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Disclaimer: CME certification for these activities has expired. All information is pertinent to the timeframe in which it was released.


Clinical and Economic Factors of Combination Therapy in Asthma


GOAL
To provide physicians and pharmacists with practical information for assessing the clinical and economic factors of dual-controller therapies for asthma management.

TARGET AUDIENCE
This activity is designed for pulmonologists, allergists, immunologists, primary care physicians, and pharmacists who manage and treat patients with asthma.

LEARNING OBJECTIVES
After reading this issue, the participant should be able to:

  • Recognize the importance of using information from controlled clinical trials and observational studies for evaluating pharmacotherapies for asthma treatment.
  • Describe the results of observational studies for assessing the effects of dual-controller regimens, including a leukotriene modifier, on outcomes in asthma.
  • Identify the 3 clinical studies that examine the fluticasone propionate-salmeterol combination for asthma treatment.

ACCREDITATION STATEMENT
This activity has been planned and produced in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education. The Johns Hopkins University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to sponsor continuing medical education for physicians. The Johns Hopkins School of Medicine takes responsibility for the content, quality, and scientific integrity of this CME activity.

CREDIT DESIGNATION STATEMENT
The Johns Hopkins University School of Medicine designates this continuing medical education activity for a maximum of 1 hour in Category 1 credit toward the American Medical Association Physicians' Recognition Award. Each physician should claim only those hours of credit that are actually spent on the educational activity. Credits are available until the expiration date of January 31, 2004.

This continuing education activity was produced under the supervision of Peter S. Creticos, MD, Associate Professor of Medicine, Johns Hopkins University School of Medicine, Clinical Director, Division of Allergy and Clinical Immunology; and Medical Director, Asthma and Allergy Diseases, Johns Hopkins Asthma and Allergy Center.

This program is supported by an unrestricted educational grant from GlaxoSmithKline.

Publisher's Note and Disclaimer: The opinions expressed in this issue are those of the authors, presenters, and/or panelists and are not attributable to the publisher, editor, advisory board of Advanced Studies in Medicine, or The Johns Hopkins University School of Medicine or its Office of Continuing Medical Education. Clinical judgment must guide each professional in weighing the benefits of treatment against the risk of toxicity. Dosages, indications, and methods of use for products referred to in this issue are not necessarily the same as indicated in the package insert for the product and may reflect the clinical experience of the authors, presenters, and/or panelists or may be derived from the professional literature or other clinical sources. Consult complete prescribing information before administering.

Advanced Studies in Medicine (ISSN-1530-3004) is published by Galen Publishing, LLC, an HMG Company. P.O. Box 340, Somerville, NJ 08876. (908) 253-9001. Web site: www.galenpublishing.com. Copyright ©2001 by Galen Publishing, LLC. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, without first obtaining permission from the publisher. Bulk postage paid at Somerville, NJ Post Office and at additional mailing offices. Advanced Studies in Medicine is a registered trademark of The Healthcare Media Group, LLC. Printed on acid-free paper. BPA Membership applied for December 2000.

CHAIR

    Peter S. Creticos, MD
    Associate Professor of Medicine
    Johns Hopkins University School of Medicine
    Clinical Director, Division of Allergy and Clinical Immunology
    Medical Director, Asthma and Allergy Diseases
    Johns Hopkins Asthma and Allergy Center
    Baltimore, Maryland
    • Dr Creticos reports receiving grant/research support from, serving as a consultant to, and is a member of the speakers' bureau for Allergenics, Aradigm, Aventis, AstraZeneca, Dynavax, GlaxoSmithKline, Merck, Muro, Pfizer, Pilot Therapeutics, Schering-Plough, and Stallergenes.

PARTICIPATING FACULTY

    Michael S. Blaiss, MD
    Clinical Professor of Pediatrics and Medicine
    University of Tennessee Center of Health Sciences
    College of Medicine
    Cordova, Tennessee
    • Dr Blaiss reports receiving honoraria from, serving as a consultant to, and is a shareholder for GlaxoSmithKline, Merck, and Aventis.

    Richard D. O'Connor, MD
    Clinical Professor of Pediatrics
    University of California, San Diego
    Director of Quality Management
    Sharp Rees-Stealy Medical Centers
    Division of Asthma, Allergy, and Clinical Immunology
    San Diego, California
    • Dr O'Connor reports serving as a consultant to Health Benchmarks Inc. and on the speakers' bureau for GlaxoSmithKline, Aventis, Pfizer, Shering, and Pharmacia, and is a shareholder for Elan, GlaxoSmithKline, and Forest.

