Halcion : an independent assessment of safety and efficacy data

Halcion an independent assessment of safety and efficacy data

Detalles Bibliográficos
Autor principal: Institute of Medicine (U.S.).
Autor Corporativo: Institute of Medicine (U.S.). Committee on Halcion: An Assessment of Data Adequacy and Confidence (-)
Formato: Libro electrónico
Idioma:Inglés
Publicado: Washington, D.C. : National Academy Press 1997.
Edición:1st ed
Materias:
Triazolam.
Tranquilizing drugs.
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009820330606719
Tabla de Contenidos:
  • Halcion
  • Copyright
  • Acknowledgments
  • Preface
  • Contents
  • Executive Summary
  • THE DATA
  • ASSESSMENT OF EFFICACY DATA
  • Conclusions and Recommendations
  • Data Adequacy
  • Clinical Trial Design
  • Tolerance
  • ASSESSMENT OF SAFETY DATA
  • Conclusions and Recommendations
  • Clinical Trials and Surveillance
  • BROADER IMPLICATIONS
  • 1 Introduction
  • HISTORICAL OVERVIEW OF HALCION
  • Overseas Events
  • FDA Activity
  • Spontaneous Reports
  • FDA Reassessment
  • FDA Task Force
  • CHARGE TO THE IOM COMMITTEE
  • ORGANIZATION OF THE REPORT
  • 2 Assessment of Efficacy Data
  • PURPOSE AND EVALUATION OF HYPNOTIC DRUGS
  • Evaluating Efficacy
  • FDA Efficacy Requirements
  • Available Efficacy Data on Halcion
  • QUALITY OF PROTOCOLS AND STUDY DESIGN
  • Study Design
  • Endpoints
  • Polysomnographic Studies
  • REVIEW OF STATISTICAL METHODS USED BY UPJOHN AND FDA TO EVALUATE EFFICACY DATA
  • Statistical Reanalysis and Evaluation of Clinical Trial Efficacy Data
  • Random-Effect Regression Models
  • Results of Reanalysis
  • Dose Response
  • LITERATURE REVIEW
  • Polysomnographic Studies of Halcion in the Published Literature
  • CONCLUSIONS AND RECOMMENDATIONS
  • Data Adequacy
  • Clinical Trial Design
  • Tolerance
  • 3 Assessment of Safety Data
  • WELL-CONTROLLED PREMARKETING CLINICAL TRIALS
  • Adverse Events
  • Integrated Summary of Safety
  • Observation 1: Comparable Safety Profile
  • Observation 2: Comparable Rates of CNS-Related Events
  • Observation 3: Increased Sensitivity in Geriatric Subjects
  • Summary
  • IOM Analysis of Upjohn's Integrated Summary of Safety
  • Nervousness
  • Memory Impairment
  • Impaired Coordination
  • Confusion
  • Summary
  • Analysis of Dropouts
  • FDA Analysis
  • IOM Analysis
  • Statistical Analysis
  • Halcion (0.5 mg) Versus Placebo in Non-geriatric Subjects.
  • Halcion (0.5 mg) Versus Flurazepam (30 mg) in Non-geriatric Subjects
  • Halcion (0.25 mg) Versus Placebo in Geriatric Subjects
  • Halcion (0.25 mg) Versus Flurazepam (15 mg) in Geriatric Subjects
  • Summary
  • DATA SETS FOR POSTMARKETING STUDIES
  • Randomized Study: Protocol M/2100/0235
  • Randomized Polysomnographic Studies
  • A Nonrandomized Controlled Study: EMIC
  • VAMP: A COHORT STUDY
  • SPONTANEOUS REPORTING OF ADVERSE EVENTS: THE FDA SYSTEM
  • Statistical Evaluation of the SRS Data
  • LITERATURE REVIEW
  • Pharmacokinetic and Pharmacodynamic Issues Regarding the Comparability of Triazolam to Other Benzodiazepines
  • Pharmacokinetic Issues
  • Affinity for Benzodiazepine Receptors
  • Lipophilicity
  • Agonist Status
  • Levels in Plasma
  • Pharmacodynamic Interactions
  • Unique Effects of Triazolobenzodiazepines on Locus Coeruleus Neurons
  • Summary
  • Consideration of Amnestic Effects of Halcion
  • Performance of Memory Tasks After Single and Multiple Doses
  • Spontaneous Reports of Memory Impairment
  • Halcion and State-Dependent Learning
  • Summary
  • Review of Data Regarding Possible Anxiogenic or Insomniac Effects Associated with Halcion Administration or Withdrawal
  • Halcion Effects on Daytime Anxiety
  • Withdrawal-Related Anxiety or Insomnia Following Short- and Long-Term Halcion Use
  • Rebound Anxiety
  • Rebound Insomnia
  • Summary
  • Ataxia, Disinhibition, and Psychotogenic, Confusional, or Dissociative Effects of Halcion
  • Consideration of Other Potential Adverse Effects
  • Early Termination of Use
  • Adverse Effects Defined Generally
  • Other Adverse Effects
  • Summaries and Meta-Analyses
  • Closing Comments
  • CONCLUSIONS AND RECOMMENDATIONS
  • Clinical Trials and Surveillance
  • 4 Additional Comments on Broader Implications
  • References
  • A FDA Safety Tables
  • B Summary Tables of Literature Reviewed for Safety of Halcion.
  • C Glossary
  • D Acronyms
  • E Resources Reviewed by the Committee
  • F Consent to Disclosure
  • CONSENT TO DISCLOSURE
  • G Committee and Staff Biographies
  • COMMITTEE
  • IOM STAFF.

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