Why the study?
Changes in clinical characteristics of SGLT2i and GLP-1RA real-world initiators following landmark cardiovascular outcome trials were not well characterized.
How did the clinical characteristics and prescribing patterns of SGLT2i and GLP-1RA initiators change following landmark cardiovascular outcome trials compared to DPP-4i initiators?
How did the clinical characteristics and prescribing patterns of SGLT2i and GLP-1RA initiators change following landmark cardiovascular outcome trials compared to DPP-4i initiators?
Following landmark cardiovascular outcome trials, SGLT2i use increased substantially as second-line therapy with only minor increases in the proportion of patients with established ASCVD, highlighting a gap in translating trial evidence to real-world high-risk populations.
Post-CVOT shifts show modest ASCVD changes and earlier SGLT2i use; leaves open whether real-world targeting matches trial populations.
BACKGROUND: We investigated changes in clinical characteristics of SGLT2i and GLP-1RA real-world initiators in Denmark before/after landmark cardiovascular outcome trials. METHODS: We compared first-time SGLT2i (25,070) and GLP-1RA (14,671) initiators to initiators of DPP-4i (n = 34,079), a class without proven cardiovascular benefits. We used linked population-based healthcare data to examine initiation incidence, medication patterns, and pre-existing atherosclerotic cardiovascular disease (ASCVD) during 2014-2017. RESULTS: Nationwide incidence of SGLT2i initiators increased 3.6-fold (53/100,000 to 172/100,000 per year) vs. a 1.5-fold increase for GLP-1RA. DPP-4i initiation remained stable. From the end of 2015, SGLT2i was increasingly used as 2nd-line therapy, while medication patterns were much more stable for GLP-1RA. Among SGLT2i users, ASCVD increased slightly from 28% to 30%; age- and gender-adj. prevalence ratio (aPR) = 1.03 (95% CI:0.97-1.10). In contrast, among GLP-1RA initiators, baseline ASCVD declined from 29% to 27% (aPR: 0.90 (95% CI:0.84-0.97)), and in DPP-4i initiators from 31% to 29% (aPR: 0.91 (95% CI:0.88-0.96)). CONCLUSIONS: Following the EMPA-REG OUTCOME trial in 2015, SGLT2i have become increasingly used as 2nd-line treatment in everyday clinical practice, with only minor increases in patient proportions with ASCVD. For GLP-1RA, we observed more stable therapy lines and slightly decreasing ASCVD in new users despite the LEADER trial.
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Knudsen et al. (2020) studied this question.
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