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The ADVANCE STUDY

The ADVANCE STUDY. Put together by Bella Starling, Senior Project Manager, Biomedical Ethics, The Wellcome Trust Anushka Patel, Deputy Director, Heart & Vascular Division, The George Institute for International Health . Justification for the study.

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The ADVANCE STUDY

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  1. The ADVANCE STUDY Put together by Bella Starling, Senior Project Manager, Biomedical Ethics, The Wellcome Trust Anushka Patel, Deputy Director, Heart & Vascular Division, The George Institute for International Health

  2. Justification for the study • “In 2000, stroke and heart attack represented the two leading causes of death worldwide, responsible for more than 10 million deaths annually. • It is estimated that by 2020, the toll in lower-income countries will outweigh that in higher-income countries by a factor of four. • The 2002 World Health Report emphasizes the potential benefits of more effective vascular disease prevention strategies. • The requirement for major new initiatives – both population and individualized interventions – that address cardiovascular health in developing countries has been clearly identified as a global health priority.

  3. Background The George Institute for International Health • The principal goal of the heart and vascular (research) division of the George Institute for International Health (Australia) is the discovery and the implementation of new strategies for the prevention of stroke, heart attack and other major vascular diseases. • In recent years the Institute has had a major focus on the initiation of new projects in middle and lower-income countries of the Asia-Pacific region.

  4. Background • A study called ADVANCE is sponsored by the George Institute as part of its overall research mandate. This study will provide new evidence about widely practical treatment strategies for the prevention of the vascular complications of diabetes. • It will determine the effects of intensive blood pressure lowering and glucose control on the risks of complications in patients with type 2 diabetes.

  5. Study population • 215 clinical centres in Asia, Europe, Australasia, North America • 20 countries • A third of participants are from high income countries • >3000 from China • India, Malaysia, Philippines, Central European countries. • 11,140 participants.

  6. ADVANCE Hypotheses In high risk patients with type 2 diabetes, • Routine lowering of blood pressure regardless of initial blood pressure levels will reduce vascular disease • More intensive lowering of blood glucose levels than is recommended in current guidelines will also produce similar benefits

  7. Study Design • Factorial, multicenter, RCT in patients with type 2 diabetes who are at a high risk of developing vascular disease

  8. Study Design

  9. Interventions Drugs that are being tested (alone and in combination) are • A fixed low dose perindopril-indapamide combination (as an additional blood pressure lowering medicine) • Gliclazide _MR for intensive glucose control

  10. Study recruitment completed September 2002 • Follow-up till December 2006 for a total of 4.5 years • Major sub-studies established in the context of this study

  11. Study outcomes Primary outcome – • Major macrovascular complications (stroke and heart attack) • Major microvascular complications – eye and renal disease

  12. Salient points • The ADVANCE project addresses a non-communicable disease • It is a very large multicenter trial involving developed and developing countries. • The types of interventions studied in the project would be needed for long-term, perhaps life-long use by patients if they are deemed successful. • This may provide a challenge in terms of post-trial access in settings where the drugs are not widely available.

  13. Points for discussion (1) If found to be successful, • Is there an obligation to provide post trial access to the interventions used in the trial? • Who should be assured post trial access? For how long? Should this be uniform for all countries or decided on a country basis • Whose responsibility is it to provide the post trial access?

  14. Points for discussion (2) • What should happen if the interventions are not proven to be successful, but all trial patients do not have access to the standard guideline based treatment ? • When is the research over? At the end of the 4.5 years of follow up? (Is a follow-up period of 4.5 years sufficient to evaluate the vascular complications?) • What and with whom should prior agreements have been put in place at local level prior to start of study?

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