Evidence map›Paper›PMID 12898007›Full record

Trial reportDiabetologia2003

Gemfibrozil considerably increases the plasma concentrations of rosiglitazone.

M Niemi, J T Backman, M Granfors, J Laitila, M Neuvonen, P J Neuvonen

Open access · bronzeAbstract readClinical TrialRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetologia, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
6.7field-weighted citation impact, top 2% 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

28 citing papers in PubMed, 187 citations in OpenAlex.

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  8. Effect of gemfibrozil on the pharmacokinetics of pioglitazone.European journal of clinical pharmacology · 2005
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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 2 institutions in 1 country.

M NiemiDepartment of Clinical Pharmacology, University of Helsinki and Helsinki University Central Hospital, Finland.
J T Backman
M Granfors
J Laitila
M Neuvonen
P J Neuvonen
Helsinki University Hospital · FIUniversity of Helsinki · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aims/hypothesisOur aim was to investigate possible interaction between gemfibrozil and rosiglitazone, a thiazolidinedione antidiabetic drug.

methodsIn a randomised crossover study with two phases, 10 healthy volunteers took 600 mg gemfibrozil or placebo orally twice daily for 4 days. On day 3, they ingested a single 4 mg dose of rosiglitazone. Plasma rosiglitazone and its N-desmethyl metabolite concentrations were measured for up to 48 h.

resultsGemfibrozil raised the mean area under the plasma rosiglitazone concentration-time curve (AUC) 2.3-fold (range 1.5- to 2.8-fold; p=0.00002) and prolonged the elimination half-life (t(1/2)) of rosiglitazone from 3.6 to 7.6 h ( p=0.000002). The peak plasma rosiglitazone concentration (C(max)) was increased only 1.2-fold (range 0.9- to 1.6-fold; p=0.01) by gemfibrozil, but gemfibrozil raised the plasma rosiglitazone concentration measured 24 h after dosing (C(24)) 9.8-fold (range, 4.5- to 33.6-fold; p=0.00008). In addition, gemfibrozil prolonged the t(max) of N-desmethylrosiglitazone from 7 to 12 h and reduced the N-desmethylrosiglitazone/rosiglitazone AUC(0-48) ratio by 38% ( p<0.01). CONCLUSIONS/

interpretationGemfibrozil raises the plasma concentrations of rosiglitazone probably by inhibiting the CYP2C8-mediated biotransformation of rosiglitazone. Co-administration of gemfibrozil, or another potent inhibitor of CYP2C8, and rosiglitazone could increase the efficacy but also the risk of concentration-dependent adverse effects of rosiglitazone.

Indexed as

AdultArea Under CurveCross-Over StudiesFemaleGemfibrozilHalf-LifeHumansHypoglycemic AgentsHypolipidemic AgentsMaleOsmolar ConcentrationRosiglitazoneThiazolidinedionesTime FactorsGemfibrozilHypoglycemic AgentsHypolipidemic AgentsN-desmethylrosiglitazoneRosiglitazoneThiazolidinediones

Identifiers

PMID12898007
OpenAlexW2100744461

What OpenQuestion 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 OpenQuestion graph.