Dipeptidyl Peptidase-4 Inhibitor Development and Post-authorisation Programme for Vildagliptin - Clinical Evidence for Optimised Management of Chronic Diseases Beyond Type 2 Diabetes

Abstract

This is the author accepted manuscript. The final version is available from the publisher via the DOI in this record.The last decade has witnessed the role of dipeptidyl peptidase-4 (DPP-4) inhibitors in producing a conceptual change in early management of type 2 diabetes (T2DM) by shifting emphasis from a gluco-centric approach to holistically treating underlying pathophysiological processes. DPP-4 inhibitors highlighted the importance of acknowledging hypoglycaemia and weight gain as barriers to optimised care in T2DM. These complications were an integral part of diabetes management before the introduction of DPP-4 inhibitors. During the development of DPP-4 inhibitors, regulatory requirements for introducing new agents underwent substantial changes, with increased emphasis on safety. This led to the systematic collection of adjudicated cardiovascular (CV) safety data, and, where 95% confidence of a lack of harm could not be demonstrated, the standardised CV safety studies. Furthermore, the growing awareness of the worldwide extent of T2DM demanded a more diverse approach to recruitment and participation in clinical trials. Finally, the global financial crisis placed a new awareness on the health economics of diabetes, which rapidly became the most expensive disease in the world. This review encompasses unique developments in the global landscape, and the role DPP-4 inhibitors, specifically vildagliptin, have played in research advancement and optimisation of diabetes care in a diverse population with T2DM worldwide.W David Strain reports grants and personal fees from Novartis, Boehringer Ingelheim, Pfizer and Novo Nordisk during the conducting of the study. Päivi M Paldánius is an employee and shareholder of Novartis. No other potential conflicts of interest relevant to this article were reported. W David Strain acknowledges the support of the National Institute for Health Research (NIHR) Exeter Clinical Research Facility. The views expressed in this publication are those of the authors and not necessarily those of the NIHR Exeter Clinical Research Facility, the National Health Service, the NIHR, or the Department of Health in England. The publication of this article was supported by Novartis Pharma AG