Effectiveness of Drugs in Routine Care: A Model for Sequential Monitoring of New Medicines Using Dronedarone as Example

• Published in: Clinical pharmacology and therapeutics Vol. 103; no. 3; p. 493
• Main Authors: Cars, T, Lindhagen, L, Malmström, R E, Neovius, M, Schwieler, J, Wettermark, B, Sundström, J
• Format: Journal Article
• Language: English
• Published: United States 01.03.2018
• Subjects: Aged; Aged, 80 and over; Anti-Arrhythmia Agents - therapeutic use; Atrial Fibrillation - drug therapy; Cohort Studies; Computer Systems; Databases, Factual; Dronedarone - therapeutic use; Drug Approval; Drug Monitoring - methods; Electronic Health Records; Female; Flecainide - therapeutic use; Humans; Male; Middle Aged; Product Surveillance, Postmarketing; Propensity Score; Sweden; Treatment Outcome; Sweden

Although there is no doubt about the scientific value of randomized controlled clinical trials, they are usually conducted in selected populations different from those treated in clinical practice. Therefore, it is important to optimize real-time postmarketing evaluation of the effectiveness, safety...