Evidence map›Paper›PMID 20002080›Full record

ArticleBritish journal of clinical pharmacology2009

Regulatory challenges for new drugs to treat obesity and comorbid metabolic disorders.

David J Heal, Jane Gosden, Sharon L Smith

Open access · bronzeAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
8.3field-weighted citation impact, top 2% 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.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 86 citations in OpenAlex.

  1. Pooled it
  2. Physical Activity and Its Impact on Cardiometabolic Disorders.Handbook of experimental pharmacology · 2026
    Review
  3. Review
  4. Review
  5. Review
  6. Feeling the pressure: (patho) physiological mechanisms of weight gain and weight loss in humans.Hypertension research : official journal of the Japanese Society of Hypertension · 2017
    Review
  7. Review
  8. Article
  9. Review
  10. Article
  11. Analysing coverage decision-making: opening Pandora's box?The European journal of health economics : HEPAC : health economics in prevention and care · 2014
    Article
  12. Inhibition of the methionine aminopeptidase 2 enzyme for the treatment of obesity.Diabetes, metabolic syndrome and obesity : targets and therapy · 2014
    Review
  13. Article
  14. Article
  15. Pharmacotherapy for childhood obesity: present and future prospects.International journal of obesity (2005) · 2013
    Review
  16. Anti-obesity drugs: past, present and future.Disease models & mechanisms · 2012
    Review
  17. Article
  18. Review
  19. Review
  20. Article
4 · The record

Corrections and comments

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

5 · Who and what money

Authors and funding

3 authors at 1 institution in 1 country.

David J HealRenaSci Consultancy Ltd, BioCity, Nottingham, UK. david.heal@renasci.co.uk
Jane Gosden
Sharon L Smith
RenaSci (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Obesity is a major cause of morbidity and mortality through cardio- and cerebrovascular diseases and cancer. The metabolic consequences of obesity include dyslipidaemia, hypertension, proinflammatory atherogenesis, pre-diabetes and Type 2 diabetes. For a significant proportion of patients, pharmacotherapy to tackle obesity is required as adjunctive support to diet, exercise and lifestyle modification. To this end, the pharmaceutical industry is pursuing many novel drug targets. Although this view is probably not justified, the recent tribulations of rimonabant have created a perception that the regulatory bar for the approval of antiobesity drugs has been raised. Although >5% of placebo-subtracted weight loss maintained over 1 year is the primary efficacy end-point, it is improvements in cardiovascular risk factors that the Food and Drug Administration (FDA) and European Medicines Agency (EMEA) require to grant approval. Safety aspects are also critical in this indication. Many companies are now switching development of their antiobesity drug candidates into other metabolic disorders. Type 2 diabetes is accepted by the industry and FDA, but not EMEA, as the most appropriate alternative. On the other hand, improvements in plasma lipids produced by antiobesity drugs are moderate compared with established therapies, suggesting dyslipidaemia is not a viable development option. Metabolic Syndrome is not accepted by FDA or EMEA as a discrete disease and the agencies will not licence antiobesity drugs for its treatment. The regulatory environment for antiobesity drugs and the spectrum of indications for which they can be approved could change dramatically if positive data for sibutramine emerge from the SCOUT outcome trial.

Indexed as

AdultAnti-Obesity AgentsChildDiabetes Mellitus, Type 2Drug ApprovalDrug DesignDrugs, InvestigationalFemaleHumansHypoglycemic AgentsMaleMetabolic SyndromeObesityRisk FactorsYoung AdultAnti-Obesity AgentsDrugs, InvestigationalHypoglycemic Agents

Identifiers

PMID20002080
PMCPMC2810797
OpenAlexW2013623792

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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 OpenQuestion graph.