Evaluation of evening versus morning levothyroxine intake in elderly (MONIALE)
Autor(a) principal: | |
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Data de Publicação: | 2019 |
Outros Autores: | , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UFRGS |
Texto Completo: | http://hdl.handle.net/10183/205851 |
Resumo: | Background: The aging population is associated with increased multimorbidity and polypharmacy. Older adults are at a higher risk of adverse events and reduced therapeutic response. This phenomenon is partially explained by drug interactions and treatment adherence. Most randomized clinical trials have found no significant differences between morning and evening levothyroxine (LT4) administration in young adults, but there is little evidence regarding alternative LT4 regimens in older populations. Thus, the MONIALE trial aims to test an alternative schedule for LT4 administration in older adults. Methods/design: This randomized crossover clinical trial will include participants aged 60 years or older with primary hypothyroidism. The trial groups will consist of morning LT4 intake (60 min before breakfast) or evening LT4 intake (60 min after supper). The primary outcome will be variation in serum thyrotropin (TSH) levels after 24 weeks of the LT4 protocol. The secondary outcomes will be the prevalence of drugs that potentially interact with LT4 and hypothyroidism control according to interaction status. The sample size was calculated to detect a minimum mean difference of 1 mUI/L in serum TSH level between the groups with 80% power and a 5% probability of type I error, resulting in 91 patients per group. The project was approved by the Hospital de Clínicas de Porto Alegre Ethics Committee. Discussion: Considering the aging population, the increased prevalence of multimorbidity and polypharmacy, as well as potential drug interactions and treatment adherence difficulties, an alternative LT4 protocol could be useful for hypothyroidism treatment in the elderly. Prior studies comparing alternative LT4 administration protocols have mainly included young adult populations and have not addressed potential drug interactions. |
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Giassi, KarinaPiccoli, VanessaRodrigues, Ticiana da CostaMello, Renato Gorga Bandeira de2020-02-13T04:22:43Z20191745-6215http://hdl.handle.net/10183/205851001109984Background: The aging population is associated with increased multimorbidity and polypharmacy. Older adults are at a higher risk of adverse events and reduced therapeutic response. This phenomenon is partially explained by drug interactions and treatment adherence. Most randomized clinical trials have found no significant differences between morning and evening levothyroxine (LT4) administration in young adults, but there is little evidence regarding alternative LT4 regimens in older populations. Thus, the MONIALE trial aims to test an alternative schedule for LT4 administration in older adults. Methods/design: This randomized crossover clinical trial will include participants aged 60 years or older with primary hypothyroidism. The trial groups will consist of morning LT4 intake (60 min before breakfast) or evening LT4 intake (60 min after supper). The primary outcome will be variation in serum thyrotropin (TSH) levels after 24 weeks of the LT4 protocol. The secondary outcomes will be the prevalence of drugs that potentially interact with LT4 and hypothyroidism control according to interaction status. The sample size was calculated to detect a minimum mean difference of 1 mUI/L in serum TSH level between the groups with 80% power and a 5% probability of type I error, resulting in 91 patients per group. The project was approved by the Hospital de Clínicas de Porto Alegre Ethics Committee. Discussion: Considering the aging population, the increased prevalence of multimorbidity and polypharmacy, as well as potential drug interactions and treatment adherence difficulties, an alternative LT4 protocol could be useful for hypothyroidism treatment in the elderly. Prior studies comparing alternative LT4 administration protocols have mainly included young adult populations and have not addressed potential drug interactions.application/pdfengTrials. [London]. Vol. 20 (2019), 742, 7 p.HipotireoidismoTiroxinaTratamento farmacológicoConduta do tratamento medicamentosoPosologiaIdosoEnsaio clínico controlado aleatórioEstudos cross-overHypothyroidismAgedLevothyroxineEvaluation of evening versus morning levothyroxine intake in elderly (MONIALE)Estrangeiroinfo: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:UFRGSTEXT001109984.pdf.txt001109984.pdf.txtExtracted Texttext/plain29039http://www.lume.ufrgs.br/bitstream/10183/205851/2/001109984.pdf.txt1e831ba760903b073fa825eca4557cbeMD52ORIGINAL001109984.pdfTexto completo (inglês)application/pdf906748http://www.lume.ufrgs.br/bitstream/10183/205851/1/001109984.pdf5669d213d6c2d44b07a1220a3d4f0582MD5110183/2058512020-02-14 05:16:37.455547oai:www.lume.ufrgs.br:10183/205851Repositório de PublicaçõesPUBhttps://lume.ufrgs.br/oai/requestopendoar:2020-02-14T07:16:37Repositório Institucional da UFRGS - Universidade Federal do Rio Grande do Sul (UFRGS)false |
