Mitral Valve Stenosis With Incompetence or Regurgitation — The Effects of Levosimendan During Mitral Valve Surgery
Citation(s)
De Hert SG, Lorsomradee S, Cromheecke S, Van der Linden PJ The effects of levosimendan in cardiac surgery patients with poor left ventricular function. Anesth Analg. 2007 Apr;104(4):766-73. Erratum in: Anesth Analg. 2007 Jun;104(6):1544. Dosage error in
García González MJ, Domínguez Rodríguez A Pharmacologic treatment of heart failure due to ventricular dysfunction by myocardial stunning: potential role of levosimendan. Am J Cardiovasc Drugs. 2006;6(2):69-75. Review.
Hernández A, Miranda A, Parada A [Levosimendan reduces mortality in cardiac surgery: a systematic review and meta-analysis]. Rev Esp Anestesiol Reanim. 2012 Jan;59(1):6-11. doi: 10.1016/j.redar.2012.02.001. Epub 2012 Mar 14. Review. Spanish.
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.
