HealthDay News — Ertugliflozin appears safe and effective at improving long-term glycemic control among adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin, according to a study published online Jan. 7 in Diabetes, Obesity and Metabolism.

Silvina Gallo, M.D., from Pfizer Deutschland in Germany, and colleagues conducted a 104-week double-blind study to evaluate the long-term efficacy and safety of ertugliflozin in adults with T2DM inadequately controlled on metformin monotherapy. The study involved a 26-week placebo-controlled period (Phase A) and a 78-week period (Phase B) during which blinded glimepiride was added to nonrescued placebo participants with fasting fingerstick glucose ≥6.1 mmol/L. Overall, 621 participants were enrolled in the trial and 581 participants entered Phase B, in which they received at least one dose of the study medication.

The researchers found that the mean change in HbA1c from baseline with ertugliflozin 5 and 15 mg, respectively, was −0.7 and −1 percent at week 52 and −0.6 and −0.9 percent at week 104. At week 52, 34.8 and 36.6 percent of participants had HbA1c <7 percent with doses of 5 and 15 mg, respectively, and 24.6 and 33.7 percent met this outcome at week 104. During the study period, ertugliflozin reduced fasting plasma glucose, body weight, and systolic blood pressure (SBP). The incidence of female genital mycotic infections was higher with ertugliflozin. Symptomatic hypoglycemia was lower for ertugliflozin compared with placebo/glimepiride. Bone mineral density (BMD) changes were similar to those with placebo/glimepiride except for total hip, where the reduction in BMD was greater with ertugliflozin 15 mg versus placebo/glimepiride.


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“In patients with T2DM and inadequate glycemic control on metformin monotherapy, adding treatment with ertugliflozin 15 mg and 5 mg provided clinically meaningful and durable improvements in glycemic control, body weight, and SBP over 104 weeks,” the authors write.

All authors disclosed financial ties to pharmaceutical companies, including Merck and Pfizer, which manufacture ertugliflozin and funded the study.

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At the start of the COVID-19 pandemic, the widespread use of telemedicine almost completely replaced in-person visits for many patients. In many states at that time, the laws governing telemedicine visits was relaxed to help ease the burden of hospital visits while ensuring patients had the necessary medical access they needed. However, some of these changes have since reverted.

According to experts, telemedicine is here to stay, and so, to help those physicians who are new to the practice of telemedicine, or unaware of the current state of affairs surrounding existing legislature, Allan Gibofsky, MD, JD and David J. Goldberg, MD, JD, discuss the legal considerations of the practice of telemedicine in a post-pandemic world.

Read the fill transcript of the episode here.

Allan Gibofsky, MD, JD, is professor of medicine at Weill Cornell Medicine. He is an attending physician and rheumatologist at New York Presbyterian Hospital, Memorial Sloan Kettering Cancer Center and Hospital for Special Surgery, where he is director of the Clinic for Inflammatory Arthritis and Biologic Therapy.

Dr Gibofsky received his BS from Brooklyn College of the City University of New York, his MD from Weill Medical College of Cornell University and his JD from Fordham University. He did his internship in pathology, followed by a residency in medicine at New York Hospital. He completed a fellowship in rheumatology/immunology jointly at Hospital for Special Surgery and at The Rockefeller University.

Dr Gibofsky is a Jonas Salk Scholar of the City University of New York. He is a past chair of the Arthritis Advisory Committee to the US Food and Drug Administration and continues as a special consultant to the agency. He is a past president of the American College of Legal Medicine, a past chair of the American Board of Legal Medicine, as well as a past president and master of The American College of Rheumatology.

David J. Goldberg, MD, JD, earned his medical degree from Yale University School of Medicine. He completed his dermatology residency and dermatologic surgical fellowship at New York University Medical Center. He has served as president as well as chairman of the Ethics Committee of the American Society for Laser Medicine and Surgery and was also chair of the Ethics Committee of the American Academy of Dermatology.

Dr Goldberg is a clinical professor of dermatology at NY’s Icahn School of Medicine at Mount Sinai. He is also an attorney and an adjunct professor at Fordham Law School. He currently writes a monthly column entitled Legal Eagle for Dermatology Times.

This article originally appeared on Rheumatology Advisor