Evidence for the efficacy of NXY-059 in experimental focal cerebral ischaemia is confounded by study quality.

Macleod, MR ; van der Worp HB ; et al.

In: Stroke, Jg. 39 (2008-10-01), Heft 10, S. 2824-9

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Background and Purpose: The neutral results of the SAINT II trial have again highlighted difficulties translating neuroprotective efficacy from bench to bedside. Animal studies are susceptible to study quality biases, which may lead to overstatement of efficacy. We report the impact of study quality on published estimates of the efficacy of NXY-059 in animal models of stroke.

Methods: We conducted a systematic review and stratified meta-analysis of published studies describing the efficacy of NXY-059 in experimental focal cerebral ischemia.

Results: Overall, NXY-059 improved infarct volume by 43.3% (95% CI, 34.7 to 52.8). Only 2 of 9 publications reported randomization, concealment of treatment allocation, and blinded outcome assessment. Studies not reporting these quality items gave substantially higher estimates of efficacy than did higher-quality studies.

Conclusions: The reported efficacy of NXY-059 in animal models of stroke is confounded by low study quality. The failure of SAINT II highlights the need for substantial improvements in the design, conduct, and reporting of animal studies; journals can play an important role in this by adopting standards for animal studies similar to those agreed over 10 years ago for clinical trials.

Titel:	Evidence for the efficacy of NXY-059 in experimental focal cerebral ischaemia is confounded by study quality.
Autor/in / Beteiligte Person:	Macleod, MR ; van der Worp HB ; Sena, ES ; Howells, DW ; Dirnagl, U ; Donnan, GA
Link:	Zum Volltext
Zeitschrift:	Stroke, Jg. 39 (2008-10-01), Heft 10, S. 2824-9
Veröffentlichung:	1998- : Baltimore, Md. : Lippincott Williams & Wilkins ; <i>Original Publication</i>: Dallas : American Heart Association, 2008
Medientyp:	academicJournal
ISSN:	1524-4628 (electronic)
DOI:	10.1161/STROKEAHA.108.515957
Schlagwort:	Animals Bias Clinical Trials as Topic Benzenesulfonates pharmacology Brain Ischemia drug therapy Cardiovascular Agents pharmacology Research Design standards
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Journal Article; Meta-Analysis; Research Support, Non-U.S. Gov't; Systematic Review Language: English [Stroke] 2008 Oct; Vol. 39 (10), pp. 2824-9. <i>Date of Electronic Publication: </i>2008 Jul 17. MeSH Terms: Benzenesulfonates / pharmacology ; Brain Ischemia / drug therapy ; Cardiovascular Agents / pharmacology ; Research Design / standards ; Animals ; Bias ; Clinical Trials as Topic Comments: Comment in: Stroke. 2008 Oct;39(10):2697-8. (PMID: 18635834) Grant Information: CZB/4/531 United Kingdom CSO_ Chief Scientist Office Substance Nomenclature: 0 (Benzenesulfonates) ; 0 (Cardiovascular Agents) ; 7M1J3HN9VO (disufenton sodium) Entry Date(s): Date Created: 20080719 Date Completed: 20081021 Latest Revision: 20211028 Update Code: 20240513

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