Simvastatin in the Prevention of Recurrent Pancreatitis: Design and Rationale of a Multicenter Triple-Blind Randomized Controlled Trial, the SIMBA Trial
Background: One in every four patients with a first episode of non-gallstone-related acute pancreatitis (AP) develops recurrent disease. Recurrent episodes of AP or acute flares of chronic pancreatitis (CP) are associated with decreased quality of life and progression of the disease. Besides removin...
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Frontiers Media S.A.
2021-02-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2020.00494/full |
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| author | Karina Cárdenas-Jaén Alicia Vaillo-Rocamora Ángel Gracia Pramoud K. Garg Pedro Zapater Georgios I. Papachristou Vikesh K. Singh Bechien U. Wu Enrique de-Madaria |
| author_facet | Karina Cárdenas-Jaén Alicia Vaillo-Rocamora Ángel Gracia Pramoud K. Garg Pedro Zapater Georgios I. Papachristou Vikesh K. Singh Bechien U. Wu Enrique de-Madaria |
| author_sort | Karina Cárdenas-Jaén |
| collection | DOAJ |
| description | Background: One in every four patients with a first episode of non-gallstone-related acute pancreatitis (AP) develops recurrent disease. Recurrent episodes of AP or acute flares of chronic pancreatitis (CP) are associated with decreased quality of life and progression of the disease. Besides removing the etiology of pancreatitis (which sometimes is not possible), there are no effective measures to prevent recurrence. Meta-analyses of randomized controlled trials, as well as epidemiological and cohort studies, suggest that statins may be protective against the development of index AP.Methods: The SIMBA study is a triple-blind randomized placebo-controlled, parallel-group multicenter trial. Patients with recurrent AP or with acute flares of CP (at least two episodes in the last 12 months) will be randomized to receive simvastatin 40 mg daily or placebo. During a 3-year study period, 144 patients (72 per arm of treatment) from 26 centers will be enrolled. The patients will receive the study treatment for 1 year. The primary aim is to compare the recurrence of AP or acute flares in CP. Secondary endpoints include the incidence of new-onset diabetes mellitus, new-onset exocrine pancreatic insufficiency (EPI), new-onset imaging signs of CP, frequency of all-cause hospital admissions, severity of AP, adherence to treatment, and frequency of adverse events.Discussion: The SIMBA trial will ascertain whether simvastatin, a safe, widely used and inexpensive drug, can change the natural course of recurrent pancreatitis.Trial Registration: ClinicalTrials.gov Identifier: NCT04021498 |
| first_indexed | 2024-12-22T16:54:10Z |
| format | Article |
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| institution | Directory Open Access Journal |
| issn | 2296-858X |
| language | English |
| last_indexed | 2024-12-22T16:54:10Z |
| publishDate | 2021-02-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medicine |
| spelling | doaj.art-4de459fd74b54ce499dca54d3252267d2022-12-21T18:19:30ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2021-02-01710.3389/fmed.2020.00494559309Simvastatin in the Prevention of Recurrent Pancreatitis: Design and Rationale of a Multicenter Triple-Blind Randomized Controlled Trial, the SIMBA TrialKarina Cárdenas-Jaén0Alicia Vaillo-Rocamora1Ángel Gracia2Pramoud K. Garg3Pedro Zapater4Georgios I. Papachristou5Vikesh K. Singh6Bechien U. Wu7Enrique de-Madaria8Pancreatic Unit, Department of Gastroenterology, Alicante University General Hospital, Alicante Institute for Health and Biomedical Research (ISABIAL), Alicante, SpainPancreatic Unit, Department of Gastroenterology, Alicante University General Hospital, Alicante Institute for Health and Biomedical Research (ISABIAL), Alicante, SpainPharmacy Department, Alicante University General Hospital, Alicante Institute for Health and Biomedical Research (ISABIAL), Alicante, SpainDepartment of Gastroenterology, All India Institute of Medical Sciences, New Delhi, IndiaDepartment of Clinical Pharmacology, Alicante University General