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'Heart Failure Is Killing Your Diabetes Patients,' Experts Warn At EASD

Posted on Monday, 30 September 2013


Indonersia - Cardiologists speaking here at the European Association for the Study of Diabetes (EASD) 2013 Meeting are urging diabetologists to sit up and take notice: heart failure is killing their patients and is not getting the attention it deserves.

Not only is heart failure one of the most lethalif not the most lethalcomplications of diabetes, its role in diabetes is being routinely overlooked by physicians, by journals publishing diabetes research, and perhaps worst of all, by regulators tasked with telling companies what's important for trials of new diabetes drugs.

Heart Failure in the Hot Seat
Their pleas come at a time when heart failure has vaulted once again onto the radar of physicians studying and treating diabetes, this time after a signal of increased heart failure was seen in the SAVOR TIMI 53 trial. The results were presented at the recent European Society of Cardiology (ESC) 2013 Congress meeting and published simultaneously in the New England Journal of Medicine.
As reported by heartwire , patients randomized to the dipeptidyl peptidase-4 (DPP-4) inhibitor saxagliptin had a 27% increased risk of hospitalizations for HF as compared with placebo-treated patients. EXAMINE , a second cardiovascular-outcomes study of another DPP-4 inhibitor, alogliptin, also presented and published during the ESC meeting, did not include heart failure as a prespecified end point. A post hoc analysis presented for the first time here today indicated that HF hospitalizations were numerically higher in the alogliptin group than in the placebo-treated group, but the difference was not statistically significant.

Just how a clinical trial could travel from conception to publication without including heart failure as a stand-alone end point, given the lethal nature of this complication in diabetic patients, was a key talking point in an EASD session devoted to heart failure and diabetes.

"Not only do diabetologists, along with cardiologists, need to take heart failure seriously in patients with diabetes, but the regulators do as well," Dr John J McMurray (University of Glasgow, Scotland) urged the audience. "We need to make heart failure a much more prominent component of our clinical trials, and we must not see major journals publishing major CV-outcomes trials in diabetes and not even mentioning one of the most important if not the most important cardiovascular complication of diabetes, which is heart failure."

Heart Failure, Mortality, and Diabetes
For his presentation, McMurray reviewed the largest cardiovascular-outcome trials that included a predefined subset of diabetic patients, as well as the major diabetes trials that included cardiovascular outcomes. Only seven of 12 major CV-outcomes trials actually reported heart failure as an outcome, and worse still, of the 24 major diabetes-outcome trials, only 10 reported heart-failure outcomes.

In slide after slide, McMurray showed data from clinical trials that, for years, were household names for cardiologists and endocrinologists alike, among them VALUE , LIFE , RENAAL , HOPE , LOOK Ahead , ADVANCE , and ACCORD . In all of them, he pointed out, the likelihood of developing or being hospitalized for heart failure among people with diabetes was as high as and in many cases higher than the risk for MI and universally higher than the risk for stroke or CV death.

"The story gets even more interesting when you look at patients who develop diabetic nephropathy," McMurray continued, showing a comparison of HF hospitalizations in diabetic patients in LIFE and RENAAL. Both of those trials evaluated losartan (vs placebo or atenolol ), and both excluded patients with heart failure at baseline. The key point, however, was that regardless of treatment assignment, rates of HF hospitalizations were two to three times higher among patients with diabetic nephropathy than in diabetics with no nephropathy. Similarly, in the RENAAL, IDNT , and ALTITUDE trials, the most common CV outcome in patients with both diabetes and nephropathy was heart failure, which, again, was sometimes twice as common as MI.
"You might be saying to yourselves, well, that's all very well, so heart failure is quite common: big deal, so what," McMurray chided the audience. "What I would like to show you is that heart failure is actually the most deadly of the cardiovascular complications."

Looking again at data from LIFE and RENAAL, McMurray showed that deaths over the several years of follow-up were at least twice as common in diabetic patients with heart failure than in diabetic patients without heart failure. In ALTITUDE, a more contemporary trial, deaths were markedly higher among patients who required HF hospitalizations than they were for patients hospitalized for death, stroke, or end-stage renal disease.

"And this doesn't speak to disability," McMurray added, noting that there is a wealth of evidence showing that HF "is a much more disabling CV disorder than MI and even stroke."

McMurray said he often hears from colleagues focused on diabetes who refer to heart failure as "just a bit of ankle swelling" or "a bit of fluid retention."

"I hope with the data I've showed you . . . that you [no longer] think that's the case."

History Repeating Itself?
Heart failure first emerged as an issue in the early glitazone trials but was ultimat
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