Evidence map›Paper›PMID 23247745›Full record

ArticleSurgical endoscopy2013

Long-term effects of gastric bypass and duodenal switch on systemic exposure of atorvastatin.

Gunn Signe Jakobsen, Ine Blankenberg Skottheim, Rune Sandbu, Hege Christensen, Jo Røislien, Anders Asberg, Jøran Hjelmesæth

Registry-linked trialAbstract readControlled Clinical Trial
In one paragraph

Article in Surgical endoscopy, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03571802 (The Need of Dosing Adjustment for Simvastatin in Obese Patients Post Bariatric Surgery- Laparoscopic Sleeve Gastrectomy), which is not on this map. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
–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.

NCT03571802 phase4unknown statusstarted 2018, after this paper: background citation

The Need of Dosing Adjustment for Simvastatin in Obese Patients Post Bariatric Surgery- Laparoscopic Sleeve Gastrectomy (LSG)

Ran2018Enrolled10Registered outcomes6Posted comparisons0ConditionsHyperlipidemias, ObesityArmssimvastatin
PMID 19494810other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. 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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  13. Modern pharmacological treatment of obese patients.Therapeutic advances in endocrinology and metabolism · 2020
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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

7 authors.

Gunn Signe JakobsenMorbid Obesity Centre, Vestfold Hospital Trust, P.O. Box 2168, 3103, Tønsberg, Norway. gunn.signe.jakobsen@siv.no
Ine Blankenberg Skottheim
Rune Sandbu
Hege Christensen
Jo Røislien
Anders Asberg
Jøran Hjelmesæth

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA previous study of 22 patients undergoing either gastric bypass or duodenal switch showed increased systemic exposure of atorvastatin acid 3-8 weeks after surgery in the majority of patients. This study aimed to investigate the long-term effects on systemic exposure of atorvastatin acid in the same group of patients.

methodsAn 8-h pharmacokinetic investigation was performed a median of 27 months (range 21-45 months) after surgery. Systemic exposure was measured as the area under the plasma concentration versus the time curve from 0 to 8 h postdose (AUC0-8). Linear mixed models with AUC0-8 as the dependent variable were implemented to assess the effect of time, surgical procedure, and body mass index (BMI) as explanatory variables.

resultsThe study enrolled 20 patients. The systemic exposure of atorvastatin acid changed significantly over time (p = 0.001), albeit there was substantial variation between subjects. The effect of time was attenuated but remained significant after adjustment for surgical procedure and BMI (p = 0.048). The initial AUC0-8 increase seen in the majority of patients 3-8 weeks after surgery was normalized long term, with 7 of the 12 gastric bypass patients and 6 of the 8 duodenal switch patients showing decreased AUC0-8 compared with preoperative values.

conclusionsThe systemic exposure of atorvastatin showed a significant change over time after bariatric surgery, albeit with large inter- and intraindividual variations. The findings indicate that patients using atorvastatin or drugs with similar pharmacokinetic properties should be monitored closely for both therapeutic effects and adverse events the first years after gastric bypass and duodenal switch.

Indexed as

AdultAtorvastatinBiliopancreatic DiversionBiological AvailabilityFemaleGastric BypassHeptanoic AcidsHumansHydroxymethylglutaryl-CoA Reductase InhibitorsMaleMiddle AgedObesity, MorbidProspective StudiesPyrrolesAtorvastatinHeptanoic AcidsHydroxymethylglutaryl-CoA Reductase InhibitorsPyrroles

Identifiers

PMID23247745
PMCPMC3661042

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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.