dc.title.pt_BR.fl_str_mv |
Evaluation of evening versus morning levothyroxine intake in elderly (MONIALE) |
title |
Evaluation of evening versus morning levothyroxine intake in elderly (MONIALE) |
spellingShingle |
Evaluation of evening versus morning levothyroxine intake in elderly (MONIALE) Giassi, Karina Hipotireoidismo Tiroxina Tratamento farmacológico Conduta do tratamento medicamentoso Posologia Idoso Ensaio clínico controlado aleatório Estudos cross-over Hypothyroidism Aged Levothyroxine |
title_short |
Evaluation of evening versus morning levothyroxine intake in elderly (MONIALE) |
title_full |
Evaluation of evening versus morning levothyroxine intake in elderly (MONIALE) |
title_fullStr |
Evaluation of evening versus morning levothyroxine intake in elderly (MONIALE) |
title_full_unstemmed |
Evaluation of evening versus morning levothyroxine intake in elderly (MONIALE) |
title_sort |
Evaluation of evening versus morning levothyroxine intake in elderly (MONIALE) |
author |
Giassi, Karina |
author_facet |
Giassi, Karina Piccoli, Vanessa Rodrigues, Ticiana da Costa Mello, Renato Gorga Bandeira de |
author_role |
author |
author2 |
Piccoli, Vanessa Rodrigues, Ticiana da Costa Mello, Renato Gorga Bandeira de |
author2_role |
author author author |
dc.contributor.author.fl_str_mv |
Giassi, Karina Piccoli, Vanessa Rodrigues, Ticiana da Costa Mello, Renato Gorga Bandeira de |
dc.subject.por.fl_str_mv |
Hipotireoidismo Tiroxina Tratamento farmacológico Conduta do tratamento medicamentoso Posologia Idoso Ensaio clínico controlado aleatório Estudos cross-over |
topic |
Hipotireoidismo Tiroxina Tratamento farmacológico Conduta do tratamento medicamentoso Posologia Idoso Ensaio clínico controlado aleatório Estudos cross-over Hypothyroidism Aged Levothyroxine |
dc.subject.eng.fl_str_mv |
Hypothyroidism Aged Levothyroxine |
description |
Background: The aging population is associated with increased multimorbidity and polypharmacy. Older adults are at a higher risk of adverse events and reduced therapeutic response. This phenomenon is partially explained by drug interactions and treatment adherence. Most randomized clinical trials have found no significant differences between morning and evening levothyroxine (LT4) administration in young adults, but there is little evidence regarding alternative LT4 regimens in older populations. Thus, the MONIALE trial aims to test an alternative schedule for LT4 administration in older adults. Methods/design: This randomized crossover clinical trial will include participants aged 60 years or older with primary hypothyroidism. The trial groups will consist of morning LT4 intake (60 min before breakfast) or evening LT4 intake (60 min after supper). The primary outcome will be variation in serum thyrotropin (TSH) levels after 24 weeks of the LT4 protocol. The secondary outcomes will be the prevalence of drugs that potentially interact with LT4 and hypothyroidism control according to interaction status. The sample size was calculated to detect a minimum mean difference of 1 mUI/L in serum TSH level between the groups with 80% power and a 5% probability of type I error, resulting in 91 patients per group. The project was approved by the Hospital de Clínicas de Porto Alegre Ethics Committee. Discussion: Considering the aging population, the increased prevalence of multimorbidity and polypharmacy, as well as potential drug interactions and treatment adherence difficulties, an alternative LT4 protocol could be useful for hypothyroidism treatment in the elderly. Prior studies comparing alternative LT4 administration protocols have mainly included young adult populations and have not addressed potential drug interactions. |
publishDate |
2019 |
dc.date.issued.fl_str_mv |
2019 |
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2020-02-13T04:22:43Z |
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Trials. [London]. Vol. 20 (2019), 742, 7 p. |
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