Congestive heart failure is an important cause of morbidity and mortality i
n western countries. The profound impact that congestive heart failure has
on life expectancy and quality of life has been a continuous stimulus for t
he development of new drugs for the treatment of this condition. Despite fa
vourable effects on (aspects of) quality of life in short term studies, sev
eral of these new agents have been shown to reduce survival in mortality tr
ials.
However, patients with severe congestive heart failure may experience such
incapacitating symptoms that the question should be raised as to whether an
improvement in quality of life makes the increased risk of mortality assoc
iated with these new agents acceptable. Drugs which improve quality of life
at the expense of an increased risk of mortality can be of value in the tr
eatment of patients with severe congestive heart failure. However, this is
only the case if the probability of improvement in quality of life and prol
ongation of life expectancy for those using the drug exceeds the probabilit
y of improvement in quality of life and prolongation of life expectancy for
those not using the drug. Unfortunately most clinical trials in which both
mortality and quality of life are evaluated fail to provide information on
this composite probability.
Despite disappointing results of some recent mortality trials on new pharma
cological treatments of congestive heart failure, sound and well designed c
linical trials on innovative heart failure treatments in which these compos
ite probabilities are also assessed should be carried out.