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Diabetic Drugs’ High Risk of Heart Problems, Study

The National Institutes of Health did a study, aiming to see if the dual drug therapy could reduce the cardiovascular events in patients at particularly high risk of serious heart problems due to additional risk factors, such as obesity and .

All subjects in the 5,518-patient trial took Merck & Co’s -reducing Zocor, which is available generically as simvastatin. One group also received TriCor, an Abbott Laboratories medicine to lower the blood fat triglycerides and raise good HDL that belongs to a class of drugs called fibrates.

Only 8-percent was a risk reduction from the combination therapy compared with the statin plus placebo, but researchers said the result did not approach statistical significance, so the small difference could have been a fluke.

Scientists have said the study was stacked against TriCor, as the median baseline triglyceride level of patients in the trial — about 162 — is well below the level of about 300 at which the drug would typically be prescribed.

Among the patients — some 17 percent of participants — the combination therapy led to about a 30-percent reduction in the risk of the composite goal of , stroke and cardiovascular death.

“This possibly indicates that we need more research on that specific sub group that there was a potential effect in,” said Denise Simons-Morton, project officer for the Accord study, which was overseen by NIH’s National, Heart, Lung and Blood Institute.

Further, researchers found that men may have benefited from the dual therapy, while women appeared to have more heart problems than those on stains alone.

The overall result could color perception of a pill awaiting a US approval decision that combines TriLipix with AstraZeneca’s powerful stain Crestor. A strong finding in favour of combination therapy might have raised the profile of that pill to be marketed under the brand name Certriad.

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