Polypharmacy in the Heart Failure Patient: Are All Prescribed Drug Classes Required? Statin Withdrawal Study
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
Heart failure (cardiomyopathy) is a chronic condition in which the heart fails to function as
a pump to move blood around the body. This sets up a complex physiologic response to
compensate, which include activation of many hormonal mechanisms which result in fluid
accumulation.
In recent years, medications to block the hormonal response to heart failure are given as
standard drugs, and these include ACE inhibitors and beta blockers. Mortality is reduced with
these medications, as well as symptoms improved. Other medications are also used in heart
failure, for which a clear-cut benefit has not been demonstrated. Statins, also called HMG
CoA reductase inhibitors, are used to reduce cholesterol levels and can help to prevent heart
failure by preventing heart attacks. They have been used in heart failure that is not caused
by heart attacks in the belief that they had "pleiotropic" effects, meaning that they had
beneficial effects in heart failure separate from the reduction in cholesterol.
However large trials in heart failure have demonstrated that statins do not increase survival
compared with placebo. There is no evidence to recommend their routine use in established
heart failure caused by either heart attacks or genetics.
The investigators propose that the use of statins in heart failure is unnecessary and could
be stopped. The importance of finding evidence to cease unproven medications in heart failure
cannot be understated. Patients with heart failure take an average of six prescription
medications each day. Each medication has side effects and the interactions of all the drugs
together are unknown. Statins are the commonest reason for side effects in patients with
heart failure, causing muscle pains and gastrointestinal upset.
In this study, the investigators plan to withdraw statins from patients with stable heart
failure in a closely monitored environment and watch for the effect of this on heart failure
and on how they feel generally.