title: Prescribing of long-acting beta-2-agonists/inhaled corticosteroids after the SMART trial.
abstract: BACKGROUND
  After the SMART trial evaluating the safety of salmeterol (long-acting beta-2-agonist (LABA)) in asthma patients, regulatory actions were taken to promote a guideline-adherent prescribing of LABA only to patients receiving inhaled corticosteroids (ICS). We aim to analyse LABA- and ICS-related prescription patterns after the SMART trial in Germany.
  
  
  METHODS
  Patients documented in the Bavarian Association of Statutory Health Insurance Physicians database (approximately 10.5 million people) were included if they had a diagnosis of asthma and at least one prescription of LABA and/or ICS between 2004 and 2008. Annual period prevalence rates (PPRs) were estimated and Cochrane Armitage tests were used for time trend analyses.
  
  
  RESULTS
  Highest annual PPRs were found for budesonide and the fixed combination of salmeterol/fluticasone. The proportion of "concomitant LABA and ICS users" increased from 52.0 to 57.6% within the study period, whereas for "LABA users without ICS" a slight decrease from 6.5 to 5.4% was found. In 2008, the proportion of patients with at least one quarter with a LABA prescription without concomitant ICS was highest in elderly, male patients (≈20%). In the majority of these patients, a concomitant diagnosis of COPD (i.e. asthma-COPD overlap syndrome [ACOS]) was present.
  
  
  CONCLUSIONS
  Between 2004 and 2008, we found a moderate increase in guideline-adherent LABA prescribing in a representative German population. Elderly men received a significant number of LABA prescriptions without concomitant ICS probably due to ACOS.
authors.affiliation: Institute for Medical Information Sciences, Biometry, and Epidemiology, Ludwig-Maximilians-Universitaet, Marchioninistr. 15, D-81377, Munich, Germany. marietta.rottenkolber@med.uni-muenchen.de.
authors.forename: Marietta
authors.initials: M
authors.lastname: Rottenkolber
authors.affiliation: Pneumologische Praxis Muenchen - Pasing, Munich, Germany. rainald.fischer@gmail.com.
authors.forename: Rainald
authors.initials: R
authors.lastname: Fischer
authors.affiliation: Fundació Institut Català de Farmacologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain. li@icf.uab.es.|Departament de Farmacologia, Terapèutica i Toxicologia, Universitat Autònoma de Barcelona, Barcelona, Spain. li@icf.uab.es.
authors.forename: Luisa
authors.initials: L
authors.lastname: Ibáñez
authors.affiliation: Novartis Farmaceutica SA, Barcelona, Spain. jfortuny@rti.org.
authors.forename: Joan
authors.initials: J
authors.lastname: Fortuny
authors.affiliation: Pfizer Research & Development, New York, USA. robert.reynolds@pfizer.com.
authors.forename: Robert
authors.initials: R
authors.lastname: Reynolds
authors.affiliation: Amgen Ltd, Uxbridge, UK. jamelio@amgen.com.
authors.forename: Justyna
authors.initials: J
authors.lastname: Amelio
authors.affiliation: National Association of Statutory Health Insurance Physicians of Bavaria, Munich, Germany. Roman.Gerlach@KVB.de.
authors.forename: Roman
authors.initials: R
authors.lastname: Gerlach
authors.affiliation: National Association of Statutory Health Insurance Physicians of Bavaria, Munich, Germany. Martin.Tauscher@KVB.de.
authors.forename: Martin
authors.initials: M
authors.lastname: Tauscher
authors.affiliation: Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany. petra.thuermann@helios-kliniken.de.|Philipp Klee-Institute for Clinical Pharmacology, HELIOS Clinic Wuppertal, Wuppertal, Germany. petra.thuermann@helios-kliniken.de.
authors.forename: Petra
authors.initials: P
authors.lastname: Thürmann
authors.affiliation: Institute for Medical Information Sciences, Biometry, and Epidemiology, Ludwig-Maximilians-Universitaet, Marchioninistr. 15, D-81377, Munich, Germany. has@ibe.med.uni-muenchen.de.
authors.forename: Joerg
authors.initials: J
authors.lastname: Hasford
authors.affiliation: Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany. sven.schmiedl@helios-kliniken.de.|Philipp Klee-Institute for Clinical Pharmacology, HELIOS Clinic Wuppertal, Wuppertal, Germany. sven.schmiedl@helios-kliniken.de.
authors.forename: Sven
authors.initials: S
authors.lastname: Schmiedl
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D058666:Adrenergic beta-2 Receptor Agonists / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D001249:Asthma / Q000188:drug therapy*; D001507:Beclomethasone / Q000627:therapeutic use; D019819:Budesonide / Q000627:therapeutic use; D000069502:Budesonide, Formoterol Fumarate Drug Combination / Q000627:therapeutic use; D002648:Child; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D017723:Drug Utilization Review; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination / Q000627:therapeutic use; D005858:Germany; D005938:Glucocorticoids / Q000627:therapeutic use*; D019983:Guideline Adherence / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000068656:Mometasone Furoate / Q000627:therapeutic use; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D000068299:Salmeterol Xinafoate / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D000069502:Budesonide, Formoterol Fumarate Drug Combination; D004338:Drug Combinations; D000068297:Fluticasone-Salmeterol Drug Combination; D005938:Glucocorticoids; D000068656:Mometasone Furoate; D019819:Budesonide; D000068299:Salmeterol Xinafoate; D001507:Beclomethasone