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SGLT-2 Inhibitors and Cardiovascular Risk: An Analysis of CVD-REAL
Matthew A Cavender1, Anna Norhammar2, Kåre I Birkeland3
1University of North Carolina, Chapel Hill, North Carolina; Baim Institute of Clinical Research, Boston, Massachusetts.
Insights
Sodium-glucose co-transporter-2 inhibitors (SGLT-2i) reduce the risk of death and heart failure (HF) in patients with type 2 diabetes. These cardiovascular benefits were observed consistently, regardless of whether patients had pre-existing cardiovascular disease (CVD).
Area of Science:
- Cardiology
- Endocrinology
- Pharmacology
Background:
- Prior research indicated sodium-glucose co-transporter-2 inhibitors (SGLT-2i) reduce risks of death and heart failure (HF).
- It remains uncertain if SGLT-2i benefits differ based on the presence of cardiovascular disease (CVD).
Purpose of the Study:
- To investigate the association between initiating SGLT-2i therapy and the risks of HF or death.
- To compare these risks in patients with and without established CVD.
Main Methods:
- A multinational, observational study (CVD-REAL) included adults with type 2 diabetes.
- Propensity score matching was used to compare patients initiating SGLT-2i versus other glucose-lowering drugs (GLDs).
- Hazard ratios (HRs) for death, HF, and the composite of HF or death were estimated and pooled.
Main Results:
- Initiating SGLT-2i was linked to a significantly lower risk of death in both patients with and without CVD.
- SGLT-2i initiation also showed associations with reduced risk of HF and the composite outcome of HF or death.
- These benefits were consistent across patient groups, irrespective of established cardiovascular disease status.
Conclusions:
- Initiation of SGLT-2i is associated with reduced risks of death and HF in patients with type 2 diabetes.
- These benefits were observed regardless of pre-existing cardiovascular disease.
- Further clinical trials are ongoing to confirm SGLT-2i benefits in patients without established CVD.
Background:
Prior studies found patients treated with sodium-glucose co-transporter-2 inhibitors (SGLT-2i) had lower rates of death and heart failure (HF). Whether the benefits of SGLT-2i vary based upon the presence of cardiovascular disease (CVD) is unknown.
Objectives:
This study sought to determine the association between initiation of SGLT-2i therapy and HF or death in patients with and without CVD.
Methods:
The CVD-REAL (Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT-2 Inhibitors) study was a multinational, observational study in which adults with type 2 diabetes were identified. Patients prescribed an SGLT-2i or other glucose-lowering drugs (GLDs) were matched based on a propensity score for initiation of an SGLT-2i. Hazard ratios (HRs) for the risk of death, HF, and HF or death in patients with and without established CVD were estimated for each country and pooled.
Results:
After propensity score matching, 153,078 patients were included in each group. At baseline, 13% had established CVD. Compared with therapy using other GLDs, initiation of an SGLT-2i was associated with lower risk of death in patients with and without CVD (HR: 0.56; 95% confidence interval [CI]: 0.44 to 0.70; and HR: 0.56; 95% CI: 0.50 to 0.63, respectively). There were also associations between SGLT-2i and lower risk of HF (HR: 0.72; 95% CI: 0.63 to 0.82; and HR: 0.61; 95% CI: 0.48 to 0.78, respectively) and the composite of HF or death (HR: 0.63; 95% CI: 0.57 to 0.70; and HR: 0.56; 95% CI: 0.50 to 0.62, respectively) observed in patients with and without established CVD.
Conclusions:
In this large, multinational, observational study, initiation of SGLT-2i was associated with lower risk of death and HF regardless of pre-existing CVD. Ongoing clinical trials will provide further evidence regarding the benefit of SGLT-2i in patients without established CVD. (Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT-2 Inhibitors [CVD-REAL]; NCT02993614).
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