Hospital, Alicante Institute for Health and Biomedical Research (ISABIAL), Alicante, SpainDivision of Gastroenterology, Hepatology and Nutrition, Ohio State University Wexner Medical Center, Columbus, OH, United StatesPancreatitis Center, Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, MD, United StatesCenter for Pancreatic Care, Division of Gastroenterology, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA, United StatesPancreatic Unit, Department of Gastroenterology, Alicante University General Hospital, Alicante Institute for Health and Biomedical Research (ISABIAL), Alicante, SpainBackground: One in every four patients with a first episode of non-gallstone-related acute pancreatitis (AP) develops recurrent disease. Recurrent episodes of AP or acute flares of chronic pancreatitis (CP) are associated with decreased quality of life and progression of the disease. Besides removing the etiology of pancreatitis (which sometimes is not possible), there are no effective measures to prevent recurrence. Meta-analyses of randomized controlled trials, as well as epidemiological and cohort studies, suggest that statins may be protective against the development of index AP.Methods: The SIMBA study is a triple-blind randomized placebo-controlled, parallel-group multicenter trial. Patients with recurrent AP or with acute flares of CP (at least two episodes in the last 12 months) will be randomized to receive simvastatin 40 mg daily or placebo. During a 3-year study period, 144 patients (72 per arm of treatment) from 26 centers will be enrolled. The patients will receive the study treatment for 1 year. The primary aim is to compare the recurrence of AP or acute flares in CP. Secondary endpoints include the incidence of new-onset diabetes mellitus, new-onset exocrine pancreatic insufficiency (EPI), new-onset imaging signs of CP, frequency of all-cause hospital admissions, severity of AP, adherence to treatment, and frequency of adverse events.Discussion: The SIMBA trial will ascertain whether simvastatin, a safe, widely used and inexpensive drug, can change the natural course of recurrent pancreatitis.Trial Registration: ClinicalTrials.gov Identifier: NCT04021498https://www.frontiersin.org/articles/10.3389/fmed.2020.00494/fullhydroxymethylglutaryl-CoA reductase inhibitorsstatinssimvastatinacute pancreatitischronic pancreatitisrecurrent |
| spellingShingle | Karina Cárdenas-Jaén Alicia Vaillo-Rocamora Ángel Gracia Pramoud K. Garg Pedro Zapater Georgios I. Papachristou Vikesh K. Singh Bechien U. Wu Enrique de-Madaria Simvastatin in the Prevention of Recurrent Pancreatitis: Design and Rationale of a Multicenter Triple-Blind Randomized Controlled Trial, the SIMBA Trial Frontiers in Medicine hydroxymethylglutaryl-CoA reductase inhibitors statins simvastatin acute pancreatitis chronic pancreatitis recurrent |
| title | Simvastatin in the Prevention of Recurrent Pancreatitis: Design and Rationale of a Multicenter Triple-Blind Randomized Controlled Trial, the SIMBA Trial |
| title_full | Simvastatin in the Prevention of Recurrent Pancreatitis: Design and Rationale of a Multicenter Triple-Blind Randomized Controlled Trial, the SIMBA Trial |
| title_fullStr | Simvastatin in the Prevention of Recurrent Pancreatitis: Design and Rationale of a Multicenter Triple-Blind Randomized Controlled Trial, the SIMBA Trial |
| title_full_unstemmed | Simvastatin in the Prevention of Recurrent Pancreatitis: Design and Rationale of a Multicenter Triple-Blind Randomized Controlled Trial, the SIMBA Trial |
| title_short | Simvastatin in the Prevention of Recurrent Pancreatitis: Design and Rationale of a Multicenter Triple-Blind Randomized Controlled Trial, the SIMBA Trial |
| title_sort | simvastatin in the prevention of recurrent pancreatitis design and rationale of a multicenter triple blind randomized controlled trial the simba trial |
| topic | hydroxymethylglutaryl-CoA reductase inhibitors statins simvastatin acute pancreatitis chronic pancreatitis recurrent |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2020.00494/full |
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