10/18/2024

Janusmed sex and gender

Janusmed sex and gender – dronedarone hydrochloride

Janusmed Sex and Gender is a knowledge database providing information on sex and gender aspects of drug treatment. The knowledge database is primarily intended to be used by physicians and healthcare professionals. The texts are general and should not be considered as treatment guidelines. The individual patient’s physician is responsible for the patient’s drug treatment.

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Dronedarone

Dronedarone

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  1. Multaq (dronedaron). European Medicines Agency (EMA) [www]. [updated 2017-02-01, cited 2019-02-27].
  2. Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - dronedarone hydrochloride.
  3. Hohnloser SH, Crijns HJ, van Eickels M, Gaudin C, Page RL, Torp-Pedersen C et al. Effect of dronedarone on cardiovascular events in atrial fibrillation. N Engl J Med. 2009;360:668-78.
  4. De Ferrari GM, Dusi V. Drug safety evaluation of dronedarone in atrial fibrillation. Expert Opin Drug Saf. 2012;11:1023-45.
  5. Touboul P, Brugada J, Capucci A, Crijns HJ, Edvardsson N, Hohnloser SH. Dronedarone for prevention of atrial fibrillation: a dose-ranging study. Eur Heart J. 2003;24:1481-7.
  6. Singh BN, Connolly SJ, Crijns HJ, Roy D, Kowey PR, Capucci A et al. Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. N Engl J Med. 2007;357:987-99.
  7. Davy JM, Herold M, Hoglund C, Timmermans A, Alings A, Radzik D et al. Dronedarone for the control of ventricular rate in permanent atrial fibrillation: the Efficacy and safety of dRonedArone for the cOntrol of ventricular rate during atrial fibrillation (ERATO) study. Am Heart J. 2008;156:527e1-9.
  8. Køber L, Torp-Pedersen C, McMurray JJ, Gøtzsche O, Lévy S, Crijns H et al. Increased mortality after dronedarone therapy for severe heart failure. N Engl J Med. 2008;358:2678-87.
  9. Hohnloser SH, Connolly SJ, Crijns HJ, Page RL, Seiz W, Torp-Petersen C. Rationale and design of ATHENA: A placebo-controlled, double-blind, parallel arm Trial to assess the efficacy of dronedarone 400 mg bid for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation/atrial flutter. J Cardiovasc Electrophysiol. 2008;19:69-73.
  10. Le Heuzey JY, De Ferrari GM, Radzik D, Santini M, Zhu J, Davy JM. A short-term, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of dronedarone versus amiodarone in patients with persistent atrial fibrillation: the DIONYSOS study. J Cardiovasc Electrophysiol. 2010;21:597-605.
  11. Connolly SJ, Camm AJ, Halperin JL, Joyner C, Alings M, Amerena J et al. Dronedarone in high-risk permanent atrial fibrillation. N Engl J Med. 2011;365:2268-76.
  12. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2018 [cited 2019-03-08.]