In CAROLINA®, TRAJENTA® demonstrated a long-term cardiovascular safety profile with a consistently lower risk of hypoglycaemic events*1,2.
CV safety profile*2
(vs glimepiride)HR 0.98 (95% CI 0.84, 1.14); p=0.76**
(vs glimepiride)Incidence of hypoglycaemic events was lower with linagliptin versus glimepiride across all predefined hypoglycaemia-severity categories***
- Primary endpoint
Time to first occurrence of any of the following components: CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI), or non-fatal stroke (3P-MACE)
- Key secondary endpoint
Proportion of patients on-treatment and maintaining HbA1c <7.0% at final visit without the need for rescue medication, without any moderate or severe hypoglycaemic episodes, and without >2% weight gain between end of titration and final visit
*The CAROLINA® primary endpoint was defined as TRAJENTA® vs glimepiride in time to first occurrence of CV death, non-fatal Ml or non-fatal stroke. The primary endpoint was tested for non-inferiority (against 1.3 for the upper bound of the 95% confidence interval) followed by superiority. The primary endpoint occurred in 356/3,023 (11.8%) and 362/3,010 (12.0%) patients in the linagliptin and glimepiride groups, respectively (HR: 0.98 (95% Cl, 0.84, 1.14) p<0.001 for non-inferiority);
**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.
***Because the test for superiority of the primary endpoint was null, findings for the secondary outcomes should be interpreted as exploratory. Percentage of patients experiencing a hypoglycaemic event (for events classified as either moderate or severe) was 6.8% for linagliptin and 33.0% for glimepiride. Moderate hypoglycaemia was defined as symptomatic with plasma glucose ≤70 mg/dL, and severe hypoglycaemia was any event requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitativeactions. (HR 0.18 (95% CI, 0.15, 0.21) p<0.0001).