Health - Prescriptions: Lowering Bad Cholesterol Reduced Heart Problems in Kidney Patients, Study Shows

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Prescriptions: Lowering Bad Cholesterol Reduced Heart Problems in Kidney Patients, Study Shows Posted: 20 Nov 2010 11:27 AM PST

Study Suggests a Cholesterol Pill Benefits Patients With Kidney Disease Posted: 20 Nov 2010 12:13 PM PST Patients with chronic kidney disease who took Vytorin, a cholesterol-lowering pill, had one-sixth fewer heart attacks, strokes or operations to unblock their arteries than patients taking a placebo, according to the results of a study presented on Saturday. The main benefit was not in reducing the risk of heart attacks and related deaths but in reducing the artery operations and certain kinds of strokes, according to the data presented at a meeting of kidney specialists this weekend in Denver. The difference in operations to unblock arteries — 284 in the treated group compared with 352 in the placebo group — was statistically significant, said Dr. Colin Baigent, a professor at Oxford University and one of two principal investigators on the study. But the disparity between the groups was not statistically significant for major coronary events, he said. There were 213 such events, including heart attacks and deaths, in the group that took the cholesterol pill compared with 230 in the placebo group. The study, even though it was large, had not included enough people to demonstrate a significant difference in heart attacks and related deaths, he said. The cholesterol treatment also had no significant impact in slowing the progression of disease, specifically in reducing the need for patients to start dialysis or receive a kidney transplant, he said. The five-year study, called the Sharp trial, involved more than 9,000 patients who were randomly assigned to take either a placebo or Vytorin, a medicine from Merck. Vytorin combines in one pill two different kinds of treatments — a statin called simvastatin and a newer drug called ezetimibe, also known as Zetia — that lower LDL or “bad” cholesterol. The study, coordinated by researchers at Oxford University and funded primarily by Merck, examined whether patients with chronic kidney disease, who are at high risk for heart problems, could safely benefit from significantly reducing their bad cholesterol. After the Oxford researchers sent out an upbeat press release saying that the combination pill could help people with chronic kidney disease avoid 25 percent of all heart attacks, strokes and surgeries to open blocked arteries, Merck issued its own press release with a positive, but more sober, assessment. In an interview Saturday, Dr. Baigent said his figure was an extrapolation that reflected the number of problems that might be reduced if people took the drug as prescribed — not the way they had in the study, in which one-third of both treated and placebo patients stopped taking their pills. “This is an important step forward for kidney disease,” Dr. Baigent said. “We’ve estimated that widespread use of lipid-lowering treatment would result in the prevention of heart attacks, strokes and operations to unblock arteries in 250,000 people” with chronic kidney disease each year. But Merck said that Vytorin had reduced the risk of a non-fatal heart attack, stroke, cardiac death or artery operations by about 16 percent compared with a placebo, an analysis based on the originally designated goal of the study that had included a wider variety of health problems. Based on these results, Merck said in a statement Saturday that it planned to ask regulators to approve Vytorin for patients with chronic kidney disease.

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