Age Bias in Clinical Trials in Sepsis: How Relevant Are Guidelines to Older People?

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.