin treatment of patients who have not reached LDL-C goal (EzCoA). The results of this analysis indicate large increases in projected benefits in terms of both percent LDL-C reduction (ST-11, 1.1%; ST-100, 18.0%; EzCoA, 26.7%) and percent CHD of patients on statins that would be expected to reach LDL-C goal (ST-11, 1.8%; ST-100, 35.7%; EzCoA, 44.3%). Dr. Alemao noted that in terms of the incremental life years gained, that of 0.03 for the ST-11 projections should rise to 0.77 for EzCoA. While this data is a projection of potential benefits that could arise from these alternatives based on present and previous experience, Dr. Alemao added that this model has been validated recently through its application to the 4400 patients of the 4S study, the full details of which are due to be published in the October 2004 edition of Pharmacoeconomics.
[Presentation title: "Projected Benefit of Ezetimibe in CDH Patients Not at LDL-C Goal With Current Statin Therapy in Germany." Poster 188]
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