In CARMELINA®, TRAJENTA® demonstrated a long-term cardiovascular and kidney safety profile*1,2.



Demonstrated long-term CV safety profile†1HR 1.02 (95% CI 0.89, 1.17); p=0.74#

Unlike some other DPP4i, TRAJENTA® is not associated with increased risk of HHF vs placebo‡1,3-6HR 0.90 (95% CI 0.74, 1.08); p=0.26**

Demonstrated long-term kidney safety profile§1HR 1.04 (95% CI 0.89, 1.22); p=0.62††

Study Design

  • Primary endpoint
    Time to first occurrence of any of the following components:
    CV death, non-fatal MI, non-fatal stroke (3P-MACE)

  • Key secondary endpoint
    Time to first occurrence of the any of the following components:
    Death due to kidney disease, sustained ESRD or a sustained decrease of ≥40% in eGFR from baseline

*When added to standard of care.

The primary endpoint was time to first occurrence of any of the following components: CV death, non-fatal MI, non-fatal stroke. The primary endpoint occurred in 434/3,494 (12.4%) and 420/3,485 (12.1%) patients in the linagliptin and placebo groups, respectively (HR: 1.02 (95% CI, 0.89, 1.17) non-inferiority p<0.001).

Hospitalisation for heart failure occurred in 209/3,494 (6.0%) vs 226/3,485 (6.5%) patients in the linagliptin and placebo groups, respectively (HR: 0.90 (95% CI, 0.74, 1.08) p=0.26).

§The key secondary endpoint was time to first occurrence of any of the following components: Death due to kidney disease, sustained ESRD or a sustained decrease of ≥40% in eGFR from baseline. The key secondary kidney endpoint occurred in 327/3,494 (9.4%) and 306/3,485 (8.8%) patients in the linagliptin and placebo groups, respectively (HR: 1.04 (95% CI 0.89, 1.22) p=0.62).

#P value for superiority. Hazard ratio for time to 3P-MACE based on Cox regression analyses in patients treated with at least 1 dose of study drug. Median observation time was 2.1 (IQR, 1.5-2.9) years for linagliptin and 2.1 (IQR, 1.5-2.8) years for placebo.

**Hazard ratio based on Cox regression analyses in patients treated with at least 1 dose of study drug.

††Hazard ratio for time to secondary kidney endpoint based on Cox regression analyses in patients treated with at least 1 dose of study drug.

‡‡Albuminuria defined as UACR ≥30 mg/g or ≥30 μg albumin/min or ≥30 mg albumin/24h. Previous macrovascular disease defined as ≥1 of the following: confirmed history of MI, advanced CAD, high-risk single-vessel CAD, history of ischaemic or haemorrhagic stroke, presence of carotid artery disease and presence of peripheral artery disease.

§§Impaired kidney function defined as eGFR 15 to <45 mL/min/1.73 m2 at screening or, eGFR ≥45 to 75 mL/min/1.73 m2 at screening with UACR >200 mg/g or >200 μg albumin/min or >200 mg albumin/24h.

##No head-to-head comparisons.

BMI: Body mass index; CAD: Coronary artery disease; CI: Confidence intervals; CV: Cardiovascular; eGFR: Estimted glomerular filtration rate; ESRD: End-stage renal disease; HHF: Hospitalisation for heart failure; HR: Hazard ratio; IQR: Interquartile range; MI: Myocardial infarction; UACR: Urinary albumin-to-creatinine ratio.

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