Early Response to Sibutramine in Patients Not Meeting Current Label Criteria: Preliminary Analysis of SCOUT Lead‐in Period Article Swipe
Ian D. Caterson
,
Walmir Coutinho
,
Nick Finer
,
Luc Van Gaal
,
Aldo P. Maggioni
,
Christian Torp‐Pedersen
,
Arya M. Sharma
,
Hong Ge
,
D Santoro
,
Gillian Shepherd
,
Philip James
·
YOU?
·
· 2009
· Open Access
·
· DOI: https://doi.org/10.1038/oby.2009.327
YOU?
·
· 2009
· Open Access
·
· DOI: https://doi.org/10.1038/oby.2009.327
The Sibutramine Cardiovascular Outcomes (SCOUT) trial protocol defines a patient population predominantly outside current European Union label criteria. This article explores responses to sibutramine during the 6‐week, single‐blind, lead‐in period between patients who conformed to the label requirements (“conformers”) and those who did not (“nonconformers”). SCOUT is an ongoing, randomized, double‐blind, placebo‐controlled outcome trial in overweight/obese patients at high risk of a cardiovascular event. In total, 10,742 patients received sibutramine and weight management during the lead‐in period. Initial responses were assessed post hoc in label conformers and nonconformers. Of that 8.1% patients met label criteria; 91.9%, the majority with cardiovascular disease and/or blood pressure >145/90 mm Hg, were nonconformers. Conformers and nonconformers had similar reductions in body weight (median change −2.2 kg) and waist circumference (women: −2.0 cm for both groups; men: −1.5 cm vs. −2.0 cm for conformers and nonconformers, respectively) over the 6‐week period. Greater blood pressure falls were evident in nonconformers (median change −3.5/−1.0 vs. −1.0/0.0 mm Hg). Both groups had small pulse rate increases; median 1.5 bpm (nonconformers) vs. 3.0 bpm (conformers). There was a low incidence of serious adverse events (conformers: 1.0%; nonconformers: 2.8%) and ∼93% of patients in both groups completed the 6‐week period. The SCOUT lead‐in period evaluating weight management with sibutramine confirms its good tolerability and efficacy in patients who meet current label criteria. Preliminary data from high‐risk patients for whom sibutramine is currently contraindicated suggest a low discontinuation rate and few serious adverse events but confirmation from the SCOUT outcome data is needed.
Related Topics
Concepts
Sibutramine
Medicine
Tolerability
Population
Weight loss
Overweight
Blood pressure
Adverse effect
Weight management
Internal medicine
Obesity
Environmental health
Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1038/oby.2009.327
- https://onlinelibrary.wiley.com/doi/pdfdirect/10.1038/oby.2009.327
- OA Status
- bronze
- Cited By
- 19
- References
- 18
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W2025150013
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W2025150013Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1038/oby.2009.327Digital Object Identifier
- Title
-
Early Response to Sibutramine in Patients Not Meeting Current Label Criteria: Preliminary Analysis of SCOUT Lead‐in PeriodWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2009Year of publication
- Publication date
-
2009-10-08Full publication date if available
- Authors
-
Ian D. Caterson, Walmir Coutinho, Nick Finer, Luc Van Gaal, Aldo P. Maggioni, Christian Torp‐Pedersen, Arya M. Sharma, Hong Ge, D Santoro, Gillian Shepherd, Philip JamesList of authors in order
- Landing page
-
https://doi.org/10.1038/oby.2009.327Publisher landing page
- PDF URL
-
https://onlinelibrary.wiley.com/doi/pdfdirect/10.1038/oby.2009.327Direct link to full text PDF
- Open access
-
YesWhether a free full text is available
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-
bronzeOpen access status per OpenAlex
- OA URL
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https://onlinelibrary.wiley.com/doi/pdfdirect/10.1038/oby.2009.327Direct OA link when available
- Concepts
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Sibutramine, Medicine, Tolerability, Population, Weight loss, Overweight, Blood pressure, Adverse effect, Weight management, Internal medicine, Obesity, Environmental healthTop concepts (fields/topics) attached by OpenAlex
- Cited by
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19Total citation count in OpenAlex
- Citations by year (recent)
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2025: 1, 2017: 1, 2016: 1, 2015: 1, 2014: 1Per-year citation counts (last 5 years)
- References (count)
-
18Number of works referenced by this work
- Related works (count)
-
10Other works algorithmically related by OpenAlex
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