MANILA, Philippines - A new investigational study of Ezetimibe/Simvastatin, the cholesterol-lowering medicine from MSD (known as Merck in US and Canada) showed that at dosage of 10/20 mg, it reduced the incidence of first major vascular events defined as non-fatal heart attacks or cardiac death, stroke or any revascularization procedure by a highly statistically significant 16.1 percent compared to placebo (p=0.0010).
The SHARP (Study of Heart and Renal Protection) study involved more than 9,000 patients who, on average, had advanced or end-stage chronic kidney disease (CKD), and is the first prospective clinical study of patients with CKD to demonstrate the benefit of lowering LDL (bad) cholesterol on major vascular events. The results were presented at Renal Week, the American Society of Nephrology’s annual meeting, by Professor Colin Baigent and Dr. Martin Landray, the principal investigators of SHARP, from the Oxford University Clinical Trial Service Unit (CTSU), Oxford, England.
“This is an important study,” said Dr. Peter S. Kim, PhD, president, Merck Research Laboratories. “Patients with CKD have a high risk of ischemic vascular disease and increased rates of heart attack, stroke, other cardiovascular events, and revascularization procedures. In SHARP, the investigational use of Ezetimibe/Simvastatin significantly reduced the risk of these events in a spectrum of patients with chronic kidney disease — and this was the first demonstration that an LDL cholesterol- lowering medicine could do so.”
MSD plans to seek regulatory approvals for the use of Ezetimibe/Simvastatin in patients with CKD based on the results from the SHARP study. It is currently indicated as adjunctive therapy to diet for the reduction of LDL cholesterol in patients with primary hypercholesterolemia or mixed hyperlipidemia.