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Increased risk of severe hypoglycemic events before and after cardiovascular outcomes in TECOS suggests an at-risk type 2 diabetes frail patient phenotype

Diabetes Care Jan 21, 2018

Standl E, et al. - Researchers performed this study to investigate whether cardiovascular (CV) events were correlated with subsequent severe hypoglycemic events (SHE) risk. Greater risk of SHEs was noted after CV events and greater risk of CV events was revealed following SHEs. The findings indicated a common at-risk type 2 diabetes frail patient phenotype.

Methods

  • The researchers examined time-dependent associations between SHEs and a composite CV end point (fatal/nonfatal myocardial infarction or stroke, hospitalization for unstable angina, hospitalization for heart failure [hHF]) post hoc in 14,671 TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin) participants with type 2 diabetes and CV disease followed for a median of 3.0 years.

Results

  • With sitagliptin therapy, SHEs were uncommon and unassociated (N = 160 [2.2%], 0.78/100 patient-years vs. N = 143 [1.9%], 0.70/100 patient-years for placebo; hazard ratio [HR] 1.12 [95% CI 0.89, 1.40], P=0.33).
  • Patients with SHEs, compared to patients without SHEs, were found to be older with longer diabetes duration, lower body weight, and lower estimated glomerular filtration rate; were more frequently women, nonwhite, and insulin treated; and more often had microalbuminuria or macroalbuminuria.
  • Analyses adjusted for clinical factors demonstrated that SHEs were correlated with increased risk of the primary composite CV end point (1.55 [1.06, 2.28], P=0.025), all-cause death (1.83 [1.22, 2.75], P=0.004), and CV death (1.72 [1.02, 2.87], P=0.040).
  • On the other hand, nonfatal myocardial infarction (3.02 [1.83, 4.96], P < 0.001), nonfatal stroke (2.77 [1.36, 5.63], P=0.005), and hHF (3.68 [2.13, 6.36], P < 0.001) were associated with increased risk of SHEs.
  • Fully adjusted models revealed no association between SHEs and subsequent CV or hHF events.
  • However, the association between CV events and subsequent SHEs remained robust.

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