Real world data confirm CV benefits of SGLT-2 inhibitors in diabetic patients
Lower Rates of Hospitalization for Heart Failure and All-Cause Death in New Users of SGLT-2 Inhibitors: The CVD-REAL Study
Presented at ACC.17 by Mikhail KosiborodNews - Mar. 19, 2017
The EMPA-REG OUTCOME trial demonstrated a reduction in HF hospitalisation and all-cause death with empagliflozin, a sodium-glucose co-transporter-2 inhibitor (SGLT-2i), in patients with T2DM and established CVD, who are at high risk for CVD complications, including HF.
However, it is not clear whether the observed benefits are compound-specific, or if they represent a class effect. Moreover, it is not known whether the observed effects also apply to a T2DM population with a broader CV risk profile in real world clinical practice.
In this study, the risk of HF hospitalisation (HHF) in patients with T2DM newly initiated on SGLT-2i versus other glucose-lowering drugs (oGLDs) was evaluated. Moreover, the risk of all-cause death, as well as the risk of all-cause death plus HHF was compared between the two treatment groups, using health records of 6 countries, including 1 299 915 patients. The studied SGLT-2 inhibitors were canagliflozin, dapagliflozin, and empagliflozin. A meta-analysis approach was used, in which hazard ratios from each country were pooled to obtain summary weighted point estimates with 95% CI.
- The rates of HHF were lower in patients on SGLT-2i's compared with oGLDs (HR: 0.61; 95% CI: 0.51-0.73; P<0.001).
- In a sensitivity on-treatment analysis, after adjustment for history of HF or MI or AF, age, gender, frailty, hypertension, obesity/BMI, duration of DM, ACEi or ARB or b-blocker or a-blocker or Ca+-channel blocker or loop diuretic or thiazide diuretic therapy, the rates of HHF were still lower in patients on SGLT-2's compared with oGLDs (HR: 0.61; 95% CI: 0.53-0.69; P<0.001).
- The unadjusted rates of all-cause death also favoured SGLT-2i therapy vs. oGLD (HR: 0.49; 95% CI: 0.41-0.57; P<0.001).
- The unadjusted rates of all-cause death or HHF were lower in patients on SGLT-2's compared with oGLDs (HR: 0.54; 95% CI: 0.48-0.60; P<0.001).
In a large real-world study across six countries and a broad population of T2DM patients, treatment with SGLT-2i versus oGLDs was associated with significant reductions in hospitalisation for HF, all-cause death, and the combined endpoint of HF hospitalization or all-cause death. The observed CV benefits seem to be class-related and, given the broad population of patients with T2DM in general practice, may extrapolate to real world clinical practice. Since the majority (87%) of patients did not have known CV disease, these benefits may extend to those at the lower end of the risk spectrum.
No significant heterogeneity was observed between countries, despite geographic variations in use of SGLT-2i (predominance of canagliflozin in US and dapagliflozin in other countries).
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