Inhaled Salmeterol/Fluticasone Propionate
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ADIS DRUG EVALUATION
© 2005 Adis Data Information BV. All rights reserved.
Inhaled Salmeterol/ Fluticasone Propionate A Review of its Use in Asthma Neil A. Reynolds, Katherine A. Lyseng-Williamson and Lynda R. Wiseman Adis International Limited, Auckland, New Zealand Various sections of the manuscript reviewed by: W. Boonsawat, Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand; P.W. Ind, Clinical Investigation Unit, Respiratory Medicine, Hammersmith Hospital, London, UK; G. Johansson, Nyby Health Care Centre, Uppsala, Sweden; W.R. Pieters, Elkerliek Ziekenhuis, Helmond, The Netherlands; A.J. Tatum, Asthma Inc. Clinical Research Center, Seattle, Washington, USA. Data Selection Sources: Medical literature published in any language since 1980 on salmeterol/fluticasone propionate, identified using MEDLINE and EMBASE, supplemented by AdisBase (a proprietary database of Adis International). Additional references were identified from the reference lists of published articles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug. Search strategy: MEDLINE and EMBASE search terms were ‘salmeterol fluticasone propionate’ and ‘asthma’. AdisBase search terms were ‘salmeterol/fluticasone propionate’ and ‘asthma’. Searches were last updated 12 July 2005. Selection: Studies in patients with asthma who received salmeterol/fluticasone propionate. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included. Index terms: Asthma, fluticasone propionate, salmeterol, salmeterol/fluticasone propionate, pharmacodynamics, pharmacoeconomics, pharmacokinetics, therapeutic use.
Contents Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1716 1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1717 2. Pharmacodynamic Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1718 3. Pharmacokinetic Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1718 4. Therapeutic Efficacy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1719 4.1 Comparison with Inhaled Corticosteroid or Salmeterol Monotherapy . . . . . . . . . . . . . . . . . . . . . 1720 4.1.1 Effects on Asthma Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1720 4.1.2 Effects on Lung Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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