LT4/LT3 Combination therapy for hypothyroidism (T3-4-Hypo trial)
Samenvatting van de aanvraag
1. Problem definition/rationale:
Hypothyroidism is among the most common diseases in the general population, for which levothyroxine (LT4) is the standard treatment.
A substantial group of patients (~10%) do not feel well on LT4 monotherapy and have persisting debilitating complaints, leading to a poor quality of life.
These patients could benefit from the addition of LT3, but results have been contradictory, largely due to a wrong study design.
To investigate the efficacy of LT4/LT3 combination therapy in hypothyroidism, and what factors (genetic, biochemical, or metabolic profiles) predict its efficacy.
3. Study design:
Multicenter double-blind randomized placebo-controlled trial.
4. Patient population:
Patients with autoimmune hypothyroidism on LT4 monotherapy with persisting complaints.
5. Investigational product & comparator:
LT4/LT3 vs LT4/placebo. Treatment duration: 52 weeks.
6. Outcome variables & assessment:
The primary study endpoints are the Hypothyroid Symptoms and the Tiredness scores of the thyroid-specific ThyPRO questionnaire.
Primary analyses include the mean change from baseline to 52 weeks in the ThyPRO scores.
8. Sample size calculation:
With 600 patients we will have 80% power to detect changes of 3.7 and 5.0 points on the Hypothyroid Symptoms and on the Tiredness scales, respectively.
9. Economic evaluation:
Cost-utility analysis from a societal perspective.
Projectnummer - 848043003
Status - Lopend
Looptijd - 2019/2024
Onderdeel van programma - Goed Gebruik Geneesmiddelen
Projectleider en penvoerder:
Dr. M. Medici Radboud Umc
https://www.zonmw.nl/nl/over-zonmw/inno ... verslagen/