ABSTRACT
PURPOSE: Studies have suggested benefits from magnesium sulphate in thrombotic thrombocytopenic purpura (TTP). We aimed to measure the effects of magnesium sulphate supplementation on TTP recovery. METHODS: In this multicenter, randomised, double-blind, controlled, superiority study, we enrolled adults with a clinical diagnosis of TTP. Patients were randomly allocated to receive magnesium sulphate (6 g intravenously followed by a continuous infusion of 6 g/24 h for 3 days) or placebo, in addition to the standard treatment. The primary outcome was the median time to platelet normalisation (defined as a platelet count ≥ 150 G/L). Efficacy and safety were assessed by intention-to-treat. RESULTS: Overall, we enrolled 74 participants, including one who withdrew his/her consent. Seventy-three patients were further analyzed, 35 (48%) allocated to magnesium sulphate and 38 (52%) to placebo. The median time to platelet normalisation was 4 days (95% confidence interval [CI], 3-4) in the magnesium sulphate group and 4 days (95% CI 3-5) in the placebo group. The cause-specific hazard ratio of response was 0.93 (95% CI 0.58-1.48, p = 0.75). The number of patients with ≥ 1 serious adverse reactions was similar in the two groups. By day 90, four patients in the magnesium sulphate group and two patients in the placebo group had died (p = 0.42). The most frequent adverse event was low blood pressure occurring in 34% in the magnesium sulphate group and 29% in the placebo group (p = 0.80). CONCLUSION: Among patients with TTP, the addition of magnesium sulphate to the standard of care did not result in a significant improvement in time to platelet normalisation.
Subject(s)
Magnesium Sulfate , Purpura, Thrombotic Thrombocytopenic , Adult , Female , Humans , Male , Death , Double-Blind Method , Magnesium Sulfate/adverse effects , Platelet Count , Purpura, Thrombotic Thrombocytopenic/drug therapy , Treatment OutcomeABSTRACT
The Innovative Medicine Initiative (IMI) is a joint technology initiative jointly implemented by the European Commission and by the European Federation of Pharmaceutical Industries and Associations (EFPIA). The objective of IMI, officially launched on April 30th 2008, is to identify and address the bottlenecks of the drug discovery and development process. IMI will reinforce the public-private partnerships and will be focused towards critical nodes of the drug discovery such as efficacy predictivity, safety predictivity, knowledge management and education and training. This initiative will also reinforce the attractivity of Europe for biomedical science and will then lead to the discovery of novel therapeutic strategies for the patients.