Simvastatin in the Prevention of Recurrent Pancreatitis

Last updated: March 16, 2025
Sponsor: Enrique de-Madaria
Overall Status: Terminated

Phase

3

Condition

Pancreatitis

Primary Biliary Cholangitis

Treatment

Simvastatin 40mg

Placebo

Clinical Study ID

NCT04021498
SIMBA-16
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult (>=18) patients

  2. At least 2 episodes of acute pancreatitis or acute flares of chronic pancreatitis

  3. Written consent to participate in the study

Exclusion

Exclusion Criteria:

  1. <2 episodes of pancreatitis in the last 12 months.

  2. Statin consumption in the previous year.

  3. Contraindications to the use of Statins

  4. Cholelithiasis or choledocholitiasis diagnosed in the last episode of pancreatitis

  5. Endoscopic sphyncterotomy and/or cholecystectomy and/or pancreatic surgery betweenlast episode of AP and recruitment or patients who are expected to undergo one ofthis techniques in less than a year.

  6. Serum triglycerides >500 mg/dL without previous specific treatment before the lastepisode of pancreatitis, or in patients expected to have a change in their specifichypertriglyceridemia treatment in less than 1 year

  7. Primary hyperparathyroidism that has been operated between last episode ofpancreatitis and recruitment or will be operated in less than 1 year

  8. Iatrogenic Pancreatitis

  9. Abstinence syndrome due to alcohol or drugs and/or delirium tremens in the last 6months before recruitment

  10. Previous (last year) failure to attend follow-up medical visits, social problemsthat may be associated to failure to take the medication or to perform an adequatefollow-up

  11. Pregnancy, breastfeeding

Study Design

Total Participants: 83
Treatment Group(s): 2
Primary Treatment: Simvastatin 40mg
Phase: 3
Study Start date:
September 29, 2017
Estimated Completion Date:
March 01, 2025

Study Description

Acute pancreatitis (AP) is the 3rd cause of hospital admission due to gastrointestinal disease. Approximately 20% of the patients will relapse after a first episode of AP. The low frequency of relapse in biliary AP is due to the high effectiveness of cholecystectomy but a first episode of AP due to alcoholic or other etiologies is associated with relapse in one every four patients. Currently, besides counselling for alcohol and tobacco abstinence, there is no specific medical treatment that changes the natural history of recurrent AP. Recurrent AP is an intermediary stage in the pathogenesis of chronic pancreatitis (CP) and a subset of recurrent AP patients during their natural course transition to CP (one every three patients). Forty-five percent of patients with CP experience intermittent flares of pain. Simvastatin has been associated to a decrease in the incidence of AP in a population-based study (Wu et al, Gut. 2015) and in a meta-analysis of randomized controlled trials (Preiss et al, JAMA 2012).

The main aim of SIMBA (SIMvastatin in the prevention of recurrent pancreatitis, a triple Blind rAndomized controlled multicenter trial) is to compare the recurrence rate of pancreatitis in patients with established recurrent pancreatitis (acute pancreatitis and acute flares in chronic pancreatitis) consuming simvastatin versus placebo.

The secondary aims are 1) to compare in patients with recurrent AP at the end of follow-up period the progression to chronic pancreatitis on imaging (calcifications and/or dilated ductal system), as well as endocrine and exocrine pancreatic function; 2) to compare the severity of recurrent pancreatitis between both treatment arms.

Design: SIMBA is a triple-blind randomized placebo-controlled, parallel-group, superiority multicenter (27 Spanish centers) trial. This final protocol (version 4) was finished on June 20th 2018.

Connect with a study center

  • Alicante

    Alicante, 03010
    Spain

    Site Not Available

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