Endocrinology Month in Review: January 2024

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This endocrinology month in review spotlights FDA news, a pair of studies examining cardiovascular and renal risk reduction in type 2 diabetes, results from a subtrial examining testosterone’s effect on fracture risk, and 4 new episodes of diabetes dialgoue

After a 2023 where the field was firmly in the spotlight, primarily as the result of the GLP-1 receptor agonist class, advances in diabetes technology, and a booming obesity epidemic, the consistent and steady stream of updates within field of endocrinology carried over into the first month of 2024. In this January 2024 endocrine month in review, we recap the most popular and clinically important news in the field.

This month in review spotlights FDA news, a pair of studies examining cardiovascular and renal risk reduction in type 2 diabetes, results from a sub trial of the phase 4 TRAVERSE trial examining testosterone’s effect on fracture risk, and 4 new episodes of our flagship endocrinology podcast, Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives.

FDA News and Updates in Endocrinology

FDA Adds Boxed Warning to Denosumab (Prolia) for Severe Hypocalcemia

On January 19, 2024, the US Food and Drug Administration has announced the addition of a Boxed Warning, its most prominent warning, to denosumab (Prolia) for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD). According to a release from the FDA, the decision is based on an evaluation of studies, primarily from the Centers for Medicare and Medicaid Services, as well as multiple cases reported to the FDA’s Adverse Event Report System database. The move represents an update to a November 2022 announcement detailing the agency’s investigation into this risk, which came as the result of a separate internal FDA study investigating hypocalcemia in dialysis patients treated with denosumab suggesting a substantial risk with serious outcomes, including hospitalization and death.

FDA Authorizes Program Allowing Import of Prescription Drugs from Canada

Although not specifically pertaining to management of endocrine disorders or diabetes, the FDA’s authorization of a program allowing the import of prescription drugs from Canada could have implications for people with diabetes in Florida. Announced on January 5, 2024, the authorization falls under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and will be authorized for two years from the date the FDA is notified of the first imported drug shipment.

Managing Cardiovascular and Renal Risk in T2D

Achieving Diabetes Remission, For No Matter How Long, Can Lower Kidney, Cardiovascular Risk

New findings from the Look AHEAD study, which tracked 5000 patients with type 2 diabetes, suggest achieving remission is linked to greater than 30% reductions in CKD and cardiovascular disease. The 12-year study, comparing intensive lifestyle intervention with disease support and education, found any remission was associated with long-term health benefits, with greater benefits seen with more time in remission.

International Study ID's 13-Biomarker Panel for Predicting Cardiovascular Disease in Type 2 Diabetes

A systematic review and meta-analysis of more than 400 studies of individuals with type 2 diabetes has identified 13 biomarkers that could significantly enhance the prediction of cardiovascular disease risk. Conducted as part of the Precision Medicine in Diabetes Initiative, the study suggests these biomarkers, including NT-proBNP and troponin-t, may improve risk prediction in people with type 2 diabetes.

Testosterone and Fracture Risk

Testosterone Treatment Does Not Reduce Fracture Risk in Men with Hypogonadism

A subtrial of the phase 4 TRAVERSE trial found that testosterone treatment did not reduce the incidence of clinical fractures compared to a placebo in middle-aged and older men with hypogonadism. The 3-year cumulative incidence of all clinical fractures was nearly 4% in the testosterone group versus 2.8% in the placebo group. The unexpected results challenge previous findings that suggested testosterone improved bone structure and quality measures.

Diabetes Dialogue Enters Year 2 on HCPLive

After being introduced to the HCPLive audience in January 2023, Diabetes Dialogue published more than 45 episodes and featured nearly 2 dozen special guests. Hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, did not miss a beat entering 2024, with the launch of 5 new episodes to ring in the new year, including a recap of last year’s most popular episodes.

January 1: 2023 Top Episodes Recap

January 2: Baricitinib & the Potential Disease-Modifying Therapies in Type 1 Diabetes

January 5: Latest Updates on Diabetes Management in Pregnancy

January 9: Updates in Management of Hypercortisolism in Type 2 Diabetes

January 10: Diabetes Technology Updates in January 2024

Check out this preview from our January 10 episode on diabetes technology updates:

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