Document Detail

Symmetrical analysis of risk-benefit.
MedLine Citation:
PMID:  22404284     Owner:  NLM     Status:  MEDLINE    
To quantify the value of a medical therapy the benefits are weighed against the risks. Effectiveness is defined by objective evidence from predefined endpoints. This benefit is offset against the disadvantage of adverse events. The safety assessment is usually a subjective summary of concerns that can often be neither confirmed nor dismissed. But sometimes a clinical database is so large that a parameter common to both efficacy and safety can be quantified with reasonable certainty: myocardial infarction (MI) is used here as an example. Recently the Food and Drug Administration (FDA) proposed set limits for the incidence of MI as a safety threshold for diabetes treatment. Setting a threshold before something is considered as a safety concern opens the possibility of setting a threshold for clinically important efficacy. When a parameter is common to both safety and efficacy, then logically a unit change in either direction should be of equal weight in the risk and benefit analysis. For example, a doubling in the incidence of myocardial infarction as a safety signal should be given equal weight to the halving of the incidence of myocardial infarction as an efficacy signal. Similarly, if FDA guidance suggests that a less than a 30% increase in the incidence of MI as a safety parameter is considered acceptable, for example for diabetes treatment, when there is no other major toxicity, this opens a debate about a possible inverse threshold for clinical benefit for drugs that reduce a risk factor, such as antihypertensives.
John B Warren; Simon Day; Peter Feldschreiber
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  British journal of clinical pharmacology     Volume:  74     ISSN:  1365-2125     ISO Abbreviation:  Br J Clin Pharmacol     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-10-09     Completed Date:  2013-03-06     Revised Date:  2013-11-07    
Medline Journal Info:
Nlm Unique ID:  7503323     Medline TA:  Br J Clin Pharmacol     Country:  England    
Other Details:
Languages:  eng     Pagination:  757-61     Citation Subset:  IM    
Copyright Information:
© 2012 The Authors. British Journal of Clinical Pharmacology © 2012 The British Pharmacological Society.
Medicines Assessment, 196 Rotherhithe Street, London, UK.
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MeSH Terms
Databases, Factual
Diabetes Mellitus / drug therapy*
Drug Design
Hypoglycemic Agents / adverse effects*,  therapeutic use
Myocardial Infarction / chemically induced*,  epidemiology
Pharmaceutical Preparations / administration & dosage,  adverse effects
United States
United States Food and Drug Administration
Reg. No./Substance:
0/Hypoglycemic Agents; 0/Pharmaceutical Preparations

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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