Impact of study design and patient population on outcomes from cholinesterase inhibitor trials
| Autor: | Stephen M. Graham, Ravi Anand, Hyesung Sohn, Richard Hartman, Jacquiline Danyluk |
|---|---|
| Rok vydání: | 2003 |
| Předmět: |
medicine.medical_specialty
Maximum Tolerated Dose Health Status Population Severity of Illness Index Double-Blind Method Alzheimer Disease Galantamine medicine Humans Dosing Intensive care medicine Adverse effect education Donepezil Aged Randomized Controlled Trials as Topic Rivastigmine education.field_of_study Dose-Response Relationship Drug business.industry Clinical study design Patient Selection Psychiatry and Mental health Tolerability Research Design Anesthesia Cholinesterase Inhibitors Geriatrics and Gerontology business Cognition Disorders medicine.drug |
| Zdroj: | The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry. 11(2) |
| ISSN: | 1064-7481 |
| Popis: | The authors conducted a comparative review of study designs and patient populations used in pivotal trials investigating various cholinesterase inhibitors (tacrine, donepezil, rivastigmine, galantamine, controlled-release physostigmine, and metrifionate) and their impact on outcomes reported. Study design parameters that were investigated included patient selection, definitions of adverse dropouts and serious adverse events, effective doses used, dosing flexibility (fixed versus flexible), forced titration, and titration rate. Population characteristics included medical comorbidity and disease severity. Data suggest that differences in study designs and patient populations affect outcomes. Therefore, caution should be taken before making decisions on relative efficacy, safety, and tolerability, because clinical studies are not always directly comparable. |
| Databáze: | OpenAIRE |
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