By Bill Berkrot and Debra Sherman
ATLANTA (Reuters) – 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 percent 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 U.S. Food and Drug Administration on Sunday said the data will undergo close scrutiny.
“The FDA will conduct a thorough review of the primary Accord data as soon as they become available,” said agency spokeswoman Karen Riley.
“The results of Accord were widely expected and not surprising given that two-thirds of patients in the trial would not be treated with fibrates under current guidelines,” Eugene Sun, Abbott’s vice president for global pharmaceutical development, said in a statement.
“The results support how fibrates are used in treatment today.”
LOWERING BLOOD PRESSURE NO HELP, EITHER
A second prong of the NIH Accord program tested 4,733 patients with Type 2 diabetes and elevated blood pressure.
It found that more intensive blood pressure lowering failed to cut the risk of heart attacks, strokes and cardiovascular death significantly more than the current standard of care.
There were 208 heart disease or stroke-related events in patients whose systolic blood pressure was reduced to below 120, compared with 237 among patients whose target goal was less than 140 – results researchers deemed a potential statistical fluke.
Current guidelines recommend that adults with Type 2 diabetes maintain systolic blood pressure – the top number of a blood pressure reading – at less than 130.
The risk of stroke alone was significantly cut by about 40 percent in the intensive treatment group, although the total numbers were low – 36 versus 62 in the standard care group.
Researchers also noted higher incidence of complications in the intensive group, including abnormally high levels of blood potassium, and some measures of kidney function were worse.
“Both of these studies provide evidence that going beyond the standard of care provides no substantive additional benefit in this population of adults with diabetes at especially high risk of cardiovascular events,” said Denise Simons-Morton, the NIH’s Accord project officer.