Evidence map›GLP-1 receptor agonists × adverse events & safety›PMID 23942319›Full record

Trial reportInternational journal of obesity (2005)2014

Tolerability of nausea and vomiting and associations with weight loss in a randomized trial of liraglutide in obese, non-diabetic adults.

M E J Lean, R Carraro, N Finer, H Hartvig, M L Lindegaard, S Rössner, L Van Gaal, A Astrup, NN8022-1807 Investigators

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of obesity (2005), 2014. The graph read 1 number from its abstract, feeding 1 cell of the map: it supports the treatment in 1. It reports registered trial NCT00422058. Cited by 78 papers, 7 of them syntheses that pooled it.

1number the graph read from it
1cell of the map it votes in
78citing papers in PubMed, 7 pooled it
11.2field-weighted citation impact, top 1% 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.

← favours the treatmentfavours the comparator →
5.300 · no effect
Adverse events & safetyfavours the comparator · against placebo · obesityfeeds one cell of the map
Δ 2.900.50 to 5.30P=0.02
The mean 1-year weight loss on treatment with liraglutide 3.0 mg from randomization was 9.2 kg for participants reporting nausea/vomiting episodes, versus 6.3 kg for those with none (a treatment difference of 2.9 kg (95% confidence interval 0.5-5.3); P=0.02).
FeedsGLP-1 receptor agonists×adverse events & safety

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

GLP-1 receptor agonists×adverse events & safety

SupportsOpen on the map →What to test next →

40 readable studies in this cell: 47 favour the treatment, 14 find no difference, 2 favour the comparator.

Belief with this paper
0.02contested · 1 family supports, 41 contradict · against placebo
Without it
0.00This paper moves it by +0.02.
← favours the treatmentfavours the comparator →
0 · no effect
NCT017204463,297 enrolled · 2013
Δ -0.66-0.80 to -0.52
NCT036893742,274 enrolled · 2018
Δ -0.29-0.38 to -0.20
NCT013360231,663 enrolled · 2011
Treatment contrast -0.64-0.75 to -0.53
NCT040178321,441 enrolled · 2019
Δ -0.20-0.30 to -0.10
NCT018365231,398 enrolled · 2013
Δ -0.20-0.32 to -0.07
NCT019301881,231 enrolled · 2013
Δ -1.06-1.21 to -0.91
NCT007344741,202 enrolled · 2008
Δ -0.71-0.87 to -0.55
NCT008389031,049 enrolled · 2009
Δ -0.91-1.16 to -0.65
NCT009606611,036 enrolled · 2009
Δ -0.04-0.18 to 0.11
NCT050350821,018 enrolled · 2021
Δ -0.24-0.44 to -0.04
NCT01064687978 enrolled · 2010
Δ -1.05-1.22 to -0.88
NCT01117350978 enrolled · 2010
Δ 2.54-3.88 to 8.93

This paper's own estimate is on a different scale from the rest of the cell, so it is not drawn here.

4 · 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.

NCT00422058 phase2completed

Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes: A 20-week Randomised, Double-blind, Placebo-controlled, Six Armed Parallel Group, Multi-centre, Multinational Trial With an Open Label Orlistat Comparator Arm and With an 84-week Extension Period

Ran2007Enrolled564Registered outcomes20Posted comparisons0ConditionsMetabolism and Nutrition Disorder, ObesityArmsliraglutide, Orlistat, Placebo
PMID 19853906PMID 28473337PMID 28950422PMID 28386912PMID 21844879other papers from this trial
Open the trial in the graph
5 · Its place in the literature

Who cites it

78 citing papers in PubMed, 7 syntheses or guidelines pooled it, 205 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. European Guidelines for Obesity Management in Adults.Obesity facts · 2015 · on this map
    Guideline
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Exposure-response analyses of liraglutide 3.0 mg for weight management.Diabetes, obesity & metabolism · 2016 · on this map
    Trial
  15. Trial
  16. Trial
  17. Trial
  18. Review
  19. Article
  20. Article

18 more citing papers are in PubMed but not listed here.

