TRAJENTA®

Footnotes

• *CARMELINA® and CAROLINA® included 6,979 and 6,033 patients respectively.
• †CARMELINA® included patients with albuminuria & previous macrovascular disease, and/or impaired kidney function with or without CV comorbidities.
• ‡When added to standard of care.
• #The CARMELINA® primary endpoint was time to first occurrence of any of the following components: cardiovascular (CV) death, non-fatal myocardial infarction (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).
• §The CARMELINA® key secondary endpoint was time to first occurrence of any of the following components: Death due to kidney disease, sustained end-stage renal disease (ESRD) or a sustained decrease of ≥40% in estimated glomerular filtration rate (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).
• ††Because the test for superiority of the primary endpoint was null, findings for the secondary outcomes should be interpreted as exploratory. Time to first occurrence of any hypoglycaemic adverse event within the treated set (events occurring between first study drug intake until 7 days after last permanent study drug stop). Percentage of patients experiencing a hypoglycaemic event was 10.6% for linagliptin and 37.7% for glimepiride (HR: 0.23 (95% CI, 0.21, 0.26) non-inferiority p<0.001).
• ‡‡Renal and other monitoring in patients with type 2 diabetes should be undertaken as per National Institute for Health and Care Excellence (NICE) Guidelines (NG28 T2DM and NG203 CKD).^7,8
• ##Patients with Type 2 Diabetes aged ≥18 years, treated with DPP-4 inhibitors from 15 July 2018 were identified in the Clinical Practice Research Datalink (CPRD) Database. Patients on linagliptin were excluded from the denominator for percentage calculations as no dose reduction is required regardless of renal function. For patients treated with a non-linagliptin DPP-4 inhibitor requiring dose reduction, 33.6% (336/1,000) of patients received a higher dose than specified in the Summary of Product Characteristics (SmPC). For patients who did not require a dose reduction, 11.4% (1,296/11,411) received a lower dose than specified in the SmPC.
• §§For individual dosing on DPP-4 inhibitor dosing in renal impairment, please refer to the individual product SmPC.
• ¶¶eGFR (mL/min/1.73m²) = 175 Å~ (Scr)-1.154 Å~ (Age)-0.203 Å~ (0.742 if female).⁹
• ***Creatinine clearance (CrCl) = (140 - age) x (body weight)/(72 x Scr), x 0.85 for females.
• ** Trajenta® is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control as: monotherapy, when metformin is inappropriate due to intolerance, or contraindicated due to renal impairment; combination therapy, in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control.