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Randomized double-blind placebo-controlled trial of 40 mg/day of atorvastatin in reducing the severity of sepsis in ward patients (ASEPSIS Trial)
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Patel, Jaimin M., Snaith, Catherine, Thickett, David R., Linhartova, Lucie, Melody, Teresa, Hawkey, P. M., Barnett, A. H., Jones, Alan, Hong, Tan, Cooke, Matthew, Perkins, Gavin D. and Smith, F. Gao (2012) Randomized double-blind placebo-controlled trial of 40 mg/day of atorvastatin in reducing the severity of sepsis in ward patients (ASEPSIS Trial). Critical Care, Volume 16 (Number 6). Article number R231. doi:10.1186/cc11895 ISSN 1466-609X.
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Official URL: http://dx.doi.org/10.1186/cc11895
Abstract
Introduction: Several observational studies suggest that statins modulate the pathophysiology of sepsis and may
prevent its progression. The aim of this study was to determine if the acute administration of atorvastatin reduces
sepsis progression in statin naïve patients hospitalized with sepsis.
Methods: A single centre phase II randomized double-blind placebo-controlled trial. Patients with sepsis were
randomized to atorvastatin 40 mg daily or placebo for the duration of their hospital stay up to a maximum of
28-days. The primary end-point was the rate of sepsis progressing to severe sepsis during hospitalization.
Results: 100 patients were randomized, 49 to the treatment with atorvastatin and 51 to placebo. Patients in the
atorvastatin group had a significantly lower conversion rate to severe sepsis compared to placebo (4% vs. 24% p =
0.007.), with a number needed to treat of 5. No significant difference in length of hospital stay, critical care unit
admissions, 28-day and 12-month readmissions or mortality was observed. Plasma cholesterol and albumin
creatinine ratios were significantly lower at day 4 in the atorvastatin group (p < 0.0001 and p = 0.049 respectively).
No difference in adverse events between the two groups was observed (p = 0.238).
Conclusions: Acute administration of atorvastatin in patients with sepsis may prevent sepsis progression. Further
multi-centre trials are required to verify these findings.
Trial Registration: International Standard Randomized Control Trial Registry ISRCTN64637517.
| Item Type: | Journal Article | ||||
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| Subjects: | R Medicine > R Medicine (General) R Medicine > RM Therapeutics. Pharmacology |
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Septicemia, Blood -- Diseases , Clinical trials, Clinical medicine -- Research, Statins (Cardiovascular agents), Hospital patients | ||||
| Journal or Publication Title: | Critical Care | ||||
| Publisher: | BioMed Central Ltd. | ||||
| ISSN: | 1466-609X | ||||
| Official Date: | 11 December 2012 | ||||
| Dates: |
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| Volume: | Volume 16 | ||||
| Number: | Number 6 | ||||
| Page Range: | Article number R231 | ||||
| DOI: | 10.1186/cc11895 | ||||
| Status: | Peer Reviewed | ||||
| Publication Status: | Published | ||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||
| Date of first compliant deposit: | 24 December 2015 | ||||
| Date of first compliant Open Access: | 24 December 2015 | ||||
| Funder: | J P Moulton Charitable Foundation, Pfizer Inc. |
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