Evidence map›Paper›PMID 34979510›Full record

ArticleObesity facts2022

Effect of Obesity and Roux-En-Y Gastric Surgery on Omeprazole Pharmacokinetics.

Antonio Portolés-Pérez, Ana Belén Rivas Paterna, Andrés Sánchez Pernaute, Antonio José Torres García, Carmen Moreno Lopera, Luis M Chicharro, Fernando Bandrés, Amanda López-Picado, Miguel A Rubio, Emilio Vargas Castrillón

Abstract readControlled Clinical Trial
In one paragraph

Article in Obesity facts, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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

5 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. 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

10 authors.

Antonio Portolés-PérezServicio de Farmacología Clínica, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.
Ana Belén Rivas PaternaUnidad de Investigación Clínica y Ensayos Clínicos, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain, ab.rivas@enf.ucm.es.
Andrés Sánchez PernauteServicio de Cirugía General y Digestiva, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.
Antonio José Torres GarcíaServicio de Cirugía General y Digestiva, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.
Carmen Moreno LoperaCentro de Salud Lucera, Servicio Madrileño de Salud, Madrid, Spain.
Luis M ChicharroCátedra Complutense de Diagnóstico e Innovación, Facultad de Medicina, Universidad Complutense de Madrid, Madrid, Spain.
Fernando BandrésCátedra Complutense de Diagnóstico e Innovación, Facultad de Medicina, Universidad Complutense de Madrid, Madrid, Spain.
Amanda López-PicadoUnidad de Investigación Clínica y Ensayos Clínicos, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.
Miguel A RubioServicio de Endocrinología y Nutrición, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.
Emilio Vargas CastrillónServicio de Farmacología Clínica, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe prevalence of obesity is increasing globally. The principal aim was to evaluate whether gastric bypass surgery modifies the bioavailability and pharmacokinetic (PK) parameters of omeprazole.

methodsControlled, open-label, bioavailability clinical trial in patients undergoing Roux-en-Y gastric bypass (RYGB). Healthy patients with obesity (body mass index >35) were included and assessed for omeprazole PKs before and after RYGB (1 and 6 months). PK sampling was done at baseline and several times up to 12 h after drug dosing. Pre- and post-surgery parameters were compared using paired ANOVA or Wilcoxon tests, and control versus cases using ANOVA or Mann-Whitney tests. Given the post-surgery change in body weight, parameters were corrected by dose/body weight.

resultsFourteen case and 24 control subjects were recruited; 92% were women (N = 35/38). In patients who underwent RYGB, maximum plasma concentration (Cmax) was significantly reduced at 1 and 6 months after surgery compared with presurgery values (p = 0.001). Regarding the AUC, the values are lower at 1 and 6 months after surgery than at baseline (p < 0.001). The drug clearance was also increased in the first month after surgery. No differences were found between patients 6 months after surgery and controls. Cmax and AUC corrected by dose/body weight were significantly different between the baseline surgery subjects and controls. Discusion/Conclusions: Omeprazole bioavailability is reduced in patients with obesity at 1 and 6 months after RYGB. However, omeprazole PK parameters 6 months after RYGB are similar to control subjects, and thus no dose correction is required after RYGB for a given indication.

Indexed as

Gastric BypassObesity, MorbidBody Mass IndexBody WeightFemaleHumansMaleObesityOmeprazoleOmeprazoleBariatric surgeryBioavailabilityObesityOmeprazolePharmacokinetics-pharmacodynamics

Identifiers

PMID34979510
PMCPMC9021662

What OpenQuestion holds

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Registered trials

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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.