Evaluation of bedtime vs. morning levothyroxine intake to control hypothyroidism in older patients : a pragmatic crossover randomized clinical trial
Autor(a) principal: | |
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Data de Publicação: | 2022 |
Outros Autores: | , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UFRGS |
Texto Completo: | http://hdl.handle.net/10183/250414 |
Resumo: | Introduction: Drug scheduling in older adults can be a challenge, especially considering polypharmacy, physical dependency, and possible drug interactions. Properly testing alternative treatment regimens could therefore help to overcome treatment barriers. Hypothyroidism is a prevalent condition in older adults, however, studies evaluating Lthyroxine treatment effectiveness in this specific age group are still lacking. Most studies testing an evening administration of levothyroxine were mainly composed of younger adults. Therefore, this trial is aimed to assess if evening levothyroxine (LT4) administration can effectively control hypothyroidism in older patients. Materials and Methods: A randomized crossover clinical trial was conducted between June 2018 and March 2020 at the Hospital de Clínicas de Porto Alegre, a teaching hospital in Brazil, to compare the efficacy of morning and evening administration of LT4 for hypothyroidism control in older patients. The study protocol is published elsewhere. A total of 201 participants, ≥60 years old, with primary hypothyroidism treated with LT4 for at least 6 months and on stable doses for at least 3 months were included. Participants were randomly assigned to a starting group of morning LT4 intake (60min before breakfast) or bedtime LT4 intake (60min after the last meal). After ≥12 weeks of follow-up, a crossover between strategies was performed. The primary outcome was the change in serum thyrotropin (Thyroid-Stimulating Hormone; TSH) levels after 12 weeks of each LT4 administration regimen. Results: A total of 201 participants with mean age of 72.4 ± 7.2 years were included, out of which 84.1% were women; baseline characteristics and frequency of controlled hypothyroidism were similar between groups. Mean baseline TSH was 3.43 ± 0.25 mUI/L. In total, 118 participants attended three meetings, allowing 135 comparisons by crossover analytic strategy. Mean TSH levels after follow-up were 2.95 ± 2.86 in the morning group and 3.64 ± 2.86 in the bedtime group, p = 0.107. Discussion: Thyroid-Stimulating Hormone levels and frequency of controlled hypothyroidism were similar during the follow-up period regardless of the treatment regimen (morning or bedtime). |
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Mello, Renato Gorga Bandeira deGiassi, KarinaStahl, GabrielaAssis, Maria Luísa MachadoFlores, Marina SiqueiraLima, Bruna Cambrussi dePiccoli, VanessaRodrigues, Ticiana da Costa2022-10-27T04:50:14Z20222296-858Xhttp://hdl.handle.net/10183/250414001151740Introduction: Drug scheduling in older adults can be a challenge, especially considering polypharmacy, physical dependency, and possible drug interactions. Properly testing alternative treatment regimens could therefore help to overcome treatment barriers. Hypothyroidism is a prevalent condition in older adults, however, studies evaluating Lthyroxine treatment effectiveness in this specific age group are still lacking. Most studies testing an evening administration of levothyroxine were mainly composed of younger adults. Therefore, this trial is aimed to assess if evening levothyroxine (LT4) administration can effectively control hypothyroidism in older patients. Materials and Methods: A randomized crossover clinical trial was conducted between June 2018 and March 2020 at the Hospital de Clínicas de Porto Alegre, a teaching hospital in Brazil, to compare the efficacy of morning and evening administration of LT4 for hypothyroidism control in older patients. The study protocol is published elsewhere. A total of 201 participants, ≥60 years old, with primary hypothyroidism treated with LT4 for at least 6 months and on stable doses for at least 3 months were included. Participants were randomly assigned to a starting group of morning LT4 intake (60min before breakfast) or bedtime LT4 intake (60min after the last meal). After ≥12 weeks of follow-up, a crossover between strategies was performed. The primary outcome was the change in serum thyrotropin (Thyroid-Stimulating Hormone; TSH) levels after 12 weeks of each LT4 administration regimen. Results: A total of 201 participants with mean age of 72.4 ± 7.2 years were included, out of which 84.1% were women; baseline characteristics and frequency of controlled hypothyroidism were similar between groups. Mean baseline TSH was 3.43 ± 0.25 mUI/L. In total, 118 participants attended three meetings, allowing 135 comparisons by crossover analytic strategy. Mean TSH levels after follow-up were 2.95 ± 2.86 in the morning group and 3.64 ± 2.86 in the bedtime group, p = 0.107. Discussion: Thyroid-Stimulating Hormone levels and frequency of controlled hypothyroidism were similar during the follow-up period regardless of the treatment regimen (morning or bedtime).application/pdfengFrontiers in medicine. Lausanne, Switzerland. Vol. 9 (Jun. 2022), 828762, 9 p.Idoso fragilizadoTiroxinaHipotireoidismoEnsaio clínicoOlder adultsThyroxineHypothyroidismClinical trialTreatmentEveningEvaluation of bedtime vs. morning levothyroxine intake to control hypothyroidism in older patients : a pragmatic crossover randomized clinical trialEstrangeiroinfo:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFRGSinstname:Universidade Federal do Rio Grande do Sul (UFRGS)instacron:UFRGSTEXT001151740.pdf.txt001151740.pdf.txtExtracted Texttext/plain44247http://www.lume.ufrgs.br/bitstream/10183/250414/2/001151740.pdf.txt222e0662aac170bd67cf69fff9a53dbeMD52ORIGINAL001151740.pdfTexto completo (inglês)application/pdf785313http://www.lume.ufrgs.br/bitstream/10183/250414/1/001151740.pdf26d86bc023c995769c3062ee1db2403eMD5110183/2504142022-10-28 04:46:14.090385oai:www.lume.ufrgs.br:10183/250414Repositório de PublicaçõesPUBhttps://lume.ufrgs.br/oai/requestopendoar:2022-10-28T07:46:14Repositório Institucional da UFRGS - Universidade Federal do Rio Grande do Sul (UFRGS)false |
