'Hard, 'soft' and 'surrogate' endpoints in diabetes

摘要

Since the publication of the UK Prospective Diabetes Study (UKPDS), much of the discourse around the management of type 2 diabetes has been dominated by an emphasis on reduction in levels of glycated haemoglobin (HbAlc). This emphasis is ubiquitous in clinical guidelines, in quality measures for healthcare organisations, and in metrics for reimbursement. Yet, recent evidence suggests the need for a shift in this paradigm. This is particularly the case in terms of the ability of lowering HbAlc to predict cardiovascular benefit, but we argue that it also applies to the persistent faith in glycated haemoglobin reduction as a marker of microvascular complication risk. We have previously argued that because HbAlc is a poor surrogate disease marker for cardiovascular disease (CVD), it is important to engage patients with diabetes in decision making based on discussion of the risks and benefits of treatment on outcomes that have clinical meaning to them. While recent guidelines now call for its use as a treatment measure to be tailored to the individual patient, we argue now that there remains a reluctance to apply this in practice.