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Title: Dual Cholesterol Agents Vytorin (Ezetimibe/Simvastatin) Effective, Well-Tolerated in Older Patients: Presented at ACC

"Dual Cholesterol Agents Vytorin (Ezetimibe/Simvastatin) Effective, Well-Tolerated in Older Patients: Presented at ACC"

By Ed Susman ORLANDO, FL -- March 10, 2005 -- Patients who are older than 65 years appear to tolerate the combination cholesterol-lowering drug Vytorin (ezetimibe/simvastatin) as well as they do simvastatin alone -- and they are also able to effectively reduce their cholesterol levels. In fact, a study's findings show that the combination drug's cholesterol lowering activity was actually greater in patients over age 65 than in patients younger than 65 years. Theodore Feldman, MD, clinical assistant professor of medicine, University of Miami, Florida, United States, and colleagues scrutinized data from a randomized, double-blind, placebo-controlled study that enrolled 1,183 patients under the age of 65 years and 345 patients 65 years of age or older. Patients had high levels of LDL-cholesterol and high triglyceride levels and were assigned to various doses of Vytorin or various does of simvastatin monotherapy. The researchers pooled the patients in each group and then analyzed the results with an eye to efficacy and tolerability in younger and older individuals. They found that in the older group, 87% of patients on the combination were able to achieve a low-density lipoprotein (LDL) cholesterol level of less than 100 mg/dL compared to 56% of patients receiving simvastatin monotherapy. In the younger group, 76% of patients on the combination reached this LDL target level compared to 43% of patients on simvastatin monotherapy. "The incidence of cardiovascular disease increases with advancing age," Dr. Feldman said in a poster presentation here March 7[^th at the American College of Cardiology 54^th Scientific Sessions 2005. "Statins prevent both primary and secondary coronary events in men and women aged 70 years and older. Since older adults may be at increased risk of adverse experiences with higher doses of statins, alternative lipid-modifying therapies may be beneficial in this population."

When the researchers examined safety outcomes, they found no difference between older and younger patients who had any clinical adverse event, no difference in drug-related adverse events, no age-related difference in serious clinical event, and no significant difference in treatment-related serious event.

"Ezetimibe/simvastatin was well tolerated, having a similar overall safety profile to that of simvastatin monotherapy," he said.

"Ezetimibe/simvastatin inhibits both cholesterol absorption and biosynthesis and may help to optimize treatment of older individuals with hypercholesterolemia," he said.

"Ezetimibe/simvastatin offers a highly efficacious and well-tolerated lipid-altering option for the treatment of primary hypercholesterolemia in elderly patients," he concluded.

[Presentation title: Lipid Research and Possible Impact on Existing Guidelines. (Poster 1070-127]

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