Evidence mapPaperPMID 21340661Full record

Trial reportEuropean journal of drug metabolism and pharmacokinetics2011

Evaluation of the pharmacokinetic interaction after multiple oral doses of linagliptin and digoxin in healthy volunteers.

C Friedrich, A Ring, T Brand, R Sennewald, E U Graefe-Mody, H-J Woerle

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of drug metabolism and pharmacokinetics, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
5.3field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 42 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Emerging DPP-4 inhibitors: focus on linagliptin for type 2 diabetes.Diabetes, metabolic syndrome and obesity : targets and therapy · 2013
    Article
  6. Article
  7. Review
  8. Review
  9. Review
  10. Linagliptin-a novel dipeptidyl peptidase inhibitor for type 2 diabetes therapy.Clinical medicine insights. Endocrinology and diabetes · 2012
    Article
  11. Efficacy and safety of linagliptin (tradjenta) in adults with type-2 diabetes mellitus.P & T : a peer-reviewed journal for formulary management · 2011
    Article
  12. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

C FriedrichTranslational Medicine, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397, Biberach, Germany. Christian.Friedrich@boehringer-ingelheim.com
A Ring
T Brand
R Sennewald
E U Graefe-Mody
H-J Woerle
Boehringer Ingelheim (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of this study was to investigate whether multiple doses of the oral and highly selective dipeptidyl peptidase-4 inhibitor linagliptin affect the steady-state pharmacokinetics of the P-glycoprotein substrate digoxin. This single-center, open-label, two-period cross-over study involved healthy subjects (n = 20), randomized to treatment sequence AB or BA, where A comprised 0.25 mg digoxin qd for 5 days, then 0.25 mg digoxin qd plus 5 mg linagliptin qd for 6 days, and B comprised 0.25 mg digoxin qd for 11 days. A treatment-free period (≥35 days for AB and 14 days for BA) separated each treatment in both sequences. There were no clinically significant changes in steady-state pharmacokinetic parameters of digoxin when it was co-administered with linagliptin. The ratio of the adjusted-by-treatment geometric mean ratios and associated 90% confidence intervals for the AUC(τ,ss), C (max,ss) and renal clearance (CL( R,0-24,ss)) of digoxin were all within the bioequivalence range 80-125%, which is important as digoxin has a narrow therapeutic range. There was a low incidence of adverse events, which were randomly distributed between treatment groups. In conclusion, linagliptin did not alter the pharmacokinetics of digoxin in this study, indicating that linagliptin does not inhibit P-glycoprotein or other transporters relevant for digoxin pharmacokinetics. These results suggest that linagliptin and digoxin can be co-administered without dose adjustment. Administration of digoxin alone and with linagliptin was well tolerated.

Indexed as

Administration, OralAdolescentAdultCross-Over StudiesDigoxinDipeptidyl-Peptidase IV InhibitorsDrug InteractionsFemaleHumansLinagliptinMaleMiddle AgedPurinesQuinazolinesYoung AdultDigoxinDipeptidyl-Peptidase IV InhibitorsLinagliptinPurinesQuinazolines

Identifiers

PMID21340661
OpenAlexW1976971977

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.