
Adding a drug that lowers blood fats known as triglycerides to cholesterol-fighting statins provided no additional protection from heart attack, stroke and death from heart disease in patients with Type 2 diabetes, according to data from a large study.
The study run by the National Institutes of Health, dubbed Accord, aimed to see if the dual-drug therapy could reduce heart disease and stroke-related events in diabetes patients at particularly high risk of serious heart problems due to additional risk factors, such as obesity and high blood pressure.
All subjects in the 5,518-patient trial took Zocor, which is available generically as simvastatin.
One group also received TriCor, which is designed to lower the blood fats known as triglycerides and raise "good" HDL cholesterol. TriCor belongs to a class of drugs called fibrates.
There was an 8 per cent risk reduction from the combination therapy compared with the statin plus dummy pill, but researchers said the result could have been a statistical fluke.
"Although our analysis suggests that certain patients may benefit from combination therapy, this study provides important information that should spare many people with diabetes unneeded therapy with fibrates," said Dr. Henry Ginsberg, the study's lead investigator, who presented the data at the American College of Cardiology scientific meeting in Atlanta.
Based on the results, Dr. Steven Nissen, a prominent cardiologist with the Cleveland Clinic, predicted that "the use of fenofibrates will decline precipitously. It's another troubling example of a drug that was approved that didn't work."
The US Food and Drug Administration on Sunday said the data will undergo close scrutiny.
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