STATINS: Study of Atorvastatin Therapy In Sepsis
The STATINS Study was a stratified prospective, randomised double-blind, placebo-controlled, phase II trial to assess the effects of atorvastatin on the biological and clinical outcomes of adult intensive care patients with severe sepsis. The study was to establish whether a definitive phase III trial in Australia and New Zealand is feasible and justifiable, and to provide essential information on the cost and likely sample size for such a trial.
Goals: The aims of this study were to conduct a phase II trial in adult intensive care patients with severe sepsis to assess: 1) the effects of atorvastatin on biological markers and clinical outcomes in severe sepsis; 2) atorvastatin population pharmacokinetics and safety profile; 3) the number of eligible patients, potential recruitment rates and barriers to recruitment; and 4) the feasibility and cost of a definitive phase III trial. A total of 250 patients across 20 sites were recruited into the study.
Rationale: The statins are a class of drug that have been used for many years and are known to reduce mortality from cardiovascular disease. In addition to their action in reducing hepatic synthesis of cholesterol they also have several anti-inflammatory properties that may be of benefit in the treatment of patients with sepsis. A number of observational studies had revealed that patients on statin therapy were at reduced risk of developing sepsis, and that in patients that develop sepsis, the incidence of severe sepsis and death are reduced. In addition, cessation of pre-existing statin therapy had been shown to be associated with a worse outcome in those patients that present with sepsis.
Study Progress: Patient recruitment commenced in July 2007 and completed in August 2010. In March 2011, the results of the STATINS Study were presented at the ANZICS Clinical Trials Group 13th Annual Meeting on Clinical Trials in Intensive Care in Noosa and the 31st International Symposium of Intensive Care and Emergency Medicine in Brussels, Belgium.
Endorsement: The STATINS Study was endorsed by the Australian and New Zealand Intensive Care Clinical Trials Group (ANZICS-CTG).
Funding: The STATINS Study was funded by a National Health and Medical Research Council (NHMRC) project grant.
Contact: For further information about this study, please contact Belinda Howe, on email: email@example.com.
The publications relating to this study include:
Kruger P, Bailey M, Bellomo R, Cooper DJ, Harward M, Higgins A, Howe B, Jones D, Joyce C, Kostner K, McNeil J, Nichol A, Roberts MS, Syres G, Venkatesh B; ANZ-STATInS Investigators-ANZICS Clinical Trials Group. A multicenter randomized trial of atorvastatin therapy in intensive care patients with severe sepsis. Am J Respir Crit Care Med. 2013 Apr 1;187(7):743-50. doi: 10.1164/rccm.201209-1718OC.