Merck Cholesterol Drug Is Found to Help Kidney Patients
Generic Cholesterol Drug
A new study concluded Merck & Co.’s cholesterol-lowering drug Vytorin modestly reduced the risk of heart attacks and related disease among people with chronic kidney disease, when compared with a fake drug.
Merck said that based on the results, it will seek regulatory approval for the use of Vytorin in chronic-kidney disease patients. The drug is currently approved to improve cholesterol levels in people with abnormal cholesterol levels.
The study’s finding, however, may not resolve broader questions surrounding Vytorin’s efficacy and safety that have been raised by studies over the past three years. Vytorin is a single-pill combination of the drugs Zetia and simvastatin, which work by different mechanisms to lower bad cholesterol.
Some critics say there is still no solid proof that adding Zetia to simvastatin—either in the form of Vytorin or taken separately—can reduce the risk of heart attacks and stroke beyond what can be achieve by simvastatin alone. The latest study skirted the question because it primarily compared Vytorin with a placebo.
“These results don’t provide any insight into whether [Zetia] is beneficial,” said Steven Nissen, chairman of the cardiovascular department at the Cleveland Clinic.
A large trial is under way to test whether Vytorin is more effective than simvastatin alone in preventing heart attacks and strokes, but it isn’t due to be completed until 2013.
Sales of Vytorin and Zetia have declined over the past three years, though they still generated a combined .1 billion for the first nine months of 2010.
Merck has defended their efficacy and safety. Simvastatin is available as a cheaper generic pill from multiple manufacturers.
The latest study, titled “Sharp,” was designed to test whether Vytorin could help prevent cardiovascular disease in more than 9,000 people with chronic kidney disease. People with chronic kidney disease are at increased risk of cardiovascular disease, but there has been uncertainty about whether reducing cholesterol levels in kidney-disease patients would help.
Prior studies of cholesterol drugs known as statins in people with end-stage renal disease, who were on dialysis, failed to show a significant benefit. The Sharp study, however, started with about two-thirds of patients not on dialysis.
About half the patients were given Vytorin and the other half placebo, and were tracked for an average of more than four years. The study’s primary goal was to compare rates of major vascular events between groups—heart attack, cardiac death, stroke, or revascularization procedures to unclog arteries.
The study found that 701 of those taking Vytorin had a major vascular event, or 15% of users, versus 814, or 18% of placebo users, for a relative risk reduction of 15%, according to the trial’s principal investigator, Colin Baigent of the clinical-trial division of Oxford University in the U.K.
“This is the first clear evidence we can prevent cardiovascular disease in chronic kidney disease patients,” Mr. Baigent said. He presented the results Saturday at the annual meeting of the American Society of Nephrology in Denver.
The study also found no increased risk of cancer associated with Vytorin; a previous study raised this potential link. Rates of muscle weakness were similar between groups.
The handling of the Sharp trial has generated some controversy. Although funded by Merck, it was conducted independently by Oxford. Last year, a committee overseeing the trial recommended the primary measure be changed to exclude noncoronary deaths such as those due to heart failure, and to exclude hemorrhagic stroke. The committee cited evidence that emerged after the trial began suggesting these kinds of events aren’t prevented by lowering bad cholesterol.
Merck, of Whitehouse Station, N.J., objected to the protocol change. “The trial being as far along as it was at that point, we didn’t want to have the primary endpoint changed,” said Yale Mitchel, vice president of clinical research at Merck.
Still, the trial’s independent steering committee decided it was appropriate to use the revised measure as the “chief emphasis,” and Baigent presented results under this methodology as well. The relative risk reduction under the revised measure was 17%, roughly in line with the original endpoint.
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