Linagliptin vs glimepiride for cardiovascular risk in early T2D

  • JAMA
  • 19 Sep 2019

  • International Clinical Digest
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Takeaway

  • Linagliptin is noninferior to glimepiride for cardiovascular safety in adults with relatively early type 2 diabetes (T2D) and elevated cardiovascular risk.

Why this matters

  • “When choosing medications to manage type 2 diabetes, cardiovascular safety, glucose-lowering potency, hypoglycaemia risk, effect on body weight, and cost are important considerations,” say researchers.

Study design

  • CAROLINA noninferiority trial of 6033 patients (mean age, 64.0 years; 39.9% women) with T2D (mean HbA1c, 7.2% [range, 6.5%-8.5%]) and elevated cardiovascular risk.
  • Participants were randomly assigned to receive 5 mg of linagliptin or 1-4 mg of glimepiride once daily in addition to usual care.
  • Funding: Boehringer Ingelheim; Eli Lilly and Company.

Key results

  • Primary endpoint was time to first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke over a median follow-up of 6.3 years.
  • The primary outcome occurred in 11.8% (356/3023) of linagliptin-treated patients vs 12.0% (362/3010) receiving glimepiride.
    • HR was 0.98 and met the criteria for noninferiority (P<.001 but not superiority>
  • Proportion of patients with ≥1 hypoglycaemic adverse event was lower with linagliptin vs glimepiride (10.6% vs 37.7%), corresponding to a 77% risk reduction (HR=0.23; 95% CI, 0.21-0.26).

Limitations

  • Results may not apply to patients with more advanced diabetes.