Leading U.S. Medical Association’s Assembly of Domestic and International Diabetes Experts Concludes Use of SGLT2 Inhibitors for Treatment of Diabetes Should Continue With No Changes in Current Recommendations

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JACKSONVILLE, Fla.–(BUSINESS WIRE)–The American Association of Clinical Endocrinologists (AACE) and the
American College of Endocrinology (ACE) organized a gathering of U.S.
and international diabetes physicians, scientists, and other experts to
conduct a rigorous examination of potential issues surrounding SGLT2i (sodium-glucose
cotransporter-2 inhibitors), a class of prescription medicines used to
lower blood sugar in adults with diabetes, and its possible relationship
to diabetic ketoacidosis (DKA).

The distinguished group of experts met in Dallas, Texas October 24 – 25,
to conduct an intensive review of the available scientific and clinical
data during the “AACE/ACE Scientific and Clinical Review: Association
of SGLT2 Inhibitors and DKA.”

Upon review of the available material, together with a thorough
discussion of the impact of SGLT2i on human metabolism, the experts
concluded that the prevalence of DKA is infrequent and the risk-benefit
ratio overwhelmingly favors continued use of SGLT2i with no changes in
current recommendations.

The conference was convened in response to published reports of DKA
occurring in type 1 and type 2 diabetes patients being treated with
SGLT2i, prompting the U.S. Food and Drug Administration (FDA) and the
European Medicines Agency (EMA) to issue a warning advising caution when
prescribing this agent until evidence is gathered and examined. DKA is
an acute, potentially life-threatening complication of diabetes. A full
media toolkit is available here.

The prominent U.S. and international medical dignitaries included:
Henning Beck-Nielsen, MD, DMSc, head of the Danish Diabetes Academy and
chairman of the Board of the Danish Centre for Strategic Research in
Type 2 Diabetes – DD2; Ele Ferrannini, MD, Associate of the Metabolism
Unit at Italy’s National Research Council Institute of Clinical
Physiology; John Nolan, FRCPI, FRCP (ED), CEO, Director of the Steno
Diabetes Center in Denmark; Ralph DeFronzo, MD, BMS, MS, BS, Deputy
Director, Texas Diabetes Institute; Sam Dagogo-Jack, MD, MBBS, FRCP,
FACE, President, Medicine and Science, American Diabetes Association;
and Arthur Vinik, MD, PhD, Professor of Medicine, Pathology and Anatomy,
Eastern Virginia Medical School.

AACE and ACE call upon pharmaceutical companies to continue to
investigate the mechanisms behind the metabolic effect of SGLT2i, and
make note that the diagnosis of DKA is often missed or delayed due to
atypical presentation involving lower-than-anticipated glucose levels or
other misleading laboratory values. In addition, AACE and ACE encourages
all associated stakeholders including medical societies, insurance
companies, the pharmaceutical industry, hospitals, patient associations,
and other interested parties to initiate educational activities to teach
physicians and other related healthcare professionals who manage
diabetes, on the proper ways to identify and treat DKA.

“With the input of the noteworthy expertise assembled during the
conference, we achieved our objective of performing a thorough,
objective and balanced evaluation of the data in order to issue
recommendations for this important issue,” said Yehuda Handelsman, MD,
FACP, FACE, FNLA, Committee Program Chair and Medical Director of the
Metabolic Institute of America in California.

“The wealth of scientific and clinical data presented at this symposium
has been ideal to enhance our understanding of the relationship between
SGLT2 inhibitors and DKA,” said Robert Henry, MD, FACE, Program Chair
and Chief, Section of Diabetes, Endocrinology & Metabolism and the
Center for Metabolic Research at the San Diego VA Medical Center. “I am
confident this data will enable AACE to provide recommendations to
minimize the occurrence of this complication in patients with diabetes.”

“This successful conference was yet another example of what AACE does
best to enhance the ability of its members to deliver optimal care to
their patients,” said AACE President George Grunberger, MD, FACP, FACE.
“When important clinical issues arise to which we do not have definite
answers, we assemble the best minds nationally and globally to examine
the available evidence and provide practical guidance to health care
professionals and patients as well as to the scientific community to
guide future research. We have done this recently for prediabetes,
diabetes and cancer, obesity, glucose monitoring and now for the
question of the relationship of use of SGLT2 inhibitors and DKA.”

A summary of the conference conclusions can be found here.
A complete white paper with clinical recommendations will be
published in a future issue of the AACE scientific journal, Endocrine
Practice
.

About the American Association of Clinical
Endocrinologists (AACE)

The American Association of Clinical Endocrinologists (AACE)
represents more than 6,000 endocrinologists in the United States and
abroad. AACE is the largest association of clinical endocrinologists in
the world. The majority of AACE members are certified in Diabetes,
Endocrinology and Metabolism and concentrate on the treatment of
patients with endocrine and metabolic disorders including diabetes,
thyroid disorders, osteoporosis, growth hormone deficiency, cholesterol
disorders, hypertension and obesity. Visit our website at
www.aace.com.

About the American College of Endocrinology
(ACE)

The American College of Endocrinology (ACE) is the charitable,
educational and scientific arm of the American Association of Clinical
Endocrinologists (AACE). ACE is the leader in advancing the care and
prevention of endocrine and metabolic disorders by: providing
professional education and reliable public health information;
recognizing excellence in education, research and service; promoting
clinical research and defining the future of Clinical Endocrinology. For
more information, please visit
http://www.aace.com/college/.

Contacts

AACE
Glenn Sebold, 904-353-7878 Ext. 122
gsebold@aace.com