Findings of a new study offer evidence that Merck's Vytorin cholesterol drug, a combination of the Zetia (ezetimibe) drug and the statin Simvastatin can reduce levels of LDL, also known as bad cholesterol, thereby helping prevent strokes, heart attacks and other cardiovascular events in individuals with acute coronary syndrome.
Although previous research has questioned the effectiveness of Vytorin, the new study called IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial), which was presented at the annual conference of the American Heart Association in Chicago on Monday, Nov. 17 shows that the drug works modestly.
For the study, the researchers involved over 18,000 individuals who had a heart attack or suffered from chest pain for six years on average. The participants were randomly given either Vytorin or the statin Simvastatin alone.
Of the patients who took only Simvastatin, 34.7 percent suffered from heart attacks and strokes during the course of the clinical trial, which is 2 percent higher compared with the 32.7 percent incidence in those who received Vytorin, a difference considered as statistically significant.
"The study is the first to show that adding a non-statin drug to a statin to improve cholesterol levels can help patients with specific heart problems do better," said Christopher Cannon, from the Harvard Medical School and Brigham and Women's Hospital, who led the study.
Statins work by blocking the production of cholesterol in the liver while ezetimibe works by reducing the absorption of cholesterol in the intestine. In the study, the patients who received Vytorin reduced their average LDL cholesterol to 54 mg/dL, which is lower compared with the 69 mg/dL in patients who received only statin.
The patients who received Vytorin were found to have 6.4 percent reduced risks of all cardiovascular events, 21 percent lower odds of ischemic stroke, 14 percent reduced risks of heart attacks and 14 percent less likely to have stroke compared with their counterparts who only received statin.
"This is a reminder to everybody that all the stuff they've heard about cholesterol is true," Cannon said. "Lowering the cholesterol to even lower levels than we had in the past looks to be beneficial."
Given the number of participants involved in IMPROVE-IT, the trial is expensive and while it could be difficult to calculate the exact cost of the trial, a spokesperson for Merck said it was in the range of hundreds of millions of dollars.
There's no wonder why the drug does not come cheap either. A 30-day supply could fetch more than $200.
