Thyroxine Treatment With Softgel Capsule Formulation: Usefulness in Hypothyroid Patients Without Malabsorption

[helvella]

This a somewhat odd paper. It says:

Secondly, free-T4 and free-T3 values were not available for all patients because of the use of reflex TSH in clinical practice.

But just what is an improved TSH? Lower, I understand.

The paper also says:

Secondly, free-T4 and free-T3 values were not available for all patients because of the use of reflex TSH in clinical practice.

Which yet again demonstrates the short-term, short-sighted approach of reflex testing (not doing FT3 if FT4 is in range, not doing FT4 if TSH is in range). Even when serious research is attempted it is stymied because the information was flushed away without being analysed.

And Tirosint is still not available in the UK.

Front Endocrinol (Lausanne). 2018; 9: 118.

Published online 2018 Mar 21. doi: 10.3389/fendo.2018.00118

PMCID: PMC5871661

PMID: 29619010

Thyroxine Treatment With Softgel Capsule Formulation: Usefulness in Hypothyroid Patients Without Malabsorption

Pierpaolo Trimboli,1,*† Camilla Virili,2,† Marco Centanni,2 and Luca Giovanella1

1Department of Nuclear Medicine and Thyroid Centre, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland

2Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy

Edited by: Alessandro Antonelli, Università degli Studi di Pisa, Italy

Reviewed by: Silvia Martina Ferrari, Università degli Studi di Pisa, Italy; Roberto Vita, Università degli Studi di Messina, Italy

†These authors have contributed equally to this work.

Abstract

Background

Levothyroxine sodium (LT4) is the therapy of choice for hypothyroidism. In the last decade, new LT4 formulations, such as liquid and softgel capsules, became available. Even if some evidence has been reached in the efficacy of liquid LT4 in patients with suboptimal TSH on tablet LT4, the usefulness of softgel LT4 has been rarely studied. This study aimed at evaluating the effect of switching from tablet to softgel LT4 patients without increased need for LT4. TSH was used as proxy of LT4 bioavailability and effectiveness.

Methods

During the period from April to August 2017, 19 patients on tablet LT4 treatment for hypothyroidism, mostly due to autoimmune thyroiditis, were enrolled. Subjects with causes of malabsorption or increased requirement of LT4 were previously excluded. Patients finally included were asked to switch from tablet to softgel LT4 formulation at unchanged dose and ingestion fashion (30 min before breakfast). TSH was measured with chemiluminescence immunoassays.

Results

According to exclusion and inclusion criteria, 19 patients were finally selected. One of these had headache 4 days later and come back to tablet LT4, and 18 of them (16W/2M; mean age = 55 years; BMI 22.7 kg/m2) completed the study. They were treated with a median LT4 dose of 88 μg/day and showed a median TSH value of 3.33 mIU/L. The rate of cases with TSH ≤ 4.0 mIU/L was 61.1% (11/18 cases). When patients were re-evaluated after 3 months of softgel LT4, we observed that TSH reached levels under 4.0 mIU/L in 16/18 (88.9%) patients, TSH was lower in 11 cases, and in 6 out of 7 patients with pre-switch TSH values over the normal range. Overall, TSH values on softgel LT4 (median 1.90 mIU/L) was significantly lower from that observed during tablet LT4 (p = 0.0039).

Conclusion

These data show that hypothyroid patients with no proven malabsorption may have an improved TSH following 3 months from the switch from tablet to softgel LT4 preparation at unchanged dose.

Keywords: hypothyroidism, thyroxine absorption, softgel, levothyroxine, drugs dissolution

Rest of paper here:

ncbi.nlm.nih.gov/pmc/articl...

[crimple]

how can info from 19 patients be useful?!

[helvella Administrator Thyroid UK in reply to crimple]

I agree - woefully inadequate.

