Thyroid antibodies and levothyroxine effects in subclinical hypothyroidism: A pooled analysis of two randomized controlled trials
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Thyroid antibodies and levothyroxine effects in subclinical hypothyroidism : A pooled analysis of two randomized controlled trials. / Lyko, Christina; Blum, Manuel R.; Abolhassani, Nazanin; Stuber, Mirah J.; Del Giovane, Cinzia; Feller, Martin; Moutzouri, Elisavet; Oberle, Jolanda; Jungo, Katharina T.; Collet, Tinh-Hai; den Elzen, Wendy P. J.; Poortvliet, Rosalinde K. E.; Du Puy, Robert S.; Dekkers, Olaf M.; Trompet, Stella; Jukema, J. Wouter; Aujesky, Drahomir; Quinn, Terry; Westendorp, Rudi; Kearney, Patricia M.; Gussekloo, Jacobijn; Van Heemst, Diana; Mooijaart, Simon P.; Bauer, Douglas C.; Rodondi, Nicolas.
I: Journal of Internal Medicine, Bind 292, Nr. 6, 2022, s. 892-903.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Thyroid antibodies and levothyroxine effects in subclinical hypothyroidism
T2 - A pooled analysis of two randomized controlled trials
AU - Lyko, Christina
AU - Blum, Manuel R.
AU - Abolhassani, Nazanin
AU - Stuber, Mirah J.
AU - Del Giovane, Cinzia
AU - Feller, Martin
AU - Moutzouri, Elisavet
AU - Oberle, Jolanda
AU - Jungo, Katharina T.
AU - Collet, Tinh-Hai
AU - den Elzen, Wendy P. J.
AU - Poortvliet, Rosalinde K. E.
AU - Du Puy, Robert S.
AU - Dekkers, Olaf M.
AU - Trompet, Stella
AU - Jukema, J. Wouter
AU - Aujesky, Drahomir
AU - Quinn, Terry
AU - Westendorp, Rudi
AU - Kearney, Patricia M.
AU - Gussekloo, Jacobijn
AU - Van Heemst, Diana
AU - Mooijaart, Simon P.
AU - Bauer, Douglas C.
AU - Rodondi, Nicolas
PY - 2022
Y1 - 2022
N2 - Background Antithyroid antibodies increase the likelihood of developing overt hypothyroidism, but their clinical utility remains unclear. No large randomized controlled trial (RCT) has assessed whether older adults with subclinical hypothyroidism (SHypo) caused by autoimmune thyroid disease derive more benefits from levothyroxine treatment (LT4). Objective To determine whether older adults with SHypo and positive antibodies derive more clinical benefits from LT4 than those with negative antibodies. Methods We pooled individual participant data from two RCTs, Thyroid Hormone Replacement for Untreated Older Adults with Subclinical Hypothyroidism and IEMO 80+. Participants with persistent SHypo were randomly assigned to receive LT4 or placebo. We compared the effects of LT4 versus placebo in participants with and without anti-thyroid peroxidase (TPO) at baseline. The two primary outcomes were 1-year change in Hypothyroid Symptoms and Tiredness scores on the Thyroid-Related Quality-of-Life Patient-Reported Outcome Questionnaire. Results Among 660 participants (54% women) >= 65 years, 188 (28.5%) had positive anti-TPO. LT4 versus placebo on Hypothyroid Symptoms lead to an adjusted between-group difference of -2.07 (95% confidence interval: -6.04 to 1.90) for positive antibodies versus 0.89 (-1.76 to 3.54) for negative antibodies (p for interaction = 0.31). Similarly, there was no treatment effect modification by baseline antibody status for Tiredness scores-adjusted between-group difference 1.75 (-3.60 to 7.09) for positive antibodies versus 1.14 (-1.90 to 4.19) for negative antibodies (p for interaction = 0.98). Positive anti-TPO were not associated with better quality of life, improvement in handgrip strength, or fewer cardiovascular outcomes with levothyroxine treatment. Conclusions Among older adults with SHypo, positive antithyroid antibodies are not associated with more benefits on clinical outcomes with LT4.
AB - Background Antithyroid antibodies increase the likelihood of developing overt hypothyroidism, but their clinical utility remains unclear. No large randomized controlled trial (RCT) has assessed whether older adults with subclinical hypothyroidism (SHypo) caused by autoimmune thyroid disease derive more benefits from levothyroxine treatment (LT4). Objective To determine whether older adults with SHypo and positive antibodies derive more clinical benefits from LT4 than those with negative antibodies. Methods We pooled individual participant data from two RCTs, Thyroid Hormone Replacement for Untreated Older Adults with Subclinical Hypothyroidism and IEMO 80+. Participants with persistent SHypo were randomly assigned to receive LT4 or placebo. We compared the effects of LT4 versus placebo in participants with and without anti-thyroid peroxidase (TPO) at baseline. The two primary outcomes were 1-year change in Hypothyroid Symptoms and Tiredness scores on the Thyroid-Related Quality-of-Life Patient-Reported Outcome Questionnaire. Results Among 660 participants (54% women) >= 65 years, 188 (28.5%) had positive anti-TPO. LT4 versus placebo on Hypothyroid Symptoms lead to an adjusted between-group difference of -2.07 (95% confidence interval: -6.04 to 1.90) for positive antibodies versus 0.89 (-1.76 to 3.54) for negative antibodies (p for interaction = 0.31). Similarly, there was no treatment effect modification by baseline antibody status for Tiredness scores-adjusted between-group difference 1.75 (-3.60 to 7.09) for positive antibodies versus 1.14 (-1.90 to 4.19) for negative antibodies (p for interaction = 0.98). Positive anti-TPO were not associated with better quality of life, improvement in handgrip strength, or fewer cardiovascular outcomes with levothyroxine treatment. Conclusions Among older adults with SHypo, positive antithyroid antibodies are not associated with more benefits on clinical outcomes with LT4.
KW - autoimmune thyroid disease
KW - levothyroxine treatment
KW - subclinical hypothyroidism
KW - QUALITY-OF-LIFE
KW - PEROXIDASE ANTIBODIES
KW - CARDIOVASCULAR RISK
KW - L-THYROXINE
KW - HEALTH
KW - THYROTROPIN
KW - COMMUNITY
KW - SYMPTOMS
KW - DISEASE
KW - ASSOCIATION
U2 - 10.1111/joim.13544
DO - 10.1111/joim.13544
M3 - Journal article
C2 - 35894851
VL - 292
SP - 892
EP - 903
JO - Journal of Internal Medicine
JF - Journal of Internal Medicine
SN - 0955-7873
IS - 6
ER -
ID: 315161457