title: Retrospective Study of Patients Switched from Tablet Formulations to a Gel Cap Formulation of Levothyroxine: Results of the CONTROL Switch Study.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Health Economics and Outcomes Research, Indegene, Inc., 222 Chastain Meadows Court, Suite 300, Kennesaw, GA, 30144, USA. frankrernstrx@gmail.com.
authors.forename: Frank R
authors.initials: FR
authors.lastname: Ernst
authors.affiliation: Akrimax Pharmaceuticals, LLC, Cranford, NJ, USA.
authors.forename: Walter
authors.initials: W
authors.lastname: Sandulli
authors.affiliation: Health Economics and Outcomes Research, Indegene, Inc., 222 Chastain Meadows Court, Suite 300, Kennesaw, GA, 30144, USA.
authors.forename: Riad
authors.initials: R
authors.lastname: Elmor
authors.affiliation: Health Economics and Outcomes Research, Indegene, Inc., 222 Chastain Meadows Court, Suite 300, Kennesaw, GA, 30144, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Welstead
authors.affiliation: Arnold Sterman, LLC, Morristown, NJ, USA.
authors.forename: Arnold B
authors.initials: AB
authors.lastname: Sterman
authors.affiliation: Akrimax Pharmaceuticals, LLC, Cranford, NJ, USA.
authors.forename: MaryKate
authors.initials: M
authors.lastname: Lavan
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D004305:Dose-Response Relationship, Drug; D004339:Drug Compounding; D005260:Female; D005782:Gels; D006801:Humans; D007037:Hypothyroidism / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D013607:Tablets; D013974:Thyroxine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D005782:Gels; D013607:Tablets; D013974:Thyroxine