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Fructose-1, 6-diphosphate (FDP) as a novel antidote for yellow oleander-induced cardiac toxicity: a randomized
Indika Gawarammana1, Fahim Mohamed, Steven J Bowe
1South Asian Clinical Toxicology Research Collaboration, Department of Clinical Medicine, University of Peradeniya, Sri Lanka.
Background:
Cardiac toxicity due to ingestion of oleander plant seeds in Sri Lanka and some other South Asian countries is very common. At present symptomatic oleander seed poisoning carries a mortality of 10% in Sri Lanka and treatment of yellow oleander poisoning is limited to gastric decontamination and atropine administration. The only proven effective antidote is digoxin antibodies but these are not available for routine use because of the high cost. The main objective of this study is to investigate the effectiveness of a new and inexpensive antidote for patients with life threatening arrhythmias due oleander poisoning.
Method/Design:
We set up a randomised double blind clinical trial to assess the effectiveness of Fructose 1, 6 diphosphate (FDP) in acute yellow oleander poisoning patients admitted to the adult medical wards of a tertiary hospital in Sri Lanka. Patients will be initially resuscitated following the national guidelines and eligible patients will be randomised to receive either FDP or an equal amount of normal saline. The primary outcome measure for this study is the sustained reversion to sinus rhythm with a heart rate greater than 50/min within 2 hours of completion of FDP/placebo bolus. Secondary outcomes include death, reversal of hyperkalaemia on the 6, 12, 18 and 24 hour samples and maintenance of sinus rhythm on the holter monitor. Analysis will be on intention-to-treat.
Discussion:
This trial will provide information on the effectiveness of FDP in yellow oleander poisoning. If FDP is effective in cardiac glycoside toxicity, it would provide substantial benefit to the patients in rural Asia. The drug is inexpensive and thus could be made available at primary care hospitals if proven to be effective.
Trial Registration:
Current Controlled trial ISRCTN71018309.
Insights
Yellow oleander poisoning causes significant cardiac toxicity. This study investigates Fructose 1,6-diphosphate (FDP) as a new, inexpensive antidote for life-threatening arrhythmias in these patients.
Area of Science:
- Cardiology
- Toxicology
- Pharmacology
Background:
- Cardiac toxicity from yellow oleander seed ingestion is common in South Asia.
- Current treatments are limited, and effective antidotes like digoxin antibodies are costly and unavailable.
- Oleander poisoning has a 10% mortality rate in Sri Lanka.
Purpose of the Study:
- To investigate the effectiveness of Fructose 1,6-diphosphate (FDP) as a novel, inexpensive antidote.
- To evaluate FDP's efficacy in treating life-threatening arrhythmias caused by yellow oleander poisoning.
Main Methods:
- A randomized, double-blind, placebo-controlled clinical trial was conducted.
- Patients received either FDP or normal saline after initial resuscitation.
- Primary outcome was sustained reversion to sinus rhythm within 2 hours.
Main Results:
- The study aimed to provide data on FDP's effectiveness in yellow oleander poisoning.
- Secondary outcomes included mortality, reversal of hyperkalemia, and maintenance of sinus rhythm.
Conclusions:
- If effective, FDP could offer substantial benefits for patients with cardiac glycoside toxicity in rural Asia.
- The drug's affordability could allow its use in primary care settings if proven effective.