[Elizabetha3 in reply to helvella]

Hi helvella. I was contacted by Health Unlocked, requesting possible advice for you. If I can help in any way, I will be more than happy to. I am just an average "Jane" from the U.S. ~ Some of your writings are way above any knowledge I have..I feel like I went through hell and back regarding my "numbers" not falling 'in range'..was sent to an Endocrinologist. Prim care changed my levo from 175 to 150. Endocrinologist changed my 150 Levo to 90 Armour. Had never heard of Armour, as I don't think it's used a lot in the States. I was a lathargic (sp) mess! And, that's when I found HEALTH UNLOCKED. This site has been a life saver ! I now have some knowledge on TSH, T3 & T4. Well, enough knowledge to let the nurse know that my 'numbers' were still off the chart, when she tried to tell me my numbers had improved. My advice to everyone. Do your homework. Read up on everything pertaining to your particular 'situation.' Every since I was put on 150 Levo from 175, my weight started climbing, even more so with 90 Armour. I put on 35 lbs! I am now on 200 MCG Synthroid. I lost 7 lbs the first month. My energy level is much better. This is my story. I don't know if will help anyone else. I hope so.. I can't stress enough to read up (and I took notes)..some sites have different ranges of 'normal.' Good Luck and Blessing to all who struggle with thyroid issues. Don't give up, and, keep informed on your blood work. Elizabetha3

[Elizabetha3 in reply to helvella]

Now wonder you're so informed, you're an Administrator ! Cheers !

[StarFlower2]

I’m on liquid Levo thyroxine as tablet form did not suit me due to malabsorption. I’m wondering if softgel is a good option as have to take bottles of the liquid when I travel!

I’m definitely feeling better since taking liquid Levo. Must be due to absorption being better!

[helvella Administrator Thyroid UK in reply to StarFlower2]

If you can get hold of gel caps, it might be worth seeing how you get on with them.

[StarFlower2 in reply to helvella]

Thanks Helvella, I’m going to try and get a scrip from GP. Worth a try!

[Angel_of_the_North]

So a small number of under medicated people were still under medicated though perhaps not quite as much after 3mths on soft gel t4. Marvellous. And we don't know if any of them were starting a Hashi flare and had lower TSH because of that. I bet people get paid for this rubbish.

[helvella Administrator Thyroid UK in reply to Angel_of_the_North]

I think some achieved adequate medication level - if you happened to believe in dosing by TSH.

But one of the issues is quite clearly that testing absorption in healthy volunteers is an absolute nonsense. We need to know what happens in those who are not yet treated, inadequately treated and seemingly adequately treated.

[HelsS]

Hi - just to mention, having read your post, that I do manage to get Tirosint in the UK. I was fine on a very low dose of levothyroxine for years (25 mcg per day) but then, I think largely due to a stressful event I went through, developed malapsorption and nutritional problems and for the first time in years couldn't tolerate any levothyroxine in tablet form or even liquid form. I did heaps of research and found Tirosint and mentioned it to my endocrinologist who hadn't come across it, but I managed to get it prescribed and it was ordered in I think initially from the US but since from Switzerland, everyone really went to a lot of trouble to get it for me including the hospital pharmacy. It is expensive, I pay privately unfortunately, but I'm so grateful I have access to it via my endocrinologist's prescription. He has been very interested to hear about it, it's been a huge relief for me as I had absolutely no absorption issues, and no gastrointestinal symptoms having taken it, and I take the same small dosage I took when taking tablet form.

[helvella Administrator Thyroid UK in reply to HelsS]

Interesting and thanks for letting us know.

I got the impression that it is just about affordable in Italy - but don't know how we could go about getting it from there.

[HelsS]

It's gone up a little in price over the 3 years I have taken it, it is now about £1.50 per capsule so I feel quite lucky that I only take a small dosage. My GP is great and I get TSH, FT4 and FT3 tested regularly and all are as they should be (FT3 mid to upper range, FT4 mid range, TSH 2ish).

[helvella Administrator Thyroid UK in reply to HelsS]

However, last I checked, all dosages were the same price! Only if you need two or more caps would it cost more!