2023-09-18 04:39:26
Clinical evaluation was conducted on Japanese subjects, and diabetic ketoacidosis and muscle weakness were not observed.
Entered 2023.09.18 13:39 Views 1 Entered 2023.09.18 13:39 Modified 2023.09.18 13:41 Views 1
Jardiance 10mg product photo. [사진=베링거인겔하임]
The safety of SGLT-2 inhibitors in elderly patients with type 2 diabetes was acceptable. No problems were found regarding the controversial ‘risk of sarcopenia in elderly patients’ with the same class of treatments.
As a result of evaluating ‘Jadien’ (ingredient name: empagliflozin), a representative SGLT-2 inhibitor, a significant blood sugar control effect was confirmed without a decrease in muscle mass or strength in patients aged 65 years or older.
On the 18th, Boehringer Ingelheim and Eli Lilly released the results of the EMPA-ELDERLY study, which analyzed the blood sugar control effect and safety of Jardiance in elderly patients diagnosed with type 2 diabetes.
The study was conducted on Japanese elderly patients over 65 years old (average age 74.1 years), and was published on August 25 in the journal Diabetes, Obesity and Metabolism (DOM). . The study enrolled type 2 diabetes patients aged 65 years or older with a body mass index (BMI) of 22 kg/m2 or more and a glycated hemoglobin (HbA1c) of 7.0 to 10.0%.
Looking at the main results, in the Jardiance treatment group, glycated hemoglobin decreased by 0.57% at week 52 compared to the placebo (fake drug) group, and this blood sugar reduction effect was consistent regardless of age, gender, glomerular filtration rate (eGFR), BMI, etc. The rate of reaching the target glycated hemoglobin was also reported to be 54.7% (35 people) in the Jardiance treatment group, which was more than double the difference from 22.2% (14 people) in the placebo group.
Furthermore, it was confirmed that blood sugar and weight control is possible without reducing muscle mass, even in the face of increased risk of sarcopenia, which is continuously raised with SGLT-2 inhibitors. At week 52, the weight change in the Jardiance treatment group decreased by 3.27 kg and the placebo group increased by 0.90 kg, confirming a significant weight loss benefit in the Jardiance treatment group. There was no significant difference regarding changes in muscle mass and body fat mass.
The incidence of adverse reactions was similar in the two treatment groups, and adverse reactions requiring caution, such as diabetic ketoacidosis, hypoglycemia, and muscle weakness, were not observed.
Soyoung Shin, Vice President and Head of the Medical Department at Boehringer Ingelheim Korea, said, “While several concerns have been raised regarding the use of SGLT-2 inhibitors in elderly patients with type 2 diabetes, Jardiance has demonstrated the ability to safely manage blood sugar in elderly patients through these results. “We confirmed that it is a treatment option,” he emphasized.
He said, “As the study was conducted on Japanese patients with a similar profile to Koreans, we hope that it will serve as a helpful basis for establishing treatment strategies for elderly patients in clinical settings.”
Meanwhile, Jardiance has been approved by the Ministry of Food and Drug Safety as a treatment for adult type 2 diabetes patients whose blood sugar level is not sufficiently controlled and chronic heart failure patients regardless of ejection fraction.
Recently, in Europe (EU), it was approved as a treatment for chronic kidney disease following adult type 2 diabetes and chronic heart failure, expanding its status as a treatment for integrated management of heart-kidney-metabolic diseases.
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