Clinically relevant subgroups of cardiovascular patients are under-represented in pre-registration phase III trials. These findings concern major areas of cardiovascular diseases, i.e. hypertension, hypercholesterolaemia, angina pectoris and myocardial infarction. Widely used therapeutic classes of drugs are affected and regional differences in trial performance are present.
Phase III trials testing cardiovascular drugs included patients with concomitant cardiovascular, endocrine and metabolic diseases, but discrepancies were present with patients in daily practice. Development of guidelines for uniform collection and reporting of co-morbidity data in pre-marketing trials is recommended, as well as further utilization of data.
To contribute to the social debate about the role of functional foods in the prevention of overweight and obesity using an ecological model to study the positioning of functional foods and their social implications. Positioning was conceptualized as the relative attention given to functional foods within the range of preventive strategies, and the way in which they address specific causes of overweight. A systematic review was conducted to identify (A) preventive strategies aiming at the individual; (B) technological approaches; and (C) environmental strategies. All strategies were further classified according to the nature of causes they refer to - either individual or environmental. In the prevention of overweight/obesity, an emphasis on strategies designed to change the quality of food products and supplies has developed. Technological strategies particularly relate to functional foods; however, while providing a new dimension to food products, they do not challenge the underlying lifestyles causing overweight. Furthermore, they also stress individual responsibility for overweight/obesity and technological solutions to it. From a societal perspective, the characteristics of functional foods indicate that they can only be expected to play a limited role in overweight/obesity prevention. The ecological approach suggests that other strategies targeting individual and social causes need to be developed and marketed equally well.
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