Abstract
PURPOSE: To investigate the impact and safety of canagliflozin combined with metformin on reducing cardiovascular risk in patients with type 2 diabetes mellitus (T2DM). METHODS: A total of 258 patients with T2DM admitted to our hospital from March 2021 to March 2022 were selected and divided into a control group and an observation group using a random number table. The control group received metformin combined with a placebo, while the observation group received canagliflozin combined with metformin therapy. All patients received drug treatment for 52 weeks. The primary endpoint of the study was major adverse cardiovascular events (MACE), including myocardial infarction, ischemic stroke, and cardiovascular death. Other study parameters included safety after medication, severe adverse reactions, levels of glycated hemoglobin (HbA1c), body mass index (BMI), systolic blood pressure (SBP), diastolic blood pressure (DBP), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and estimated glomerular filtration rate (eGFR). RESULTS: After treatment, HbA1c, FPG, BMI, SBP, and DBP in both groups were lower than before treatment, and those indicators in the observation group were lower than those in the control group (P < 0.05). The eGFR, HDL-C, and LDL-C levels in both groups were higher than before treatment, with the eGFR in the observation group being higher than that in the control group (P < 0.05). The incidence of MACE (myocardial infarction, ischemic stroke, cardiovascular death) in the observation group (5.17%) was significantly lower than that in the control group (12.93%) (HR: 2.16, 95%CI:2.04-2.59, P < 0.05). There were no significant differences in the rates of hospitalization for heart failure (3.45% vs. 1.72%), renal adverse events (4.31% vs. 3.45%), non-cardiovascular death (1.72% vs. 0.86%), all-cause mortality (2.59% vs. 0.86%), and severe adverse reactions (12.07% vs. 9.48%) between the two groups (P > 0.05). CONCLUSION: In patients with T2DM who received the canagliflozin combined with metformin, the mortality rate of cardiovascular causes was significantly reduced. Compared with metformin monotherapy, there is no significant difference in the incidence of serious adverse reactions, and the safety of medication is better, while the blood sugar, blood pressure, and weight of T2DM patients are more actively improved. For T2DM patients with high risk of cardiovascular disease, the combination of canagliflozin and metformin could have a higher benefit in cardiovascular outcomes.