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Electronic Letters to:

Review Articles:
F. Gao, L. Linhartova, A. McD. Johnston, and D. R. Thickett
Statins and sepsis
Br. J. Anaesth. 2008; 100: 288-298 [Abstract] [Full text] [PDF]
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Electronic letters published:

[Read E-letter] Randomised Trials for Statins in sepsis
Peter S Kruger, The STATInS Investigators   (9 March 2008)

Randomised Trials for Statins in sepsis 9 March 2008
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Peter S Kruger ,
The STATInS Investigators

Send letter to journal:
Re: Randomised Trials for Statins in sepsis

We congratulate Gao et al (1) on the timely review of the place of statin therapy is sepsis. We agree that further prospective clinical research is required to evaluate the potential benefits and limitations of statin use in patients with sepsis and that such studies would need to specifically consider both current statin users and patients not taking statin therapy.

Stopping established statin therapy in patients with acute coronary disease (2), Recent major vascular surgery (3) or recent stroke (4) has been suggested to be associated with worse outcomes. This has not been specifically assessed in patients with sepsis, although a retrospective study by Kruger et al (5) in patients with bacteraemia showed continuing statin use after bacteremia was associated with significantly reduced mortality. These findings suggest that ceasing pre-existing statin therapy in sepsis (as recommended by current prescribing guidelines) may be associated with increased mortality. These findings require further evaluation in an appropriate prospective randomised trial.

Whilst the available evidence suggests that the potential for statins as adjuvant therapy in sepsis should be tested, we believe that an international multicentre trial with mortality as an endpoint would be premature. Preliminary data on absorption, pharmacokinetics, physiological effects and possible adverse effects in critically ill patients with sepsis are required.

With the support of the Australian and New Zealand Intensive Care (ANZIC) Clinical Trials Group and the ANZIC research Centre, we have commenced an Australian National Health and Medical Research Council (NHMRC)-funded multicentre phase II trial in 2007. The STATInS trial (ACTRN 12607000028404) (www.anzctr.org.au/trial_view.aspx?ID=81692) is a phase II, randomised, placebo-controlled study of the safety, pharmacokinetics and effect on inflammatory marker levels of atorvastatin in intensive care patients with severe sepsis. This trial is currently underway in more than 14 Intensive Care Units in Australia and New Zealand and we hope the results will provide a platform to plan future trials examining mortality as an end point.

The STATInS Trial investigators

References:

1 Gao F, Linhartova L, Johnston AM, et al. Statins and sepsis. Br J Anaesth 2008; 100:288-298

2 Heeschen C, Hamm CW, Laufs U, et al. Withdrawal of statins increases event rates in patients with acute coronary syndromes. Circulation 2002; 105:1446-1452

3 Schouten O, Hoeks SE, Welten GM, et al. Effect of statin withdrawal on frequency of cardiac events after vascular surgery. Am J Cardiol 2007; 100:316-320

4 Blanco M, Nombela F, Castellanos M, et al. Statin treatment withdrawal in ischemic stroke: a controlled randomized study. Neurology 2007; 69:904-910

5 Kruger P, Fitzsimmons K, Cook D, et al. Statin therapy is associated with fewer deaths in patients with bacteraemia. Intensive Care Med 2006; 32:75-79

Conflict of Interest:

None declared