Retrospective Study of Patients Switched from Tablet Formulations to a Gel Cap Formulation of Levothyroxine: Results of the CONTROL Switch Study
Autor: | Arnold B. Sterman, Frank R. Ernst, Jennifer Welstead, Riad Elmor, Walter Sandulli, MaryKate Lavan |
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Jazyk: | angličtina |
Rok vydání: | 2016 |
Předmět: |
Adult
Male medicine.medical_specialty Control switch Drug Compounding Levothyroxine Administration Oral 030209 endocrinology & metabolism Pharmacology 03 medical and health sciences Young Adult 0302 clinical medicine Pharmacotherapy Hypothyroidism Internal medicine Medicine Humans In patient Symptom control 030212 general & internal medicine Original Research Article Young adult Aged Retrospective Studies Dose-Response Relationship Drug business.industry Retrospective cohort study Middle Aged Thyroxine Tolerability Female business Gels medicine.drug Tablets |
Zdroj: | Drugs in R&D |
ISSN: | 1179-6901 1174-5886 |
Popis: | 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 |
Databáze: | OpenAIRE |
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