Vytorin cuts heart problems in kidney patients
pharmafile | November 23, 2010 | News story | Sales and Marketing | Merck, Vytorin, cardiovascular, simvastatin
Vytorin has been shown to reduce potentially heart problems in patients with chronic kidney disease (CKD) in a new study.
Merck‘s Vytorin (ezetimibe/simvastatin) 10/20 mg reduced the incidence of major vascular events by 16.1% compared to placebo, which suggests the drug could help prevent many heart attacks and strokes.
The combination treatment is currently licensed for the reduction of LDL cholesterol, but Merck now plans to seek approval for its use in CKD.
The rate of major vascular events in patients taking Vytorin was 15.1% compared to 17.6% of patients taking placebo.
The 9,000-patient SHARP trial is the first prospective clinical study in patients with CKD to show the benefit of lowering LDL (bad) cholesterol on major vascular events.
Patients on the trial had never suffered a heart attack, but who were at risk of suffering one in the future.
One third of patients were undergoing dialysis for end-stage kidney disease, and the rest were pre-dialysis patients with advanced CKD.
This is an important study,” said Dr. Peter S. Kim, 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.”
Better than simvastatin
The trial also suggests that Vytorin is far more effective in these patients than treatment with simvastatin alone, the standard cholesterol-lowering treatment.
Even including patients who took simvastatin alone for the first year and were then re-randomized to either Vytorin or placebo, Vytorin reduced first events by 15.3% versus placebo.
The results are welcome news for Merck, which has suffered from poor results in earlier trials. The ENHANCE study results published in 2008 suggested Vytorin was no better than Zocor at reducing the build up of plaque in neck arteries. These results added to doubts about the drug which has seen its sales decline in the last few years.
In the first year of the SHARP trial, Vytorin 10/20mg lowered LDL cholesterol by 40% percent compared to placebo, while simvastatin 20 mg lowered it by 28% versus placebo.
This meant the reduction achieved by Vytorin was 30% greater than by simvastatin alone.
The data is strengthened by the length of the study, which lasted for five years. After two and half years of treatment, Vytorin lowered LDL cholesterol by 32 mg/dL, or 30% from baseline, compared to placebo.
The average LDL cholesterol of all patients enrolled in SHARP was 108 mg/dL and patients were followed for a median of 4.9 years.
Around a third of patients who enrolled at the beginning dropped out of the study, but this drop out rate was seen equally in the drug and placebo arms of the trial.
Adam Hill
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