Results 31 to 40 of about 79,600 (335)

Metformin for non-diabetic patients with coronary heart disease (the CAMERA study): a randomised controlled trial [PDF]

, 2009
<br>Background: Metformin reduces cardiovascular risk in patients with type 2 diabetes seemingly independent of lowering blood glucose concentration. We assessed the cardiovascular effects of metformin in individuals without type 2 diabetes.</br&
Eddy, Despres, Grundy, Bird, Seifarth, Nathan, Fontbonne, Charles, Holman, Kooy, Knowler, Alberti, Vergeer, Touboul, Liang, Spence, Levey, Meaney, Taylor, Selvin, Boussageon, Sjöström, Shyangdan, de Jager, Bots, Taylor, Boden, Huang, Baigent, Lorenz, Mazzone, Taylor, Lonn, Lexis   +33 more
core   +5 more sources

How to use frailtypack for validating failure-time surrogate endpoints using individual patient data from meta-analyses of randomized controlled trials.

PLoS ONE, 2020
BACKGROUND AND OBJECTIVE:The use of valid surrogate endpoints can accelerate the development of phase III trials. Numerous validation methods have been proposed with the most popular used in a context of meta-analyses, based on a two-step analysis ...
Casimir Ledoux Sofeu, Virginie Rondeau
doaj   +1 more source

Two Decades of Cardiovascular Trials With Primary Surrogate Endpoints: 1990–2011

Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease, 2017
Background Surrogate endpoint trials test strategies more efficiently but are accompanied by uncertainty about the relationship between changes in surrogate markers and clinical outcomes.
Behnood Bikdeli, Natdanai Punnanithinont, Yasir Akram, Ike Lee, Nihar R. Desai, Joseph S. Ross, Harlan M. Krumholz   +6 more
doaj   +1 more source

Evaluation of the effectiveness of lipid-lowering agents

Учёные записки Санкт-Петербургского государственного медицинского университета им. Акад. И.П. Павлова, 2020
Introduction. Nowadays, lipid-lowering therapy is considered an essential strategy for primary and secondary prevention of cardiovascular outcomes, which is confirmed by numerous studies. Nevertheless, researches are often guided by analysis of surrogate
V. G. Shevko, M. A. Galas, T. L. Galankin, A. S. Kolbin   +3 more
doaj   +1 more source

Results of the MRI substudy of the intravenous magnesium efficacy in stroke trial [PDF]

, 2009
<p><b>Background and Purpose:</b>Although magnesium is neuroprotective in animal stroke models, no clinical benefit was confirmed in the Intravenous Magnesium Efficacy in Stroke (IMAGES) trial of acute stroke patients.
Alger, J.R., Chen, C., Davis, S.M., De Silva, D.A., Kidwell, C.S., Lees, K.R., Muir, K.W., Saver, J.L., Starkman, S., Weir, C.J.   +9 more
core   +1 more source

Evaluating the evidence behind the surrogate measures included in the FDA's table of surrogate endpoints as supporting approval of cancer drugs

EClinicalMedicine, 2020
Background: In July 2018, the FDA first published a table listing all surrogate measures that it has used, and may accept for future use, in regulatory approval. However, the strength of surrogacy for those measures was not formally assessed.
Bishal Gyawali, Spencer P. Hey, Aaron S. Kesselheim   +2 more
doaj   +1 more source

Surrogate endpoint evaluation using data from one large global randomized controlled trial

BMC Medical Informatics and Decision Making, 2021
Background Robust identification of surrogate endpoints can help accelerate the development of pharmacotherapies for diseases traditionally evaluated using true endpoints associated with prolonged follow-up.
Milan Geybels, Benjamin Ole Wolthers, Frederik Flindt Kreiner, Søren Rasmussen, Robert Bauer   +4 more
doaj   +1 more source

Time to review the role of surrogate endpoints in health policy: state of the art and the way forward [PDF]

, 2017
The efficacy of medicines, medical devices, and other health technologies should be proved in trials that assess final patient-relevant outcomes such as survival or morbidity.
Buyse, M., Ciani, O., Drummond, M.F., Rasi, G., Saad, E.D., Taylor, R.S.   +5 more
core   +2 more sources

The use of validated and nonvalidated surrogate endpoints in two European Medicines Agency expedited approval pathways: A cross-sectional study of products authorised 2011-2018.

PLoS Medicine, 2019
BackgroundIn situations of unmet medical need or in the interests of public health, expedited approval pathways, including conditional marketing authorisation (CMA) and accelerated assessment (AA), speed up European Medicines Agency (EMA) marketing ...
Catherine Schuster Bruce, Petra Brhlikova, Joseph Heath, Patricia McGettigan   +3 more
doaj   +1 more source

Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study

BMC Medicine, 2018
Background The U.S. Food and Drug Administration (FDA) often approves new drugs based on trials that use surrogate markers for endpoints, which involve certain trade-offs and may risk making erroneous inferences about the medical product’s actual ...
Joshua D. Wallach, Oriana Ciani, Alison M. Pease, Gregg S. Gonsalves, Harlan M. Krumholz, Rod S. Taylor, Joseph S. Ross   +6 more
doaj   +1 more source