×
Choose Speciality

EXPLORE!

LOGIN

Evolving Landscape of DPP-4i CVOTs with CARMELINA in Focus

  1014 Views

Dr Sanjay Kalra, Haryana    20 November 2018

  1. Linagliptin is a single-dose dipeptidyl peptidase-4 inhibitor (DPP-4i) with established clinical efficacy and safety. It is the only globally available DPP-4i excreted mainly via gut/bile. The drug requires no dose adjustment.
  2. The CARMELINA trial was designed to evaluate the cardiovascular (CV) and kidney safety of linagliptin in patients with type 2 diabetes mellitus (T2DM) vs. placebo. Primary endpoint included CV death, nonfatal MI and nonfatal stroke. Key secondary endpoint included sustained estimated glomerular filtration rate (eGFR) decrease by ≥40%, progression to sustained end-stage kidney disease (ESKD) and death due to kidney disease. Patients included in the trial had established cardiovascular disease (CVD), kidney disease or both. Patients with T2DM were randomized to oral treatment with linagliptin or placebo on top of standard of care.
  3. The trial included a broad group of kidney disease patients.
  4. The trial showed no increased risk for hospitalization for HF even in high-risk patients with pre-existing HF.
  5. Event rate of hospitalized HF was 2.8 times higher in patients with eGFR <45.
  6. The long-term kidney safety profile of linagliptin was confirmed in the first prespecified adjudicated kidney outcome data with DPP-4i.
  7. The number of patients who had ≥1 new glucose-lowering medication introduced post-baseline was significantly lower with linagliptin compared to placebo.
  8. With linagliptin, fewer patients initiated or increased insulin dose.
  9. Overall, linagliptin did not increase the risk of hypoglycemia.
  10. The trial showed a reassuring long-term kidney safety profile. It fills a data gap as it included patients across the full range of kidney function.
  11. With CARMELINA, linagliptin showed a reassuring CV safety profile and a robust and reassuring HF safety.

To comment on this article,
create a free account.

Sign Up to instantly get access to 10000+ Articles & 1000+ Cases

Already registered?

Login Now

Most Popular Articles

News and Updates

eMediNexus provides latest updates on medical news, medical case studies from India. In-depth medical case studies and research designed for doctors and healthcare professionals.