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Amiodarone Clinical Trials for low dose medication

bennie06 profile image
13 Replies

I take 200mg maintenance of Amio daily and became intrigued as to what was a low dose? After some research i realised that the majority of trials were decades of years old, some of which had few sampling numbers but that 200mg was being quoted as a "small" maintenance dose. Then i came across a relatively recent trial published in 2014 from Korea. The trial covered a period of 11 years and comprised of 900 participants and the results were very encouraging regarding side effects and efficacy. Other trials pretty much confirmed the Korean data sets with marked improvement in Liver, Thyroid, Eye and Lung toxicities. One swallow does not make a summer but numbers do not lie although they can be massaged and are subject to environmental influences.

Unfortunately I could only find 1 trial which focused on a 100mg daily maintenance which had a very small sampling rate. Sooooo is anybody here on 100mg/day or know of any other relevant trials???

Korean link.

KJIM.org/journal/view.php?n...

All responses gratefully received.

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bennie06
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ILowe profile image
ILowe

I would like to take time to answer -- I have bad internet for a few days. Good question. I hope others answer.

myheart18 profile image
myheart18

my doc told me yesterday amio is not a long term option because of the toxicity levels. makes me wonder at what point is this medication the only option to keep heart rhythms under control.

bennie06 profile image
bennie06 in reply to myheart18

Other meds are available including Deronadrone and Solatol, both of which are iodine free which is the "bad boy" of Amiodarone. Both Deronadrone and Solatol obviously come with unwelcome guests and are less effective.

maund profile image
maund in reply to bennie06

I was on low does of 100 mg a day for 2 years all was fine , until things started happening! Eyes started getting blurry at night in light , balance started to become effected , then my thyroid died ! Been of it now for 9 months all side effects are gone except my thyroid is stuffed never to work again ! The drug worked great but should have listened to others and demanded of it quicker

bennie06 profile image
bennie06 in reply to maund

Sorrry to read your bad experience and thanks for posting. Thyroid problems top of the list when it comes to side effects at around 4%. (Strangely the Korean trial had Bradycardia at the top with 9%, although their numbers were collated differently).

Can you remember whether you had Amio-induced-thyroidism(AIH) OR thyrotoxocosis(AIT)? AIT is less common and in males, more difficult to treat, and more likely in Iodine deficient areas. On a lighter note a recent survey in Bristol found that children were iodine deficient. Now this can be caused by drinking organic milk!!! (Milk being a major iodine source). Enjoy the weekend.

maund profile image
maund in reply to bennie06

Yer it was Amiodarone induced thyrotoxocosis , because it damaged thyroid so much now have hypothyroid

bennie06 profile image
bennie06 in reply to myheart18

Forgot to mention a good pocket guide. (It's American but ok). Especially good flowchart that takes you through the different options. Google; "hrsonline rhythm rate guide 2013". Then download pdf. Enjoy.

maund profile image
maund in reply to bennie06

All I can say is ablation was the best thing that I have done

Heddeball profile image
Heddeball

I've found it hard to find anything definitive for my specific situation when researching trials etc.

I've had PAF for about 12 years (maybe more). I don't recall the initial meds I was on (apart from Nuseal Aspirin) but they were changed at least once as the condition progressed. In 2007 I had a TIA and was switched (too late, I reckon) to Warfarin and 200mg Amiodorone. The only consistent thing I found about PAF was it's inconsistency and unpredictability. There were periods when I having 2 episodes a month, to periods when it was up to 4 a week. Each was of different intensity and duration. It was inconvenient and uncomfortable. It was distressing at first, but I got used to it.

Over a period of years I lost weight, and was given a CPAP machine after a diagnosis of Sleep Apnoea. My PAF improved significantly as a result. Last year I managed to reduce my Amidorone dosage to 75mg, but was still getting generally moderate episodes on average once every 3 weeks, lasting 6 hours (average). My cardiologist had been offering me the ablation consistently over the years, but felt at 75mg per day, the risks from that medication was quite low.

However in December last I got a flu, and my AF went Bananas!! I was getting difficult episodes almost every day. He put me up to 300mg, and strongly suggested that this was the optimum time for me to have the ablation. I felt though that the flu had caused a once off spike, and that I wanted to see if I could get it down to lower levels again, which I've been trying to do. I'm currently on 225mg, and doing pretty well.

I'm considering the ablation more seriously than before but, although I know the risk of seriously bad outcome (eg stroke) from having that procedure are very small, it could be an immediate debilitating risk. I know some of my family and friends think I should just go and get it done. I probably should.

At the end of the day it's a bit like tossing a coin, because there is no entirely risk free treatment.

I started this post to reply to the issue of Amidorone dosage and trials, but ended up with a very long winded (first) post, So apologies to you bennie06 for that.

bennie06 profile image
bennie06 in reply to Heddeball

Seem to have lost my reply to you Heddeball... absolutely no need for apologies and as you say ultimately your decision and looks like your stuck between a rock and a hard place. Also as you say every route has associated risks.

Found a good pocket book just google; "hrsonline rhythm rate guide 2013" Good luck with which ever way you jump and enjoy your weekend.

Heddeball profile image
Heddeball

Many thanks bennie06 for taking the trouble to reply. Thanks too for that link. I'll definitely check it out.

ILowe profile image
ILowe

OK, back at work. You specifically asked about similar articles. The way to find them is to go to google scholar, type in the name of the article or similar, when you find it, notice under the title, two links: "cited by" and "related articles". The cited by enables you to go forwards in time and is extremely useful and time saving. When I do that I find that 8 articles have referred to it. One of these references is onlinelibrary.wiley.com/doi...

"Population‐level incidence and monitoring of adverse drug reactions with long‐term amiodarone therapy"

I agree, there is a scarcity of articles on "low dose", defined as 200mg or less. The BNF does say that the maintenance dose is 200mg or less.

It seems that part of the problem is the health system NOT monitoring side effects adequately, even according to existing guidelines. Even so, I was surprised how low the incidence of reported side effects, and there was no mention of the potentially fatal lung problems.

My personal experience is that you have to insist on baseline checks being done. Also, six months is too long to wait for another check -- I was in a position to get thyroid testing done after 3 months, and I was able to catch it before it needed treatment.

There is another parameter I cannot see. Somewhere I read that side effects click in after 30g of Amiodarone. Unfortunately, that figure was without a margin of error (scientists nowadays use something called 95% confidence intervals, which is stating the minimum, maximum, for 95% of those tested). I suspect Amiodarone tolerance is also related to male/female, and body shape, amount of fat etc.

A safer approach is to use Amiodarone for extremely short periods of time in order to get NSR back, then to use other, safer meds such as Flecainide to maintain the NSR. Comparative studies have been done and Amiodarone is only marginally more successful than Flecainide. Ask if you want me to find and post the links. I also have some threads on the use of oral Amiodarone (two high doses) followed by alternate day moderate doses for 6 weeks then discontinue. This is a method used in the French speaking world and seems unknown in English. The idea is high pulses to hit the heart, using Amiodarone as a PIP rather than maintenance dose.

healthunlocked.com/afassoci...

healthunlocked.com/afassoci...

bennie06 profile image
bennie06

Thank you for your response, very much appreciated especially the link provided. Totally agree with the baseline checks and 3 month check on thyroid which i will insist upon when i have my MOT. Thanks again and good luck with that work "thing".

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