Relevant outcomes in the frail elderly

We found no studies that report the effect of lipid lowering in severely frail older adults in primary or secondary prevention; therefore studies of the non-frail elderly that reported outcomes meaningful to the frail elderly were examined and assessed for applicability. 

• Mortality: There are competing causes for mortality in the frail elderly; therefore we cannot assume that a mortality benefit shown in non-frail populations applies to frail populations. In addition, the goals of therapy may not be to prolong life in the frail.
• CHD events: For the frail elderly, the important outcome is symptomatic non-fatal MI (eg., leading to morbidity such as angina or heart failure.) In some statin studies, the primary composite outcome and the outcome of CHD events include those with asymptomatic heart disease such as silent MIs. Prevent asymptomatic heart disease might not prevent morbidity for the frail. Therefore, the outcome of CHD events, as reported in studies of the non-frail, might not be applicable for the frail.
• Stroke: For the frail elderly, the important outcome is non-fatal stroke leading to disability. However, sometimes the outcome of non-fatal stroke includes mild strokes and TIAs and the number of strokes leading to disability is not reported separately. Therefore, the outcome of non-fatal stroke as reported in studies of the non-frail might not be applicable to the frail.

We consider the following outcomes as most meaningful for the frail elderly: symptomatic non-fatal myocardial infarction (MI) (e.g., leading to morbidity such as angina or heart failure) and non fatal stroke leading to disability. The effect of treatment on mortality is difficult to evaluate with frailty.