Cancer in cardiovascular drug trials and vice versa: a personal perspective

Abstract

Acknowledging uncertainties and balancing the opportunity for benefit with the offsetting potential to harm are integral concepts for clinical decision-making. Caregivers consciously risk profile (stratify) their patient to try to fit best currently available observational and clinical trial data to formulate a particular recommendation for each unique patient. Advice to adopt prudent lifestyle approaches, such as avoidance of smoking, maintaining adequate activity levels, and adhering to a nutritious diet, have such a favourable benefit/risk ratio that they have become fundamental tenets of cardiovascular preventive care. On the other hand, recommendations for the use of pharmacologic therapies in an effort to improve prognosis requires careful consideration of possible adverse consequences in relation to potential benefits. The fundamental principle of ‘Primum non nocere’, above all first, do no harm, rightfully dominates most clinicians' therapeutic decision making. To initiate and maintain a pharmaceutical agent or recommend a procedure, the physician, patient, and even the payers must be adequately persuaded that in the long term, the risk/benefit considerations favour the intervention. In cardiovascular medicine, strong and consistent information from both pioneering epidemiologic and clinical trial data have coalesced to generate convincing, indeed, compelling rationale for the use of pharmacologic agents in individuals with hypertension to lower arterial blood pressure in order to reduce their risk for subsequent major cardiovascular events.1–3 Similarly, there is consistent convincing data demonstrating the effectiveness of HMG-CoA reductase inhibitors (statins) in lowering cardiovascular event rates in both secondary and in a large segment of the primary prevention populations.4 Pharmacologic agents in these categories have achieved privileged regulatory and clinical usage status to be administered to asymptomatic individuals for the purpose of reducing cardiovascular event rates. At this elite level, in addition to sufficient safety experience, a particular agent must also have excellent tolerability and often even …