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Meta analysis on individual patient data from clinical trials of cardio-vascular prevention by drug treatment in hypertension

Objective

OBJECTIVES
Accumulation of growth factors on glycosaminoglycans (GAGs) in the arterial wall contributes to proliferation of arterial smooth muscle cells (ASMC). A better understanding of the factors contributing to ASMC proliferation and of the mechanism behind growth factors-GAGs interactions will create possibilities for tailored construction of molecules preventing proliferation of human ASMC.

Objectives :
* To study the relationship between treatment induced blood pressure reduction and clinical efficacy
* To assess whether the treatment effect is negative if blood pressure is reduced to much
* To quantify the treatment effect according to characteristics of patients Brief description :
Efficacy of two categories of blood pressure lowering drugs (diuretics and beta-blockers) on the reduction of risks associated to hypertension have been extensively assessed in the past. More than 95% of the data from all trials assessing the efficacy of antihypertensive drugs on clinical outcomes have already been pooled together at the individual patient level by the co-ordinator, which represents over 53,000 patients and 5400 cardiovascular events. This extensive database will be shared by all participants and used to conduct statistical analyses aimed at answering to the three objectives. Co-operation between an academic medical statistics unit in London, a clinical group specialised in hypertension in Belgium and the co-ordinator involved in the conduct of clinical trials and meta-analyses will be required at all steps of the project, from the design of the protocol, the choice of statistical methods to be used, the statistical analysis and the report of results in scientific publications.
Keywords:
Hypertension, Meta-analysis, Clinical trial, Surrogate endpoint, J-shaped curve, Quantity of treatment effect

Funding Scheme

CON - Coordination of research actions

Coordinator

Université Claude Bernard Lyon 1
Address
162,Avenue Lacassagne
69394 Lyon
France