Cargando…
Retrospective Study of Patients Switched from Tablet Formulations to a Gel Cap Formulation of Levothyroxine: Results of the CONTROL Switch Study
INTRODUCTION: Medication changes involving levothyroxine—either dose titrations or switching formulations—occur frequently in patients with erratic thyroid-stimulating hormone (TSH) levels and persistent hypothyroid symptoms. We investigated whether switching patients from levothyroxine tablets to a...
Autores principales: | , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2016
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5318319/ https://www.ncbi.nlm.nih.gov/pubmed/27943146 http://dx.doi.org/10.1007/s40268-016-0150-z |
_version_ | 1782509158028804096 |
---|---|
author | Ernst, Frank R. Sandulli, Walter Elmor, Riad Welstead, Jennifer Sterman, Arnold B. Lavan, MaryKate |
author_facet | Ernst, Frank R. Sandulli, Walter Elmor, Riad Welstead, Jennifer Sterman, Arnold B. Lavan, MaryKate |
author_sort | Ernst, Frank R. |
collection | PubMed |
description | INTRODUCTION: Medication changes involving levothyroxine—either dose titrations or switching formulations—occur frequently in patients with erratic thyroid-stimulating hormone (TSH) levels and persistent hypothyroid symptoms. We investigated whether switching patients from levothyroxine tablets to a gel cap formulation of levothyroxine might reduce dose adjustments and improve tolerability and efficacy outcomes. OBJECTIVES: Primary study objectives included quantifying the percentage of patients achieving TSH levels within a pre-specified range, median dose changes experienced, and the percentage of patients with improved hypothyroid symptom control after switching from levothyroxine tablets to levothyroxine gel caps. METHODS: A retrospective medical chart review was conducted among 99 randomly selected hypothyroid patients who were switched from a tablet to a gel cap formulation of levothyroxine. Patients were required to have been on levothyroxine monotherapy for ≥1 year prior to the medication switch. Data was collected for 6 months pre-switch and up to 6 months post-switch. RESULTS: Of the 99 patients studied, the majority (51.5%) experienced no documented change in TSH status after the switch (P < 0.0001). However, there was a decrease in the mean number of dose changes experienced (1.61 ± 0.96 vs. 0.73 ± 0.96; P < 0.0001). Improved hypothyroid symptom control was reported among 61.6% of patients (61 of 99; P < 0.0001). CONCLUSION: The results of CONTROL Switch support a strategy of switching patients who may experience tolerability or efficacy problems with standard levothyroxine tablets to the levothyroxine gel cap formulation. |
format | Online Article Text |
id | pubmed-5318319 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-53183192017-03-03 Retrospective Study of Patients Switched from Tablet Formulations to a Gel Cap Formulation of Levothyroxine: Results of the CONTROL Switch Study Ernst, Frank R. Sandulli, Walter Elmor, Riad Welstead, Jennifer Sterman, Arnold B. Lavan, MaryKate Drugs R D Original Research Article INTRODUCTION: Medication changes involving levothyroxine—either dose titrations or switching formulations—occur frequently in patients with erratic thyroid-stimulating hormone (TSH) levels and persistent hypothyroid symptoms. We investigated whether switching patients from levothyroxine tablets to a gel cap formulation of levothyroxine might reduce dose adjustments and improve tolerability and efficacy outcomes. OBJECTIVES: Primary study objectives included quantifying the percentage of patients achieving TSH levels within a pre-specified range, median dose changes experienced, and the percentage of patients with improved hypothyroid symptom control after switching from levothyroxine tablets to levothyroxine gel caps. METHODS: A retrospective medical chart review was conducted among 99 randomly selected hypothyroid patients who were switched from a tablet to a gel cap formulation of levothyroxine. Patients were required to have been on levothyroxine monotherapy for ≥1 year prior to the medication switch. Data was collected for 6 months pre-switch and up to 6 months post-switch. RESULTS: Of the 99 patients studied, the majority (51.5%) experienced no documented change in TSH status after the switch (P < 0.0001). However, there was a decrease in the mean number of dose changes experienced (1.61 ± 0.96 vs. 0.73 ± 0.96; P < 0.0001). Improved hypothyroid symptom control was reported among 61.6% of patients (61 of 99; P < 0.0001). CONCLUSION: The results of CONTROL Switch support a strategy of switching patients who may experience tolerability or efficacy problems with standard levothyroxine tablets to the levothyroxine gel cap formulation. Springer International Publishing 2016-12-09 2017-03 /pmc/articles/PMC5318319/ /pubmed/27943146 http://dx.doi.org/10.1007/s40268-016-0150-z Text en © The Author(s) 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Original Research Article Ernst, Frank R. Sandulli, Walter Elmor, Riad Welstead, Jennifer Sterman, Arnold B. Lavan, MaryKate Retrospective Study of Patients Switched from Tablet Formulations to a Gel Cap Formulation of Levothyroxine: Results of the CONTROL Switch Study |
title | Retrospective Study of Patients Switched from Tablet Formulations to a Gel Cap Formulation of Levothyroxine: Results of the CONTROL Switch Study |
title_full | Retrospective Study of Patients Switched from Tablet Formulations to a Gel Cap Formulation of Levothyroxine: Results of the CONTROL Switch Study |
title_fullStr | Retrospective Study of Patients Switched from Tablet Formulations to a Gel Cap Formulation of Levothyroxine: Results of the CONTROL Switch Study |
title_full_unstemmed | Retrospective Study of Patients Switched from Tablet Formulations to a Gel Cap Formulation of Levothyroxine: Results of the CONTROL Switch Study |
title_short | Retrospective Study of Patients Switched from Tablet Formulations to a Gel Cap Formulation of Levothyroxine: Results of the CONTROL Switch Study |
title_sort | retrospective study of patients switched from tablet formulations to a gel cap formulation of levothyroxine: results of the control switch study |
topic | Original Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5318319/ https://www.ncbi.nlm.nih.gov/pubmed/27943146 http://dx.doi.org/10.1007/s40268-016-0150-z |
work_keys_str_mv | AT ernstfrankr retrospectivestudyofpatientsswitchedfromtabletformulationstoagelcapformulationoflevothyroxineresultsofthecontrolswitchstudy AT sandulliwalter retrospectivestudyofpatientsswitchedfromtabletformulationstoagelcapformulationoflevothyroxineresultsofthecontrolswitchstudy AT elmorriad retrospectivestudyofpatientsswitchedfromtabletformulationstoagelcapformulationoflevothyroxineresultsofthecontrolswitchstudy AT welsteadjennifer retrospectivestudyofpatientsswitchedfromtabletformulationstoagelcapformulationoflevothyroxineresultsofthecontrolswitchstudy AT stermanarnoldb retrospectivestudyofpatientsswitchedfromtabletformulationstoagelcapformulationoflevothyroxineresultsofthecontrolswitchstudy AT lavanmarykate retrospectivestudyofpatientsswitchedfromtabletformulationstoagelcapformulationoflevothyroxineresultsofthecontrolswitchstudy |