overt or subclinical hypothyroidism
Conditions
Interventions
First, all participants are switched to the same generic LT4 preparation as there are seven LT4 preparations available in the Netherlands with different pharmacokinetic properties, which would otherwi
Sponsors
Erasmus Medical Center Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: - Patients with overt or subclinical primary hypothyroidism aged 18 years or older.* - LT4 monotherapy for at least 6 months. - LT4 monotherapy dose of 75-225 microg, with at least a dose of 1.2 microg/kg. - TSH levels within the assay-specific reference ranges for at least 3 months. - Severe tiredness with a large negative impact on daily life for at least 6 months, with or without other persisting complaints. This is based on the patient’s own experience, without judgment of the treating physician. - Sufficiently fluent in Dutch and able to read Dutch. *Thyroid peroxidase (TPO) and/or thyroglobulin (Tg) antibody positivity is not a requirement as these have frequently not been determined. Instead, we ensure that we only include patients with autoimmune hypothyroidism by excluding other causes of hypothyroidism (see exclusion criteria).
Exclusion criteria
Exclusion criteria: - Congenital hypothyroidism, hypothyroidism after (sub)acute thyroiditis, secondary (central) hypothyroidism. - Thyroid surgery, radioactive iodine treatment, or head and/or neck radiotherapy. - Use of thyroid interfering drugs (current/past use of amiodarone, immunotherapy, tyrosin kinase inhibitors, interferon, or lithium and current use of oral or iv corticosteroids or dopamine). - Current psychiatric disease treated at a “gespecialiseerde GGZ instelling”* - Clinical diagnosis of dementia. - Pregnancy, breastfeeding or wish to become pregnant within 2 years. - Women of reproductive age not using adequate contraception, who are not sterilized and do not have a sterilized partner. Adequate contraceptives include the contraceptive pill, patch, injection, implant, intrauterine device or system, vaginal ring, diaphragm or cap, and condom. - Functional or structural abnormal heart (e.g., cardiomyopathy or valve disease) - Recent acute coronary syndrome or unstable angina pectoris (100 ms or prolonged QTc (women=460 ms and men=450 ms)). - Frequent ventricular extrasystole (=doublet, trigeminy, bigeminy or (non-sustained) ventricular tachycardia) in the past or on current ECG. - Other obvious medical explanation for tiredness (e.g. end-stage renal disease, anemia, COPD stage IV, cancer, etc.) - Other obvious major life event explanation for tiredness (e.g., mourning, loss of job) *Treatments of mild non-complex psychological/psychiatric complaints are done in the “ basis GGZ”, e.g. consisting of conversations with a psychologist or psychotherapist, or via internet (e-health). “Gespecialiseerde GGZ” encompasses treatments of more severe psychological/psychiatric complaints.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effects of LT4/LT3 combination therapy compared to LT4 monotherapy on tiredness in those patients with autoimmune hypothyroidism and persisting tiredness on LT4 monotherapy, after 1 year of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. other determinants of effects of LT4/LT3 combination therapy compared to LT4 therapy alone on tiredness. 2. the (determinants of the) effects of LT4/LT3 combination therapy compared to LT4 therapy alone on other thyroid related complaints and quality of life. 3. the (determinants of the) effects of LT4/LT3 combination therapy compared to LT4 therapy alone on cardiovascular, metabolic, and bone outcomes. 4. the (determinants of the) effects of LT4/LT3 combination therapy compared to LT4 therapy alone on neurocognitive function. 5. an economic evaluation including cost-effectiveness analysis comparing LT4/LT3 combination therapy and LT4 monotherapy. 6. the number of adverse events during LT4/LT3 combination therapy vs LT4 therapy alone | — |
Contacts
Public ContactMarco Medici
Erasmus Medical Center
Outcome results
None listed