Merck announced that patients in the IMPROVE-IT study taking ezetimibe/simvastatin (Vytorin) experienced significantly fewer cardiovascular events compared to those taking simvastatin alone. This is the first study to show that reducing low-density lipoprotein cholesterol (LDL-C) with a combination of a statin and non-statin to levels lower than those achieved with the statin alone is associated with significant clinical benefit. The research findings were presented at the American Heart Association 2014 Scientific Sessions.
The IMPROVE-IT study sought to evaluate if lowering LDL-C to well under 70mg/dL by adding ezetimibe to a statin further reduced cardiovascular events. A total of 18,144 high-risk patients with acute coronary syndromes were randomized to receive (ezetimibe/simvastatin) 10/40mg or simvastatin 40mg, with a follow-up of nine years and a median clinical follow-up of approximately six years. At one year, patients taking ezetimibe/simvastatin had a mean LCL-C level of 53mg/dL vs. 70mg/dL in the simvastatin group. The ezetimibe/simvastatin arm had a reduced risk of all-cause mortality, major coronary events, and non-fatal stroke, a reduced incidence of the composite endpoint of death due to coronary heart disease (CHD), non-fatal myocardial infarction (MI), and urgent coronary revascularization with either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) occurring at least 30 days after randomization. Ezetimibe/simvastatin also reduced the incidence of the composite endpoint of cardiovascular death, non-fatal MI, documented unstable angina that requires admission into a hospital, all revascularization (including both coronary and non-coronary) occurring at least 30 days after randomization, and non-fatal stroke more than simvastatin alone.
Merck plans to submit this study data to the Food and Drug Administration (FDA) in mid-2015 to support a new indication for reduction of major cardiovascular events for ezetimibe/simvastatin and ezetimibe. Ezetimibe/simvastatin is currently indicated as an adjunct to diet in primary hyperlipidemia (heterozygous familial and non-familial) or mixed hyperlipidemia; to reduce elevated total-C, LDL-C, apo B, TG and non-HDL-C, and to increase HDL-C; as an adjunct to or when other lipid-lowering treatments for homozygous familial hypercholesterolemia (HoFH) are not available; and to reduce elevated total-C and LDL-C. Ezetimibe is currently indicated as an adjunct to diet, alone or in combination with an HMG-CoA reductase inhibitor (statin), in primary hyperlipidemia (heterozygous familial and non-familial) to reduce elevated total-C, LDL-C, Apo B, and non-HDL-C; as an adjunct to diet and in combination with fenofibrate to reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in mixed hyperlipidemia; as an adjunct to other lipid-lowering treatments, or if these treatments are unavailable, with atorvastatin or simvastatin to reduce elevated total-C and LDL-C in homozygous familial hypercholesterolemia; and as an adjunct to diet in homozygous familial sitosterolemia to reduce elevated sitosterol and campesterol.
For more information visit Merck.com.