Q3136821 (Q3136821): Difference between revisions
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(Created claim: summary (P836): Acute pancreatitis (PA) is the 3 rd cause of admission due to pathology of the digestive system. 30 % of BP income is due to recurrence of the disease. While in certain etiologies we have effective forms of prophylaxis (such as cholecystectomy in BP of biliary origin), in other situations such as recurrent idiopathic BP we cannot offer patients effective methods to prevent recurrence. Simvastatin has shown in population studies to be associated...) |
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Acute pancreatitis (PA) is the 3 rd cause of admission due to pathology of the digestive system. 30 % of BP income is due to recurrence of the disease. While in certain etiologies we have effective forms of prophylaxis (such as cholecystectomy in BP of biliary origin), in other situations such as recurrent idiopathic BP we cannot offer patients effective methods to prevent recurrence. Simvastatin has shown in population studies to be associated with a decrease in the incidence of pancreatitis in all risk groups. The aim of the study was to compare the incidence of new episodes of BP in patients with recurrent BP who consume simvastatin versus placebo. Secondary objectives: evaluate exocrine pancreatic function (fecalelastase) and endocrine (fasting glycemia and Hb1Ac), as well as signs of chronic pancreatitis in imaging tests at the end of the study period. Design: Multicenter phase III randomised clinical trial, comparing (double-blind) simvastatin (40 mg/day) versus placebo (lactose). 158 participants (79 per treatment arm) with recurrent BP (at least 2 episodes) will be included. Treatment and follow-up of patients will last one year. The main outcome variable is the number of recurrent BP suffered by the patient during the year of treatment. (English) | |||||||||||||||
| Property / summary: Acute pancreatitis (PA) is the 3 rd cause of admission due to pathology of the digestive system. 30 % of BP income is due to recurrence of the disease. While in certain etiologies we have effective forms of prophylaxis (such as cholecystectomy in BP of biliary origin), in other situations such as recurrent idiopathic BP we cannot offer patients effective methods to prevent recurrence. Simvastatin has shown in population studies to be associated with a decrease in the incidence of pancreatitis in all risk groups. The aim of the study was to compare the incidence of new episodes of BP in patients with recurrent BP who consume simvastatin versus placebo. Secondary objectives: evaluate exocrine pancreatic function (fecalelastase) and endocrine (fasting glycemia and Hb1Ac), as well as signs of chronic pancreatitis in imaging tests at the end of the study period. Design: Multicenter phase III randomised clinical trial, comparing (double-blind) simvastatin (40 mg/day) versus placebo (lactose). 158 participants (79 per treatment arm) with recurrent BP (at least 2 episodes) will be included. Treatment and follow-up of patients will last one year. The main outcome variable is the number of recurrent BP suffered by the patient during the year of treatment. (English) / rank | |||||||||||||||
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| Property / summary: Acute pancreatitis (PA) is the 3 rd cause of admission due to pathology of the digestive system. 30 % of BP income is due to recurrence of the disease. While in certain etiologies we have effective forms of prophylaxis (such as cholecystectomy in BP of biliary origin), in other situations such as recurrent idiopathic BP we cannot offer patients effective methods to prevent recurrence. Simvastatin has shown in population studies to be associated with a decrease in the incidence of pancreatitis in all risk groups. The aim of the study was to compare the incidence of new episodes of BP in patients with recurrent BP who consume simvastatin versus placebo. Secondary objectives: evaluate exocrine pancreatic function (fecalelastase) and endocrine (fasting glycemia and Hb1Ac), as well as signs of chronic pancreatitis in imaging tests at the end of the study period. Design: Multicenter phase III randomised clinical trial, comparing (double-blind) simvastatin (40 mg/day) versus placebo (lactose). 158 participants (79 per treatment arm) with recurrent BP (at least 2 episodes) will be included. Treatment and follow-up of patients will last one year. The main outcome variable is the number of recurrent BP suffered by the patient during the year of treatment. (English) / qualifier | |||||||||||||||
point in time: 12 October 2021
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Revision as of 13:40, 12 October 2021
Project Q3136821 in Spain
| Language | Label | Description | Also known as |
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| English | No label defined |
Project Q3136821 in Spain |
Statements
15,250.0 Euro
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30,500.0 Euro
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50.0 percent
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1 January 2017
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30 September 2021
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FUNDACION PARA EL FOMENTO DE LA INV. SANITARIA Y BIOMEDICA DE LA COMUNIDAD VALENCIANA (FISABIO)
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38°20'37.10"N, 0°29'17.41"W
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03014
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La pancreatitis aguda (PA) es la 3ª causa de ingreso por patología del aparato digestivo. Un 30% de los ingresos por PA se deben a recurrencia de la enfermedad. Mientras que en ciertas etiologías disponemos de formas efectivas de profilaxis (como la colecistectomía en la PA de origen biliar), en otras situaciones como en la PA recurrente idiopática no podemos ofrecer a los pacientes métodos efectivos para impedir la recurrencia. La simvastatina ha mostrado en estudios poblacionales asociarse a una disminución en la incidencia de pancreatitis en todos los grupos de riesgo. El objetivo del estudio es comparar la incidencia de nuevos episodios de PA en pacientes con PA recurrente que consumen simvastatina frente a placebo. Objetivos secundarios: valorar la función pancreática exocrina (elastasa fecal) y endocrina (glucemia en ayunas y Hb1Ac), así como signos de pancreatitis crónica en pruebas de imagen al finalizar el periodo de estudio. Diseño: Ensayo clínico aleatorizado multicéntrico de fase III, comparando (doble ciego) simvastatina (40 mg/día) frente a placebo (lactosa). Se incluirán 158 participantes (79 por brazo de tratamiento) con PA recurrente (al menos 2 episodios). El tratamiento y el seguimiento de los pacientes durará un año. La variable principal de resultado es el número de PA recurrentes sufridas por el paciente durante el año de tratamiento. (Spanish)
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Acute pancreatitis (PA) is the 3 rd cause of admission due to pathology of the digestive system. 30 % of BP income is due to recurrence of the disease. While in certain etiologies we have effective forms of prophylaxis (such as cholecystectomy in BP of biliary origin), in other situations such as recurrent idiopathic BP we cannot offer patients effective methods to prevent recurrence. Simvastatin has shown in population studies to be associated with a decrease in the incidence of pancreatitis in all risk groups. The aim of the study was to compare the incidence of new episodes of BP in patients with recurrent BP who consume simvastatin versus placebo. Secondary objectives: evaluate exocrine pancreatic function (fecalelastase) and endocrine (fasting glycemia and Hb1Ac), as well as signs of chronic pancreatitis in imaging tests at the end of the study period. Design: Multicenter phase III randomised clinical trial, comparing (double-blind) simvastatin (40 mg/day) versus placebo (lactose). 158 participants (79 per treatment arm) with recurrent BP (at least 2 episodes) will be included. Treatment and follow-up of patients will last one year. The main outcome variable is the number of recurrent BP suffered by the patient during the year of treatment. (English)
12 October 2021
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Alicante/Alacant
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Identifiers
PI16_01181
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