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Assessing the Risk for Peripheral Neuropathy in Patients Treated With Dronedarone Compared With That in Other Antiarrhythmics
- Source :
- Clinical Therapeutics. 40:450-455.e1
- Publication Year :
- 2018
- Publisher :
- Elsevier BV, 2018.
-
Abstract
- Purpose There are few data on the risk for peripheral neuropathy associated with dronedarone, a newer antiarrhythmic medicine. The objective of this study was to assess whether dronedarone is potentially associated with an increased risk for peripheral neuropathy compared with other antiarrhythmics, including amiodarone, sotalol, flecainide, and propafenone. Methods The MarketScan database was used for identifying patients who were at least 18 years of age, had atrial fibrillation or flutter, and had not been diagnosed with peripheral neuropathy in the 180-day period prior to or on the date of the first prescription of an antiarrhythmic between July 20, 2009, and December 31, 2011. Peripheral neuropathy that occurred during the treatment period for a study drug was ascertained using ICD-9-CM diagnostic codes. For each antiarrhythmic, the incidence rate of peripheral neuropathy was calculated. The adjusted hazard ratio (aHR) for peripheral neuropathy for dronedarone compared with another antiarrhythmic was obtained, with control for age, sex, diabetes mellitus status, and the presence of other comorbidities. Findings The study population included 106,933 patients treated with dronedarone (n = 12,989), amiodarone (n = 45,173), sotalol (n = 22,036), flecainide (n = 14,244), or propafenone (n = 12,491). The incidence rates (per 1000 person–years) of peripheral neuropathy were 1.33 for dronedarone, 2.38 for amiodarone, 1.20 for sotalol, 1.08 for flecainide, and 1.97 for propafenone. The aHRs for peripheral neuropathy for dronedarone relative to other drugs ranged from 0.53 (95% CI, 0.21–1.34) compared with propafenone, to 0.94 (95% CI, 0.38–2.30) compared with sotalol. A new-user analysis showed similar results. Implications The risks for peripheral neuropathy were not significantly different between dronedarone and other antiarrhythmics.
- Subjects :
- Adult
Male
medicine.medical_specialty
Databases, Factual
Amiodarone
Propafenone
030204 cardiovascular system & hematology
Cohort Studies
03 medical and health sciences
0302 clinical medicine
Internal medicine
Atrial Fibrillation
medicine
Humans
Pharmacology (medical)
Dronedarone
Flecainide
Aged
Retrospective Studies
Aged, 80 and over
Pharmacology
business.industry
Sotalol
Hazard ratio
Peripheral Nervous System Diseases
Atrial fibrillation
Middle Aged
medicine.disease
Peripheral neuropathy
Cardiology
Female
business
Anti-Arrhythmia Agents
030217 neurology & neurosurgery
medicine.drug
Subjects
Details
- ISSN :
- 01492918
- Volume :
- 40
- Database :
- OpenAIRE
- Journal :
- Clinical Therapeutics
- Accession number :
- edsair.doi.dedup.....3d309736a60a146738ecc2c837e3bd52