Trial reportAmerican heart journal2007
Absence of bilateral vision loss from amiodarone: a randomized trial.
Trial report in American heart journal, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 9 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.
- Amiodarone versus other pharmacological interventions for prevention of sudden cardiac death.The Cochrane database of systematic reviews · 2015Pooled it
- Article
- Clinical and Mechanistic Review of Amiodarone-Associated Optic Neuropathy.Biomolecules · 2022Review
- Low-dose Amiodarone Is Safe: A Systematic Review and Meta-analysis.The Journal of innovations in cardiac rhythm management · 2020Article
- Adverse reactions of Amiodarone.Journal of geriatric cardiology : JGC · 2019Review
- Amiodarone-associated Optic Neuropathy-A Clinical Criteria-based Diagnosis?Neuro-ophthalmology (Aeolus Press) · 2018Article
- Amiodarone-Associated Optic Neuropathy: Clinical Review.Neuro-ophthalmology (Aeolus Press) · 2017Review
- Current concepts in the diagnosis, pathogenesis and management of nonarteritic anterior ischaemic optic neuropathy.Eye (London, England) · 2015Article
- Amiodarone-associated optic neuropathy: a critical review.The American journal of medicine · 2012Review
Corrections and comments
- Erratum issued
Authors and funding
9 authors at 5 institutions in 1 country.
Funding
Abstract
backgroundAmiodarone'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.
methodsRandomized 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.
resultsNo 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%.
conclusionsAt the doses commonly used clinically, bilateral vision loss from amiodarone toxic optic neuropathy occurs infrequently, if at all.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.