dc.title.pt_BR.fl_str_mv |
Evaluation of bedtime vs. morning levothyroxine intake to control hypothyroidism in older patients : a pragmatic crossover randomized clinical trial |
title |
Evaluation of bedtime vs. morning levothyroxine intake to control hypothyroidism in older patients : a pragmatic crossover randomized clinical trial |
spellingShingle |
Evaluation of bedtime vs. morning levothyroxine intake to control hypothyroidism in older patients : a pragmatic crossover randomized clinical trial Mello, Renato Gorga Bandeira de Idoso fragilizado Tiroxina Hipotireoidismo Ensaio clínico Older adults Thyroxine Hypothyroidism Clinical trial Treatment Evening |
title_short |
Evaluation of bedtime vs. morning levothyroxine intake to control hypothyroidism in older patients : a pragmatic crossover randomized clinical trial |
title_full |
Evaluation of bedtime vs. morning levothyroxine intake to control hypothyroidism in older patients : a pragmatic crossover randomized clinical trial |
title_fullStr |
Evaluation of bedtime vs. morning levothyroxine intake to control hypothyroidism in older patients : a pragmatic crossover randomized clinical trial |
title_full_unstemmed |
Evaluation of bedtime vs. morning levothyroxine intake to control hypothyroidism in older patients : a pragmatic crossover randomized clinical trial |
title_sort |
Evaluation of bedtime vs. morning levothyroxine intake to control hypothyroidism in older patients : a pragmatic crossover randomized clinical trial |
author |
Mello, Renato Gorga Bandeira de |
author_facet |
Mello, Renato Gorga Bandeira de Giassi, Karina Stahl, Gabriela Assis, Maria Luísa Machado Flores, Marina Siqueira Lima, Bruna Cambrussi de Piccoli, Vanessa Rodrigues, Ticiana da Costa |
author_role |
author |
author2 |
Giassi, Karina Stahl, Gabriela Assis, Maria Luísa Machado Flores, Marina Siqueira Lima, Bruna Cambrussi de Piccoli, Vanessa Rodrigues, Ticiana da Costa |
author2_role |
author author author author author author author |
dc.contributor.author.fl_str_mv |
Mello, Renato Gorga Bandeira de Giassi, Karina Stahl, Gabriela Assis, Maria Luísa Machado Flores, Marina Siqueira Lima, Bruna Cambrussi de Piccoli, Vanessa Rodrigues, Ticiana da Costa |
dc.subject.por.fl_str_mv |
Idoso fragilizado Tiroxina Hipotireoidismo Ensaio clínico |
topic |
Idoso fragilizado Tiroxina Hipotireoidismo Ensaio clínico Older adults Thyroxine Hypothyroidism Clinical trial Treatment Evening |
dc.subject.eng.fl_str_mv |
Older adults Thyroxine Hypothyroidism Clinical trial Treatment Evening |
description |
Introduction: Drug scheduling in older adults can be a challenge, especially considering polypharmacy, physical dependency, and possible drug interactions. Properly testing alternative treatment regimens could therefore help to overcome treatment barriers. Hypothyroidism is a prevalent condition in older adults, however, studies evaluating Lthyroxine treatment effectiveness in this specific age group are still lacking. Most studies testing an evening administration of levothyroxine were mainly composed of younger adults. Therefore, this trial is aimed to assess if evening levothyroxine (LT4) administration can effectively control hypothyroidism in older patients. Materials and Methods: A randomized crossover clinical trial was conducted between June 2018 and March 2020 at the Hospital de Clínicas de Porto Alegre, a teaching hospital in Brazil, to compare the efficacy of morning and evening administration of LT4 for hypothyroidism control in older patients. The study protocol is published elsewhere. A total of 201 participants, ≥60 years old, with primary hypothyroidism treated with LT4 for at least 6 months and on stable doses for at least 3 months were included. Participants were randomly assigned to a starting group of morning LT4 intake (60min before breakfast) or bedtime LT4 intake (60min after the last meal). After ≥12 weeks of follow-up, a crossover between strategies was performed. The primary outcome was the change in serum thyrotropin (Thyroid-Stimulating Hormone; TSH) levels after 12 weeks of each LT4 administration regimen. Results: A total of 201 participants with mean age of 72.4 ± 7.2 years were included, out of which 84.1% were women; baseline characteristics and frequency of controlled hypothyroidism were similar between groups. Mean baseline TSH was 3.43 ± 0.25 mUI/L. In total, 118 participants attended three meetings, allowing 135 comparisons by crossover analytic strategy. Mean TSH levels after follow-up were 2.95 ± 2.86 in the morning group and 3.64 ± 2.86 in the bedtime group, p = 0.107. Discussion: Thyroid-Stimulating Hormone levels and frequency of controlled hypothyroidism were similar during the follow-up period regardless of the treatment regimen (morning or bedtime). |
publishDate |
2022 |
dc.date.accessioned.fl_str_mv |
2022-10-27T04:50:14Z |
dc.date.issued.fl_str_mv |
2022 |
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Estrangeiro info:eu-repo/semantics/article |
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2296-858X |
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Frontiers in medicine. Lausanne, Switzerland. Vol. 9 (Jun. 2022), 828762, 9 p. |
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