Trulicity® (dulaglutide) is now indicated as an adjunct to diet, exercise, and standard of care therapy to reduce the risk o...
September 22 2020 - 9:29AM
On September 11, 2020, Health Canada approved Trulicity®
(dulaglutide) to reduce the risk of non-fatal stroke in adults with
type 2 diabetes mellitus who have multiple cardiovascular risk
factors or established cardiovascular disease, as an adjunct to
diet, exercise, and standard of care therapy. This decision makes
Eli Lilly and Company’s Trulicity the first and only GLP1 receptor
agonist (RA) approved to provide a cardiovascular benefit in people
with multiple CV risk factors or with established cardiovascular
disease.
The new indication reflects the differentiated patient
population of REWIND, the Trulicity cardiovascular outcomes trial.
The study consisted primarily of people with multiple
cardiovascular risk factors without established cardiovascular
disease. REWIND showed a significant risk reduction in MACE-3, a
composite endpoint of nonfatal myocardial infarction (heart
attack), non-fatal stroke or CV death. Results demonstrated
consistent MACE-3 risk reduction with Trulicity across major
demographic subgroups. Trulicity's safety profile was consistent
with the GLP-1 RA class. The most common adverse events leading to
the discontinuation of Trulicity were gastrointestinal events.
“REWIND showed that the drug dulaglutide (marketed as Trulicity)
reduced major cardiovascular events, including non-fatal stroke, in
adults with type 2 diabetes who either had multiple cardiovascular
risk factors or established cardiovascular disease,” says Dr.
Hertzel Gerstein, Professor, and Deputy Director of the Population
Health Research Institute at McMaster University and Hamilton
Health Sciences, Hamilton, ON. “Trulicity’s new indication to
reduce the risk of non-fatal stroke in these patients will provide
physicians with an important tool for type 2 diabetes care.”
In addition to its proven glycemic efficacy and easy-to-use
device*, Trulicity can now be prescribed to provide cardiovascular
benefit to people with type 2 diabetes.
“The GLP-1 RA class represents an important advancement in the
treatment of type 2 diabetes,” says Dr. Doron Sagman, Vice
President, R&D and Medical Affairs, Eli Lilly Canada. “The
combination of Trulicity’s proven efficacy along with a new
indication for non-fatal stroke represents a significant milestone
in diabetes and cardiovascular management.”
About the REWIND Study REWIND
(Researching cardiovascular
Events with a Weekly
INcretin in Diabetes) was a
multicenter, randomized, double-blind, placebo-controlled trial
designed to assess the effect of Trulicity 1.5 mg, a weekly
glucagon-like peptide 1 receptor agonist (GLP-1 RA), compared to
placebo, both added to standard of care (according to local
standard of care guidelines), on cardiovascular (CV) events in
adults with type 2 diabetes. The primary CV outcome was the first
occurrence of MACE (the composite of CV death or nonfatal
myocardial infarction or nonfatal stroke). Secondary outcomes
include each component of the primary composite CV outcome, a
composite clinical microvascular outcome comprising retinal or
renal disease, hospitalization for unstable angina, heart failure
requiring hospitalization or an urgent heart failure visit, and
all-cause mortality. The 9,901 participants from 24 countries had a
mean duration of diabetes of 10.5 years and a median baseline A1C
of 7.2 percent. While all participants had CV risk factors, only
31.5 percent of the study participants had established CV disease
while 62.8 percent only had multiple CV risk factors Prior
(established) cardiovascular disease in REWIND was defined as a
history of myocardial infarction, ischemic stroke, unstable angina,
revascularization (coronary, carotid, or peripheral), myocardial
ischemia by a stress test or cardiac imaging or hospitalization for
unstable angina with at least one of the following: ECG changes,
myocardial ischemia on imaging, or a need for percutaneous coronary
intervention.
The REWIND trial's international scope, high proportion of
women, high proportion of people without established cardiovascular
disease and inclusion of participants with a lower mean baseline
A1C suggest that the findings will be directly relevant to the
typical type 2 diabetes patient seen in general practice.
About Diabetes in CanadaApproximately 11
million Canadians live with diabetes or prediabetes. People with
diabetes are over three times more likely to be hospitalized with
cardiovascular disease and contribute to 30% of strokes and 40% of
heart attacks. Diabetes can reduce lifespan by 5 to 15 years and
complications are associated with premature death. It is estimated
that the all-cause mortality rate among Canadians living with
diabetes is twice as high as the all-cause mortality rate for
people without diabetes.1
About Lilly DiabetesLilly has been a global
leader in diabetes care since 1923, when we introduced the world’s
first commercial insulin. Today we are building upon this heritage
by working to meet the diverse needs of people with diabetes and
people who care for them. Through research, collaboration and
quality manufacturing we strive to make life better for people
affected by diabetes and related conditions. We work to deliver
breakthrough outcomes through innovative solutions—from medicines
and technologies to support programs and more.
About Lilly CanadaEli Lilly and Company is a
global healthcare leader that unites caring with discovery to make
life better for people around the world. We were founded more than
a century ago by Colonel Eli Lilly, who was committed to creating
high quality medicines that meet people’s needs, and today we
remain true to that mission in all our work. Lilly employees work
to discover and bring life-changing medicines to people who need
them, improve the understanding and management of disease, and
contribute to our communities through philanthropy and
volunteerism.
Eli Lilly Canada was established in 1938, the result of a
research collaboration with scientists at the University of
Toronto, which eventually produced the world’s first commercially
available insulin. Our work focuses on oncology, diabetes,
autoimmunity, neurodegeneration, and pain. To learn more about
Lilly Canada, please visit us at www.lilly.ca.
For our perspective on issues in healthcare and innovation,
follow us on twitter @LillyPadCA and @LillyMedicalCA
Media Contact: Samira
RehmanRehman_Samira@lilly.com 647-617-1994
REFERENCES 1 www.diabetes.ca, Diabetes in
Canada - Backgrounder, pg. 1, February 2020.*In a study, 94% of
people said it was easy to use.
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