(Press-News.org)
Embargoed for release: Monday, December 11, 11:00 AM ET
Key points:
In a study of 3.5 million pregnancies across four countries between 2009 and 2021, researchers observed no elevated risk of major congenital malformations, including major cardiac malformations, among infants born to pregnant women with pre-gestational type 2 diabetes who took second-line non-insulin antidiabetic medications compared with those who took insulin.
The researchers observed an increase in use of second-line non-insulin antidiabetic medications throughout the study period, especially use of GLP-1 receptor agonists in the U.S., suggesting the number of infants prenatally exposed to these drugs will continue to increase.
Boston, MA—Infants born to women with pre-gestational type 2 diabetes who take second-line non-insulin antidiabetic medications (ADMs) during pregnancy are at no higher risk of major congenital malformations (MCMs) than infants born to those who take insulin, according to a new study led by Harvard T.H. Chan School of Public Health. While MCMs, including major cardiac malformations, are more prevalent among infants born to women with pre-gestational diabetes, the researchers observed no differences in risk between infants whose mother treated her diabetes with insulin versus with non-insulin second-line ADMs.
The study also found an increase in use of second-line non-insulin ADMs throughout the study period, especially use of GLP-1 receptor agonists in the U.S., suggesting the number of infants prenatally exposed to these drugs will continue to increase.
The study will be published on December 11, 2023, in JAMA Internal Medicine. It is the first large study to examine the potential risks second-line non-insulin ADMs pose to fetal development in humans.
“As type 2 diabetes becomes a more common condition among women of reproductive age, and with the recent approval of GLP-1 receptor agonists such as semaglutide to treat obesity, the number of exposed pregnancies is likely to increase. Our findings provide initial reassurance of safety for infants prenatally exposed to these medications,” said first author Carolyn Cesta, assistant professor at Karolinska Institutet in Sweden.
Using health databases in Finland, Iceland, Norway, Sweden, the United States, and Israel, the researchers examined the outcomes of more than 3.5 million pregnancies between 2009 and 2021. Among these pregnancies, 51,826 (1.5%) comprised the study group of women with pre-gestational type 2 diabetes. In the periconceptional period—between three months before and three months after conception—15,148 (29.2%) of these individuals filled a prescription for a first- or second-line ADM.
The study found that infants whose mother had pre-gestational type 2 diabetes had a substantially higher prevalence of MCMs, including cardiac malformations, compared with infants in the general population. Within the study population of women with type 2 diabetes, 5.58% of infants were born with an MCM and 2.25% were born with a cardiac malformation, compared to 3.76% and 1.31%, respectively, of infants born to the general population. However, within infants born to women with diabetes who took second-line non-insulin ADMs—sulfonylureas, DPP-4 inhibitors, GLP-1 receptor agonists, or SGLT2 inhibitors—the study did not find a greater risk of MCMs after periconceptional exposure compared with infants exposed to insulin.
The researchers noted that some of the study’s findings were imprecise, and that continuous monitoring and further research will provide more precise risk estimates.
“As more and more parents and their health care providers search for evidence on the safety of these medications, our research can help inform their decisions,” said senior author Sonia Hernández-Díaz, professor of epidemiology at Harvard Chan School.
The study was funded by the National Institute of Child Health and Development (grant R01 HD097778); the European Union’s Horizon 2020 research and innovation program (grant 844728); NordForsk Nordic Program on Health and Welfare (Nordic Pregnancy Drug Safety Studies, project no. 83539); the Research Council of Norway (International Pregnancy Drug Safety Studies, project no. 273366); and the Research Council of Norway’s Centres of Excellence (project no. 262700).
“Safety of GLP-1 receptor agonists and other 2nd-line antidiabetics in early pregnancy: an international cohort study,” Carolyn E. Cesta, Ran Rotem, Brian T. Bateman, Gabriel Chodick, Jacqueline M. Cohen, Kari Furu, Mika Gissler, Krista F. Huybrechts, Lars J. Kjerpeseth, Maarit K. Leinonen, Laura Pazzagli, Helga Zoega, Ellen W. Seely, Elisabetta Patorno, Sonia Hernández-Díaz, JAMA Internal Medicine, December 11, 2023, doi: 10.1001/jamainternalmed.2023.6663
Visit the Harvard Chan School website for the latest news, press releases, and multimedia offerings.
###
Harvard T.H. Chan School of Public Health brings together dedicated experts from many disciplines to educate new generations of global health leaders and produce powerful ideas that improve the lives and health of people everywhere. As a community of leading scientists, educators, and students, we work together to take innovative ideas from the laboratory to people’s lives—not only making scientific breakthroughs, but also working to change individual behaviors, public policies, and health care practices. Each year, more than 400 faculty members at Harvard Chan School teach 1,000-plus full-time students from around the world and train thousands more through online and executive education courses. Founded in 1913 as the Harvard-MIT School of Health Officers, the School is recognized as America’s oldest professional training program in public health.
