{
  "abstract": "Background Recurrent acute pancreatitis (RAP) or acute-on-chronic flares in chronic pancreatitis (CP) have limited preventive options beyond addressing the underlying aetiology. Statins, due to their anti-inflammatory properties, have been proposed as a potential prophylactic treatment.Objective We aimed to evaluate whether simvastatin could reduce the recurrence of pancreatitis.Design At 23 centres, we conducted a triple-blind, randomised, controlled, superiority trial enrolling patients with at least two episodes of RAP or CP flares in the previous 12 months. Participants were randomly assigned to receive simvastatin or placebo for 1 year. The primary endpoint was the recurrence of pancreatitis. The target sample size was 144 patients; however, an interim analysis was planned in the event of slow recruitment.Results A total of 85 patients (42.1% women) were included in the interim analysis. In the intention-to-treat analysis, no significant differences were observed regarding recurrence: 46.2% simvastatin versus 44.4% placebo; OR 1.07, 95% CI 0.43 to 2.66; p=0.88, or time to recurrence. No statistically significant differences were observed in recurrence in per-protocol analysis (35.5% simvastatin vs 41.9% placebo; OR 0.76, 95% CI 0.27 to 2.12; p=0.60). Development of diabetes mellitus was more frequent in the simvastatin group (4 vs 0 patients; OR not calculable, p=0.04).Conclusion This trial, evaluating simvastatin versus placebo for the prevention of pancreatitis, did not demonstrate a reduction in recurrence rate, although results might be underpowered due to early termination. The relationship between statins in these patients and new-onset diabetes requires further investigation.Trial registration number NCT04021498.",
  "authors": [
    {
      "affiliations": [
        "Gastroenterology Department, Dr. Balmis General University Hospital-Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Alicante, Spain"
      ],
      "name": "Lucía Guilabert"
    },
    {
      "affiliations": [
        "Gastroenterology Department, Dr. Balmis General University Hospital-Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Alicante, Spain"
      ],
      "name": "Karina Cárdenas-Jaén"
    },
    {
      "affiliations": [
        "Gastroenterology Department, Dr. Balmis General University Hospital-Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Alicante, Spain"
      ],
      "name": "Alicia Vaillo-Rocamora"
    },
    {
      "affiliations": [
        "Gastroenterology Department, Hospital Clinico Universitario de Valladolid, Valladolid, Spain"
      ],
      "name": "María Lourdes Ruiz-Rebollo"
    },
    {
      "affiliations": [
        "Gastroenterology Department, University Hospital of Navarre, Pamplona, Spain"
      ],
      "name": "Federico Bolado-Concejo"
    },
    {
      "affiliations": [
        "Gastroenterology Department, Cruces University Hospital, Barakaldo, Spain"
      ],
      "name": "Emma Martínez-Moneo"
    },
    {
      "affiliations": [
        "Gastroenterology Department, Costa del Sol University Hospital, Marbella, Spain"
      ],
      "name": "Robin Rivera-Irigoin"
    },
    {
      "affiliations": [
        "Gastroenterology and Hepatology, Hospital Universitario Ramon y Cajal, Madrid, Spain",
        "Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Instituto de Salud Carlos III, Madrid, Spain"
      ],
      "name": "Rosa Martin-Mateos"
    },
    {
      "affiliations": [
        "Gastroenterology Department, Lozano Blesa University Clinic Hospital-Health Research Institute of Aragón (IIS Aragón), Zaragoza, Spain"
      ],
      "name": "Guillermo García-Rayado"
    },
    {
      "affiliations": [
        "Gastroenterology Department, Hospital Universitario Dr Peset, Valencia, Spain"
      ],
      "name": "Antonio López-Serrano"
    },
    {
      "affiliations": [
        "Gastroenterology Department, University Hospital Lucus Augusti, Lugo, Spain"
      ],
      "name": "Eva Martí-Marqués"
    },
    {
      "affiliations": [
