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 TERMINÉ 

Safety Evaluation of Adverse Reactions in Diabetes (SAFEGUARD)

Date du début: 1 oct. 2011, Date de fin: 30 sept. 2015,

"In 2010 a widely marketed drug for the treatment of type 2 diabetes (T2DM) (rosiglitazone) was taken from the market as it was associated with an increased risk of myocardial infarction, a T2DM complication it was actually supposed to prevent. This example shows several things. First, the approval requirements do not guarantee a longer term positive benefit risk profile. Second, large scale postm ...
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 TERMINÉ 

Arrhythmogenic potential of drugs (ARITMO)

Date du début: 1 janv. 2010, Date de fin: 30 juin 2013,

...f some compounds to prolong the QT interval of the electrocardiogram and to precipitate Torsade de Pointes (TdP, a potentially fatal arrhythmia) has caused several regulatory interventions, including drug withdrawals. Specific guidelines have been implemented to detect QT liability of new compounds as early as possible. However there is growing evidence that an increase in the QT interval does not ...
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