Evidence map›Paper›PMID 27418973›Full record

ReviewEuropean heart journal. Cardiovascular pharmacotherapy2016

Assessment of cardiovascular risk of new drugs for the treatment of diabetes mellitus: risk assessment vs. risk aversion.

Faiez Zannad, Wendy Gattis Stough, Raymond J Lipicky, Juan Tamargo, George L Bakris, Jeffrey S Borer, Maria de Los Angeles Alonso García, Samy Hadjadj, Wolfgang Koenig, Stuart Kupfer and 9 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in European heart journal. Cardiovascular pharmacotherapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  8. Observational
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors.

Faiez ZannadINSERM, Centre d'Investigation Clinique - 1433 and Unité 1116, CHU Nancy, Université de Lorraine and F-CRIN INI-CRCT, 54500 Nancy, France f.zannad@chu-nancy.fr.
Wendy Gattis StoughCampbell University College of Pharmacy and Health Sciences, Buies Creek, NC, USA.
Raymond J LipickyLipicky, LLC, North Potomac, MD, USA.
Juan TamargoDepartment of Pharmacology, School of Medicine, Universidad Complutense, Madrid, Spain.
George L BakrisASH Comprehensive Hypertension Center, The University of Chicago Medicine, Chicago, IL, USA.
Jeffrey S BorerThe Howard Gilman Institute, State University of New York Downstate Medical Center, Brooklyn, NY, USA.
Maria de Los Angeles Alonso GarcíaScientific Advice Working Party, European Medicines Agency, London, UK Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK Department of Cardiology, Imperial College Healthcare NHS Trust, London, UK.
Samy HadjadjCHU de Poitiers, Endocrinologie, Université de Poitiers, INSERM CIC1402, Poitiers, France.
Wolfgang KoenigDeutsches Herzzentrum München, Technische Universität München, Munich, Germany DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany.
Stuart KupferTakeda Pharmaceuticals International, Deerfield, IL, USA.
Peter A McCulloughBaylor University Medical Center, Baylor Heart and Vascular Institute, Dallas, TX, USA.
Ofri MosenzonDiabetes Unit, Hadassah Hebrew University Hospital, Jerusalem, Israel.
Stuart PocockDepartment of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
André J ScheenDivision of Diabetes, Nutrition, and Metabolic Disorders, Division of Clinical Pharmacology, CHU de Liège, University of Liège, Liège, Belgium.
Harald SourijDivision of Endocrinology and Diabetology, Medical University of Graz, Centre for Biomarker Research in Medicine, Graz, Austria.
Bart Van der SchuerenLaboratory of Experimental Medicine and Endocrinology, University of Leuven, Leuven, Belgium.
Christina StahreAstraZeneca, Gothenburg, Sweden.
William B WhiteCalhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, CT, USA.
Gonzalo CalvoHospital Clinic of Barcelona, Barcelona, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Food and Drug Administration issued guidance for evaluating the cardiovascular risk of new diabetes mellitus drugs in 2008. Accumulating evidence from several completed trials conducted within this framework raises questions as to whether requiring safety outcome studies for all new diabetes mellitus therapies remains justified. Given the burden of cardiovascular disease in patients with diabetes, the focus should shift towards cardiovascular outcome studies designed to evaluate efficacy (i.e. to determine the efficacy of a drug over placebo or standard care) rather than demonstrating that risk is not increased by a pre-specified safety margin. All stakeholders are responsible for ensuring that new drug approvals occur under conditions of appropriate safety and effectiveness. It is also a shared responsibility to avoid unnecessary hurdles that may compromise access to useful drugs and threaten the sustainability of health systems. It is critical to renew this debate so that stakeholders can collectively determine the optimal approach for developing new drugs to treat type 2 diabetes mellitus.

Indexed as

AnimalsCardiovascular DiseasesDiabetes MellitusGuidelines as TopicHumansHypoglycemic AgentsRisk AssessmentRisk ManagementUnited StatesUnited States Food and Drug AdministrationHypoglycemic AgentsCardiovascular diseaseClinical trialsDiabetes mellitus

Identifiers

PMID27418973
PMCPMC4907355

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.