Efficacy of Methimazole Dosing Algorithm

Cook County Health11 enrolled

Overview

To prospectively study the efficacy and safety of the Cook County Health (CCH) methimazole (MMI) dosing algorithm in the setting of new onset Graves' disease.

To conduct a prospective observational study in 60 patients with newly diagnosed Graves' disease who are either methimazole naive or who have been initiated on MMI within previous 4-6 weeks per CCH algorithm and assess for efficacy and safety of MMI dosing administered. Study group size is based on 90% power and projected efficacy of 70% patients reaching target.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Graves Disease

Interventions

Methimazole TabletsDRUG

Testing dosing algorithm for efficacy.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Non-pregnant adults (\>18 years of age) with new diagnosis of Graves' Disease (elevated free T4, Free T3, low or suppressed TSH, positive TSI and or thyroid eye disease) and * either drug naïve or who have been initiated on MMI within previous 4-6 weeks per CCH algorithm. Exclusion Criteria: * Pregnant patients * hyperthyroidism due to other causes, example - Toxic Multinodular Goiter, Iodine induced thyrotoxicosis, etc. * Graves patients who present with atrial fibrillation, CHF or other end organ damage

Locations (1)

Cook County Health

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Achievement of euthyroid state

The proportion of patients achieving euthyroid state during the study period

Time frame: 17 weeks

Secondary Outcomes

Factors influencing achievement of euthyroid state

Identifying variables that correlate with achievement of euthyroid state

Time frame: 17 weeks

Data from ClinicalTrials.gov

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