Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC)

Effect of Simvastatin on the Prognosis of Primary Sclerosing Cholangitis (PSC); A Randomized, Double-blind, Placebo Controlled Multicenter Study

This is a randomized, double-blind, placebo controlled multicenter study.

A total of 700 patients will be included. After an updated powercalculation 560 was condidered enough

The study will include patients with primary sclerosing cholangitis (PSC) for daily intake of 40 mg simvastatin/placebo for 5 years. The aim is to study effect of prognosis of PSC by long term intake of simvastatin. Outcome measures are death, liver transplantation, cholangiocarcinoma or bleeding from esophageal varices.

Subjects will be randomized (1:1) between Simvastatin and placebo.

Please see published protocol

Long Term Effect of Simvastatin in Primary Sclerosing Cholangitits: A Placebo-Controlled, Double-Blind, Multicenter Phase III Study (Piscatin)

A. Bergquist, H. U. Marschall, E. Nilsson, N. Nyhlin, M. Werner, A. Klein, et al.

British Journal of Gastroenterolgy 2022 Vol. 1 Pages 235-241.

Inclusion Criteria:

• PSC verified by cholangiography or liver biopsy, with or without irritable bowel disease (IBD).
• Men and women between ≥18 years and ≤75 years.
• Written informed consent.
• A magnetic resonance imaging (MRI) or Magnetic resonance cholangiopancreatography (MRCP) performed within 4 months prior to randomization.
• Colonoscopy performed within 24 months prior to randomization, if known IBD.
• For women of childbearing potential efficient contraceptive.

Exclusion Criteria:

• Subjects on waiting list for transplantation
• Transplanted subjects
• Previous variceal bleeding
• Previous hepatobiliary malignancy
• Subjects with secondary sclerosing cholangitis
• Intake of any type of statins within 3 months prior to randmization
• Known intolerance to simvastatin.
• Pregnancy or breastfeeding.