Linagliptin doesn’t raise CVD, CKD risk in high-risk T2D patients

  • Rosenstock J & al.
  • JAMA
  • 9 Nov 2018

  • curated by Emily Willingham, PhD
  • Clinical Essentials
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • Adults with type 2 diabetes (T2D) and high risk for cardiovascular disease (CVD) and chronic kidney disease (CKD) see no increased risk for either with linagliptin (e.g., Tradjenta) vs placebo.

Why this matters

  • Linagliptin is a selective dipeptidyl peptidase 4 inhibitor, a drug class showing cardiovascular safety in previous trials.
  • Those trials did not, however, include patients at high CVD, renal risk.

Key results

  • Primary outcome (CVD composite) in 12.4% with linagliptin (5.77/100 person-years) vs 12.1% with placebo (5.63/100 person-years):
    • Absolute incidence rate difference, 0.13 (95% CI, −0.63 to 0.90) per 100 person-years;
    • HR, 1.02 (95% CI, 0.89-1.17); and 
    • P<.001 for noninferiority.>
  • Secondary outcome, composite kidney disease, in 9.4% with linagliptin (4.89/100 person-years) vs 8.8% on placebo (4.66/100 person-years):
    • Absolute incidence rate difference, 0.22 (95% CI, −0.52 to 0.97) per 100 person-years;
    • HR, 1.04 (95% CI, 0.89-1.22); and
    • P=.62. 
  • Adverse events:
    • 77.2% linagliptin;
    • 78.1% placebo.
  • Death, heart failure hospitalization also did not differ.

Study design

  • Randomized controlled trial (RCT; CARMELINA), August 2013-2016; 605 clinics, 27 countries.
  • Linagliptin 5 mg/day (n=3494) vs placebo (n=3485); median follow-up, 2.2 years.
  • Outcomes: CVD composite (primary); renal outcome composite (secondary).
  • Funding: Boehringer Ingelheim; Eli Lilly.

Limitations

  • Better glycemic control on study drug.
  • Short duration.

Please confirm your acceptance

To gain full access to GPnotebook please confirm:

By submitting here you confirm that you have accepted Terms of Use and Privacy Policy of GPnotebook.

Submit