Endocrinology Month in Review: June 2023

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Our endocrinology month in review for June 2023, highlights FDA decisions in type 1 and type 2 diabetes, studies from ENDO 2023, and new data presented at the 83rd Scientific Sessions of the American Diabetes Association.

In the world of endocrinology, the month of June was defined by a flurry of regulatory news and a pair of major meetings. In our endocrinology month in review for June 2023, we highlight our most popular endocrinology-related pieces of content, including FDA decisions in type 1 and type 2 diabetes, studies from the Endocrine Society’s (ENDO 2023) annual meeting, and new data presented at the 83rd Scientific Sessions of the American Diabetes Association (ADA 2023).

FDA News

FDA Approves Donislecel (Lantidra), an Allogeneic Cellular Therapy, for Type 1 Diabetes

On June 28, 2023, the FDA announced the historic first approval of an allogeneic pancreatic islet cellular therapy made from deceased donor pancreatic cells for type 1 diabetes. The approval of donislecel (Lantidra) indicates the therapy for treatment of adults with type 1 diabetes who are unable to approach target glycated hemoglobin because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education.

FDA Approves Empagliflozin, Empagliflozin plus Metformin for Pediatric Type 2 Diabetes

On June 20, 2023, the FDA announced the approval of empagliflozin (Jardiance) and empagliflozin plus metformin hydrochloride (Synjardy) for the treatment of pediatric type 2 diabetes. The approval, which indicates both agents as an adjunct to diet and exercise to improve glycemic control in children 10 years and older with type 2 diabetes, marks the first approval for an SGLT2 inhibitor in pediatric type 2 diabetes.

ENDO 2023

Hosted in Chicago, Il from June 15-18, 2023, ENDO 2023 attracted more than 7000 attendees. Containing nearly 2000 abstracts and more than 200 sessions, the meeting contained a diverse array of topics within endocrinology and grabbed headlines, with 3 articles included in our most popular stories of June 2023, including a study diving deeper into the effects of testosterone therapy in men and further insight into a pair of agents.

TRAVERSE Trial: No Increased Cardiovascular Risk with Testosterone Replacement Therapy

Results of a phase 4 trial presented at ENDO 2023 could put an end to the long-standing debate regarding the effects of testosterone replacement therapy in men. Named the TRAVERSE study, results of the trial, which compared risk of cardiovascular events in people with hypogonadism using testosterone therapy versus placebo, indicate use of testosterone therapy was noninferior to placebo for incidence of major adverse cardiovascular events.

CLEAR Outcomes Data at ENDO 2023 Provides Further Insight into Effects of Bempedoic Acid

Data from the CLEAR Outcomes trial presented at ENDO 2023 suggests use of the lipid-lowering medication bempedoic acid (Nexletol) was associated with a reduction in major vascular events in the trial. Less than 3 months after Steve Nissen, MD, presented the initial results of the CLEAR Outcomes trial at the American College of Cardiology 72nd Annual Scientific Sessions, the latest analysis of data from the landmark trial suggests use of bempedoic acid was associated with a 23% relative reduction in risk for major vascular events at 1 year and a 28% reduction in relative risk at 4 years compared to placebo therapy.

Phase 4 Trial Data Supports Efficacy of Teprotumumab-trbw for Thyroid Eye Disease

phase 4 clinical trial data reinforce the efficacy of teprotumumab-trbw (TEPEZZA®) in patients with thyroid eye disease (TED), regardless of disease activity or duration, according to research presented at the Endocrine Society Annual Meeting. The findings, announced in a release by Horizon Therapeutics, follow an update to the teprotumumab-trbw indication language approved by the FDA in April, indicating the therapy for use in all patients with TED regardless of disease activity or duration.

ADA 2023

Right on the heels of ENDO 2023, the ADA 2023 meeting took place in San Diego, CA from June 24-27, 2023. The meeting itself was dominated by news related to novel incretin therapies, including retatrutide, as well as other late-breaking data related to an increased dosing of oral semaglutide for weight management and another posthoc analysis of CLEAR Outcomes. Also included in our most popular stories countdown are episodes of Diabetes Dialogue from our on-site coverage.

Retatrutide Showcases Historic Weight-Lowering, Glycemic Control Benefits in Phase 2 Data

The future appears bright for Eli Lilly and Company’s novel GIP/GLP-1/Glucagon triagonist, retatrutide, based on phase 2 data presented at ADA 2023.

Results of the trials, which were simultaneously published in the New England Journal of Medicine and The Lancet, suggest use of retatrutide was associated with a mean body weight reduction of 17.5% at 24 weeks and 24.2% at the end of the 48-week treatment duration, with phase 2 data in type 2 diabetes indicating use was associated with a reduction in mean HbA1c of –2.02% and no reports of severe hypoglycemia.

Increased Doses of Oral Semaglutide Can Induce Pronounced Weight Loss, Improve Glycemic Control

New indications could be on the horizon for oral semaglutide based on data from OASIS-1 and PIONEER PLUS trials. Results of OASIS-1, which compared oral semaglutide 50 mg with placebo in patients with overweight or obesity, found use was associated with an estimated mean change in body weight of -15.1% from baseline to week 68 compared to -2.4% with placebo therapy (P < .0001). In PIONEER-PLUS, which examined use of oral semaglutide 25 mg and 50 mg relative to oral semaglutide 14 mg among adults with type 2 diabetes, results suggested use was associated with mean changes in HbA1c at week 52 of -1.5 percentage points with oral semaglutide 14 mg, -1.8 percentage points with oral semaglutide 25 mg (P =.0006), and -2.0 percentage points with oral semaglutide 50 mg (P < .0001).

Study Suggests Bempedoic Acid Could Find Role in Primary Prevention

At ADA 2023, Nissen presented a subgroup analysis of a primary prevention cohort within the CLEAR Outcomes trial. Results of the study, which included data from 4206 of the 13,970 included in the overall trial, suggest use of bempedoic acid was associated with a 30% reduction in relative risk of the primary MACE endpoint in adjusted analyses.

Diabetes Dialogue at ADA 2023

As part of our on-site coverage of ADA 2023, hosts of HCPLive Endocrinology’s flagship podcast Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives recorded 9 on-site episodes with 10 special guests, including Jane Dickinson, RN, PhD, president-elect of the Association of Diabetes Care and Education Specialists, W. Timothy Garvey, MD, principal investigator of SURMOUNT-2, Cari Berget, RN, MPH, director of the PANTHER Program, and more! Use the link above to check out the full list of episodes.

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