Ressource pédagogique : Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Globalization of Diabetes trials: Epidemiology of diabetes in the Middle East and Asian countries

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Title : Globalization of Diabetes trials: Epidemiology of diabetes in the Middle East and Asian countries Speaker: Mohamed SOBHY, Alexandria, EGY Abstract : Diabetes is one of the major public health problems worldwide due to its chronic nature and severe complications; it’s projected to become one of the world’s main disablers and killers within the next twenty five years as the number of people with diabetes is increasing in every country. The global epidemic of Diabetes Mellitus disproportionately affects indigenous and developing populations. Most people with diabetes live in the economically less developed regions of the world in middle and low income countries with the greatest number of people with diabetes between 40 to 59 years of age and this may be due to lack of investment in the treatment of people with diabetes in low-income countries.This difference in diabetes expenditures may explain the high relative mortality rate between low and high income countries. There are several etiological factors leading to this increase in the prevalence of diabetes, from the most important factors are: ethnicity-based differences, Obesity, Sedentary life style, childhood obesity as well as genetic Susceptibility. These factors are the main reasons that Africa, Middle East & Asia have the highest increasing percentage of diabetes between 2011 and 2030 as estimated from IDF Diabetes Atlas 2011. According to IDF Diabetes Atlas 2011, the prevalence of Diabetes in Egypt is 15.2%, in Middle East 9.1% and in Asia 8.3%. L’auteur n’a pas transmis de conflit d’intérêt concernant les données diffusées dans cette vidéo ou publiées dans la référence citée. Conférence enregistrée : 9th Global Cardiovascular Clinical Trialists Forum • Paris 2012 Diabetes clinical trials : helped or hindered by the current shift in regulatory requirements? Glycaemic control is an inadequate surrogate marker of cardiovascular event reduction in patients with type 2 diabetes. Clinical trials to date have been unsuccessful in identifying a therapeutic approach that addresses the underlying problem in diabetes (glycaemic control) and reduces cardiovascular risk. The potential for some agents to increase the risk of cardiovascular events has led to substantial changes in regulatory requirements for new anti-diabetic therapies. These requirements, while key to ensuring the cardiovascular safety of new agents, fail to emphasize the need to show clinical benefits, such as less visual impairment, less need for dialysis, or fewer cardiovascular events and deaths. Changes in test results such as glycaemic control, serum creatinine, micro-albuminuria, or retinopathy are inadequate surrogates. Regulators should consider the potential advantages of offering extended patent protection in order to encourage companies to conduct long-term trials in diabetes and many other chronic medical conditions. Cooperative efforts among physicians, clinical trialists, regulators, and sponsors are needed to address unresolved issues including re-defining therapeutic targets that are meaningful to patients with diabetes, determining the appropriate length of follow-up for future trials, and considering the ethical and operational challenges of non-inferiority designs. Chairpersons: Marc PFEFFER, Boston, USA - Kausik RAY, London, GBR Réalisation, production : Canal U/3S et CERIMES Keyword : Cardiovascular Clinical Trialists, Paris, 2012, Cardiovascular prevention, Baro-stimulation, diabetes

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