Caplacizumab use for immune thrombotic thrombocytopenic purpura: the Milan thrombotic thrombocytopenic purpura registry
Pasquale AgostiPasqualina De LeoMarco CapecchiBarbara FerrariIlaria ManciniSalvatore GattilloSilvia Maria TrisoliniErminia RinaldiGian Marco PoddaLucia PreziosoPrassede SalutariLuca FacchiniDomenica CaramazzaGiulia TolomelliAndrea ArtoniFlora Peyvandi
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Abstract:
Data on caplacizumab use for thrombotic thrombocytopenic purpura (TTP) in Italy are missing.• Twenty-six Italian patients were treated with caplacizumab for an acute immune TTP episode.• Caplacizumab was effective in treating acute TTP in the Italian real-world clinical setting.• Two major bleeds leading to drug discontinuation were observed.Keywords:
Discontinuation
Thrombocytopenic purpura
Purpura (gastropod)
Background: Reasons for treatment discontinuation are important not only to understand the benefit and risk profile of experimental treatments, but also to help choose appropriate strategies to handle intercurrent events in defining estimands. The current case report form (CRF) commonly in use mixes the underlying reasons for treatment discontinuation and who makes the decision for treatment discontinuation, often resulting in an inaccurate collection of reasons for treatment discontinuation. Methods and results: We systematically reviewed and analyzed treatment discontinuation data from nine phase 2 and phase 3 studies for insulin peglispro. A total of 857 participants with treatment discontinuation were included in the analysis. Our review suggested that, due to the vague multiple-choice options for treatment discontinuation present in the CRF, different reasons were sometimes recorded for the same underlying reason for treatment discontinuation. Based on our review and analysis, we suggest an intermediate solution and a more systematic way to improve the current CRF for treatment discontinuations. Conclusion: This research provides insight and directions on how to optimize the CRF for recording treatment discontinuation. Further work needs to be done to build the learning into Clinical Data Interchange Standards Consortium standards.
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This paper addresses current issues associated with medication discontinuation in panic disorder, with specific focus on one of the most frequently used medication classes for this indication, the benzodiazepines. The majority of patients, when slowly tapered, are able to discontinue the benzodiazepines without a great deal of difficulty, particularly after short-term therapy. Patients treated with long-term therapy at high therapeutic doses may experience greater difficulty with discontinuation. If patients are adequately prepared and if discontinuation is conducted slowly and gradually, discontinuation symptoms, if they occur, are transient, mild to moderate, and generally tolerable. However, return of the original condition (relapse) during discontinuation can greatly complicate clinical management.
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There is concern that bluish skin discoloration associated with ezogabine treatment could be permanent. We present a case of ezogabine-induced skin discoloration that resolved completely after discontinuation. A 55-year-old woman started ezogabine 400 mg three times a day at age 41. Bluish pigmentation over the toe nails, finger nails, around eyes and over and around lips was first noted after 5 years of treatment. Ezogabine was discontinued eight years after initiation. Skin discoloration improved within 6 months and completely resolved within 6 years of discontinuation. This case suggests that ezogabine-induced discoloration is reversible after discontinuation of treatment.
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