High‐sensitivity C‐reactive protein, low‐density lipoprotein cholesterol and cardiovascular outcomes in patients with type 2 diabetes in the EXAMINE (Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care) trial

AIMS: We sought to assess the risk of major adverse cardiovascular events (MACE) by utilizing high‐sensitivity C‐reactive protein (hsCRP) level and low‐density lipoprotein cholesterol (LDL‐C) in patients with type 2 diabetes and recent acute coronary syndrome. MATERIALS AND METHODS: Study participants enrolled in the EXAMINE trial (Clinical trials registration number: NCT00968708) and were stratified by baseline hsCRP levels (<1, 1‐3 and >3 mg/L). They were also sub‐divided into 4 groups according to baseline hsCRP (≤3 or >3 mg/L) and achieved LDL‐C (<70 or ≥70 mg/dL) levels. Among 5380 patients, the MACE rate, a composite of cardiovascular death, non‐fatal acute myocardial infarction and non‐fatal stroke, was evaluated during the 30 months of follow‐up. RESULTS: Cumulative incidence of MACE was 11.5% (119 events), 14.6% (209 events) and 18.4% (287 events) in patients with hsCRP levels of <1, 1 to 3 and >3 mg/L, respectively (P < .001). In patients with hsCRP >3 mg/L, the adjusted hazard ratio (95% confidence interval) was 1.42 (1.13, 1.78; P = .002) for MACE compared with patients with hsCRP <1 mg/L. MACE cumulative incidences were 11.0% (128 events), 14.4% (100 events), 15.6% (194 events) and 21.3% (182 events) in patients with low LDL‐C and low hsCRP, low LDL‐C and high hsCRP, high LDL‐C and low hsCRP, and high LDL‐C and high hsCRP levels, respectively (P < .001). CONCLUSIONS: Levels of hsCRP were associated with recurrent cardiovascular events in patients with type 2 diabetes and recent acute coronary syndrome, and this association appears to be independent of and additive to the achieved LDL‐C level.