A recent Journal of Clinical Medicine study investigates the efficacy of oral semaglutide in patients with type 2 diabetes (T2D).
Study: Oral Semaglutide in Routine Clinical Practice: Characteristics of People with Type 2 Diabetes Started on the Drug and Changes in Their Clinical Parameters after 24 Weeks of Treatment. Image Credit: Andrei_R / Shutterstock.com
Indications for semaglutide
Semaglutide, the first oral antidiabetic medicine for T2D, is a unique glucagon-like peptide-1 receptor agonist (GLP-1RA) that can control the glycemic index and reduce body weight (BW). In addition to its efficacy, multiple clinical trials have confirmed the safety profile of semaglutide.
The PIONEER program was conducted to determine the effectiveness of oral semaglutide in patients at different stages of diabetes. Depending on the stage of diabetes, patients received either monotherapy or multiple doses of oral glucose-lowering agents. Based on the findings of the PIONEER program, the United States Food and Drug Administration (FDA) supported the safety and efficacy of oral semaglutide in 2019, followed by approval from the European Medicines Agency (EMA) in 2020.
According to the American and European guidelines for T2D management, oral semaglutide has beneficial cardiovascular effects and is recommended for T2D patients, particularly those at high or very high risk of cardiovascular diseases (CVD), regardless of glycated hemoglobin (HbA1c) levels.
Although the findings of the PIONEER study were promising, additional research using a large cohort is needed to validate the efficacy of oral semaglutide in reducing CVD risk. Physicians’ inclination to use this drug in routine clinical practice must also be assessed.
About the study
The current retrospective study was conducted at two university-based diabetes centers in Italy. Data were obtained from an electronic chart system software created by Italian diabetes outpatient clinics to manage patients’ medical history.
This platform collected information about diabetic patients, including BW, HbA1c levels, waist circumference (WC), serum creatinine, blood glucose levels, blood pressure, lipid profile, aspartate aminotransferase (AST), estimated glomerular filtration rate (eGFR), and other laboratory tests. The system also provided data on the selected patients' concomitant medications.
Patients were prescribed oral semaglutide during an outpatient visit to the clinic. Initially, patients were treated with a low dose of three mg, followed by seven mg, which was eventually increased to 14 mg in some patients to improve the glycemic index further. These patients were monitored for up to six months after initiating the treatment.
Study findings
In a routine clinical setting, patients treated with initiating oral semaglutide doses exhibited sub-optimal metabolic control and short diabetes duration. However, a significant clinical improvement in HbA1c levels and a reduction in BW were achieved after six months of treatment. These improvements were primarily observed in recently diagnosed patients with diabetes, thus demonstrating the effectiveness of oral semaglutide in the early stages of the disease.
A total of 192 patients with T2D were recruited between September 2021 and December 2022 to assess the effectiveness of oral semaglutide. All participants were Caucasian, with a median age of 67 years.
Approximately 44% of the cohort were women. Study participants were diagnosed with diabetes for an average of nine years. Median fasting glucose and HbA1c levels were 146 mg/dL and 7.9%, respectively.
Before receiving oral semaglutide treatment, study participants had already undergone treatment with sodium-glucose cotransporter-2 inhibitors (SGLT2i), basal or fast-acting insulin, GLP-1RA, pioglitazone, metformin, DPP4i, or sulfonylureas for T2D. During the study period, at six months of oral semaglutide treatment, most patients received seven mg semaglutide, whereas only 2% received the 14 mg dose.
Compared to previous studies, the current study did not observe a significant difference in HbA1c reduction based on gender. All participants exhibited comparable weight loss, thus indicating the effectiveness of oral semaglutide in reducing weight, irrespective of BW at baseline.
The metabolic benefits of this treatment were confirmed through a significant improvement in lipid profiles and WC after six months of oral semaglutide therapy. Blood pressure and microalbuminuria levels also significantly improved with semaglutide treatment. Taken together, the role of oral semaglutide in reducing obesity, improving metabolic health, and lowering the glycemic index has a holistically positive effect on CVD.
Conclusions
The current study demonstrated the potential of oral semaglutide in maintaining glycemic index and reducing BW. This treatment also improved cardiovascular risk parameters, such as lipid profiles, blood pressure levels, and metabolic health.
The clinical significance of oral semaglutide therapy was observed even at a low dose of seven mg, particularly in patients recently diagnosed with diabetes. Importantly, patients also exhibited tolerance to a high dose of 14 mg of oral semaglutide.
- Baldassarre, M. P. A.., Di Dalmazi, G., Coluzzi, S., et al. (2024) Oral Semaglutide in Routine Clinical Practice: Characteristics of People with Type 2 Diabetes Started on the Drug and Changes in Their Clinical Parameters after 24 Weeks of Treatment. Journal of Clinical Medicine 13(11); 3054. doi:10/10.3390/jcm13113054
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2024-05-30 01:05:00Z
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