6 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

7 · Who and what money

Authors and funding

9 authors at 5 institutions in 5 countries.

M E J LeanLife-Course Nutrition and Health, School of Medicine, University of Glasgow, Glasgow Royal Infirmary, Glasgow, UK.
R CarraroDepartment of Endocrinology, University Hospital La Princesa, Instituto de Investigación Sanitaria Princesa, Madrid, Spain.
N FinerNational Centre for Cardiovascular Prevention and Outcomes, UCL Institute of Cardiovascular Science, London, UK.
H HartvigNovo Nordisk A/S, Søborg, Denmark.
M L LindegaardNovo Nordisk A/S, Søborg, Denmark.
S RössnerObesity Unit, Karolinska University Hospital Huddinge, Stockholm, Sweden.
L Van GaalDepartment of Endocrinology, Diabetology and Metabolism, Antwerp University Hospital, Antwerp, Belgium.
A AstrupDepartment of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Frederiksberg, Denmark.
NN8022-1807 Investigators
Glasgow Royal Infirmary · GBKarolinska University Hospital · SENovo Nordisk (Denmark) · DKUniversity of Copenhagen · DKHospital Universitario de La Princesa · ES

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

backgroundLiraglutide 3.0 mg, with diet and exercise, produced substantial weight loss over 1 year that was sustained over 2 years in obese non-diabetic adults. Nausea was the most frequent side effect.

objectiveTo evaluate routinely collected data on nausea and vomiting among individuals on liraglutide and their influence on tolerability and body weight.

designA randomized, placebo-controlled, double-blind 20-week study with an 84-week extension (sponsor unblinded at 20 weeks, open-label after 1 year) in eight European countries (Clinicaltrials.gov: NCT00422058). SUBJECTS: After commencing a 500-kcal/day deficit diet plus exercise, 564 participants (18-65 years, body mass index (BMI) 30-40 kg m(-2)) were randomly assigned (after a 2-week run-in period) to once-daily subcutaneous liraglutide (1.2, 1.8, 2.4 or 3.0 mg), placebo or open-label orlistat (120 mg × 3 per day). After 1 year, participants on liraglutide/placebo switched to liraglutide 2.4 mg, and subsequently, to liraglutide 3.0 mg (based on 20-week and 1-year results, respectively).

resultsThe intention-to-treat population comprised 561 participants (n=90-98 per arm, age 45.9±10.3 years, BMI 34.8±2.7 kg m(-2) (mean±s.d.)). In year 1, more participants reported ⩾1 episode of nausea/vomiting on treatment with liraglutide 1.2-3.0 mg (17-38%) than with placebo or orlistat (both 4%, P⩽0.001). Most episodes occurred during dose escalation (weeks 1-6), with 'mild' or 'moderate' symptoms. Among participants on liraglutide 3.0 mg, 48% reported some nausea and 13% some vomiting, with considerable variation between countries, but only 4 out of 93 (4%) reported withdrawals. The mean 1-year weight loss on treatment with liraglutide 3.0 mg from randomization was 9.2 kg for participants reporting nausea/vomiting episodes, versus 6.3 kg for those with none (a treatment difference of 2.9 kg (95% confidence interval 0.5-5.3); P=0.02). Both weight losses were significantly greater than the respective weight losses for participants on placebo (P<0.001) or orlistat (P<0.05). Quality-of-life scores at 20 weeks improved similarly with or without nausea/vomiting on treatment with liraglutide 3.0 mg.

conclusionTransient nausea and vomiting on treatment with liraglutide 3.0 mg was associated with greater weight loss, although symptoms appeared tolerable and did not attenuate quality-of-life improvements. Improved data collection methods on nausea are warranted.

Indexed as

AdolescentAdultAgedAnti-Obesity AgentsBody Mass IndexDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleEuropeFemaleGlucagon-Like Peptide 1HumansLiraglutideMaleMiddle AgedNauseaAnti-Obesity AgentsGlucagon-Like Peptide 1Liraglutide

Identifiers

PMID23942319
PMCPMC4010971
OpenAlexW1997595732

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC-ND
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 Socratic graph.