Evidence map›Paper›PMID 25141973›Full record

Trial reportClinical pharmacokinetics2014

Effect of a Roux-en-Y gastric bypass on the pharmacokinetics of oral morphine using a population approach.

Célia Lloret-Linares, Déborah Hirt, Christophe Bardin, Jean-Luc Bouillot, Jean-Michel Oppert, Christine Poitou, François Chast, Stéphane Mouly, Jean-Michel Scherrmann, Jean-François Bergmann and 1 more

Registry-linked trialAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Clinical pharmacokinetics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02641301 (Study of the Concentrations of Long Acting Morphine After Oral Absorption in Subjects Who Underwent Gastric Bypass), which is not on this map. Cited by 31 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 2 pooled it
4.7field-weighted citation impact, top 5% 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.

NCT02641301 phase4unknown statusnot on this mapstarted 2015, after this paper: background citation

Study of the Concentrations of Long Acting Morphine After Oral Absorption in Subjects Who Underwent Gastric Bypass (OBEMO 2)

TypeinterventionalSponsorHopital LariboisièreRan2015 to 2017Enrolled24ConditionsBypass ComplicationsArmsSustained release morphine sulfate, 30 mg
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 2 syntheses or guidelines pooled it, 64 citations in OpenAlex.

  1. The influence of bariatric surgery on oral drug bioavailability in patients with obesity: A systematic review.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2019
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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

11 authors at 6 institutions in 1 country.

Célia Lloret-LinaresInserm, UMR-S 1144 Université Paris Descartes-Paris Diderot, Variabilité de réponse aux psychotropes, Paris, France, celialloret@yahoo.fr.
Déborah Hirt
Christophe Bardin
Jean-Luc Bouillot
Jean-Michel Oppert
Christine Poitou
François Chast
Stéphane Mouly
Jean-Michel Scherrmann
Jean-François Bergmann
Xavier Declèves
Université Paris Cité · FRAssistance Publique – Hôpitaux de Paris · FRHôpital Cochin · FRInserm · FRHôpital Ambroise-Paré · FRHôpital Lariboisière · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesObesity and opioid use for chronic pain in obese individuals are both important public health concerns. The pharmacokinetics of oral morphine after Roux-en-Y gastric bypass (RYGB) are unknown. Therefore, we aimed to study the pharmacokinetics of oral morphine in morbidly obese patients before and after RYGB surgery, to identify the effects of RYGB and the subsequent reversal of morbid obesity on the pharmacokinetic parameters of morphine.

methodsThe pharmacokinetics of oral morphine (30 mg) were studied in 30 obese patients before (Visit 1) and then 7-15 days (Visit 2) and 6 months (Visit 3) after RYGB. A population pharmacokinetic model was used to describe the time course of the plasma morphine concentration, to study the effect of RYGB on morphine pharmacokinetics and to estimate inter-patient variability.

resultsThe oral morphine time to maximum plasma concentration (t max) was twofold lower and maximum plasma concentration (C max) was 1.7 times higher at Visit 2, and t max was 7.5 times lower and C max 3.3 times higher at Visit 3 than at Visit 1. The mean oral morphine area under the plasma concentration-time curve (AUC) increased significantly (1.55-fold) between Visits 1 and 3. Changes in body mass index (BMI) after RYGB were clearly associated with decreased apparent oral morphine clearance and apparent central and peripheral morphine volumes of distribution. None of the other anthropometric parameters explained the inter-subject variability in morphine exposure better than BMI.

conclusionRYGB and the BMI reduction that followed it dramatically increased the rate of morphine absorption and slightly increased morphine exposure. The dose of immediate-release forms of morphine may be divided in obese patients after RYGB to prevent adverse events due to early and high morphine plasma peaks.

Indexed as

Gastric BypassAdministration, OralAdolescentAdultAnalgesics, OpioidBody Mass IndexFemaleHumansMaleMiddle AgedModels, BiologicalMorphineObesity, MorbidPainSleepYoung AdultAnalgesics, OpioidMorphine

Identifiers

PMID25141973
OpenAlexW2056396446

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.