Patient-Reported Satisfaction with Thyroid Hormone Replacement Therapy for Subclinical Hypothyroidism in Older Adults: A Pooled Analysis of Individual Participant Data from Two Randomized Controlled Trials
Thyroid, vol. 34, pp. 702–712
Abstract
Background: The benefit of levothyroxine treatment of subclinical hypothyroidism (SCH) is subject to debate. This study compared treatment satisfaction between older adults with SCH using levothyroxine or placebo. Methods: We analyzed pooled individual participant data from two randomized, double-blind, placebo-controlled trials investigating the effects of levothyroxine treatment in older adults with SCH. Community-dwelling participants aged ≥65 years, with SCH (persistent thyrotropin levels 4.60–19.99 mIU/L for >3 months and normal free T4 level), were included. Intervention dose titration until thyrotropin levels normalized, with a mock dose adjustment of placebo. Treatment satisfaction was determined during the final study visit using the Treatment Satisfaction Questionnaire for Medication (TSQM), encompassing perceived effectiveness, side effects, convenience, and global satisfaction, along with the participants’ desire to continue study medication after the trial. Results: We included 536 participants. At baseline, the median (interquartile range [IQR]) age was 74.9 (69.7–81.4) years, and 292 (55%) were women. The median (IQR) thyrotropin levels were 5.80 (5.10–7.00) mIU/L at baseline in both groups; at final visit, 4.97 (3.90–6.35) mIU/L in the placebo and 3.24 (2.49–4.41) mIU/L in the levothyroxine group. After treatment, the groups did not differ significantly in global satisfaction (mean difference [CI] −1.1 [−4.5 to 2.1], p = 0.48), nor in any other domain of treatment satisfaction. These results held true regardless of baseline thyrotropin levels or symptom burden. No major differences were found in the numbers of participants who wished to continue medication after the trial (levothyroxine 35% vs. placebo 27%), did not wish to continue (levothyroxine 27% vs. placebo 30%), or did not know (levothyroxine 37% vs. placebo 42%) ( p = 0.14). In a subpopulation with high symptom burden from hypothyroid symptoms at baseline, those using levothyroxine more often desired to continue the medication after the trial than those using placebo (mean difference [CI]: −21.1% [−35.6% to −6.5%]). Conclusion: These pooled data from two RCTs showed no major differences in treatment satisfaction between older adults receiving levothyroxine or placebo. This finding has important implications for decision-making regarding initiating levothyroxine treatment for SCH. Our findings generally support refraining from routinely prescribing levothyroxine in older adults with SCH.
Authors 11
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A. Janneke Ravensberg corresponding Aachen Department of Public Health and Primary Care LUMC Center for Medicine for Older People
Leiden University Medical Center
Affiliation as printed
Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands
LUMC Center for Medicine for Older People, Leiden University Medical Center, Leiden, Netherlands
Leiden University Medical Center, 4501, Department of Public Health and Primary Care, Leiden, Netherlands, +31 (0)71 5268444
Leiden University Medical Center, 4501, LUMC Center for Medicine for Older People, Leiden, Zuid-Holland, Netherlands, +31 (0)71 5268444
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Rosalinde K. E. Poortvliet Aachen Department of Public Health and Primary Care LUMC Center for Medicine for Older People
Leiden University Medical Center
Affiliation as printed
Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands
LUMC Center for Medicine for Older People, Leiden University Medical Center, Leiden, Netherlands
Leiden University Medical Center, 4501, Department of Public Health and Primary Care, Leiden, Zuid-Holland, Netherlands, +31 (0)71 526 8444
Leiden University Medical Center, 4501, LUMC Center for Medicine for Older People, Leiden, Zuid-Holland, Netherlands, +31 (0)71 5268444
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Leiden University Medical Center
Affiliation as printed
Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands
Leiden University Medical Center, 4501, Department of Public Health and Primary Care, Leiden, Zuid-Holland, Netherlands, +31 (0)71 526 8444
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University of Bern · University Hospital of Bern
Affiliation as printed
Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland
Inselspital University Hospital Bern, 27252, Department of General Internal Medicine, Bern, Bern, Switzerland, +41 31 684 57 93
University of Bern, 27210, Institute of Primary Health Care (BIHAM), Bern, Bern, Switzerland, +41 31 684 57 93
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University of Bern · University Hospital of Bern
Affiliation as printed
Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland
Inselspital University Hospital Bern, 27252, Department of General Medicine, Bern, Bern, Switzerland, + 41 31 632 41 63
University of Bern, 27210, Institute of Primary Health Care (BIHAM), Bern, Bern, Switzerland, + 41 31 6845793
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Affiliation as printed
School of Public Health, University College Cork, Cork, Ireland
University College Cork, 8795, School of Public Health, Cork, Cork, Ireland, +353 (0)21 490 3000
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Affiliation as printed
School of Nursing and Midwifery, University College Cork, Cork, Ireland
University College Cork, 8795, School of Nursing and Midwifery, Cork, Cork, Ireland, +353 (0)21 4903000
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Leiden University Medical Center
Affiliation as printed
Department of Endocrinology and Metabolic Disorders, Leiden University Medical Center, Leiden, Netherlands
Leiden University Medical Center, 4501, Department of Endocrinology and Metabolic Disorders, Leiden, Zuid-Holland, Netherlands, +31 (0)71 526 30 82
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J. Wouter Jukema Aachen Department of Cardiology, Leiden University Medical Center Department Of Cardiology, Leiden
Leiden University Medical Center · Netherlands Heart Institute
Affiliation as printed
Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands
Netherlands Heart Institute, Utrecht, Netherlands
Leiden University Medical Center, 4501, Department of Cardiology, Leiden, Zuid-Holland, Netherlands, +31 (0)71 5262020
Netherlands Heart Institute, 26068, Utrecht, Utrecht, Netherlands, +31 (0)88 233 3600
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Simon P. Mooijaart Aachen Department of Internal Medicine Section of Gerontology and Geriatrics LUMC Center for Medicine for Older People
Leiden University Medical Center
Affiliation as printed
Department of Internal Medicine, Section of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, Netherlands
LUMC Center for Medicine for Older People, Leiden University Medical Center, Leiden, Netherlands
Leiden University Medical Center, 4501, Department of Internal Medicine, Section of Gerontology and Geriatrics, Leiden, Zuid-Holland, Netherlands, +31 (0)71 5266640
Leiden University Medical Center, 4501, LUMC Center for Medicine for Older People, Leiden, Zuid-Holland, Netherlands, +31 (0)71 5266640
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Jacobijn Gussekloo Aachen Department of Public Health and Primary Care LUMC Center for Medicine for Older People
Leiden University Medical Center
Affiliation as printed
Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands
LUMC Center for Medicine for Older People, Leiden University Medical Center, Leiden, Netherlands
Leiden University Medical Center, 4501, Department of Public Health and Primary Care, Leiden, Zuid-Holland, Netherlands, +31 (0)71 526 8444
Leiden University Medical Center, 4501, LUMC Center for Medicine for Older People, Leiden, Zuid-Holland, Netherlands, +31 (0)71 526 8444
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