Kidney Disease End Points in a Pooled Analysis of Individual Patient–Level Data From a Large Clinical Trials Program of the Dipeptidyl Peptidase 4 Inhibitor Linagliptin in Type 2 Diabetes
Why the study?
Does linagliptin reduce kidney disease events in patients with inadequately controlled type 2 diabetes?
Population
5,466 individuals with inadequately controlled type 2 diabetes from 13 pooled phase 2 or 3 trials
Comparison
Linagliptin 5 mg/d vs Placebo
Design
Meta-analysis, randomized, double-blind
Authors
Discussion
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Member takes
Implication
Supports linagliptin renal safety in T2D; extends CV-mandated trial data to kidney disease end points.
Structured PICO
Does linagliptin reduce kidney disease events in patients with inadequately controlled type 2 diabetes?
P
Population
5,466 individuals with inadequately controlled type 2 diabetes (drug-naive with hemoglobin A1c 7.0%-11.0% or on background glucose-lowering therapy with hemoglobin A1c 6.5%-10.5%) from 13 pooled phase 2 or 3 trials
I
Intervention
Linagliptin 5 mg/d
C
Comparator
Placebo
O
Outcome
Composite of first occurrence of new onset of moderate elevation of albuminuria, new onset of severe elevation of albuminuria, reduction in kidney function (serum creatinine increase to ≥250 μmol/L), halving of estimated glomerular filtration rate, acute renal failure, or death from any causecomposite
In a pooled analysis of 13 trials, linagliptin was associated with a 16% reduction in a composite of kidney disease events compared to placebo in patients with type 2 diabetes.
Limitations
- Retrospective and hypothesis-generating study
- Involves short- to midterm clinical trials
Cite This Study
Cooper et al. (2015) studied this question.