The overall objective of this task order shall be to perform a clinical trial testing the effects of simvastatin on bicarbonate concentration in patients with acute pancreatitis (AP). Acute pancreatitis (AP) is an inflammatory disorder of the pancreas of varying severity and with variable involvement of other regional tissues. Patients with AP have an approximately 20-30% chance of developing recurrent episodes, with 10% of the patients progressing to chronic pancreatitis (CP). Chronic pancreatitis, which results from repeated episodes of acute pancreatitis, is the strongest identified risk factor for pancreatic cancer (PC) and increases the risk by at least 13.3 fold. Preclinical studies support the rationale for the use of this agent in pancreatitis, progression of pancreatic inflammation, fibrosis and exocrine dysfunction. Early research indicated that patients taking simvastatin experienced a dramatic reduction in pancreatitis incidence. Simvastatin was independently associated with a 70% reduced risk of pancreatitis, with a rate ratio of 0.29 (95% CL 0.27, 0.31) after adjustment for age, sex, race/ethnicity, gallstone disorders, hypertriglyceridemia, and alcohol and tobacco use. The hypothesis of the trial is that subjects randomized to simvastatin will experience a greater increase from baseline in peak bicarbonate concentration measured at 6-months compared to the placebo group.
