Efficacy and safety of pasireotide-LAR for the treatment of refractory bleeding due to gastrointestinal angiodysplasias: results of the ANGIOPAS multicenter phase II noncomparative prospective double-blinded randomized study
| Autor: | Jean-Jacques Raynaud, Bakhtiar Bejou, Gheorghe Airinei, Philippe Grandval, Vincent Levy, Elia Samaha, Rodica Gincul, Christophe Cellier, Denis Sautereau, René Laugier, Jean-Christophe Saurin, Cyriaque Bon, Christian Boustière, Magalie Vincent, Robert Benamouzig, Mourad Benallaoua, Thomas Aparicio, Marouane Boubaya |
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| Rok vydání: | 2018 |
| Předmět: |
GIADs bleeding
medicine.medical_specialty Double blinded Gastroenterology Severe anemia law.invention 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Randomized controlled trial Refractory law Internal medicine angiodysplasia Medicine 030212 general & internal medicine lcsh:RC799-869 Angiodysplasia Original Research business.industry medicine.disease Pasireotide Somatostatin chemistry Recurrent bleeding lcsh:Diseases of the digestive system. Gastroenterology 030211 gastroenterology & hepatology somatostatin analog business |
| Zdroj: | Therapeutic Advances in Gastroenterology, Vol 11 (2018) Therapeutic Advances in Gastroenterology |
| ISSN: | 1756-2848 |
| Popis: | Background: Gastrointestinal angiodysplasias (GIADs) could be responsible for recurrent bleeding and severe anemia. Somatostatin analogs could reduce transfusion requirements in these patients but no randomized controlled study is available. The main objective of the ANGIOPAS phase II double-blinded randomized, noncomparative study was to assess the effectiveness of pasireotide-LAR in reducing transfusion requirements in patients with refractory GIADs bleeding. Methods: A total of 22 patients with transfusion requirements ⩾6 units of packed red blood cells (pRBCs) during the 6 months prior to inclusion were randomized to receive pasireotide-LAR 60 mg ( n = 10) or placebo ( n = 12) every 28 days for 6 months. Patients were then followed for an additional 6 months after stopping treatment. Results: The pasireotide-LAR and placebo groups were equivalent for age, sex, comorbidities and transfusion requirement during the reference period (median 13 and 9.5 pRBCs). A 50 and 83% success rate (success defined as a decrease of at least 30% of transfused pRBCs) was observed in the pasireotide-LAR arm in the Intent to Treat (ITT) and per protocol (PP) analysis respectively. The need for transfusion during the intervention period was 3 pRBC units in the pasireotide-LAR group (range 0–26) and 11.5 pRBC units in the placebo group (range 0–23). Overall, three cases with glycemic control impairment were observed in the pasireotide-LAR group including one de novo diabetes. Conclusion: This double-blinded noncomparative randomized phase II study suggests, for the first time, the effectiveness of pasireotide-LAR 60 mg every 28 days to decrease the transfusion requirement in patients with recurrent bleeding due to GIADs. |
| Databáze: | OpenAIRE |
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