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Tuesday, December 7, 2010

VYTORIN MAY LOWER RISK OF HEART COMPLICATIONS IN PATIENTS WITH CKD

The New York Times (11/21, A25, Singer) reported, "Patients with chronic kidney disease (CKD) who took Vytorin [ezetimibe and simvastatin], a cholesterol-lowering pill, had one-sixth fewer heart attacks, strokes or operations to unblock their arteries than patients taking a placebo, according to" research presented during the American Society of Nephrology's 43rd Annual Meeting and Scientific Exposition. "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," the Times added. The study's authors pointed out that "the difference in operations to unblock arteries -- 284 in the treated group compared with 352 in the placebo group -- was statistically significant."

"The trial was the largest ever on Vytorin," Bloomberg News (11/20, Cortez) reported. "Patients on the drug were 16 percent less likely to suffer a heart attack or stroke, need a procedure to clear arteries or die from heart disease than those given a placebo over five years." Based on these findings, Merck "said it will seek US approval to use the drug in" CKD patients.

The AP (11/21) reported, "The Oxford University study looked at more than 9,000 patients who had advanced or end-stage" CKD. According to Merck, "the result is significant because kidney patients have a high risk of vascular disease."

However, the "lipid-lowering therapy did not significantly affect progression of kidney disease, investigators reported," according to MedPage Today (11/20, Bankhead). "Renal outcomes in the trial included progression to end-stage renal disease (ESRD), ESRD or death, and ESRD or a twofold increase in serum creatinine level. The simvastatin/ezetimibe and placebo groups did not differ significantly in the rates of any renal endpoints," MedPage Today noted. The Wall Street Journal (11/22, Loftus, subscription required) and HeartWire (11/20, Wood) also covered the story.

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