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Le Projet INDANA : Méta-analyse sur données individuelles des essais cliniques du traitement médicamenteux de l'hypertension artérielle

Abstract : INDANA is a collaborative project to synthesize the results of randomized clinical trials which have shown the value of blood pressure lowering drugs in hypertension, using the most precise and detailed level of information, the participant. The objectives were multiple, around the identification of responders to treatment, in analyzing subgroups or searching for interactions in a multivariable approach. Analyzes of most of the available individual characteristics did not show results likely to identify non-responders. Despite the power of the database, it was not possible to exclude clinically relevant interactions. The analysis of the treatment effect model conducted on the INDANA database suggests that the baseline risk is the essential determinant of absolute benefit at a given time scale, 5 or 10 years, e.g. clearly explaining all of the apparent disparities in benefit between women and men. The determinants of this baseline risk have been the subject of specific and powerful analyses, the international nature of which has revealed disparities in risk between countries, which we could not explain by the distribution of risk factors alone. The analysis of the change in effect over time showed a profile contradicting earlier hypotheses, of a delayed effect on the risk of coronary heart accident, later than that observed on the risk of stroke: this hypothesis was in perfect opposition with the reality revealed by the specific IDNANA analyses. INDANA therefore illustrated the feasibility of setting up data sets common to several large clinical trials, with objectives complementary to those classic of meta-analysis on summarized data: search for interactions or response markers, analyses of variations in effect of treatment as a function of time or geographic regions. We systematically published these results, endorsed by the international collaborative group.
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Submitted on : Wednesday, May 27, 2020 - 10:55:34 AM
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François Gueyffier. Le Projet INDANA : Méta-analyse sur données individuelles des essais cliniques du traitement médicamenteux de l'hypertension artérielle. Pharmacologie. Université Claude Bernard Lyon 1, 1997. Français. ⟨tel-02632535⟩



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