medwireNews: Treatment with canagliflozin has positive effects on biomarkers of cardiovascular disease (CVD) risk in older patients with type 2 diabetes, research shows.
The 666 patients were participants of a previously published safety and efficacy trial of canagliflozin (100 or 300 mg/day) versus placebo. They were aged between 55 and 80 years at baseline and had no overt CVD, although around three-quarters had a history of hypertension and about a third had microvascular disease.
James Januzzi Jr (Massachusetts General Hospital, Boston, USA) and co-researchers found that levels of two biomarkers “with proven prognostic value for cardiovascular risk” in diabetes patients remained stable in the 450 patients given canagliflozin for 104 weeks, whereas they increased significantly in the 216 patients given placebo.
One biomarker was N-terminal pro–B-type natriuretic peptide, which increased by 2.4 pg/mL from a baseline value of 47.4 pg/mL in the canagliflozin group, compared with a 12.5 pg/mL increase from a baseline of 43.4 pg/mL in the placebo group.
The other biomarker was high-sensitivity troponin I, which did not change from a starting point of 3.2 pg/mL in the canagliflozin group, compared with a rise from 3.3 to 3.6 pg/mL in the placebo group.
The findings are “compatible with the early and sustained cardiovascular benefits seen in the EMPA-REG OUTCOME study,” writes the team in the Journal of the American College of Cardiology.
However, the author of an accompanying editorial, Nikolaus Marx, from University Hospital Aachen in Germany, cautions that the recent CV outcomes trials in diabetes patients have shown that those with overt CVD may respond differently to treatment, compared with those who are at risk but have not yet had a CVD event.
“As such, the biomarker data shown here can only to a limited extent be extrapolated to the higher-risk populations in EMPA-REG OUTCOME and the Integrated CANVAS Program,” he says.
Changes in soluble ST2 did not differ according to treatment allocation, and canagliflozin-treated patients had a slight rise in galectin-3 levels, whereas the placebo group did not.
The researchers suggest this latter finding could be linked to the confounding effect of changes in estimated glomerular filtration rate. “It is unknown whether a small early increase in galectin-3 with canagliflozin is clinically relevant,” they say.
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