        "Gastroenterology Department, Santa María University Hospital, Lleida, Spain",
        "Gastroenterology Department, Arnau de Vilanova University Hospital, Lleida, Spain"
      ],
      "name": "Juan Armando Rodríguez-Oballe"
    },
    {
      "affiliations": [
        "Gastroenterology Department, Ourense University Hospital, Ourense, Spain"
      ],
      "name": "María Francisco-González"
    },
    {
      "affiliations": [
        "Gastroenterology Department, Burgos University Hospital, Burgos, Spain"
      ],
      "name": "Manuel A Jiménez-Moreno"
    },
    {
      "affiliations": [
        "Gastroenterology Department, San Jorge University General Hospital of Huesca, Huesca, Spain"
      ],
      "name": "Pablo Cañamares-Orbís"
    },
    {
      "affiliations": [
        "Gastroenterology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain"
      ],
      "name": "Mar Concepción-Martín"
    },
    {
      "affiliations": [
        "Gastroenterology Department, Hospital Clinico Universitario, Valencia, Spain"
      ],
      "name": "Isabel Pascual-Moreno"
    },
    {
      "affiliations": [
        "Gastroenterology Department, La Fe University and Polytechnic Hospital, Valencia, Spain"
      ],
      "name": "Adolfo Del Val"
    },
    {
      "affiliations": [
        "Gastroenterology, Hospital Universitario Central de Asturias, Oviedo, Spain"
      ],
      "name": "Eugenia Lauret-Braña"
    },
    {
      "affiliations": [
        "Gastroenterology and Hepatology Department, Grupo de Investigación Clínica y Traslacional en Enfermedades Digestivas, Instituto de Investigación Marqués de Valdecilla, Santander, Spain"
      ],
      "name": "Claudia Sánchez-Marin"
    },
    {
      "affiliations": [
        "Gastroenterology Department, 12 de Octubre University Hospital, Madrid, Spain"
      ],
      "name": "Andrés J Del Pozo-García"
    },
    {
      "affiliations": [
        "Gastroenterology Department, La Merced University Hospital, Osuna, Spain"
      ],
      "name": "Diego Ledro-Cano"
    },
    {
      "affiliations": [
        "Clinical Pharmacology Department, Dr Balmis General University Hospital, Alicante, Spain",
        "Miguel Hernandez University of Elche Institute of Research Development and Innovation in Healthcare Biotechnology, Alicante, Spain"
      ],
      "name": "Pedro Zapater"
    },
    {
      "affiliations": [
        "Gastroenterology, Hospital Universitario del Sureste, Madrid, Spain"
      ],
      "name": "Jorge Núñez-Otero"
    },
    {
      "affiliations": [
        "Gastroenterology Department, Dr. Balmis General University Hospital- Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Alicante, Spain"
      ],
      "name": "Lorena Bernal-Luján"
    },
    {
      "affiliations": [
        "Gastroenterology, Johns Hopkins Medical Institutions Campus, Baltimore, Maryland, USA"
      ],
      "name": "Vikesh K Singh"
    },
    {
      "affiliations": [
        "Division of Gastroenterology, Hepatology, and Nutrition, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA"
      ],
      "name": "Georgios I Papachristou"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences New Delhi, New Delhi, India"
      ],
      "name": "Pramod K Garg"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, USA"
      ],
      "name": "Bechien U Wu"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Surat Institute of Digestive Science (SIDS) Hospital and Research Centre, Surat, India"
      ],
      "name": "Rajiv M Mehta"
    },
    {
      "affiliations": [
        "Gastroenterology Department, Dr. Balmis General University Hospital-Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Alicante, Spain",
        "Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Instituto de Salud Carlos III, Madrid, Spain"
      ],
      "name": "Enrique de-Madaria"
    }
  ],
  "title": "Simvastatin in the prevention of recurrent pancreatitis: a triple-blinded randomised clinical trial (the SIMBA trial)",
  "uid": "d3c20c6d-5abb-503d-a0ad-30c0ae60e0c9"
}