Papamargaritis, Dimitris 
ORCID: 0000-0001-5044-1515, Al-Najim, Werd, Lim, Jonathan ZM, Crane, James, Bodicoat, Danielle H, Barber, Shaun, Lean, Michael, McGowan, Barbara, O’Shea, Donal, Webb, David R et al (show 3 more authors)
(2024)
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.
The Lancet Regional Health - Europe, 39.
p. 100853.
Abstract
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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Clinical Trials and Supportive Activities, Clinical Research, 6 Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, 3 Good Health and Well Being |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 21 Mar 2024 14:54 |
| Last Modified: | 12 Apr 2024 03:12 |
| DOI: | 10.1016/j.lanepe.2024.100853 |
| Open Access URL: | https://www.thelancet.com/journals/lanepe/article/... |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3179800 |
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