Simvastatin in the Prevention of Recurrent Pancreatitis
Summary
Recurrent acute pancreatitis and recurrent relapses of inflammation in chronic pancreatitis are an important problem. In some cases, prevention of these acute flares of inflammation is not possible. Population-based studies and meta-analysis of randomized controlled trials suggest that statins may decrease the incidence of acute pancreatitis. SIMBA aims to investigate the effect of simvastatin on the incidence of new episodes of pancreatitis in recurrent acute pancreatitis and chronic pancreatitis. This is a non-profit, researcher-driven placebo-controlled multicenter (27 Spanish centers) randomized controlled trial
Timeline
- Start
- 2017-09-29
- Primary completion
- 2025-03-01
- Completion
- 2025-03-01
Outcome
Missed primary endpoint
Stopped (Enrollment): “Slow recruitment”
paper 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 PMID 41482454 ↗
paper This trial, evaluating simvastatin versus placebo for the prevention of pancreatitis, did not demonstrate a reduction in recurrence rate PMID 41482454 ↗
Publications
- Guilabert L, Cardenas-Jaen K, Vaillo-Rocamora A, Ruiz-Rebollo ML, Bolado-Concejo F, Martinez-Moneo E, Rivera-Irigoin R, Martin-Mateos R, Garcia-Rayado G, Lopez-Serrano A, Marti-Marques E, Rodriguez-Oballe JA, Francisco-Gonzalez M, Jimenez-Moreno MA, Canamares-Orbis P, Concepcion-Martin M, Pascual-Moreno I, Del Val A, Lauret-Brana E, Sanchez-Marin C, Del Pozo-Garcia AJ, Ledro-Cano D, Zapater P, Nunez-Otero J, Bernal-Lujan L, Singh VK, Papachristou GI, Garg PK, Wu BU, Mehta RM, de-Madaria E. Simvastatin in the prevention of recurrent pancreatitis: a triple-blinded randomised clinical trial (the SIMBA trial). Gut. 2026 May 12;75(6):1160-1168. doi: 10.1136/gutjnl-2025-337154.
- Cardenas-Jaen K, Vaillo-Rocamora A, Gracia A, Garg PK, Zapater P, Papachristou GI, Singh VK, Wu BU, de-Madaria E. Simvastatin in the Prevention of Recurrent Pancreatitis: Design and Rationale of a Multicenter Triple-Blind Randomized Controlled Trial, the SIMBA Trial. Front Med (Lausanne). 2021 Feb 10;7:494. doi: 10.3389/fmed.2020.00494. eCollection 2020.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Simvastatin | Small molecule | 40 mg | — |