According to the United States Centers for Disease Control and Prevention, over 800,000 Americans die each year from heart disease and stroke. Acute coronary syndrome, which includes heart attack and unstable angina, a condition that can lead to a heart attack, are among the leading causes of death and disability worldwide. In addition to lifestyle changes, medications that lower blood cholesterol are helpful in preventing future cardiac and vascular events, including heart attack and stroke.
New data from a clinical trial led by cardiologists at Brigham and Women's Hospital (BWH) and the Duke Clinical Research Institute indicates that the non-statin, cholesterol-lowering drug ezetimibe, when added to a statin in patients admitted to the hospital with an acute coronary syndrome, demonstrated particular benefit in patients with diabetes. Patients with diabetes who did not receive ezetimibe in the study had a nearly 1 in 2 chance of having a major cardiac event or stroke over the next 7 years. Treatment with ezetimibe reduced the relative risk of having another major cardiac or vascular event by 14 percent when compared to patients who did not receive ezetimibe.
These findings were presented as a clinical trial update at the European Society of Cardiology Congress on August 30, 2015.
"Our study findings represent particularly good news for patients with diabetes who have coronary artery disease," says Robert Giugliano, MD, a senior investigator with the TIMI (Thrombolysis In Myocardial Infarction) Study Group and cardiologist at BWH. "We believe that patients who suffer a heart attack and cannot get to a very low level of LDL-C with a statin should be considered for ezetimibe, particularly if they have diabetes."
In the IMPROVE-IT trial, the largest (18,144 participants) and longest (6 years) study of ezetimibe to date, researchers demonstrated that when ezetimibe was added to statin (simvastatin) therapy, patients experienced a further lowering of LDL-cholesterol by 23-24 percent. Participants who were recruited to the trial had been hospitalized with acute coronary syndrome within the prior 10 days, were not being treated with ezetimibe or the highest dose of potent statins, and had an LDL-cholesterol between 50 and 125 mg/dL. Previous trial findings demonstrated that ezetimibe significantly reduced the relative risk of a future major cardiac or vascular event by 6.4 percent compared to placebo, with no increase in adverse safety events.
In this new analysis, researchers used data from the 27 percent of patients in the IMPROVE-IT trial who had diabetes at the start of the study and found that ezetimibe added to simvastatin reduced LDL-cholesterol by 43 mg/dL after one year compared to 23 mg/dL with simvastatin alone.
According to Dr. Giugliano, "The greater reduction of LDL-cholesterol seen in patients with diabetes who received ezetimibe along with a statin resulted in lower risks of future ischemic (non-bleeding) stroke (by 39 percent), heart attack (by 24 percent), and the composite of death due to cardiovascular causes, including heart attack or stroke (by 20 percent), when compared to patients with diabetes who received statin therapy alone.
Additionally, researchers report that regardless of the presence or absence of diabetes, the benefits of ezetimibe were observed without an increase in rates of liver test abnormalities, muscle side effects, gall-bladder related events, or cancer.
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This research was supported by Merck & Co, which licenses and develops Zetia (ezetimibe), Zocor (simvastatin), and Vytorin (ezetimibe/simvastatin combination).
Brigham and Women's Hospital (BWH) is a 793-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare. BWH has more than 4.2 million annual patient visits, nearly 46,000 inpatient stays and employs nearly 16,000 people. The Brigham's medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in patient care, quality improvement and patient safety initiatives, and its dedication to research, innovation, community engagement and educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Brigham Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, more than 1,000 physician-investigators and renowned biomedical scientists and faculty supported by nearly $600 million in funding. For the last 25 years, BWH ranked second in research funding from the National Institutes of Health (NIH) among independent hospitals. BWH continually pushes the boundaries of medicine, including building on its legacy in transplantation by performing a partial face transplant in 2009 and the nation's first full face transplant in 2011. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative as well as the TIMI Study Group, one of the premier cardiovascular clinical trials groups. For more information, resources and to follow us on social media, please visit BWH's online newsroom.