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
Jazyk: angličtina
Rok vydání: 2016
Předmět:
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