    Samy Suissa, PhD
    Director, Division of Clinical Epidemiology
    McGill University Health Center
    Royal Victoria Hospital
    Montreal, Canada
    • Dr Suissa reports receiving grant/research support from AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, and Schering-Plough; and serving as a consultant to Organon.

Advanced Studies in Medicine provides disclosure information from contributing authors, participating faculty, and presenters only. Advanced Studies in Medicine does not provide disclosure information from authors of abstracts and poster presentations. The reader shall be advised that these contributors may or may not maintain financial relationships with pharmaceutical companies.

Clinical and Economic Factors of Combination Therapy in Asthma
Peter S. Creticos, MD*

National Heart, Lung, and Blood Institute (NHLBI) guidelines for asthma management recommend that anti-inflammatory medications be the foundation of pharmacotherapy for persistent asthma in view of the importance of inflammation in asthma pathophysiology. For moderate or severe persistent asthma, dual-controller regimens (ie, combinations of 2 or more therapies with complementary mechanisms of action) are advised. The past decade has seen an explosion of research on dual-controller options for asthma therapy. This issue, which is composed of 3 review articles, discusses the sources of information that health care providers should consider in choosing among dual-controller regimens and reviews the newest data on the dual-controller options.

Dr O'Connor's article, "Evaluating Pharmacotherapies for Asthma: Empirical Sources of Information," sets the stage for this issue by considering the best sources of information for determining value in asthma management. He reviews strengths and weakness of randomized, controlled clinical trials, which are the best source of data for inferring causality about a manipulation such as administration of a drug treatment, and observational studies, which are the best source of data for gauging how a medication performs in "real-world" clinical practice. These 2 sources of data provide complementary information about pharmacotherapies and can be useful in forming a comprehensive assessment of medication effects if their results are interpreted in the context of their strengths and weaknesses.

In his article, "Dual-Controller Regimens I: Data from Randomized, Controlled Clinical Trials," Dr Suissa reviews data from randomized, controlled clinical trials of a new dual-controller therapy for asthma, the combination of the inhaled corticosteroid fluticasone propionate, and the long-acting ß2 agonist salmeterol administered in a single delivery system. In a systematic program of controlled clinical trials, the fluticasone propionate-salmeterol combination has been compared with placebo, with either medicine administered alone, and with other combination-therapy and monotherapy regimens for asthma. The body of evidence from randomized, controlled clinical trials regarding the efficacy of this form of dual-controller therapy illustrates the value of systematic, well-controlled evaluation of a medication.

Although data from randomized, controlled clinical trials are generally regarded as the gold-standard information source about medicines, the clinical trials data alone cannot provide a comprehensive assessment of the effects of dual-controller therapy. Controlled clinical trials are not always directly applicable to clinical practice, where heterogeneous patient populations are treated and are seldom monitored as consistently or effectively as they are in clinical trials. In his article, "Dual-Controller Regimens II: Observational Data," Dr Blaiss considers evidence from observational studies assessing the effects of dual-controller regimens that include a long-acting ß2 agonist and those that include a leukotriene modifier. Observational studies assess the effects of medication as they are used outside the confines of a clinical trial. By considering effects of medicines on variables such as health care costs, emergency-room visits, and other categories of health care use, observational studies help to bridge the gap between clinical trials and clinical practice.

The data reviewed in this issue illustrate the importance of considering complementary information from multiple empirical sources in forming judgments about pharmacotherapies for asthma. Considered in aggregate, the data from controlled clinical trials and observational studies yield important practical information for the health care provider choosing among dual-controller options with unique features and benefits.

A companion slide set with contents mirroring those of the publication articles is available by business-reply card. The slide set is intended for health care providers' use in disseminating the information in this publication to others who provide respiratory care.

*Johns Hopkins University School of Medicine, Division of Allergy and Clinical Immunology, Johns Hopkins Asthma and Allergy Center.





Johns Hopkins Advanced Studies in Medicine (ISSN-1558-0334), is published by Galen Publishing, LLC, d/b/a ASiM, PO Box 340, Somerville, NJ 08876. (908) 253-9001. Copyright ©2012 by Galen Publishing. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, without first obtaining permission from the publisher. ASiM is a registered trademark of The Healthcare Media Group, LLC.