Study design:¹

Spanopoulos D, et al. Clin Ther 2019. 41(8):1622–1630.

This was a real-world study in 17,102 type 2 diabetes patients treated with a DPP-4i assessed the extent to which SmPC-recommended renal thresholds are adhered to in routine clinical practice.*
The results are from patients receiving one of the other four DPP-4i therapies included in the study, and not linagliptin.^†

Cohort 1:

33.6% (336/1,000) were on a higher dose than the SmPC specified.^‡
Patients expected to have their dose adjusted according to their level of renal function (n=1,000):
included patients with index prescriptions for: saxagliptin or sitagliptin (with eGFR^# <45 ml/min/1.73m²), alogliptin (with CrCl** ≤50 ml/min) or vildagliptin (with CrCl** <50 ml/min).

Cohort 2:

11.4% (1,296/11,411) were on a higher dose than the SmPC specified.^‡
Patients expected to receive the full SmPC-recommended dose (n=11,411) including patients with index prescriptions for: saxagliptin or sitagliptin (with eGFR^# ≥45 ml/min/1.73m²), alogliptin (with CrCl** >50 ml/min) or vildagliptin (with CrCl** ≥50 ml/min).

*Renal and other monitoring in patients with type 2 diabetes should be undertaken as per NICE Guidelines (NG28 T2DM and NG203 CKD).^3,4
†Patients with type 2 diabetes aged ≥18 years, treated with non-linagliptin DPP-4is from 15 July 2018 were identified in the CPRD Database. Patients on linagliptin were excluded as no dose reduction is required regardless of renal function.
^‡For individual DPP-4i dosing in renal impairment please refer to the individual product SmPC.
**CrCl = (140 - age) × (body weight)/(72 x sCr), × 0.85 for females.
^#eGFR (mL/min/1.73m2) = 175 × (sCr)-1.154 × (Age)-0.203 × (0.742 if female).²

eGFR: estimated glomerular filtration rate; CrCl: creatinine clearance; SmPC: summary of product characteristics; sCr: serum creatinine; NICE: National Institute for Health and Care Excellence; DPP-4i: dipeptidyl peptidase 4 inhibitor; CPRD: Clinical Practice Research Datalink.