Related Experiment Video
Updated: Aug 12, 2026
Percutaneous Contrast Echocardiography-guided Intramyocardial Injection and Cell Delivery in a Large Preclinical Model
Published on: January 21, 2018
Review of clinical experience with digoxin immune Fab (ovine)
1Department of Medicine, Brigham and Women's Hospital, Boston, MA 02115.
Abstract:
Following the development of methods for eliciting and purifying digoxin-specific Fab fragments with high affinity and specificity for cardiac glycosides, clinical studies were undertaken as a multicenter, open-label trial to test safety and efficacy in patients with advanced and potentially life-threatening digitalis toxicity that failed to respond to conventional therapeutic measures. One-hundred fifty such patients were treated with digoxin-specific antibody fragments purified from immunoglobulin G (IgG) produced in sheep. Doses of Fab were equivalent to the amount of digoxin or digitoxin in the patient's body, as estimated from the medical history or serum concentration measurements. Of 150 patients included in this trial, detailed information is available on 148. One-hundred nineteen (80%) had resolution of all signs and symptoms of digitalis toxicity following specific Fab fragment infusions, 14 (10%) improved, and 15 (10%) showed no response. Among 14 patients with adverse events possibly or probably caused by Fab, the most common events were development of hypokalemia and exacerbation of congestive heart failure. Analysis of the available clinical data indicates that a treatment response was observed in at least 90% of patients with convincing evidence of advanced and potentially life-threatening digitalis toxicity. The data from this multicenter trial have been augmented by findings from an observational surveillance study conducted to monitor the safety and effectiveness of treatment with digoxin immune Fab (ovine) following commercial availability. In this experience, 74% of patients were judged to have a complete or partial response to treatment, and 12% no response. The response for the remaining 14% was not reported or reported as uncertain. In this clinical experience, digoxin-specific Fab was generally well tolerated and clinically effective in patients with potentially life-threatening digitalis toxicity.
Insights
Digoxin-specific antibody fragments (Fab) effectively treat life-threatening digitalis toxicity, with over 90% of patients showing significant improvement. This treatment is generally well-tolerated and offers a crucial option for severe cases unresponsive to standard therapies.
Area of Science:
- Cardiology
- Pharmacology
- Immunology
Background:
- Cardiac glycosides, like digoxin, are vital but can cause severe toxicity.
- Conventional treatments for digitalis toxicity have limitations, especially in advanced cases.
- Development of digoxin-specific antibody fragments (Fab) offers targeted therapy.
Purpose of the Study:
- To evaluate the safety and efficacy of digoxin-specific Fab fragments in patients with severe digitalis toxicity.
- To assess treatment response in patients unresponsive to conventional therapies.
Main Methods:
- A multicenter, open-label trial involving 148 patients with advanced digitalis toxicity.
- Treatment administered with sheep-derived digoxin-specific antibody fragments (Fab).
- Dosing based on estimated digoxin or digitoxin body burden.
Main Results:
- 80% of patients experienced complete resolution of digitalis toxicity symptoms.
- An additional 10% showed improvement, indicating a response in at least 90% of patients.
- Adverse events included hypokalemia and worsening heart failure in a small subset of patients.
Conclusions:
- Digoxin-specific Fab fragments are clinically effective and generally well-tolerated for potentially life-threatening digitalis toxicity.
- The treatment provides a vital therapeutic option for patients unresponsive to conventional measures.
- Augmented data from post-marketing surveillance confirm treatment effectiveness and safety.
