Absence of bilateral vision loss from amiodarone: A randomized trial

Mindel, Joel S.; Anderson, Jill; Johnson, George; Hellkamp, Anne; Poole, Jeanne E.; Mark, Daniel B.; Lee, Kerry L.; Bardy, Gust H.; for the SCD-HeFT Investigators,

doi:10.1016/j.ahj.2007.02.010

« Previous Next »American Heart Journal
Volume 153, Issue 5 , Pages 837-842, May 2007

Absence of bilateral vision loss from amiodarone: A randomized trial

This study was presented in part at the annual meeting of the North American Neuro-Ophthalmological Society on February 27, 2006, in Tuscon, AZ.

Joel S. Mindel, MD, PhD
- Department of Ophthalmology, Mount Sinai School of Medicine, New York, NY
- Department of Pharmacology and Biochemistry, Mount Sinai School of Medicine, New York, NY
- Reprint requests: Joel S. Mindel, MD, PhD, Department of Ophthalmology, Box 1183, The Mount Sinai Medical Center, One Gustave L. Levy Place, New York, NY 10029.
Jill Anderson, RN
- Seattle Institute for Cardiac Research, University of Washington, Seattle, WA
- Department of Biostatistics and Bioinformatics, Duke Clinical Research Institute, Durham, NC
George Johnson, BSEE
- Seattle Institute for Cardiac Research, University of Washington, Seattle, WA
Anne Hellkamp, MS
- Department of Biostatistics and Bioinformatics, Duke Clinical Research Institute, Durham, NC
Jeanne E. Poole, MD
- Department of Medicine, Duke University Medical Center, Durham, NC
Daniel B. Mark, MD, MPH
- Department of Medicine, Duke University Medical Center, Durham, NC
Kerry L. Lee, PhD
- Department of Biostatistics and Bioinformatics, Duke Clinical Research Institute, Durham, NC
Gust H. Bardy, MD
- Seattle Institute for Cardiac Research, University of Washington, Seattle, WA
for the SCD-HeFT Investigators

Received 26 January 2007; accepted 9 February 2007. published online 31 March 2007.

Background

Amiodarone's role as a cause of toxic optic neuropathy is based on case reports. Annual frequency estimates of 0.36% to 2.0%, which have been made without reference to the dose or duration of treatment, are 12 to 200 times higher than those for idiopathic nonarteritic anterior ischemic neuropathy. The object of this study was to determine the incidence, dose, and time until onset of bilateral vision loss from amiodarone as a secondary end point in an investigation of amiodarone's role in preventing sudden death.

Methods

Randomized subjects received body weight–determined doses of closed-label amiodarone (n = 837) or placebo (n = 832) in a prospective double-masked manner. Closed-label amiodarone subjects were followed, unless death occurred, for a minimum of 27 months. Median follow-up in survivors was 45.5 months. The end point was removal from the study because of bilateral vision loss.

Results

No subject was removed from the study because of bilateral vision loss. Subjects receiving continuous amiodarone for 4 to >60 months at daily doses of >2.0 mg/kg (n = 696), >3.0 mg/kg (n = 559), or >4.0 mg/kg (n = 219) had maximum possible (95% confidence) annual incidences of bilateral toxic vision loss of 0.23%, 0.29%, or 0.74%, respectively. The maximum possible annual incidence rate of bilateral vision loss from amiodarone in all 837 subjects (median age 60 years) receiving a mean daily dose of 3.7 mg/kg (300 mg) was 0.13%.

Conclusions

At the doses commonly used clinically, bilateral vision loss from amiodarone toxic optic neuropathy occurs infrequently, if at all.

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This study was supported by grants from the National Heart, Lung, and Blood Institute and the National Institutes of Health (U01 HL55766, U01 HL55496 and U01 HL55788-05); Medtronic, Minneapolis, MN; Wyeth-Ayerst Pharmaceuticals; and the Janet C Weis 1997 Charitable Lead Unitrust.

Drs Bardy and Lee received research funding from Wyeth-Ayerst Pharmaceuticals.

PII: S0002-8703(07)00143-3

doi:10.1016/j.ahj.2007.02.010