Adding the drug Ezetimibe to treatment with Simvastatin lowers the risk of future cardiovascular problems, including myocardial infarction and stroke, in high-risk patients with acute coronary syndrome.
The finding suggests that high-risk patients taking Simvastatin can benefit from additional lowering LDL cholesterol.
Compared to patients with coronary heart disease given the drug Simvastatin plus a placebo, those given both Simvastatin and the non-statin drug, Ezetimibe, had a 6.4% lower risk of all cardiovascular events, a 14% lower risk of all heart attacks, a 14% lower risk of stroke, and a 21% lower risk of ischemic stroke.
Deaths from cardiovascular disease were statistically the same in both groups.
Patients were followed an average of approximately six years, and some as long as 8.5 years. Approximately 2 patients out of every 100 patients treated for 7 years avoided a myocardial infarction or stroke. ( Number Needed to Treat; NNT= 50 ).
Acute coronary syndrome, such as myocardial infarction or unstable angina, is an umbrella term for situations where the blood supplied to the heart muscle is suddenly blocked.
The study, called IMPROVE-IT ( IMProved Reduction of Outcomes: Vytorin Efficacy International Trial ), was done at 1,158 Centers in 39 countries. It enrolled 18,144 patients with acute coronary syndrome, 50 years or older, with low-density lipoprotein ( LDL ) cholesterol levels at or less than 125, or at or less than 100 if they were already using a statin.
The patients, enrolled within 10 days of hospitalization for myocardial infarction or unstable angina, were high risk.
About 5,000 of them had suffered a full-thickness heart attack known as an ST-segment elevation myocardial infarction, or STEMI. The remaining 13,000 had suffered a non-STEMI heart attack or had unstable angina, defined by new or worsening chest pain.
Patients also had at least one feature putting them at high risk for a further cardiovascular event, including a previous myocardial infarction, diabetes mellitus, peripheral artery or cerebrovascular disease, coronary disease in multiple arteries, or bypass surgery in the past.
Statins, such as Simvastatin, block cholesterol production in the liver, while Ezetimibe, a cholesterol absorption inhibitor, reduces the body’s absorption of cholesterol in the intestine.
In the study, the dual therapy reduced patients’ LDL to an average of 54 mg/dL, compared with 69 for those treated with the statin and placebo.
The addition of Ezetimibe did not raise patients’ risk of ill effects, such as liver or muscle problems, or cancer.
Over a decade ago, researchers from the TIMI Study Group, based at Brigham and Women’s Hospital ( BWH ) demonstrated that a high dose statin, which lowered cholesterol further than a regular dose statin, provided better clinical outcomes. But questions remained about whether further reducing cholesterol would be even more effective in reducing cardiovascular-related events. And now, researchers have an answer from the results of the The IMProved Reduction of Outcomes: Vytorin Efficacy International Trial ( IMPROVE-IT ) study. ( Xagena )
Source: American Heart Association Meeting, 2014