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Drug Class Review Nasal Corticosteroids

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Drug Class Review Nasal Corticosteroids Drug Class Review Nasal Corticosteroids Final Report Update 1 June 2008 The Agency for Healthcare Research and Quality has not yet seen or approved this report The purpose of this report is to make available information regarding the comparative effectiveness and safety profiles of different drugs within pharmaceutical classes. Reports are not usage guidelines, nor should they be read as an endorsement of, or recommendation for, any particular drug, use or approach. Oregon Health & Science University does not recommend or endorse any guideline or recommendation developed by users of these reports. Dana Selover, MD Tracy Dana, MLS Colleen Smith, PharmD Kim Peterson, MS Oregon Evidence-based Practice Center Oregon Health & Science University Mark Helfand, MD, MPH, Director Marian McDonagh, PharmD, Principal Investigator, Drug Effectiveness Review Project Copyright © 2008 by Oregon Health & Science University Portland, Oregon 97239. All rights reserved. Final Report Update 1 Drug Effectiveness Review Project TABLE OF CONTENTS INTRODUCTION ..........................................................................................................................5 Scope and Key Questions .......................................................................................................................7 METHODS ....................................................................................................................................9 Literature Search .....................................................................................................................................9 Study Selection ........................................................................................................................................9 Data Abstraction ......................................................................................................................................9 Quality Assessment .................................................................................................................................9 Evidence Synthesis................................................................................................................................10 RESULTS ...................................................................................................................................12 Overall results of literature search .........................................................................................................12 Overall summary of the evidence ..........................................................................................................12 Effectiveness ....................................................................................................................................12 Efficacy and adverse effects.............................................................................................................12 Detailed assessment..............................................................................................................................14 Key Question 1. For adults and children with seasonal or perennial (allergic and non-allergic) rhinitis, do nasal corticosteroids differ in effectiveness? ....................................................................................14 Seasonal Allergic Rhinitis .................................................................................................................14 I. Adults with seasonal allergic rhinitis.........................................................................................14 A. Description of trial in adults with seasonal allergic rhinitis………………………………… ..14 B. Results of trials of treatment in adults with seasonal allergic rhinitis………………………. 16 1. Direct comparisons……………………………………………………………………………16 2. Indirect comparisons…………………………………………………………………………. 19 C. Results of prophylaxis in trials of adults with seasonal allergic rhinitis……………………..21 II. Children with seasonal allergic rhinitis.....................................................................................22 A. Direct comparisons.............................................................................................................22 B. Indirect comparisons ..........................................................................................................22 Perennial Allergic Rhinitis .................................................................................................................23 I. Adults with perennial allergic rhinitis........................................................................................23 A. Results of literature search.................................................................................................23 B. Description of trials in adults with perennial allergic rhinitis ...............................................24 C. Results of trials of treatment in adults with perennial allergic rhinitis.................................25 1. Direct comparisons ........................................................................................................25 2. Indirect comparisons......................................................................................................28 II. Adolescents and children with perennial allergic rhinitis .........................................................30 A. Direct comparisons.............................................................................................................30 B. Indirect comparisons: Placebo-controlled trials..................................................................30 Perennial Non-Allergic Rhinitis .........................................................................................................32 I. Adults ........................................................................................................................................32 A. Direct comparisons.............................................................................................................32 B. Indirect comparisons in placebo-controlled trials ...............................................................32 II. Children....................................................................................................................................32 Key Question 2. For adults and children with seasonal or perennial (allergic and non-allergic) rhinitis, do nasal corticosteroids differ in safety or adverse events?..................................................................33 All Rhinitis Types ..............................................................................................................................33 I. Adults ........................................................................................................................................33 A. Direct comparisons.............................................................................................................33 B. Indirect comparisons ..........................................................................................................34 1. Cataract ..........................................................................................................................34 2. Common adverse respiratory and nervous system effects of longer-term use..............34 II. Adolescents and children.........................................................................................................36 A. Direct comparisons.............................................................................................................36 B. Indirect comparisons ..........................................................................................................36 1. Common adverse respiratory and nervous system effects ............................................36 NCS Page 2 of 71 Final Report Update 1 Drug Effectiveness Review Project 2. Lenticular opacities .........................................................................................................37 3. Nasal carriage of staphylococcus aureus.......................................................................37 4. Growth retardation in children.........................................................................................37 Key Question 3. Are there subgroups of patients based on demographics (age, racial groups, gender), other medications, or comorbidities, or in pregnancy and lactation for which one nasal corticosteroid is more effective or associated with fewer adverse events?.....................................................................39 I. Demographics...........................................................................................................................40 II. Comorbidities...........................................................................................................................41 A. Asthma ...............................................................................................................................41 B. Daytime somnolence and/or sleep disorders.....................................................................42 III. Pregnancy...............................................................................................................................42 SUMMARY .................................................................................................................................44 REFERENCES ...........................................................................................................................46
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