[Randomized, double-blind crossover study of bioavailability of levothyroxine]. 2002

Arne Krehan, and Manuela Dittmar, and Andre Hoppen, and Klaus Lichtwald, and George J Kahaly
I. Medizinische Klinik und Poliklinik, Johannes Gutenberg-Universität Mainz.

OBJECTIVE The synthetic thyroid hormone levothyroxine-sodium (LT4) is still the treatment of choice to replace thyroid hormone deficiency in hypothyroidism, and for adjuvant treatment of euthyroid goiter. A change of LT4 preparations during treatment may lead to major changes of thyroid hormone levels. In this study, we compared the bioavailability of two LT4 preparations, L-Thyroxin Henning 100 and Eferox 100. METHODS In a double-blind trial, 60 euthyroid volunteers were randomly assigned to two treatment groups. Over a period of 2 weeks, each group received 0.1 mg/d of the different preparations according to a "crossover design". To monitor the efficacy of the different drugs, baseline serum thyrotropin (TSH) and free thyroxine (fT4) levels were measured with the help of immunoenzyme tests. RESULTS Compared to Eferox, L-Thyroxin Henning led to continuously higher fT4 levels (p = 0.0004). The area under the concentration-time curve (AUC) of fT4 also confirmed this highly significant difference. With respect to the influencing factors, a higher bioavailability in men compared to women (p = 0.004) was noted. Also, the increase of body weight was related to a lower bioavailability (p = 0.002). Regarding the baseline TSH serum levels, a reduction of 70% in the L-Thyroxin Henning group versus only 56% in the Eferox group was noted after a period of 14 days. Clinical symptoms of hyperthyroidism were not observed in the volunteers under both substances. CONCLUSIONS In this study, L-Thyroxin Henning 100 showed a significantly higher bioavailability than Eferox 100 (p = 0.001). According to these findings, we do recommend regular measurements of serum TSH and fT4 levels when changing LT4 preparations of different brands, to cope with metabolic decompensation by using a new LT4 dosage.

UI MeSH Term Description Entries
D007037 Hypothyroidism A syndrome that results from abnormally low secretion of THYROID HORMONES from the THYROID GLAND, leading to a decrease in BASAL METABOLIC RATE. In its most severe form, there is accumulation of MUCOPOLYSACCHARIDES in the SKIN and EDEMA, known as MYXEDEMA. It may be primary or secondary due to other pituitary disease, or hypothalamic dysfunction. Central Hypothyroidism,Primary Hypothyroidism,Secondary Hypothyroidism,TSH Deficiency,Thyroid-Stimulating Hormone Deficiency,Central Hypothyroidisms,Deficiency, TSH,Deficiency, Thyroid-Stimulating Hormone,Hormone Deficiency, Thyroid-Stimulating,Hypothyroidism, Central,Hypothyroidism, Primary,Hypothyroidism, Secondary,Hypothyroidisms,Primary Hypothyroidisms,Secondary Hypothyroidisms,TSH Deficiencies,Thyroid Stimulating Hormone Deficiency,Thyroid-Stimulating Hormone Deficiencies
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260 Female Females
D006042 Goiter Enlargement of the THYROID GLAND that may increase from about 20 grams to hundreds of grams in human adults. Goiter is observed in individuals with normal thyroid function (euthyroidism), thyroid deficiency (HYPOTHYROIDISM), or hormone overproduction (HYPERTHYROIDISM). Goiter may be congenital or acquired, sporadic or endemic (GOITER, ENDEMIC). Goiters
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D001682 Biological Availability The extent to which the active ingredient of a drug dosage form becomes available at the site of drug action or in a biological medium believed to reflect accessibility to a site of action. Availability Equivalency,Bioavailability,Physiologic Availability,Availability, Biologic,Availability, Biological,Availability, Physiologic,Biologic Availability,Availabilities, Biologic,Availabilities, Biological,Availabilities, Physiologic,Availability Equivalencies,Bioavailabilities,Biologic Availabilities,Biological Availabilities,Equivalencies, Availability,Equivalency, Availability,Physiologic Availabilities

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