Heart risks of glucose-lowering drugs being overlooked in clinical trials

Why is heart failure not more rigorously assessed in clinical trials of antidiabetes drugs? In a Personal View, published in The Lancet Diabetes & Endocrinology journal, Professor John McMurray of The University of Glasgow and colleagues review evidence that hospitalization for heart failure is one of the most common and prognostically important complications of diabetes. Moreover, increasing evidence shows that some glucose-lowering drugs increase the risk of heart failure. Yet, heart failure is rarely considered as a key outcome, or even part of composite cardiovascular outcomes, in clinical trials of glucose-lowering drugs.

Previously, the ability of an antidiabetes to lower glucose was used in clinical trials accepted as a surrogate of its ability to reduce the risk of microvascular disease, and possibly cardiovascular risk. Recent evidence has suggested, however, that some antidiabetes drugs may increase patients' cardiovascular risk, despite their ability to effectively lower blood glucose. These findings have prompted the FDA and EMA to make new regulations requiring trials for new antidiabetes drugs.

Such cardiovascular outcomes trials have typically used so-called major adverse cardiovascular events (MACE) as a primary outcome. This combined outcome usually includes cardiovascular death, heart attack, and stroke. However, as McMurray and colleagues explain, can be more common than any of these other cardiovascular outcomes, especially in patients with advanced diabetes, and it is also more closely associated with premature death. Thus, its omission as a key endpoint in clinical trials could mean that important cardiovascular effects of the glucose-lowering drugs being tested are being overlooked.

According to Professor McMurray, "Fortunately, some trials in progress are taking heart failure into account as a secondary outcome. But many others are neglecting to report this important complication as a key trial outcome. Until heart failure is systematically evaluated in , the cardiovascular safety of antidiabetes drugs will remain uncertain."

More information: Study paper: www.thelancet.com/journals/lan… (14)70031-2/abstract

add to favorites email to friend print save as pdf

Related Stories

Recommended for you

A novel pathway for prevention of heart attack and stroke

6 hours ago

A recent Finnish study could pave the way for preventing brain and cardiac ischemia induced by atherosclerosis. Finnish researchers have found that the low-expression variant of fatty acid-binding protein 4 (FABP4), which ...

Exercise may protect older women from irregular heartbeat

Aug 20, 2014

Increasing the amount or intensity of physical activity can cut the chances of older women developing a life-threatening irregular heartbeat, according to new research in the Journal of the American Heart Association (JAHA).

Huge discrepancies on heart disease in Europe

Aug 20, 2014

Russians and Ukrainians aged 55 to 59 die from coronary heart disease at a higher rate than Frenchmen who are 20 years older, a study released Wednesday of Europe's cardiovascular health showed.

User comments