Despite large-scale randomized clinical trials (RCTs) highlighting a consistent prognostic benefit of sodium-glucose cotransporter 2 inhibitors (SGLT2is) both in diabetic patients at high cardiovascular risk and in those with heart failure, there is relative paucity of data on their biochemical effects in a real-world setting. We performed a retrospective analysis on consecutive diabetic patients who were prescribed a SGLT2i in a tertiary referral center and completed at least 1 year of treatment. Changes in glycated hemoglobin, weight, and hematocrit were compared across 2 cardiovascular risk categories, defined through the inclusion criteria of 3 large RCTs. Of the 459 patients screened, 312 completed 1 year of treatment (68.0%), 92 interrupted the treatment prematurely (20.0%), and 55 were lost to follow-up (12.0%). The most common cause of drug discontinuation was genital or urinary tract infections (9.4%). At 1 year, reduction in glycated hemoglobin concentration (20.7 6 1.5%, P , 0.001) and body weight (2.4 6 4.6 kg, P , 0.001) was comparable between patients at high versus low cardiovascular risk, while hematocrit increase (2.3 6 3.3%, P , 0.001) was more marked in patients with high cardiovascular risk and low baseline hematocrit. In a real-world population of diabetic patients, SGLT2is were well-tolerated at 1 year and led to improved glycemic control and weight loss. Hematocrit increase was more consistent in patients with high cardiovascular risk and signs of fluid overload, indicating euvolemic restoration as a potential cardioprotective mechanism mediated by these compounds.
Aims Heart failure (HF) is a pandemic and despite improvements in therapy, the mortality rate has remained unacceptably high. Sodium glucose cotransporter-2 inhibitors (SGLT2i) have emerged as a promising new class of glucose-lowering drugs, reducing HF-related outcomes across all ejection fraction ranges in clinical trials. However, few studies have assessed their efficacy using echocardiography imaging in a real-world setting. Methods and results Type 2 diabetes mellitus (T2DM) patients treated with SGLT2i from 2015 to 2020 were enrolled in a retrospective observational study. Clinical, biochemical, and echocardiographic data at baseline and 6 and 12 months after treatment initiation were collected. Of the 459 patients screened, 312 (68%) patients completed 1 year of SGLT2i therapy. Side effects were developed in 92 (20%) patients leading them to stop treatment pre-maturely, while 55 (12%) were lost to follow-up. From the 312 patients who completed 1 year of treatment, 83 patients had echocardiography data before initiation and after either 6 or 12 months of treatment and were included in the data analysis. Sample’s average age was 65.78 ± 8.53 years, 23 (27.7%) were females, and the mean BMI was 32.10 ± 6.29 kg/m2. At baseline patients had Hb1Ac 7.94 ± 1.80% and the mean duration of diabetes was 11.19 ± 8.54 years. 59 (71.1%) patients were asymptomatic (NYHA I) at baseline. The mean left ventricular ejection fraction (LVEF) at baseline was 48.40 ± 10.89%, while mean left ventricular end-diastolic volume (LVEDV) was 127.96 ± 41.84 ml. Mean pulmonary artery systolic pressure (PASP) was 33.63 ± 7.89 mmHg and mean tricuspid annular plane systolic excursion (TAPSE) was 20.18 ± 4.17 mm before treatment started. Mean E/e′ ratio at baseline was 9.75 ± 3.50. Mean septal wall thickness before therapy was initiated was 12.05 ± 1.80 mm while mean anterior wall thickness was 11.22 ± 1.52 mm. Almost all of the patients had at least one cardiovascular risk factor, hypertension being the most common (77, 92.8%), while 53 (63.9%) patients had a history of coronary artery disease (CAD), of which 42 (50.6%) had suffered a myocardial infarction. All-cause HF was present in 31 (37.3%) patients (19 HFrEF, 7 HFmrEF, 5 HFpEF). After a mean of 12.94 ± 7.91 months of SGLT2i treatment, left ventricular function was improved as LVEF was increased to 50.62 ± 10.04% (+2.22%, P = 0.018), while LVEDV was reduced to 123.24 ± 41.41 ml (−4.72 ml, P = 0.052). A trend towards improvement of the right ventricular function was also observed as TAPSE increased to 21.45 ± 3.92 mm (+1.27 mm, P = 0.076). PASP remained rather stable (−0.83 mm, P = 0.620), as well as the E/e′ ratio (−0.11, P = 0.857). Septal wall thickness was found unchanged (−0.16 mm, P = 0.449), as well as the anterior wall thickness (−0.63 mm, P = 0.143). After 1 year of treatment the number of asymptomatic patients remained stable (60, P = 0.863). Conclusions SGLT2i improved left ventricular systolic function in a sample of real-world diabetic patients, as shown by the changes in LVEF and LVEDV. A trend towards right ventricular function improvement was also recorded, demonstrated by the TAPSE increase. These findings highlight SGLT2i action on ventricular function and might be hypothesis generating to further elucidate their cardiovascular mechanism of action, beyond their already noted diuretic effect.
Aims Sodium–glucose cotransporter 2 inhibitors (SGLT2i) have become a first-line cardiovascular medication. However, their potential side effects still limit a widespread use in real-world clinical practice. Further, there is uncertainty about the mechanisms mediating SGLT2i-associated cardiovascular benefit. Methods We performed a retrospective analysis on consecutive diabetic patients who were prescribed a SGLT2i in a tertiary referral centre. Patients who completed at least 1 year of treatment were included in the data analysis. Changes in glycated haemoglobin, weight and haematocrit were evaluated and compared across two cardiovascular risk categories, defined through the inclusion criteria of three large randomized clinical trials. Additionally, a modified clinical score (mH2FPEF) was applied to detect the probability of heart failure with preserved ejection fraction (HFpEF). Results Of the 459 patients screened from 2015 to 2020, 312 completed 1 year of treatment (68.0%), 92 interrupted the treatment prematurely (20.0%) and 55 were lost to follow-up (12.0%). The most common causes of drug discontinuation were genital or urinary tract infections (9.4%) and poor glycaemic control (5%). At 1 year, a significant reduction in glycated haemoglobin concentration (−0.6 ± 1.4%, P < 0.001) and body weight (2.4 ± 4.6 Kg, P < 0.001) was observed and was comparable between patients at high vs. low cardiovascular risk. Haematocrit increase at 1 year (2.3 ± 3.3%, P < 0.001) was more marked in patients with high cardiovascular risk and low baseline haematocrit. Among patients with no established heart failure (N = 295), 156 (52.9%) had >50% probability of HFpEF (mH2FPEF ≥3). Conclusions In a real-world population of diabetic patients, SGLT2i were well-tolerated at 1 year and led to improved glycaemic control and weight loss. Haematocrit increase was more consistent in patients with high cardiovascular risk and signs of fluid overload, indicating the potentially beneficial role of euvolemic restoration. More than half of these diabetic patients had a high likelihood of unrecognized HFpEF.
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