Randomized double-blind placebo-controlled trial on levothyroxine and liothyronine combination therapy in totally thyroidectomized subjects: the LEVOLIO study
Authors' conclusion
Six months of combination therapy with twice-daily LT3 dose adapted according to TSH-level do not significantly change peripheral tissue response or quality of life, despite an increase in the fT3/fT4 ratio.
Study context
- Population
- Totally thyroidectomized patients
- Participants
- 141 participants
- Comparison
- Twice-daily levothyroxine (LT4) + liothyronine (LT3) combination vs LT4 + placebo
- LT4 + LT3n = 70
- Placebon = 71reference
- Primary endpoint
- Effect on peripheral tissues as reflected by SHBG levels
- Follow-up
- 6 months
Methodological detailsdouble-blind, placebo-controlled
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
SHBG
- Sex hormone binding globulin (SHBG) did not differ significantly between groups
Further findings
| Outcome | LT4 + LT3 | Placebo | P value |
|---|---|---|---|
| fT3/fT4 ratio · end of treatmentLower with Placebo | 0.32 ± 0.08 | 0.26 ± 0.05 | P < 0.001 |
- Dose adjustments · greater with LT4 + LT3
- P < 0.001
Other tissue markers and quality of life · 6 months
- Other tissue markers and QoL did not differ significantly between groups
Dose adjustments
- Combination required greater dose adjustments than placebo, due to TSH reduction
LT3 dose and LT4 reduction in LT4 + LT3
µg
- Mean daily LT3 dose
- 5.00
- Mean daily LT4 reduction
- 15
Treatment preference and genetic variants
- No preference for combination therapy
- DIO2 and MCT10 variants did not influence any outcomes
Safety
- TSH reduction with combination without hyperthyroidism signs or symptoms
Original publication
Randomized double-blind placebo-controlled trial on levothyroxine and liothyronine combination therapy in totally thyroidectomized subjects: the LEVOLIO study. Eur J Endocrinol. Published 20 December 2023. doi:10.
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