Liver Injury — Liver Injury by Statins in Patients With History of Hepatitis B Virus Infection
Citation(s)
Balmer ML, Dufour JF Treatment of hypercholesterolemia in patients with primary biliary cirrhosis might be more beneficial than indicated. Swiss Med Wkly. 2008 Jul 26;138(29-30):415-9. doi: 2008/29/smw-12311. Review.
Bellosta S, Paoletti R, Corsini A Safety of statins: focus on clinical pharmacokinetics and drug interactions. Circulation. 2004 Jun 15;109(23 Suppl 1):III50-7. Review.
Watkins PB, Seeff LB Drug-induced liver injury: summary of a single topic clinical research conference. Hepatology. 2006 Mar;43(3):618-31.
Zhang Q, Yang Z Can statins be used safely in coronary heart disease patients of hepatitis B virus carriers? Int J Cardiol. 2011 Jan 21;146(2):291. doi: 10.1016/j.ijcard.2010.10.087. Epub 2010 Dec 3.
Liver Injury by Statins in Coronary Heart Disease (CHD) Patients With History of Hepatitis B Virus (HBV) Infection
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
