Challenges in trials evaluating statins in heart failure

It is proving exceedingly difficult for novel therapeutic agents to demonstrate clinical benefit additional to standard medications in patients with established chronic heart failure. Despite this, HMG CoA reductase inhibitors (statins) are being extensively evaluated for just such an indication. Challenges in conducting clinical studies in this area relate primarily to the design of trials to maximise the possibility of a beneficial effect being demonstrated, if indeed one exists. The patient population studied, eg. ischaemic versus idiopathic etiology, as well as severity of disease being evaluated are such potential challenges. Other issues relate to the drugs being studied; whether statins can be considered an exchangeable drug class and the dose of drug being studied. Finally, choice of clinical endpoints to maximise the chances of a favourable outcome add further complexity. All of the above challenges faced the recently published Conrolled Rosuvastatin Multinational Trial in Heart Failure (CORONA) study of rosuvastatin in patients with ischaemic heart failure as well as the ongoing Gruppo Italiano per lo Studio della Soprawivenza nell’Infarto Miocardio (GISSI-HF) study of both ischaemic and idiopathic dilated cardiomyopathy.