Key result
Luseogliflozin did not significantly improve high-risk lipoprotein profiles, including malondialdehyde LDL, or inflammatory markers compared to voglibose in patients with type 2 diabetes and heart failure.
Why the study?
Sodium-glucose cotransporter 2 inhibitors can reduce cardiovascular events in patients with heart failure regardless of diabetes status, but their effects on high-risk lipid profiles and inflammatory markers required investigation.
Does luseogliflozin improve atherogenic lipoproteins and inflammatory markers compared to voglibose in patients with type 2 diabetes and heart failure with preserved ejection fraction?
RCT (n=157)
Open-label
1:1 computer-generated random sequence web-response system
Yes
Does luseogliflozin improve atherogenic lipoproteins and inflammatory markers compared to voglibose in patients with type 2 diabetes and heart failure with preserved ejection fraction?
Luseogliflozin effects on lipids/inflammation in diabetic HF are hypothesis-generating; leaves open any extension to clinical outcomes.
Sodium-glucose cotransporter 2 inhibitors could reduce cardiovascular events in patients with heart failure irrespective of diabetes status. In this prespecified sub-analysis of randomised-controlled trial, we investigated the efficacy of luseogliflozin (2.5 mg daily), a sodium-glucose cotransporter 2 inhibitor, with that of voglibose (0.6 mg daily), an alpha-glucosidase inhibitor, on high-risk lipid profile and inflammatory markers in patients with type-2 diabetes and heart failure. Among the 157 patients studied, there were no significant differences in the mean malondialdehyde LDL or small-dense LDL cholesterol levels between the luseogliflozin and voglibose groups (percent change: 0.2% vs. - 0.6%, p = 0.93; - 1.7% vs. - 8.6%, p = 0.21) after 12 weeks in comparison to levels at the baseline. No significant difference was observed between the two groups in the adiponectin and high-sensitivity C-reactive protein levels after 12 weeks compared to the baseline levels (percent change, - 1.6% vs. - 4.0% and 22.5% vs. 10.0%; p = 0.52 and p = 0.55, respectively). In conclusion, in patients with type-2 diabetes and heart failure, compared to voglibose, luseogliflozin did not significantly improve the high-risk lipoprotein profile including malondialdehyde LDL and small-dense LDL cholesterol or the levels of inflammatory markers, including adiponectin and high-sensitivity C-reactive protein.Trial registration: Trial number: UMIN-CTR, UMIN000018395; Registered 23 July 2015; URL: https://www.umin.ac.jp/ctr/index.htm .
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Ejiri et al. (2022) conducted an RCT in Type 2 diabetes and heart failure with preserved ejection fraction (n=157). Luseogliflozin vs. Voglibose (0.2 mg three times daily) was evaluated on Percent change in malondialdehyde low-density lipoprotein (MDA-LDL) from baseline to 12 weeks (p=0.93). Luseogliflozin did not significantly improve high-risk lipoprotein profiles, including malondialdehyde LDL, or inflammatory markers compared to voglibose in patients with type 2 diabetes and heart failure.
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