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Drug Class Review: Controller Medications for Asthma: Final Update 1 Report [Internet]

Drug Class Review: Controller Medications for Asthma: Final Update 1 Report [Internet]

Drug Class Reviews - Oregon Health & Science University

Version: April 2011

Introduction

Asthma is a chronic lung disease characterized by reversible airway obstruction, inflammation, and increased airway responsiveness. As a result of inflammation, individuals with asthma may experience symptoms such as wheezing, difficulty breathing, or coughing. The airway obstruction which occurs with asthma is generally reversible spontaneously or with treatment. Asthma is thought to have a genetic, inheritable component, often begins early in life, and consists of variable symptoms regardless of asthma classification. The Expert Panel of the National Asthma Education and Prevention Program (NAEPP) recently reclassified asthma categories; the mild intermittent category was eliminated (now called intermittent) and the persistent category was subdivided into mild, moderate, or severe. The change was partly done to acknowledge that exacerbations can be severe in any asthma category. Table 1 lists the criteria used to classify asthma severity.

Methods

To identify relevant citations, we searched MEDLINE®, the Cochrane Database of Systematic Reviews®, the Cochrane Central Register of Controlled Trials®, and the International Pharmaceutical Abstracts (through September 2010), using terms for included drugs, indications, and study designs (see Appendix E for complete search strategies). We limited the electronic searches to “human” and “English language.” We attempted to identify additional studies through hand searches of reference lists of included studies and reviews. In addition, we searched the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), the Canadian Agency for Drugs and Technology in Health, and the National Institute for Health and Clinical Excellence web sites for medical and statistical reviews, and technology assessments. Finally, we searched dossiers submitted by pharmaceutical companies for the current review. All citations were imported into an electronic database (Endnote® v. X.02).

Summary

The main results of this review are summarized in Table 31. Summaries of the strength of evidence (SOE) for each comparison are presented in Appendix H. Efficacy studies provide moderate strength of evidence (SOE) that equipotent doses of ICSs administered through comparable delivery devices do not differ in their ability to control asthma symptoms, prevent exacerbations, reduce the need for additional rescue medication, or in the overall incidence of adverse events or withdrawals due to adverse events. Evidence does not support a difference between montelukast and zafirlukast in their ability to decrease rescue medicine use or improve quality of life (low SOE for ≥ 12 years of age, insufficient <12), or between formoterol and salmeterol in their ability to control symptoms, prevent exacerbations, improve quality of life, or cause harms among patients not controlled on ICSs alone (moderate SOE). Evidence does not support a difference between budesonide/formoterol and fluticasone/salmeterol for efficacy or harms when each combination is administered via a single inhaler (moderate SOE for ≥ 12, insufficient <12).

Results

We identified 3,745 citations from database searches and reviewing reference lists, with 960 new citations for Update 1. We identified 32 additional references (9 in the original report, 23 for Update 1) from dossiers submitted by pharmaceutical companies and 5 from public comments. The total number of citations in our database was 3,782. In total we included 289 articles: 36 systematic reviews with meta-analyses, 211 articles for randomized controlled trials 12 articles for observational studies, and one study of other design. Thirty of the included studies were rated poor quality.(Appendix F) We retrieved 108 articles for background information.

Original Report Evidence Tables A

Symptoms: [Median change in total symptom score from baseline to week 16: −1.5 vs. −1.1; P < 0.05; daily asthma scores over 28 weeks: significantly improved with OM: data NR; P < 0.01; median proportion of low symptom days for 28 week period: 0.03 vs. 0.01 (P = 0.04)]

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