Clinical application of sodium-glucose cotransporter 2 inhibitor into a real-world setting of heart failure care
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ardiovascular Diabetology Open Access
COMMENTARY
Clinical application of sodium‑glucose cotransporter 2 inhibitor into a real‑world setting of heart failure care Atsushi Tanaka* and Koichi Node
Abstract For years there have been concerns whether the results of large-scale clinical trials that include limited specific patient populations can be applied to patients in real-world clinical practice. Therefore, it is crucially important to verify whether emerging evidences obtained from large-scale clinical trials on limited specific patient populations can be applied to patients at real-world clinical settings. Recent cardiovascular outcome trials with sodium-glucose cotransporter 2 (SGLT2) inhibitors showed a consistent risk reduction of approximately 30% for hospitalization for heart failure (HF), and the SGLT2 inhibitors had a great potential to be effective for prevention of HF in a wide variety of type 2 diabetes (T2D) patients independent of their history of HF or cardiovascular disease (CVD). Furthermore, the DAPA-HF trial also demonstrated that dapagliflozin proved clinically effective in patients with HF with reduced ejection fraction regardless of diabetes, suggesting its robust benefits in some specific patients with HF. According to these evidences, SGLT2 inhibitor is increasingly recognized as an emerging and promising option to reduce the risk of HF in patient with T2D. To use appropriately SGLT2 inhibitors for HF prevention in the real-world setting, it would be required to determine the optimal patient population who can receive better clinical benefits from SGLT2 inhibitors. In this commentary, based on the current understandings and lessons learned from the most recent studies, we discussed the importance of future research on the safety and efficacy of SGLT2 inhibitor in clinical situations of HF other than those examined in previous cardiovascular outcome trials. Keywords: Type 2 diabetes, Sodium glucose co-transporter 2 inhibitor, Heart failure, Clinical outcome trial, Real-world
For years there have been concerns whether the results of large-scale clinical trials that include limited specific patient populations can be applied to patients in realworld clinical practice. When the clinical background and characteristics of a patient match those of a ‘specific’ patient population in a clinical trial it is essential to know whether the patient can achieve similar benefits to those observed in the trial, beyond consideration of the estimated number needed to treat. It is therefore important to verify whether clinical trial results can be applied to *Correspondence: [email protected]‑u.ac.jp Department of Cardiovascular Medicine, Saga University, 5‑1‑1 Nabeshima, Saga 849‑8501, Japan
patients at a general population level by evaluating realworld data and using an appropriate estimation model. This is an important step when aligning daily medical care with guidelines that are formulated based mainly on the results of large-scale clinical trials. Recent cardiovascular outcome trials (CVOTs) on newer
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