Scarce data on new glucose-lowering agents, with high risk for bias toward negative outcomes
FRIDAY, June 29, 2018 (HealthDay News) — Evidence is lacking on pregnancy outcomes with new glucose-lowering agents used for treating type 2 diabetes (T2DM), according to a study published online May 28 in Diabetes, Obesity and Metabolism.
Katrien Benhalima, M.D., Ph.D., from the UZ Gasthuisberg in Belgium, and colleagues examined available data on pregnancy outcomes from pharmaceutical safety databases. The researchers noted that due to the increase in type 2 diabetes among young adults, women of childbearing age are often treated with newer glucose-lowering therapies, and an increase in unintentional exposure to therapies that are unapproved for use during pregnancy is anticipated.
The researchers found that scarce data are available on pregnancy outcomes with new glucose-lowering agents for T2DM. These therapies also have a high risk for bias toward negative outcomes, which limits their usefulness for assessing safety. At present, the lack of information means these agents are not recommended for use during pregnancy or when planning a pregnancy.
“To better guide clinical practice, structured systems of assessing pregnancy outcomes in women receiving these novel agents are urgently needed,” the authors write.
One author is an employee and shareholder of Novartis Pharma AG. Several pharmaceutical companies provided data on pregnancies and/or outcomes.
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