Abstract
Abstract Background/Introduction The cardiovascular outcome study of linagliptin versus glimepiride in type 2 diabetes (CAROLINA) was designed to compare the effects on cardiovascular (CV) events, and other outcomes, of linagliptin with glimepiride in patients with relatively early type 2 diabetes with elevated CV risk Purpose These post hoc analyses of the CAROLINA randomized controlled trial explore outcomes in subgroups stratified by prior sulfonylurea (SU) or glinide use. Methods Participants with relatively early type 2 diabetes, high CV risk and HbA1c 6.5–8.5% were randomized to linagliptin 5 mg or glimepiride 1–4 mg once daily with standard of care. 29.5% of patients had prior SU/glinide use. SU/glinides were discontinued at trial entry. Outcomes included time to first CV death/MI/stroke (3P-MACE), time to all-cause mortality, HbA1c change from baseline and time to first hypoglycaemia event. Results 6033 participants received ≥1 study drug dose (mean [SD] age 64.0 [9.5] yrs, HbA1c 7.2 [0.6] %, median diabetes duration 6.3 yrs, 42% with CV disease); 897 linagliptin and 884 glimepiride participants had prior SU/glinide use. Results for 3P-MACE and all-cause mortality were consistent across subgroups with/without prior SU/glinide use (interaction p>0.05; Fig). After some initial differences, there was no meaningful difference in HbA1c between linagliptin vs glimepiride across SU/glinide subgroups and overall. Hypoglycaemia rates were lower with linagliptin vs glimepiride overall and across SU/glinide subgroups, with some heterogeneity for prior SU/glinide use (interaction p<0.01; Fig). Conclusion There was no difference in linagliptin versus glimepiride on 3P-MACE and all-cause mortality, with consistent results across subgroups irrespective of prior SU/glinide use. Hypoglycaemia rates were consistently lower with linagliptin vs glimepiride, regardless of prior SU/glinide use. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Boehringer Ingelheim and Eli Lilly and Company
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