Dataset Information

Impact of canagliflozin combined with metformin therapy on reducing cardiovascular risk in type 2 diabetes patients.

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.

SUBMITTER: Chen X

PROVIDER: S-EPMC11330023 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature

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Impact of canagliflozin combined with metformin therapy on reducing cardiovascular risk in type 2 diabetes patients.

Chen Xiaoyu X Shu Yimin Y Lin Xuebo X

Diabetology & metabolic syndrome 20240817 1

<h4>Purpose</h4>To investigate the impact and safety of canagliflozin combined with metformin on reducing cardiovascular risk in patients with type 2 diabetes mellitus (T2DM).<h4>Methods</h4>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 combin ...[more]

PMID: 39153984

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Project description:BACKGROUND:In randomised clinical trials, glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and sodium-glucose cotransporter 2 (SGLT-2) inhibitors reduced cardiovascular events in patients with type 2 diabetes (T2D) at high cardiovascular risk, as compared to standard care. However, data comparing these agents in patients with T2D who are at moderate risk is sparse. METHODS:From Danish national registries, we included patients with T2D previously on metformin monotherapy, who started an additional glucose-lowering agent [GLP-1 RA, SGLT-2 inhibitor, dipeptidyl peptidase-4 (DPP-4) inhibitor, sulfonylurea (SU), or insulin] in the period 2010-2016. Patients with a history of cardiovascular events [heart failure (HF), myocardial infarction (MI) or stroke] were excluded. Patients were followed for up to 2 years. Cause-specific adjusted Cox regression models were used to compare the risk of hospitalisation for HF, a composite endpoint of major adverse cardiovascular events (MACE) (MI, stroke or cardiovascular death), and all-cause mortality for each add-on therapy. Patients who initiated DPP-4 inhibitors were used as reference. RESULTS:The study included 46,986 T2D patients with a median age of 61 years and of which 59% were male. The median duration of metformin monotherapy prior to study inclusion was 5.3 years. Add-on therapy was distributed as follows: 13,148 (28%) GLP-1 RAs, 2343 (5%) SGLT-2 inhibitors, 15,426 (33%) DPP-4 inhibitors, 8917 (19%) SUs, and 7152 (15%) insulin. During follow-up, 623 (1.3%, range 0.8-2.1%) patients were hospitalised for HF-hazard ratios (HR) were 1.11 (95% CI 0.89-1.39) for GLP-1 RA, 0.84 (0.52-1.36) for SGLT-2 inhibitors, 0.98 (0.77-1.26) for SU and 1.54 (1.25-1.91) for insulin. The composite MACE endpoint occurred in 1196 (2.5%, range 1.5-3.6%) patients, yielding HRs of 0.82 (0.69-0.97) for GLP-1 RAs, 0.79 (0.56-1.12) for SGLT-2 inhibitors, 1.22 (1.03-1.49) for SU and 1.23 (1.07-1.47) for insulin. 1865 (3.9%, range 1.9-9.0%) died from any cause during follow-up. HRs for all-cause mortality were 0.91 (0.78-1.05) for GLP-1 RAs, 0.79 (0.58-1.07) for SGLT-2 inhibitors, 1.13 (0.99-1.31) for SU and 2.33 (2.08-2.61) for insulin. CONCLUSION:In a nationwide cohort of metformin-treated T2D patients and no history of cardiovascular events, the addition of either GLP-1 RA or SGLT-2 inhibitor to metformin treatment was associated with a similar risk of hospitalisation for HF and death, and a lower risk of MACE for GLP-1 RA when compared with add-on DPP-4 inhibitors. By contrast, initiation of treatment with SU and insulin were associated with a higher risk of MACE. Additionally, insulin was associated with an increased risk of all-cause mortality and hospitalisation for HF.

Project description:Metformin is recommended as a first-line therapy for patients with type 2 diabetes mellitus (T2DM). However, many patients do not achieve glycemic goals with metformin monotherapy and require subsequent combination therapy with other antihyperglycemic agents (AHAs). For newly diagnosed patients with high blood glucose, initial combination therapy may be required to achieve glycemic control. The American Association for Clinical Endocrinologists algorithm for the treatment of T2DM recommends metformin plus a sodium glucose co-transporter 2 (SGLT2) inhibitor as the first oral combination in patients who present with HbA1c ≥7.5%. Canagliflozin, an SGLT2 inhibitor, lowers the renal threshold for glucose and increases urinary glucose excretion leading to a mild osmotic diuresis and a net caloric loss. The effect of canagliflozin is insulin-independent and complementary to other AHAs, including metformin. A fixed-dose combination (FDC) of canagliflozin and metformin is also available with variable dosing, which may be attractive to some patients owing to the potential for reduced pill burden and costs. This article reviews the efficacy and safety of canagliflozin in combination with metformin based on data from the canagliflozin phase 3 clinical program. As initial combination therapy in drug-naïve patients or as dual therapy with metformin or triple therapy in combination with metformin and other AHAs, canagliflozin 100 and 300 mg improved glycemic control and provided reductions in body weight and systolic blood pressure that were sustained for up to 104 weeks. Canagliflozin was generally well tolerated across studies in combination with metformin. An increased incidence of adverse events (AEs) related to the mechanism of SGLT2 inhibition (i.e., genital mycotic infections, urinary tract infections, osmotic diuresis-related AEs) was observed with canagliflozin. Canagliflozin was associated with a low incidence of hypoglycemia when not used in conjunction with AHAs associated with hypoglycemia (i.e., insulin or sulfonylurea). Together, these results support the use of a canagliflozin and metformin FDC as a treatment approach for a broad range of patients with T2DM.FundingJanssen Scientific Affairs, LLC.

Dataset Information

Impact of canagliflozin combined with metformin therapy on reducing cardiovascular risk in type 2 diabetes patients.

Purpose

Methods

Results

Conclusion

Publications

Impact of canagliflozin combined with metformin therapy on reducing cardiovascular risk in type 2 diabetes patients.

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