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Effectiveness and cost of integrating a pragmatic pathway for prescribing liraglutide 3.0 mg in obesity services (STRIVE study): study protocol of an open-label, real-world, randomised, controlled trial.
Papamargaritis, Dimitris Al-Najim, Werd Lim, Jonathan Crane, James Lean, Mike le Roux, Carel McGowan, Barbara O'Shea, Donal Webb, David Wilding, John
Papamargaritis, Dimitris
Al-Najim, Werd
Lim, Jonathan
Crane, James
Lean, Mike
le Roux, Carel
McGowan, Barbara
O'Shea, Donal
Webb, David
Wilding, John
Advisors
Editors
Other Contributors
Departments
Date
2020-02-13
Date Submitted
Keywords
complex obesity
liraglutide 3 mg
saxenda
specialist weight management services
WEIGHT LOSS
liraglutide 3 mg
saxenda
specialist weight management services
WEIGHT LOSS
Other Subjects
Subject Mesh
Planned Date
Start Date
Collaborators
Principal Investigators
Files
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e034137.full.pdf
Adobe PDF, 989.37 KB
Alternative Titles
Publisher
Abstract
In this 2-year, multicentre, open-label, real-world randomised controlled trial, 384 adults with severe and complex obesity (defined as body mass index ≥35 kg/m2 plus either prediabetes, type 2 diabetes, hypertension or sleep apnoea) will be randomised via a 2:1 ratio to receive either standard SWMS care (n=128) or standard SWMS care plus a targeted prescribing pathway for LIRA 3 mg with prespecified stopping rules at 16, 32 and 52 weeks (n=256).The primary outcome is to compare the proportion of participants achieving a weight loss of ≥15% at 52 weeks with a targeted prescribing pathway versus standard care. Secondary outcomes include a comparison of (1) the weight loss maintenance at 104 weeks and (2) the budget impact and cost effectiveness between the two groups in a real-world setting.
Language
en
Citation
ISSN
eISSN
2044-6055
ISBN
DOI
10.1136/bmjopen-2019-034137
PMID
32060156