LOS ANGELES (Reuters) - Kidney disease patients treated with Merck & Co Inc’s cholesterol-lowering drug Vytorin were about 16 percent less likely to have a heart attack or other cardiovascular problem than patients given a dummy pill, according to a new study.
Merck said the trial of nearly 9,500 patients is the first to show that a cholesterol drug can cut the risk of heart attack, cardiac death, stroke and operations to open blocked arteries in patients with kidney disease. Kidney disease raises the risk of developing heart disease or having a stroke.
Vytorin combines Merck’s statin Zocor, or simvastatin, with the newer Zetia, or ezetimibe.
In the group that received Vytorin 15.2 percent of patients had a major vascular event, compared with 17.9 percent of patients taking placebo, Merck said.
“We’ve been studying people with kidney disease for many years,” said the trial’s co-principal investigator Dr. Martin Landray. “This is the first time that we have ever been able to prove that any treatment would lower the risk of heart disease or other cardiovascular event.”
He estimated that use of Vytorin would translate into preventing a quarter of a million heart attacks, stent procedures, and other cardiovascular events each year.
The trial -- dubbed Study of Heart and Renal Protection or “SHARP” -- was funded by Merck and conducted by Oxford University.
Patients in the trial had lost at least half their normal kidney function, with a third of them requiring dialysis treatment. None had had a previous heart attack or needed bypass surgery or stents to unblock their heart arteries.
During the 5-year trial, about a third of patients stopped taking their pills -- the rates were about the same for both the drug and placebo groups, according to the researchers.
They also said treatment with Vytorin produced a large reduction in levels of LDL, or “bad,” cholesterol, which may be particularly good for kidney patients since it avoids the possibility of side effects with high statin doses.
The researchers said the study showed no evidence of increased risk of cancer or muscle and liver problems.
“There was no evidence of any serious adverse effects and, in particular, no support for earlier concerns that ezetimibe might cause cancer,” Landray said.
Merck said it plans to seek regulatory approval of Vytorin for use in patients with chronic kidney disease, which affects about one in 10 people worldwide.
The trial results are being presented in Denver at a meeting of the American Society of Nephrology.
Editing by Carol Bishopric