Dipeptidyl Peptidase-4 Inhibitor Development and Post-authorisation Programme for Vildagliptin – Clinical Evidence for Optimised Management of Chronic Diseases Beyond Type 2 Diabetes
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 mellitus (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.
Clinical evidence, diabetes care, disease management,
dipeptidyl peptidase-4 (DPP-4) inhibitors, type
2 diabetes mellitus (T2DM), vildagliptin
William 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.
William David Strain, Diabetes and Vascular
Medicine Research Centre, NIHR Exeter Clinical Research Facility and
Institute of Biomedical and Clinical Science, University of Exeter Medical
School, Barrack Rd Exeter, EX2 5AX, UK. E: firstname.lastname@example.org
The publication of this article was supported by Novartis Pharma AG.
This article is published under the Creative Commons
Attribution Noncommercial License, which permits any noncommercial
use, distribution, adaptation and reproduction provided
the original author(s) and source are given appropriate credit.
Compliance with Ethics: This study involves a review of
the literature and did not involve any studies with human or
animal subjects performed by any of the authors.
The authors take responsibility for the content of
this article and contributed equally towards overall clinical interpretation,
data compiling and review. Editorial assistance has been provided by
Rangan Gupta, Novartis Healthcare Private Limited, Hyderabad, India.
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