What can we learn from the recent blood glucose lowering megatrials?

Abstract

In the past two decades, we have acquired an enormous amount of knowledge regarding the epidemiology, diagnosis, pathophysiology and treatment of type 2 diabetes and its comorbidities. In addition to the earlier landmark blood lipid and blood pressure lowering trials, the latest blood glucose lowering megatrials represent the zenith of this global effort to prevent and control diabetes, and its devastating consequences. Although many of these latter trials have yielded negative results and have shown the narrow risk-benefit ratio of intensive treatment in patients with advanced disease, the exceedingly low event rates in these high-risk patients who were carefully monitored and intensively managed made possible in these clinical trial settings have not been emphasized enough. The heterogeneity of the clinical outcomes in these studies further highlight the complexity of diabetes, which is more than managing a disease, but the multiple needs of a patient with multisystem dysfunction. In the final analysis, what transpires from these megatrials is the need to translate the key components of these studies, namely, protocol, team, documentation and monitoring, into our daily clinical practice to enable the care team to stratify risk, define needs, individualize therapy, monitor progress and reinforce compliance in order to achieve positive outcomes. (J Diabetes Invest, doi: 10.1111/j.2040-1124.2010.00063.x, 2010).

Keywords: Diabetes; Disease management; Randomized clinical trials.

Figure 1

Estimated annual cardiovascular event rates in large scale epidemiological studies and randomized clinical trials since 1990. Despite the high‐risk nature of type 2 diabetic (DM) patients in the ACCORD study, more than 30% of whom had a history of coronary heart disease (CHD), intensive treatment and monitoring in a trial setting has given rise to event rates lower than the younger and newly diagnosed patients in the UKPDS, and patients with multiple risk factors without prior history of CHD in the Steno‐2 study, who were managed less intensively.

Figure 2

Learning from recent megatrials. The key components of a clinical trial include baseline assessments and delivery of protocol by a team with frequent monitoring and documentation of processes and responses. This team‐based approach enables risk stratification, informed decisions, individualized regimens, regular monitoring, improved compliance and better outcomes. In order to increase the accessibility of these care models, changes in clinical practice and health care system is needed to ensure its accessibility, affordability and sustainability.