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...

Full description

Saved in:
Bibliographic Details
Published in:Drugs in R&D 2017-03, Vol.17 (1), p.103-115
Main Authors: Ernst, Frank R., Sandulli, Walter, Elmor, Riad, Welstead, Jennifer, Sterman, Arnold B., Lavan, MaryKate
Format: Article
Language:English
Subjects:
Administration, Oral
Adult
Aged
Dose-Response Relationship, Drug
Drug Compounding
Female
Gels
Humans
Hypothyroidism - drug therapy
Internal Medicine
Male
Medicine
Medicine & Public Health
Middle Aged
Original
Original Research Article
Pharmacology/Toxicology
Pharmacotherapy
Retrospective Studies
Tablets
Thyroxine - administration & dosage
Thyroxine - adverse effects
Thyroxine - therapeutic use
Young Adult
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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  
ISSN:1174-5886
1179-6901
DOI:10.1007/s40268-016-0150-z