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Effectiveness of integrating a pragmatic pathway for prescribing liraglutide 3.0 mg in weight management services (STRIVE study): a multicentre, open-label, parallel-group, randomized controlled trial

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posted on 2024-03-04, 12:47 authored by D Papamargaritis, W Al-Najim, JZM Lim, J Crane, DH Bodicoat, S Barber, M Lean, B McGowan, D O'Shea, DR Webb, JPH Wilding, CW le Roux, MJ Davies
Background: An effective prescribing pathway for liraglutide 3 mg, an approved obesity pharmacotherapy, may improve treatment access. This trial compared a targeted prescribing pathway for liraglutide 3 mg with multiple stopping rules in specialist weight management services (SWMS) to standard SWMS care. Methods: This phase four, two-year, multicentre, open-label, parallel-group, real-world randomized clinical trial (ClinicalTrials.gov: NCT03036800) enrolled adults with BMI ≥35 kg/m2 plus prediabetes, type 2 diabetes, hypertension or sleep apnoea from five SWMS in Ireland and UK. Participants were randomly allocated (2:1, stratified by centre and BMI) to SWMS care plus a targeted prescribing pathway for once daily subcutaneous liraglutide 3 mg (intervention) with stopping rules at 16 (≥5% weight loss, WL), 32 (≥10% WL) and 52 weeks (≥15% WL) or to SWMS care alone (control) through an online randomization service. The primary outcome was WL ≥15% at 52 weeks, assessed by complete cases analysis. All randomized participants were included in safety analysis. Findings: From November 28, 2017 to February 28, 2020, 434 participants were screened, and 392 randomized (260 intervention; 132 control), while 294 (201 intervention; 93 control) included in the 52 weeks complete case analysis. More intervention than control participants achieved WL ≥15% at 52 weeks [51/201 (25.4%) vs 6/93 (6.5%); odds ratio 5.18; 95% CI 2.09, 12.88; p < 0.0001]. More adverse events occurred in the intervention (238/260, 91.5%; two deaths) than control (89/132, 67.4%; no deaths) group. Interpretation: A targeted prescribing pathway for liraglutide 3 mg helps more people achieve ≥15% WL at 52 weeks than standard care alone. Funding: Novo Nordisk A/S.

Funding

Novo Nordisk A/S

History

Author affiliation

College of Life Sciences/Population Health Sciences

Version

  • VoR (Version of Record)

Published in

The Lancet Regional Health - Europe

Pagination

100853

Publisher

Elsevier BV

issn

2666-7762

eissn

2666-7762

Copyright date

2024

Available date

2024-03-04

Language

en

Deposited by

Dr Dimitrios Papamargaritis

Deposit date

2024-02-29

Data Access Statement

The corresponding author (MJD) is the custodian of the data and will provide deidentified participant data on reasonable request (melanie.davies@uhl-tr.nhs.uk), with the completion of a data access agreement.

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