Brigham: An international, multidisciplinary team including investigators from
Brigham and Women’s Hospital (BWH) has found that lixisenatide, a
member of a class
of glucose-lowering drugs frequently prescribed in Europe to
patients with diabetes, did not increase risk of cardiovascular events
including heart
failure. These results – the first to be reported on the
cardiovascular safety of a glucagon-like peptide 1 (GLP-1) receptor
agonist – were presented today
at the American Diabetes Association’s 75th Scientific Sessions.
“There are a large number of patients around the world who take this
class of agents to help manage their glucose –based on our results
patients and their
healthcare providers should be reassured of the cardiovascular
safety of lixisenatide even if they are at high risk for heart-related
problems,” said Marc
Pfeffer, MD, PhD, a member of the Cardiovascular Medicine Division at
BWH, professor at Harvard Medical School and principal investigator for
the ELIXA ( Evaluation of LIXisenatide in Acute Coronary Syndrome) trial.
Patients with type 2 diabetes are at high risk for developing
cardiovascular disease and some glucose-lowering drugs have been
associated with an
additional increase risk of adverse cardiovascular effects. These
observations prompted the US Food and Drug Administration and the
European Medicines
Agency to establish guidelines for clinical trials to ensure that
new therapies do not put type 2 diabetes patients at increased
cardiovascular risk.
In the ELIXA study, researchers enrolled more than 6,000 type 2
diabetes patients from 49 countries who had recently recovered from a
heart attack or other
acute coronary event to evaluate the effects of lixisenatide on a
population at high risk of a cardiovascular event. The large,
double-blind,
placebo-controlled study measured multiple outcomes, including
cardiovascular death, heart attack, stroke, hospitalization for chest
pain and heart
failure.
Overall, the research team found that the drug had a neutral effect
on risk of cardiovascular problems – that is, it neither increased nor
decreased risk,
all within the limits of the FDA’s safety guidelines. In addition,
lixisenatide provided a modest benefit in terms of weight gain, and no
increase in
cancers or pancreatitis.
“ELIXA provides data showing that this treatment can be used in a
safe manner without worsening cardiovascular prognosis of patients with
type 2 diabetes,
even among the highest risk population – those with a pre-existing
history of heart failure,” said Eldrin Lewis, MD MPH, a physician in the
Cardiovascular
Medicine Division at BWH and an associate professor at Harvard
Medical School.
For researchers at the Brigham and their collaborators, the results
of the study are just the beginning: the data collected from 6,000
patients all over
the world will be used for future analysis to better understand the
prognosis for patients with diabetes.
“We now have an expansive data set from patients with type 2
diabetes from around the globe, and we look forward to collaborating
with our international
ELIXA co-investigators to further explore data about cardiovascular
outcomes in this patient population,” said Brian Claggett, PhD, of BWH’s
Cardiovascular
Medicine Division.
This research was supported by Sanofi, which licenses and develops lixisenatide.