The long-awaited results of a trial of the cholesterol-lowering drug Vytorin showed modest benefit and indicated that adding a non-statin drug to a statin therapy regimen may help high-risk patients with acute coronary syndrome safely achieve lower cholesterol levels.
The findings were presented Monday during the American Heart Association's Scientific Sessions in Chicago.
Vytorin combines use of the statin simvastatin with a non-statin therapy called ezetimibe, a drug that works by blocking the body's absorption of cholesterol. The combination drug became widely used to reduce LDL, or “bad cholesterol” levels, after Merck received approval for it from the Food and Drug Administration in 2004. But the drug became the subject of controversy among critics who noted a lack of clinical research to demonstrate its clinical benefit.
The new multicenter, double-blind, randomized study compared the safety and efficacy of adding ezetimibe to statin therapy and aimed to see if the combo would result in additional lowering of LDL cholesterol and a reduction in cardiovascular events.
Compared to patients with coronary heart disease who received simvastatin and a placebo, those who were given the combination of simvastin and ezetimibe that make up Vytorin achieved lower cholesterol levels, according to the findings. The group on the standard therapy achieved a median LDL cholesterol level of 69.5 mg/dl, which met the recommended targets. However, those in the ezetimibe arm saw a 15 mg/dl drop, to 53.7 mg/dl. Patients also had a 6.4% lower risk of all cardiovascular events, a 14% lower risk of stroke and of heart attacks, and a 21% lower risk of ischemic stroke.
“The question everyone had was would this added lowering of LDL cholesterol translate to real clinical benefit,” said Dr. Christopher Cannon, a cardiologist with Brigham and Women's Hospital who presented the findings. “The answer is yes.”
Still, deaths from cardiovascular disease were statistically the same in both groups.
Acute coronary syndromes is an umbrella term for situations where the blood supplied to the heart muscle is suddenly blocked, according to the American Heart Association. The recent trial—titled Improved Reduction of Outcomes: Vytorin Efficacy International Trial or IMPROVE-IT—included 18,144 high-risk patients with acute coronary syndrome and ran for more than nine years, including an average of six years of follow-up. These high-risk patients were enrolled in the study within 10 days of hospitalization for a heart attack or unstable angina.
The study affirms the essential role of intensive LDL cholesterol reduction for the prevention of recurrent cardiac events, said Dr. Neil Stone of Northwestern University's Feinberg School of Medicine, who comment on the study results. He also said it expands the options for additional proven lipid lowering therapies.
The findings come a year after the American College of Cardiology and the American Heart Association issued revised guidelines that significantly increased the number of patients recommended to receive statin therapy. According to a study released in March, more than half of adults between ages 40 and 75 who need help managing cholesterol should be taking the drugs under the new guidelines.
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