Treating diabetic complications; from large randomized clinical trials to precision medicine

Abstract

In the last decades, many large randomized controlled trials have been conducted to assess the efficacy and safety of new interventions for the treatment of diabetic kidney disease (DKD). Unfortunately, these trials failed to demonstrate additional kidney or cardiovascular protection. One of the explanations for the failure of these trials appears to be the large variation in drug response between individual patients. All trials to date tested a drug which was targeted to a large heterogeneous population assuming that every individual will show a similar beneficial respond to the drug. Post hoc analyses from the past clinical trials, however, suggest that individual patients show a marked variation in drug response. This highlights the need to personalize treatment taking proper account of the characteristics and preferences of individual patients. Transitioning to a personalized therapy approach will have implications for clinical trial designs, drug registration and its use in clinical practice. Successful implementation of personalized medicine thus requires engagement of multiple stakeholders including academic community, pharmaceutical industry, regulatory agencies, health policy makers, physicians and patients. This supplement of Diabetes Obesity and Metabolism provides a summary on the state-of-the-art of personalized medicine in diabetic kidney disease from the views of various stakeholders.