dronedarone (Multaq)
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Introduction
Formerly Class III antiarrhythmic agent.[10]
Indications
- maintenance of sinus rhythm in patients with atrial fibrillation (AF) & heart failure (FDA-approved)*
- currently only approved for nonpermanent AF[6][7][8]*
* less effective than amiodarone, avoid[12]
Contraindications
- NYHA class 4 heart failure
- NYHA class 2 or 3 heart failure with recent myocardial infarction[10]
Adverse effects
- bradycardia, QT-interval prolongation
- nausea, diarrhea
- rash
- elevated serum creatinine
- average decrease in creatinine clearance of 18%[10]
- due to partial inhibition of tubular excretion of creatinine
- no change in glomerular filtration rate[10]
- worsens heart failure, increases mortality[1]; delays hospitalization for cardiac events[3]; does not increase mortality[3]
- increased risk for cardiovascular events in patients taking the drug for permanent atrial fibrillation[6]
- 2-fold increased risk of death
- 2-fold increased risk of stroke
- 2-fold increased risk of hospitalization for heart failure[7]
Mechanism of action
- antiarrhythmic drug with electrophysiologic effects similar to amiodarone
- does not contain iodine
Clinical trials
see ATHENA study
Notes
costs over $200/month (2009)[4]
More general terms
Additional terms
References
- ↑ Jump up to: 1.0 1.1 Kober L et al for the Dronedarone Study Group. Increased mortality after dronedarone therapy for severe heart failure. N Engl J Med 2008, 358:2678 PMID: https://www.ncbi.nlm.nih.gov/pubmed/18565860
- ↑ Hohnloser SH et al for the ATHENA Investigators. Effect of dronedarone on cardiovascular events in atrial fibrillation. N Engl J Med 2009 Feb 12; 360:668 PMID: https://www.ncbi.nlm.nih.gov/pubmed/19213680
- ↑ Jump up to: 3.0 3.1 3.2 Zimetbaum PJ. Dronedarone for atrial fibrillation-an odyssey. N Engl J Med. 2009 Apr 30;360(18):1811-3. PMID: https://www.ncbi.nlm.nih.gov/pubmed/19403901
- ↑ Jump up to: 4.0 4.1 Prescriber's Letter 16(8): 2009 COMMENTARY: New Drug: Multaq (Dronedarone) GUIDELINES: Management of Patients with Atrial Fibrillation (ACC/AHA/ESC 2006) Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=250807&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ FDA MedWatch, Jan 14, 2011 Multaq (dronedarone) - Drug Safety Communication: Risk of Severe Liver Injury http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm240110.htm
- ↑ Jump up to: 6.0 6.1 6.2 Sanofi Provides Multaq Phase IIIb PALLAS Trial Update
Indication seeking trial in permanent AF patient population stopped - Benefit-risk of Multaq remains unchanged in non-permanent AF patients - http://en.sanofi.com/binaries/20110707_PALLAS_en_tcm28-33021.pdf - ↑ Jump up to: 7.0 7.1 7.2 FDA MedWatch: 07/21/2011 Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Serious Cardiovascular Events http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm264204.htm
- ↑ Jump up to: 8.0 8.1 Prescriber's Letter 18(10): 2011 Multaq (Dronedarone) Alternatives for Atrial Fibrillation Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=271009&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ Connolly SJ et al. for the PALLAS Investigators. Dronedarone in high-risk permanent atrial fibrillation. N Engl J Med. 2011 Dec 15;365(24):2268-76. Epub 2011 Nov 14. PMID: https://www.ncbi.nlm.nih.gov/pubmed/22082198
Nattel S. Dronedarone and atrial fibrillation - Jekyll and Hyde? N Engl J Med. 2011 Dec 15;365(24):2321-2. Epub 2011 Nov 14 PMID: https://www.ncbi.nlm.nih.gov/pubmed/22082122 - ↑ Jump up to: 10.0 10.1 10.2 10.3 10.4 Medical Knowledge Self Assessment Program (MKSAP) 16, 17. American College of Physicians, Philadelphia 2012, 2015
- ↑ Patel C, Yan GX, Kowey PR. Dronedarone. Circulation. 2009 Aug 18;120(7):636-44. PMID: https://www.ncbi.nlm.nih.gov/pubmed/19687370
- ↑ Jump up to: 12.0 12.1 Therapeutics Letter #108. Therapeutics Initiative Drugs to Avoid. http://www.ti.ubc.ca/2018/01/04/108-drugs-avoid/