- Linagliptin as an add-on for patients with type 2 diabetes (T2D) carries no increased risk vs placebo for renal disease or cardiovascular (CV) disease (CVD).
Why this matters
- Goal of CARMELINA was to assess cardiovascular and renal safety of linagliptin in patients with T2D and high risk for CVD or chronic kidney disease.
- The drug appears OK for use without dose adjustment, regardless of kidney disease stage.
- Dipeptidyl peptidase 4 inhibitors like linagliptin have shown cardiovascular safety, but safety was not fully addressed in populations with specific renal or CVD risk.
- The findings offer a choice for older patients with reduced renal function, said author Mark E. Cooper, MD, head of the diabetes department in the Central Clinical School at Monash University in Melbourne, Australia, in a statement .
- Cardiovascular outcomes were similar between patients in treatment and placebo groups.
- 12.1% had composite CVD outcome (major adverse cardiac event, MACE) with placebo vs 12.4% with drug (HR, 1.02; 95% CI, 0.89-1.17).
- Heart failure hospitalization, severe kidney events also did not differ between the two.
- Of crucial note, linagliptin was associated with glucose control and reduced risk for worsening albuminuria.
- Results spanned age and renal function groups.
- Randomized, placebo-controlled, multicenter (605 sites, 27 countries) noninferiority trial, 2013-2016, with 6979 adults with T2D (57% with CVD; 74% with kidney disease).
- Treatment was 5 mg linagliptin once a day (n=3494) or placebo (n=3485).
- Patients could have other treatment per clinical need, local practices.
- Primary outcome: time to MACE.
- Funding: Boehringer Ingelheim; Eli Lilly and Company.
- Conference presentation, reported without peer review.