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[Bioequivalence of L-thyroxine Tablets and a Liquid L-thyroxine Solution in the Treatment of Hypothyroid Patients]

[Bioequivalence of L-thyroxine Tablets and a Liquid L-thyroxine Solution in the Treatment of Hypothyroid Patients]

Martin Grussendorf, Renate Vaupel, Karl Wegscheider

Med Klin (Munich). 2004 Nov 15;99(11):639-44.

PMID: 15583873

Abstract:

Background and purpose:
The therapeutic equivalence of L-thyroxine (T(4)) tablets and a new liquid T(4) solution was investigated in patients with hypothyroidism.
Patients and methods:
The study was unblinded, multicentric and prospective: 136 patients (with autoimmune thyroiditis, after thyroid surgery and/or after therapy with radioiodine), who had been treated with T(4) tablets, were switched to a treatment with a liquid T(4) solution (containing 5 microg T(4) per drop) in the same dosage. Thyrotropin (TSH) was measured after 1, 2, 3, and 6 months; the dose of the T4 solution was adapted to obtain a midnormal TSH level.
Results:
The T(4) dose remained constant during the 6 months. Dose adaptations were necessary in 19-23% of patients at the different timepoints, with dose reductions and increases, respectively, becoming equally frequently necessary. The mean TSH level was 0.79 mU/l at the beginning and 0.81 mU/l after 6 months; similarly, the mean levels of free triiodothyronine (fT(3)) and free thyroxine (fT(4)) were equivalent. The liquid T(4) solution was well tolerated: adverse events were noted in three patients (1.8%); one serious adverse event (thyroid carcinoma) showed no correlation to the treatment.
Conclusion:
T(4) tablets and liquid T(4) solution have been proven to be therapeutically equivalent; the use of liquid T(4) solutions will have advantages in the treatment of hypothyroid infants or elderly patients with disturbed swallowing, patients who need a differentiated titration of the T(4) dose, as well as patients with an allergy against inactive ingredients of L-thyroxine tablets.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP51489-A	L-Thyroxine (T4) solution		51-48-9	Price

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