#ADA2021 Weekly injection of glucose-reducing drug offers safe and effective way to significantly reduce cardiorenal events for people with type 2 diabetes

(PRNewsFoto/American Diabetes Association)

The New England Journal of Medicine: AMPLITUDE O trial reveals regular use of efpeglenatide has potential to improve outcomes for high-risk diabetes patients with heart or kidney disease

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WASHINGTON, DC (June 28, 2021) – Data released today from a large-scale,
international clinical trial show significant reduction in the first occurrence of a heart
attack, stroke, or death, and a reduction in progression of kidney disease in patients
with type 2 diabetes with weekly use of efpeglenatide, an injectable drug with glucose-
and weight-lowering effects. The findings were presented at the virtual 81st Scientific

Sessions of the American Diabetes Association® (ADA) and simultaneously published in
The New England Journal of Medicine.
The majority (98%) of adults with type 2 diabetes have at least one comorbid chronic
condition, including cardiorenal conditions impacting the heart and kidney. In fact, 24%
of people living with diabetes have kidney disease, 22% have cardiovascular disease,
and 82% of people with diabetes have hypertension—a leading cause of heart disease.1
Efpeglenatide is a glucagon-like peptide-1 receptor agonist drug (GLP-1 RA), a class of
drug used to treat diabetes that reduces glucose levels, weight, and blood pressure.
Earlier trials have shown that GLP-1 RA drugs based on human GLP-1 reduce
cardiovascular and kidney outcomes. This study assessed the effects of a GLP-1 RA
based on exendin-4 (animal GLP-1) either with or without an SGLT2 inhibitor drug in
patients with cardiovascular and/or kidney disease.
The AMPLITUDE O trial was conducted in 28 countries and included more than 4,000
participants with type 2 diabetes. Over two years, patients assigned to weekly injections
of efpeglenatide versus placebo had a 27% lower risk of a heart attack, stroke, or cardiovascular death; a 32% lower risk of kidney disease progression; and a 27% lower 1 Kristy Iglay, Hakima Hannachi, Patrick Joseph Howie, Jinfei Xu, Xueying Li, Samuel S. Engel, Lori M. Moore & Swapnil Rajpathak (2016) Prevalence and co-prevalence of comorbidities among patients with type 2 diabetes mellitus, Current Medical Research and Opinion, 32:7, 1243-1252, DOI: 10.1185/03007995.2016.1168291 risk of a heart attack, stroke, or death from any cause. Similar effects were observed in the presence and absence of an SGLT2 inhibitor drug. There were no serious side
“The AMPLITUDE O trial establishes efpeglenatide, an exendin-4 based GLP-1 RA, as
an effective cardioprotective drug for type 2 diabetes patients with cardiovascular and/or
kidney disease,” said Hertzel C. Gerstein, MD, MSc, Professor, McMaster University
and Hamilton Health Sciences, and Deputy Director Population Health Research
Institute in Ontario, Canada. “We are encouraged that this once-a-week injection, safely
and effectively reduced cardiovascular and progression of kidney disease in patients
with long-standing diabetes who had a high prevalence of cardiovascular and kidney
Research presentation details:
• Dr. Gerstein and other study investigators will present the findings of the
AMPLITUDE O trial during a symposium listed below (Dr. Gerstein will speak at
3:00 p.m. ET)
o Symposium – First Results of the Effect of Efpeglenatide on
Cardiovascular Outcomes (AMPLITUDE-O) Trial
o Date: Monday, June 28, 2:15–4:15 p.m. ET (all sessions will be recorded
and accessible for 90 days)

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