ABSTRACT
Assessing a drug for efficacy and safety in heart failure is a challenging task. Food and Drug Administration guidelines for heart failure drugs have been drafted, but considerable controversy exists in some areas. The World Health Organization has no published guidelines at present, nor do most other regulatory agencies. Guidelines have been issued for the evaluation of heart failure therapies in Japan. The syndrome of congestive heart failure (CHF) is usually seen as a relentlessly progressive, irreversible disease. However, individual patients with CHF may have marked fluctuations in their functional status independent of pharmacotherapy, which may be due to dietary indiscretions, ischaemic episodes or physical conditioning. Drug absorption, metabolism and disposition, as well as delivery of the drug to the target tissues, may be altered in CHF patients.
