Statin research in critical illness: hampered by poor trial design?

Marius Terblanche; Neill K. J. Adhikari

doi:10.1186/cc8173

Statin research in critical illness: hampered by poor trial design?

Marius Terblanche^*, Neill K. J. Adhikari

^*Corresponding author for this work

Population Health Sciences

University of Toronto

Research output: Contribution to journal › Editorial › peer-review

1 Citation (Scopus)

Abstract

Statin therapy may prevent an excessive inflammatory response after cardiopulmonary bypass for cardiac surgery. In a recent issue of Critical Care, Morgan and colleagues present data from a well-conducted systematic review and meta-analysis of randomised controlled trials using inflammatory markers as primary outcome measure. They find that pre-operative statin therapy, compared with placebo, may reduce various post-operative markers of systemic inflammation (IL-6, IL-8, C-reactive protein, tumour necrosis factor-alpha). Their ability to make definitive conclusions is limited, however, by the suboptimal methodological quality of the primary studies. Their review suggests that ICU researchers should focus on developing valid surrogate markers and use these to accurately describe the mechanisms and effectiveness of novel therapies before proceeding to large pragmatic trials using mortality as primary outcome.

Original language	English
Article number	1015
Number of pages	2
Journal	CRITICAL CARE
Volume	13
Issue number	6
DOIs	https://doi.org/10.1186/cc8173
Publication status	Published - 11 Dec 2009

Keywords

PLACEBO-CONTROLLED MULTICENTER
ARGININE HYDROCHLORIDE 546C88
MEDIATOR-DIRECTED THERAPY
DOUBLE-BLIND
CORONARY EVENTS
CLINICAL-TRIALS
SEPTIC SHOCK
NO. 144-002
SEPSIS
PROPHYLAXIS

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title = "Statin research in critical illness: hampered by poor trial design?",

abstract = "Statin therapy may prevent an excessive inflammatory response after cardiopulmonary bypass for cardiac surgery. In a recent issue of Critical Care, Morgan and colleagues present data from a well-conducted systematic review and meta-analysis of randomised controlled trials using inflammatory markers as primary outcome measure. They find that pre-operative statin therapy, compared with placebo, may reduce various post-operative markers of systemic inflammation (IL-6, IL-8, C-reactive protein, tumour necrosis factor-alpha). Their ability to make definitive conclusions is limited, however, by the suboptimal methodological quality of the primary studies. Their review suggests that ICU researchers should focus on developing valid surrogate markers and use these to accurately describe the mechanisms and effectiveness of novel therapies before proceeding to large pragmatic trials using mortality as primary outcome.",

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author = "Marius Terblanche and Adhikari, {Neill K. J.}",

year = "2009",

month = dec,

day = "11",

doi = "10.1186/cc8173",

language = "English",

volume = "13",

journal = "CRITICAL CARE",

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T1 - Statin research in critical illness

T2 - hampered by poor trial design?

AU - Terblanche, Marius

AU - Adhikari, Neill K. J.

PY - 2009/12/11

Y1 - 2009/12/11

N2 - Statin therapy may prevent an excessive inflammatory response after cardiopulmonary bypass for cardiac surgery. In a recent issue of Critical Care, Morgan and colleagues present data from a well-conducted systematic review and meta-analysis of randomised controlled trials using inflammatory markers as primary outcome measure. They find that pre-operative statin therapy, compared with placebo, may reduce various post-operative markers of systemic inflammation (IL-6, IL-8, C-reactive protein, tumour necrosis factor-alpha). Their ability to make definitive conclusions is limited, however, by the suboptimal methodological quality of the primary studies. Their review suggests that ICU researchers should focus on developing valid surrogate markers and use these to accurately describe the mechanisms and effectiveness of novel therapies before proceeding to large pragmatic trials using mortality as primary outcome.

AB - Statin therapy may prevent an excessive inflammatory response after cardiopulmonary bypass for cardiac surgery. In a recent issue of Critical Care, Morgan and colleagues present data from a well-conducted systematic review and meta-analysis of randomised controlled trials using inflammatory markers as primary outcome measure. They find that pre-operative statin therapy, compared with placebo, may reduce various post-operative markers of systemic inflammation (IL-6, IL-8, C-reactive protein, tumour necrosis factor-alpha). Their ability to make definitive conclusions is limited, however, by the suboptimal methodological quality of the primary studies. Their review suggests that ICU researchers should focus on developing valid surrogate markers and use these to accurately describe the mechanisms and effectiveness of novel therapies before proceeding to large pragmatic trials using mortality as primary outcome.

KW - PLACEBO-CONTROLLED MULTICENTER

KW - ARGININE HYDROCHLORIDE 546C88

KW - MEDIATOR-DIRECTED THERAPY

KW - DOUBLE-BLIND

KW - CORONARY EVENTS

KW - CLINICAL-TRIALS

KW - SEPTIC SHOCK

KW - NO. 144-002

KW - SEPSIS

KW - PROPHYLAXIS

U2 - 10.1186/cc8173

DO - 10.1186/cc8173

M3 - Editorial

SN - 1466-609X

VL - 13

JO - CRITICAL CARE

JF - CRITICAL CARE

IS - 6

M1 - 1015

ER -

Statin research in critical illness: hampered by poor trial design?

Abstract

Keywords

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