Medication changes after switching from CONCERTA® brand methylphenidate HCl to a generic long-acting formulation: A retrospective database study

Daniel Fife, M Soledad Cepeda, Alan Baseman, Henry Richards, Peter Hu, H Lynn Starr, Anthony G Sena, Daniel Fife, M Soledad Cepeda, Alan Baseman, Henry Richards, Peter Hu, H Lynn Starr, Anthony G Sena

Abstract

Background: Observational studies of switching from branded to generic formulations of the same drug substance often lack appropriate comparators for the subjects who switched. Three generic formulations were deemed equivalent to Concerta: an authorized generic (AG) identical except for external packaging, and two other generics (EG).

Objective: Compare the incidence of a combined endpoint (switching back to Concerta, changing the use of immediate release methylphenidate (MPH), stopping all long-acting methylphenidate, or starting a new medication) among people switched from Concerta to the AG versus the EG.

Methods: Cohort study from the Truven CCAE database of people aged 6 to 65 diagnosed with ADHD, treated with Concerta, and switched to the EG or to the AG formulation.

Results: In the EG arm 24.6% and in the AG arm 19.7% of subjects switched back to Concerta. The proportion of subjects meeting the combined endpoint was 39.5% in the EG arm, 32.9% in the AG arm, a crude risk ratio of 1.20 (95% CI 0.94, 1.54). After adjustment by propensity score stratification, the adjusted odds ratio (OR) was 1.23 (95% CI 0.90, 1.70). In an unplanned analysis using a different method of adjustment, the adjusted OR was 1.00 (95% CI 0.69, 1.44).

Discussion: This study did not detect a difference between the proportion of people who met the study endpoint in the two study arms, i.e. between those who switched to a generic formulation that was identical to Concerta except for external packaging and those who switched to the comparison generics. The high incidence of the combined endpoint in the AG arm demonstrates the need for an appropriate comparator in studies of this type.

Trial registration: ClinicalTrials.gov NCT02730572.

Conflict of interest statement

Competing Interests: At the time of the work, all authors were full-time employees of Janssen Research & Development, LLC, which markets Concerta, and as full-time employees the authors held stock or stock options. This does not alter the authors' adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1. Schematic of study design.
Fig 1. Schematic of study design.

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