Advertisement

TSH evaluation in hypothyroid patients assuming liquid levothyroxine at breakfast or 30 min before breakfast

  • I. Pirola
  • E. Gandossi
  • D. Brancato
  • F. Marini
  • A. Cristiano
  • A. Delbarba
  • B. Agosti
  • M. Castellano
  • C. Cappelli
Original Article
  • 78 Downloads

Abstract

Purpose

To compare TSH levels of hypothyroid patients treated with liquid LT4 at breakfast or 30 min before breakfast.

Patients and methods

Subjects, aged 18–75 years old, were eligible if they presented hypothyroidism, due to Hashimoto’s thyroiditis or after thyroidectomy for proven benign goiter. Seven hundred ninety-eight patients were recruited and enrolled in the study. Thirty-seven subjects withdrew from the trial. A total of 761 patients (mean age 46.2 ± 10.8 years) completed the study. The starting dose of LT4 was determined through clinical judgment, taking into account TSH levels, estimated residual thyroid function, age, body weight and comorbidities. All patients underwent TSH, fT4, and fT3 evaluation to verify achievement of euthyroidism with their initial fasting state assumption of LT4 after 8 weeks of therapy. If euthyroidism was not achieved, an appropriately adjusted LT4 dose was administered for 8 weeks, after which thyroid function parameters were checked again. If euthyroidism was achieved, the patients were asked to take LT4 at breakfast and hormone levels were checked again after 6 months.

Results

At the end of the study period, no significant differences in serum TSH level were observed whether LT4 was ingested at breakfast or 30 min prior in a fasting state: 2.61 ± 1.79 vs. 2.54 ± 1.86 mIU/L, respectively (p = 0.455).

Conclusions

This study confirms in a large set of patients that a liquid LT4 formulation can be taken directly at breakfast and potentially improve therapeutic compliance.

Keywords

Liquid levothyroxine Hypothyroidism TSH Levothyroxine formulation 

Notes

Acknowledgements

We thank the patients who volunteered to participate in this study.

Compliance with Ethical Standards

Funding

Any no funds have been provided for this study.

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in the study involving human participants were in accordance with the ethical standards of the institutional ethics committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

