TY - JOUR

T1 - Long-term methimazole therapy in Graves’ hyperthyroidism and adverse reactions

T2 - a Danish multicenter study

AU - Karmisholt, J.

AU - Andersen, S. L.

AU - Bulow-Pedersen, I.

AU - Krejbjerg, A.

AU - Nygaard, B.

AU - Carlé, A.

N1 - Publisher Copyright: © 2022 The authors Published by Bioscientifica Ltd.

PY - 2022

Y1 - 2022

N2 - Purpose: In this prospective multicenter study with patients newly diagnosed with Graves’ hyperthyroidism (GH), we studied the timing and characteristics of adverse drug reactions in patients treated with anti-thyroid drugs (ATD) for up to 48 months. Methods: Patients with GH were treated with ATD until remission and hereafter with a low-dose regime to keep the patients in remission. The patients were followed with blood samples and recording of adverse events approximately every second month for the first 2 years and every third month for the following 2 years. Results: We included 208 patients and the patients were treated for a median of 22 (range: 0.5–49) months. Ten percent of the patients experienced adverse drug reactions and 75% of the cases occurred during the first 6 months. After 24 months, the methimazole dose was lowered to 5 mg/day, and after this time point, no further adverse drug reactions were recorded. Skin reactions were the most prominent reaction, comprising 68% of the registered reactions, and no hepatic and bonemarrow affection was recorded. Conclusion: With this study, we report the frequency, timing of occurrence, and characteristics of adverse drug reactions when treating GH with the ATD drug methimazole for up to 48 months. Long-term low-dose methimazole treatment can be a cost-effective and straightforward treatment option if adverse drug reactions such as severe hepatic and bone marrow affection are kept in mind.

AB - Purpose: In this prospective multicenter study with patients newly diagnosed with Graves’ hyperthyroidism (GH), we studied the timing and characteristics of adverse drug reactions in patients treated with anti-thyroid drugs (ATD) for up to 48 months. Methods: Patients with GH were treated with ATD until remission and hereafter with a low-dose regime to keep the patients in remission. The patients were followed with blood samples and recording of adverse events approximately every second month for the first 2 years and every third month for the following 2 years. Results: We included 208 patients and the patients were treated for a median of 22 (range: 0.5–49) months. Ten percent of the patients experienced adverse drug reactions and 75% of the cases occurred during the first 6 months. After 24 months, the methimazole dose was lowered to 5 mg/day, and after this time point, no further adverse drug reactions were recorded. Skin reactions were the most prominent reaction, comprising 68% of the registered reactions, and no hepatic and bonemarrow affection was recorded. Conclusion: With this study, we report the frequency, timing of occurrence, and characteristics of adverse drug reactions when treating GH with the ATD drug methimazole for up to 48 months. Long-term low-dose methimazole treatment can be a cost-effective and straightforward treatment option if adverse drug reactions such as severe hepatic and bone marrow affection are kept in mind.

KW - anti-thyroid drugs adverse drug

KW - Graves’ disease

KW - Graves’ hyperthyroidism

KW - hyperthyroidism

KW - reactions adverse events

KW - thyrotoxicosis

KW - TSH-receptor anti-bodies

U2 - 10.1530/ETJ-22-0031

DO - 10.1530/ETJ-22-0031

M3 - Journal article

C2 - 35521775

AN - SCOPUS:85131808280

VL - 11

JO - European Thyroid Journal

JF - European Thyroid Journal

SN - 2235-0640

IS - 3

M1 - e220031

ER -