Treatment of Bile Acid Diarrhoea With Atorvastatin

Exclusion Criteria

• •Unwillingness to pause any of the following medications during the trial: bile acid sequestrants, morphine medication, liraglutide or anti-constipation medication (e.g., lactulose, laxoberal, magnesia)
• •Unwillingness to pause any anti-diarrhoea medication (e.g., imodium) from 3 days before initiation of each stool diary until after the respective visit
• •If regularly administering psyllium or metformin, unwillingness to agree to a stable dose of psyllium or metformin throughout the trial
• •Concomitant use of any drug in the GLP-1 receptor agonist drug class with the exception of paused liraglutide, see above
• •Concomitant use of any kind of insulin medication
• •Planned major changes in food consumption throughout the trial, including planned weight loss attempts
• •Prior use of any statin within the recent 6 months
• •Intake of larger quantities of grapefruit juice during trial participation, at the discretion of the investigator
• •History of/present hepatobiliary disorder (except for simple metabolic dysfunction-associated fatty liver disease) and/or alanine aminotransferase and/or serum aspartate aminotransferase ≥ 3 times upper limit of normal
• •Crohn's disease, ulcerative colitis, celiac disease or lactose intolerance
• •Previous intestinal resection or major intra-abdominal surgery incl. stoma (cholecystectomy and appendectomy not included)
• •Nephropathy with estimated glomerular filtration rate \< 45 ml/min/1,73 m2
• •Plasma level of creatine kinase ≥ 5 times the upper limit of normal
• •A recent stroke or transient ischemic attack (within 6 months)
• •Any treatment or condition requiring acute or subacute medical or surgical intervention
• •Hypothyroidism or hyperthyroidism, if not well regulated, at the discretion of the investigator
• •Active or recent (within 6 months) clinically significant malignant disease (non-melanoma skin cancer not included), at the discretion of the investigator
• •Alcohol consumption exceeding 12 units/week for women or 18 units/week for men, respectively. These thresholds are based on the limits of the European Association for the Study of the Liver
• •Drug abuse, at the discretion of the investigator
• •Fertile women not using any of the following contraceptive methods for the duration of the trial until at least 5 days after end of trial: Hormonal (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormone intrauterine devices (IUD), hormonal vaginal ring or transdermal hormonal patch) associated with inhibition of ovulation, chemical (copper IUD), sterilisation, vasectomised partner with a confirmatory test, or sexual abstinence per the investigator's discretion
• •Pregnant or nursing women
• •Known or suspected hypersensitivity to atorvastatin or any of the additives in the tablet
• •Receipt of any investigational drug within 30 days prior to visit 0
• •Concomitant treatment with any of the following (topical administration not included): ciclosporin, telithromycin, clarithromycin, delavirdin, stiripentol, ketoconazol, voriconazol, itraconazol, posaconazol, letermovir, ritonavir, lopinavir, atazanavir, indinavir, darunavir, bocepravir, telaprevir, elbasvir/grazoprevir, ledipasvir/sofosbuvir, erythromycin, niacin, ezetimibe, fusidic acid, gemfibrozil, colchicine, digoxin, warfarin
• •Unable to speak or understand Danish or mental incapacity that preclude adequate understanding or cooperation or unwillingness to comply with trial requirements
• •Active participation in any other clinical intervention trial (observational studies not included)
• •Other concomitant disease or treatment that according to the investigator's assessment makes the person unsuitable for study participation