Age bias in clinical trials in sepsis: how relevant are guidelines to older people?
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Abstract
Severe sepsis has a high mortality, and both incidence and mortality increases
with increasing age. In recent years, several specific therapies have been
recommended by guidelines to reduce mortality in severe sepsis. We review the age
distribution in the key clinical trials on which these recommendations are made.
Many therapeutic strategies have been evaluated, mainly in younger patients, with
extrapolation of evidence toward the older population. Specific evidence of
benefit in the elderly is present regarding treatment with activated protein C
and ventilatory strategies. In view of the pharmacokinetic and pharmacodynamic
differences in older people, and the higher incidence of comorbidity in the
elderly, there is a need for clinical trials in severe sepsis to specifically
include older patients.
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J Crit Care. 2009 Dec;24(4):609-13. Epub 2009 Feb 12