References

  1. 1.
    Vanderpump PJ, Tunbrldge WM, French JM, Appleton D, Bates D et al (1995) The incidence of thyroid disorders in the community: a twenty-year follow-up of the Whickham Survey. Clin Endocrinol 43:55–68CrossRefGoogle Scholar
  2. 2.
    Canaris GJ, Manowitz NR, Mayor G, Ridgway EC (2000) The Colorado thyroid disease prevalence study. Arch Internal Med 160:526–534CrossRefGoogle Scholar
  3. 3.
    Aoki Y, Belin RM, Clickner R, Jeffries R, Phillips L et al (2007) Serum TSH and total T4 in the United States population and their association with participant characteristics: National Health and Nutrition Examination Survey (NHANES 1999–2002). Thyroid 17:1211–1223CrossRefPubMedGoogle Scholar
  4. 4.
    Jonklaas J, Bianco AC, Bauer AJ, Burman KD, Cappola AR et al (2014) American Thyroid Association Task Force on Thyroid Hormone Replacement 2014 Guidelines for the treatment of hypothyroidism: prepared by the American Thyroid Association Task Force on thyroid hormone replacement. Thyroid 24:1670–1751CrossRefPubMedPubMedCentralGoogle Scholar
  5. 5.
    Vaidya B, Pearce SH (2008) Management of hypothyroidism in adults. BMJ 337:a801CrossRefPubMedGoogle Scholar
  6. 6.
    Biondi B, Bartalena L, Chiovato L, Lenzi A, Mariotti S, Pacini F et al (2016) Recommendations for treatment of hypothyroidism with levothyroxine and levotriiodothyronine: a 2016 position statement of the Italian Society of Endocrinology and the Italian Thyroid Association. J Endocrinol Invest 39:1465–1474CrossRefPubMedGoogle Scholar
  7. 7.
    Parle JV, Franklyn JA, Cross KW, Jones SR, Sheppard MC (1993) Thyroxine prescription in the community: serum thyroid stimulating hormone level assays as an indicator of undertreatment or overtreatment. Br J Gen Pract 43:107–109PubMedPubMedCentralGoogle Scholar
  8. 8.
    Liwanpo L, Hershman JM (2009) Conditions and drugs interfering with thyroxine absorption. Best Pract Res Clin Endocrinol Metab 23:781–792CrossRefPubMedGoogle Scholar
  9. 9.
    Dusing R, Lottermoser K, Mengden T (2001) Compliance with drug therapy-new answers to an old question. Nephrol Dial Transplant 16:1317–1321CrossRefPubMedGoogle Scholar
  10. 10.
    Vita R, Saraceno G, Trimarchi F, Benvenga S (2013) A novel formulation of l-thyroxine (LT4) reduces the problem of LT4 malabsorption by coffee observed with traditional tablet formulations. Endocrine 43:154–160CrossRefPubMedGoogle Scholar
  11. 11.
    Centanni M, Benvenga S, Sachmechi I (2017) Diagnosis and management of treatment-refractory hypothyroidism: an expert consensus report. J Endocrinol Invest 40:1289–1301CrossRefPubMedPubMedCentralGoogle Scholar
  12. 12.
    Cappelli C, Pirola I, Daffini L, Formenti A, Iacobello C et al (2016) A double-blind placebo-controlled trial of liquid thyroxine ingested at breakfast: results of the TICO study. Thyroid 26:197–202CrossRefPubMedGoogle Scholar
  13. 13.
    Esposito D, Rotondi M, Accardo G, Vallone G, Conzo G, Docimo G et al (2017) Influence of short-term selenium supplementation on the natural course of Hashimoto’s thyroiditis: clinical results of a blinded placebo-controlled randomized prospective trial. J Endocrinol Invest 40:83–89CrossRefPubMedGoogle Scholar
  14. 14.
    Wenzel KW, Kirschsieper HE (1997) Aspects of the absorption of oral l-thyroxine in normal man. Metabolism 26:1–8CrossRefGoogle Scholar
  15. 15.
    Benvenga S, Bartolone L, Pappalardo MA, Russo A, Lapa D et al (2008) Altered intestinal absorption of l-thyroxine caused by coffee. Thyroid 18:293–301CrossRefPubMedGoogle Scholar
  16. 16.
    Bach-Huynh TG, Nayak B, Loh J, Soldin S, Jonklaas J (2009) Timing of levothyroxine administration affects serum thyrotropin concentration. JCEM 94:3905–3912PubMedPubMedCentralGoogle Scholar
  17. 17.
    Perez CL, Araki FS, Graf H, de Carvalho GA (2013) Serum thyrotropin levels following levothyroxine administration at breakfast. Thyroid 23:779–784CrossRefPubMedGoogle Scholar
  18. 18.
    Liel Y, Harman-Boehm I, Shany S (1996) Evidence for a clinically important adverse effect of fiber-enriched diet on the bioavailability of levothyroxine in adult hypothyroid patients. J Clin Endocrinol Metab 81:857–885PubMedGoogle Scholar
  19. 19.
    Bell DS, Ovalle F (2001) Use of soy protein supplement and resultant need for increased dose of levothyroxine. Endocr Pract. 7:193–194CrossRefPubMedGoogle Scholar
  20. 20.
    Vita R, Fallahi P, Antonelli A, Benvenga S (2014) The administration of l-thyroxine as soft gel capsule or liquid solution. Expert Opin Drug Deliv 11:1103–1111CrossRefPubMedGoogle Scholar
  21. 21.
    Cappelli C, Rotondi M, Pirola I, Agosti B, Formenti A, Zarra E et al (2012) Thyreotropin levels in diabetic patients on metformin treatment. Eur J Endocrinol 167:261–265PubMedGoogle Scholar
  22. 22.
    Cappelli C, Rotondi M, Pirola I, Agosti B, Gandossi E, Valentini U et al (2009) TSH-lowering effect of metformin in type 2 diabetic patients: differences between euthyroid, untreated hypothyroid, and euthyroid on L-T4 therapy patients. Diabetes Care 32:1589–1590CrossRefPubMedPubMedCentralGoogle Scholar
  23. 23.
    Vita R, Di Bari F, Benvenga S (2017) Oral liquid levothyroxine solves the problem of tablet levothyroxine malabsorption due to concomitant intake of multiple drugs. Expert Opin Drug Deliv 14:467–472CrossRefPubMedGoogle Scholar
  24. 24.
    Ferrara R, Ientile V, Arcoraci V, Ferrajolo C, Piccinni C et al (2017) Treatment pattern and frequency of serum TSH measurement in users of different levothyroxine formulations: a population-based study during the years 2009-2015. Endocrine 58(1):143–152CrossRefPubMedGoogle Scholar
  25. 25.
    Negro R, Valcavi R, Agrimi D, Toulis KA (2014) Levothyroxine liquid solution versus tablet for replacement treatment in hypothyroid patients. Endocr Pract 1:1–20Google Scholar
  26. 26.
    Cappelli C, Pirola I, Daffini L, Gandossi E, Agosti B et al (2014) Thyroid hormonal profile in elderly patients treated with two different levothyroxine formulations: a single institute survey. Eur Geriatr Med 5:382–385CrossRefGoogle Scholar

Copyright information

© Italian Society of Endocrinology (SIE) 2018

Authors and Affiliations

  • I. Pirola
    • 1
  • E. Gandossi
    • 1
  • D. Brancato
    • 2
  • F. Marini
    • 1
  • A. Cristiano
    • 1
  • A. Delbarba
    • 1
  • B. Agosti
    • 1
  • M. Castellano
    • 1
  • C. Cappelli
    • 1
  1. 1.Endocrine and Metabolic Unit, Department of Clinical and Experimental SciencesUniversity of BresciaBresciaItaly
  2. 2.Department of Internal Medicine, Regional Reference Center for DiabetologyHospital of PartinicoPalermoItaly

Personalised recommendations