END
The Organoid Group (Hubrecht Institute) and the Rare Cancers Genomics Team (IARC/WHO) found a way to grow samples of different types of neuroendocrine tumors (NETs) in the lab. While generating their new model, the researchers discovered that some pulmonary NETs need the protein EGF to be able to grow. These types of tumors may therefore be treatable using inhibitors of the EGF receptor. The results were published in Cancer Cell on 11 December 2023.
Neuroendocrine tumors
Neuroendocrine tumors (NETs) are relatively ...
BOSTON – Physician-investigators at Beth Israel Deaconess Medical Center (BIDMC) compared a chatbot’s probabilistic reasoning to that of human clinicians. The findings, published in JAMA Network Open, suggest that artificial intelligence could serve as useful clinical decision support tools for physicians.
“Humans struggle with probabilistic reasoning, the practice of making decisions based on calculating odds,” said the study’s corresponding author Adam Rodman, MD, an internal medicine physician and investigator in ...
People who have been subject to abuse are more likely to experience physical and mental health effects than previously thought, according to a new study.
In a global review and meta-analysis of evidence published in Nature Medicine today, researchers have found that there are elevated risks between intimate partner violence or childhood sexual abuse, and some health conditions including major depressive disorder, maternal miscarriage for partners, and alcohol misuse and self-harm among children.
Globally, one in three ever-partnered women have experienced ...
McGill University researchers have made a breakthrough in diagnostic technology, inventing a ‘lab on a chip’ that can be 3D-printed in just 30 minutes. The chip has the potential to make on-the-spot testing widely accessible.
As part of a recent study, the results of which were published in the journal Advanced Materials, the McGill team developed capillaric chips that act as miniature laboratories. Unlike other computer microprocessors, these chips are single-use and require no external power source—a simple paper strip suffices. They function through capillary action – ...
BEER-SHEVA, Israel, December 11, 2023 – Fairy circles, a nearly hexagonal pattern of bare-soil circular gaps in grasslands, initially observed in Namibia and later in other parts of the world, have fascinated and baffled scientists for years. Theories for their appearance range from spatial self-organization induced by scale-dependent water-vegetation feedback to pre-existing patterns of termite nests.
Prof. Ehud Meron of Ben-Gurion University of the Negev has been studying the Namibian fairy circles as a case study for understanding how ecosystems respond to water stress. He believes that all theories ...
WASHINGTON (Dec. 11, 2023)--A new study published in Proceedings of the National Academy of Sciences Nexus provides a better understanding of how the brain responds to injuries. Researchers at the George Washington University discovered that a protein called Snail plays a key role in coordinating the response of brain cells after an injury.
The study shows that after an injury to the central nervous system (CNS) a group of localized cells start to produce Snail, a transcription factor or protein that has been implicated in the repair process.The GW researchers show that changing how much Snail is produced can significantly affect whether the injury starts ...
About The Study: In participants with obesity or overweight, withdrawing tirzepatide led to substantial regain of lost weight, whereas continued treatment maintained and augmented initial weight reduction in this randomized clinical trial that included 670 adults.
Authors: Louis J. Aronne, M.D., of Weill Cornell Medicine in New York, is the corresponding author.
To access the embargoed study: Visit our For The Media website at this link https://media.jamanetwork.com/
(doi:10.1001/jama.2023.24945)
Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, conflict ...
Lymphatic fluid from surgical drains, which is usually tossed in the trash, is a treasure in the hands of University of Pittsburgh and Washington University School of Medicine in St. Louis researchers who found that this liquid could inform more precise treatments for patients with head and neck cancer caused by human papillomavirus (HPV).
The new study, published in Clinical Cancer Research, a journal of the American Association for Cancer Research, shows for the first time that HPV DNA in lymphatic fluid collected ...
INDIANAPOLIS -- LOINC® and Health Data Standards at Regenstrief Institute has received a $4.4 million grant from the Regenstrief Foundation to support expansion of work on a global initiative to categorize and standardize social determinants of health (SDOH) information into electronic health records (EHRs), an ambitious project to integrate social needs data into clinical care to more effectively address health inequities.
The unequal distribution of income, food, safety and access to healthcare are recognized as root causes of health disparities. But, currently, data on these factors are rarely well documented within a patient’s ...
Frontline nurses who learned the Transcendental Meditation® (TM®) technique during the COVID-19 pandemic showed rapid and significant improvements in flourishing, PTSD, anxiety, and burnout over 3 months compared to controls, according to a study published today in the Journal of Nursing Administration.
The objective of this study was to evaluate the impact of Transcendental Meditation on nurses’ multidimensional well-being, conceptualized as the presence of flourishing and the absence of PTSD, anxiety, and burnout.
A total of 104 nurses in three Florida hospitals participated. ...
