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 ( Zetia ), 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% when compared to patients who did not receive Ezetimibe.
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%.
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% compared to placebo, with no increase in adverse safety events.
In this new analysis, researchers used data from the 27% of patients in the IMPROVE-IT trial who had diabetes at the start of the study and found that Ezetimibe added to Simvastatin [ Vytorin ] reduced LDL-cholesterol by 43 mg/dL after one year compared to 23 mg/dL with Simvastatin ( Zocor ) alone.
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 stroke ( by 39% ), myocardial infarction ( by 24% ), and the composite of death due to cardiovascular causes, including myocardial infarction or stroke ( by 20% ), when compared to patients with diabetes who received statin therapy alone.
Additionally, researchers reported 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. ( Xagena )
Source: Brigham and Women's Hospital, 2015