Dose-response relationship of extended-release methylphenidate for ADHD in adults: post-hoc analysis based on a systematic review

Author:

Boesen K,Jørgensen KJ,Gøtzsche PC

Abstract

AbstractObjectiveTo assess potential dose-response relationships of extended-release methylphenidate for ADHD in adults on efficacy outcomes.Study design and settingPost-hoc analysis based on a systematic review of extended-release methylphenidate (https://doi.org/10.1002/14651858.CD012857). Using data from clinical trials comparing multiple fixed-dose methylphenidate groups with placebo, we conducted subgroup meta-analyses for available efficacy outcomes.Results and conclusionFive trials used a fixed-dose design with multiple methylphenidate groups receiving different doses. All trials were pivotal industry sponsored studies conducted to obtain marketing authorisation. We analysed four efficacy outcomes: Selfrated ADHD symptoms (5 trials, 1807 participants), investigator-rated ADHD symptoms (5 trials, 1904 participants), quality of life (4 trials, 1158 participants), and peer-rated ADHD symptoms (2 trials, 879 participants). There were no dose-response relationships for any outcome.

Publisher

Cold Spring Harbor Laboratory

Reference19 articles.

1. Jaeschke R. Letter to the editor. J Clin Epidemiol 2021.

2. Boesen K , Jørgensen KJ , Gøtzsche PC . Clinical trials were missing from regulatory documents of extended-release methylphenidate for ADHD in adults: A case study of public documents. J Clin Epidemiol 2021. https://doi.org/10.1016/j.jclinepi.2021.10.027.

3. Comparative efficacy and tolerability of medications for attention-deficit hyperactivity disorder in children, adolescents, and adults: a systematic review and network meta-analysis;Lancet Psychiatry,2018

4. Boesen K , Paludan-Müller AS , Gøtzsche PC , Jørgensen KJ . Extended-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults (review). Cochrane Database Syst Rev (in press).

5. Health Canada. Clinical Study Report. Study 063-010 Report Body. 27 July 2015. Available from: https://clinical-information.canada.ca/ci-rc-vu.pdf?file=m5/53-clin-stud-rep/535-rep-effic-safety-stud/adhd/5351-stud-rep-contr/report-body-red-3.pdf&id=187330 (Dec 2021).

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