TY - JOUR
T1 - Simvastatin in the Prevention of Recurrent Pancreatitis
T2 - Design and Rationale of a Multicenter Triple-Blind Randomized Controlled Trial, the SIMBA Trial
AU - Cárdenas-Jaén, Karina
AU - Vaillo-Rocamora, Alicia
AU - Gracia, Ángel
AU - Garg, Pramoud K.
AU - Zapater, Pedro
AU - Papachristou, Georgios I.
AU - Singh, Vikesh K.
AU - Wu, Bechien U.
AU - de-Madaria, Enrique
N1 - Funding Information:
This study is endorsed by the Spanish Association of Gastroenterology (AEG) and the Spanish Association of Pancreatology (AESPANC). Dr. Juan Selva, Head of the AUGH Pharmacy Department, has been a great support for practical aspects of the study. Funding. This is a researcher-driven study funded by the following grants: Spanish Government: Acción estratégica en salud 2013-2016, convocatoria 2016, Ministerio de economía, industria y competitividad (identifier: PI16/01181). Spanish Association of Gastroenterology (AEG): Gonzalo Miño Grant for multicenter trials 2016, AEG (identifier: Beca AEG Gonzalo-Miño 2016). ISABIAL-FISABIO: III convocatoria de ayudas a proyectos de investigación ISABIAL-FISABIO (UGP-16-140).
Publisher Copyright:
© Copyright © 2021 Cárdenas-Jaén, Vaillo-Rocamora, Gracia, Garg, Zapater, Papachristou, Singh, Wu and de-Madaria.
PY - 2021/2/10
Y1 - 2021/2/10
N2 - 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
AB - 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
KW - acute pancreatitis
KW - chronic pancreatitis
KW - hydroxymethylglutaryl-CoA reductase inhibitors
KW - idiopathic
KW - prevention
KW - recurrent
KW - simvastatin
KW - statins
UR - http://www.scopus.com/inward/record.url?scp=85101642126&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85101642126&partnerID=8YFLogxK
U2 - 10.3389/fmed.2020.00494
DO - 10.3389/fmed.2020.00494
M3 - Article
C2 - 33644082
AN - SCOPUS:85101642126
VL - 7
JO - Frontiers in Medicine
JF - Frontiers in Medicine
SN - 2296-858X
M1 - 494
ER -