Evidence map›Paper›PMID 28866826›Full record

ArticleEuropean journal of clinical pharmacology2017

Impact of pioglitazone regulatory withdrawal on antidiabetic drug use and health in diabetic patients.

Antoine Pariente, Yohann Mansiaux, Ana Jarné, Francesco Salvo, Cécile Pageot, Julien Bezin, Andy Smith, Bernard Bégaud

Abstract read
PubMed Publisher
In one paragraph

Article in European journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 30% 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

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Article
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

8 authors at 2 institutions in 1 country.

Antoine ParienteInserm, Bordeaux Population Health Research Center, team Pharmacoepidemiology, UMR 1219, University of Bordeaux, 33000, Bordeaux, France. Antoine.pariente@u-bordeaux.fr.ORCID http://orcid.org/0000-0002-7873-5483
Yohann MansiauxInserm, Bordeaux Population Health Research Center, team Pharmacoepidemiology, UMR 1219, University of Bordeaux, 33000, Bordeaux, France.
Ana JarnéInserm, Bordeaux Population Health Research Center, team Pharmacoepidemiology, UMR 1219, University of Bordeaux, 33000, Bordeaux, France.
Francesco SalvoInserm, Bordeaux Population Health Research Center, team Pharmacoepidemiology, UMR 1219, University of Bordeaux, 33000, Bordeaux, France.
Cécile PageotInserm, Bordeaux Population Health Research Center, team Pharmacoepidemiology, UMR 1219, University of Bordeaux, 33000, Bordeaux, France.
Julien BezinInserm, Bordeaux Population Health Research Center, team Pharmacoepidemiology, UMR 1219, University of Bordeaux, 33000, Bordeaux, France.
Andy SmithCentre Emile Durkheim, University of Bordeaux, 33000, Bordeaux, France.
Bernard BégaudInserm, Bordeaux Population Health Research Center, team Pharmacoepidemiology, UMR 1219, University of Bordeaux, 33000, Bordeaux, France.
Université de Bordeaux · FRSciences Po Bordeaux · FR

Funding

Université de Bordeaux IdEx-HEADS
6 · The paper itself

Abstract

purposeIn 2011, pioglitazone was withdrawn from the French market owing to a potential risk of bladder cancer. This study aimed at assessing the impact of this pioglitazone withdrawal (PW) considering (i) trends in antidiabetic uses and (ii) changes in hospitalization/death rates in diabetic patients following PW.

methodsWe first considered the general population of the Echantillon Généraliste des Bénéficiaires (EGB), a 1/97th representative sample of the French healthcare insurance system beneficiaries, for the 2010-2014 period. In this, for each non-insulinic antidiabetic drug class, changes within the numbers of monthly supplied drug units for 1000 subjects were studied through times series and Unobserved Component Models. Second, we identified from the EGB a cohort of patients who were delivered a non-insulinic antidiabetic between 01 April 2011 and 01 August 2011 (date of PW). In this, post-withdrawal incidences of all-cause hospitalization and death were compared amongst pioglitazone users and non-users using proportional subdistribution hazards models.

resultsPW was accompanied by an increase in metformin (+ 11.7; 95% CI 1.1-22.3) and glinide (+ 11.0; 95% CI 1.2-20.8) numbers of monthly supplied units for 1000 subjects. No significant change was found for GLP-1 agonists, DPP-4 inhibitors, sulphonylureas or alpha-glucosidase inhibitors. In the cohort of non-insulinic antidiabetic users at the time of PW (1093 pioglitazone users, 17,900 non-users), being a pioglitazone user at PW was not associated with a subsequently higher rate of hospitalization.

conclusionsIf PW was accompanied with significant changes in the use of some antidiabetics, no adverse impact of PW on hospitalization or death rates of diabetic type 2 patients was found.

Indexed as

Diabetes MellitusHospitalizationHumansHypoglycemic AgentsPioglitazoneSubstance Withdrawal SyndromeThiazolidinedionesHypoglycemic AgentsPioglitazoneThiazolidinedionesDiabetes mellitusImpactPharmacoepidemiologyPioglitazoneSafety-based drug withdrawal

Identifiers

PMID28866826
OpenAlexW2751386076

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.