A Postmarketing Clinical Experience Study of Metadate® CD
| Autor: | D'Imperio Jm, Birdsall D, Hatch Sj, Dirksen Sj |
|---|---|
| Rok vydání: | 2002 |
| Předmět: |
Male
medicine.medical_specialty Adolescent Population Capsules Patient satisfaction Surveys and Questionnaires Internal medicine Pharmacovigilance Product Surveillance Postmarketing medicine Humans Attention deficit hyperactivity disorder Child education Adverse effect education.field_of_study Methylphenidate business.industry Metadate cd General Medicine medicine.disease Attention Deficit Disorder with Hyperactivity Patient Satisfaction Delayed-Action Preparations Anesthesia Clinical Global Impression Central Nervous System Stimulants Female business medicine.drug |
| Zdroj: | Current Medical Research and Opinion. 18:371-380 |
| ISSN: | 1473-4877 0300-7995 |
| DOI: | 10.1185/030079902125001100 |
| Popis: | The objective of the study was to investigate the effectiveness and safety of Metadate CD (methylphenidate HCl, USP) Extended Release Capsules in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD), in actual clinical practice.This was a multicenter, open-label, postmarketing study. Eligible patients were aged 6-17 with a diagnosis of ADHD and receiving either no treatment or maintenance treatment with another approved methylphenidate (MPH) product. Metadate CD was administered once daily for 3 weeks, titrated against reported and observed symptoms. Clinical Global Impression (CGI) scores at Week 3 were used for the primary efficacy evaluation. Patient treatment satisfaction was determined by questionnaire at the final evaluation visit. Safety was assessed through adverse event reporting, laboratory tests and vital sign measurements.Overall, of the 308 patients in the Intent-To-Treat population, the majority (65%) demonstrated a positive response to Metadate CD (defined as CGI Global Improvement rating of very much or much improved). In addition, patients previously treated with immediate-release or extended-release tablet formulations of MPH were successfully converted to Metadate CD at a comparable dose. Most patients (87%) were very satisfied or moderately satisfied with study treatment, and among previously treated patients, 71% rated Metadate CD as much better or better than their previous MPH treatment. Adverse events were consistent with current FDA-approved product labeling for Metadate CD.Metadate CD is effective and well-tolerated in actual clinical use for ADHD. |
| Databáze: | OpenAIRE |
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