07 Jun First-Line Treatment of Type 2 Diabetes: Cardiovascular Outcomes of SGLT-2 Inhibitors vs Metformin
MedicalResearch.com Interview with:
HoJin Shin, BPharm, PhD
Postdoctoral Research Fellow
Division of Pharmacoepidemiology and Pharmacoeconomics
Department of Medicine
Brigham and Women’s Hospital and Harvard Medical School
MedicalResearch.com: What is the background for this study?
Response: The public health burden of cardiovascular disease has been increasing in people with diabetes along with the burden of diabetes itself.
- Cardiovascular disease affects approximately one-third of the population with type 2 diabetes and accounts for 50%–80% of their mortality
- 1 in 10 people in the US has diabetes
Since 2008, the US FDA has recommended post-approval cardiovascular outcome trials to ensure the safety of new glucose-lowering drugs responding to this growing burden of cardiovascular disease in type 2 diabetes and the potential increase in cardiovascular risk with certain existing glucose-lowering drugs (e.g., rosiglitazone).
Notably, SGLT-2i have demonstrated superiority to placebo in reducing the risk of cardiovascular events, including hospitalization for heart failure. Consequently, beginning in 2018, clinical guidelines in the US have recommended SGLT-2i as a preferred second-line treatment for patients with type 2 diabetes and cardiovascular disease. As the paradigm of second-line pharmacological treatment for type 2 diabetes has shifted to include the management of cardiovascular risk in addition to glycemic control, this further raised the question of whether SGLT-2i should be advanced to first-line treatment. Since 2019, SGLT-2i have been recommended as a first-line agent for patients with type 2 diabetes and cardiovascular disease by the European guidelines (the European Society of Cardiology and the European Association for the Study of Diabetes).
In the absence of head-to-head RCTs, non-randomized studies using real-world data could provide information on whether SGLT-2i may have greater cardiovascular benefits over metformin more timely than randomized clinical trials among both patients with and without existing CVD. Therefore, we evaluated the risk for cardiovascular events among adults with T2D who initiated treatment with first-line SGLT-2i versus metformin in clinical practice.
MedicalResearch.com: What are the main findings?
Response: We found that patients treated with SGLT-2i had a similar risk of a composite of myocardial infarction, stroke, and all-cause mortality but a lower risk of hospitalization for heart failure compared with patients treated with metformin. The risk for safety events was similar except for genital infections, which was higher among patients who were treated with SGLT-2i.
MedicalResearch.com: What should readers take away from your report?
Response: Our results suggest that SGLT-2i may be considered as a first-line treatment for patients with cardiovascular disease or at increased risk for cardiovascular events; however, such consideration should be still based on the benefit and risk assessment as there is still uncertainty in terms of the safety of SGLT-2i, and treatment guidelines.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: More evidence from randomized controlled trials or observational studies will help us identify patients who would benefit most from using SGLT-2i as first-line type 2 diabetes treatment.
HoJin Shin, Sebastian Schneeweiss, Robert J. Glynn, et al; Cardiovascular Outcomes in Patients Initiating First-Line Treatment of Type 2 Diabetes With Sodium–Glucose Cotransporter-2 Inhibitors Versus Metformin: A Cohort Study. Ann Intern Med. [Epub 24 May 2022]. doi:10.7326/M21-4012
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