Document Detail

Randomized clinical trials on surrogate end points: are they useful for evaluating cardiovascular and renal disease protection in hypertension? The case for yes.
MedLine Citation:
PMID:  16565239     Owner:  NLM     Status:  MEDLINE    
Hard end point studies represent the best available evidence for demonstrating the cardiovascular and renal protection that is achievable with a given treatment in hypertensive patients, yet properly designed end point studies require large cohorts of patients and long follow-up, are expensive, and do not provide any insight on the mechanisms that lead to the clinical manifestations. Studies that are based on the incidence of preclinical alterations, i.e., the surrogate end points, may circumvent these limitations provided that their relationship with the major cardiovascular events is scientifically proved. In this respect, among the many surrogate end points that are under investigation, left ventricular hypertrophy, microalbuminuria, and treatment-induced diabetes seem most promising for replacing the hard end points in view of their undisputed mechanistic relationship with the clinical events and of the mounting evidence indicating that from their changes it is possible to predict the clinical outcome of patients. In addition, the limited resources that are required to carry out this kind of investigations make them preferable to hard end point studies for anticipating the cardiovascular and renal benefit associated with the use of antihypertensive agents.
Alberto Morganti
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of the American Society of Nephrology : JASN     Volume:  17     ISSN:  1046-6673     ISO Abbreviation:  J. Am. Soc. Nephrol.     Publication Date:  2006 Apr 
Date Detail:
Created Date:  2006-03-27     Completed Date:  2007-01-12     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  9013836     Medline TA:  J Am Soc Nephrol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  S141-4     Citation Subset:  IM    
Cattedra Medicina Interna, Centro Ipertensione Arteriosa Ospedale San Paolo, Via Di Rudinì 8, 20142 Milano, Italy.
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MeSH Terms
Albuminuria / complications,  diagnosis,  prevention & control
Cardiovascular Diseases / complications,  diagnosis*,  prevention & control*
Diabetes Complications / diagnosis
Diabetes Mellitus / diagnosis,  prevention & control
Hypertension / complications*
Hypertrophy, Left Ventricular / complications,  diagnosis,  prevention & control
Kidney Diseases / complications,  diagnosis*,  prevention & control*
Randomized Controlled Trials as Topic / methods*
Research Design

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