[Bioequivalence of a combination of levothyroxine and iodine in comparison with levothyroxine only. A controlled double-blind study of bioavailability].
BACKGROUND
Iodine deficiency is the main cause of endemic goitre. Iodine supplementation and decrease of pituitary TSH are the therapeutical aims. In this study, bioavailability of levothyroxine combined with iodide and the same dose of levothyroxine alone were compared.


METHODS
Fourty-eight subjects aged 18 to 40 years were randomly assigned for 6 days either 150 micrograms levothyroxine and 150 micrograms iodide (group A, n = 25) or 150 micrograms levothyroxine (group B, n = 23). Baseline TSH and thyroid hormones were measured 2 days before starting therapy as well as daily till day 6. TRH-test (delta TSH) and thyroid sonography were performed at day -2 and 6.


RESULTS
During therapy baseline TSH decreased markedly from 1.26 to 0.35 mU/ml (median) in group A and from 1.37 to 0.39 to 0.39 mU/ml in group B (both p < 0.001), as well as delta TSH (A from 5.66 to 2.61 mU/ml; B from 6.3 to 2.95 mU/ml; p < 0.001). Difference of delta TSH (day -2 versus day 6) was negatively correlated to body surface (r = -0.307; p < 0.05). TT4 levels increased in both groups (A from 7.1 to 9.1 microU/dl; B from 7.2 to 9.4 microU/dl; p < 0.005). No significant differences were noted between both groups for thyroid-related parameters. In both groups, confidence intervals for baseline TSH and TT4 were in the expected range.


CONCLUSIONS
In this study, similar bioavailability and bioequivalence for levothyroxine and the combination of levothyroxine with iodide were demonstrated.
Förster
G
G
Klinik und Poliklinik Innere Medizin, Endokrinologie und Stoffwechselerkrankungen, Johannes-Gutenberg-Universität Mainz.
Hansen
C
C
Mörsch
F
F
al-Hakim
K
K
Beyer
J
J
Kahaly
G
G
D000293:Adolescent; D000328:Adult; D001682:Biological Availability; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006043:Goiter, Endemic / Q000097:blood* / Q000188:drug therapy; D006801:Humans; D007455:Iodine / Q000008:administration & dosage / Q000172:deficiency / Q000493:pharmacokinetics*; D008297:Male; D013810:Therapeutic Equivalency; D013974:Thyroxine / Q000008:administration & dosage / Q000493:pharmacokinetics*
D004338:Drug Combinations; D007455:Iodine; D013974:Thyroxine