Abstract
BackgroundAfter 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.MethodsPatients 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.ResultsHighest 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.ConclusionsBetween 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.Electronic supplementary materialThe online version of this article (doi:10.1186/s12890-015-0051-x) contains supplementary material, which is available to authorized users.
Highlights
After the Salmeterol Multicentre Asthma Research Trial (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 Long-acting beta-2-agonist (LABA) only to patients receiving inhaled corticosteroids (ICS)
Period prevalence rates Within the study period, the highest annual PPRs were found for budesonide and the fixed combination of salmeterol/fluticasone
From 2004 to 2008, a significant increase in PPRs was revealed for formoterol, fixed combinations of salmeterol/fluticasone, formoterol/beclometasone, formoterol/ budesonide, and the ICS beclometasone and budesonide
Summary
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). The Salmeterol Multicentre Asthma Research Trial (SMART) [1] was a large randomized controlled trial in asthma patients evaluating the safety of salmeterol (i.e., a long-acting beta-2-agonist [LABA]) compared to placebo in addition to usual asthma care. In 2005, information for health care providers were sent out by the FDA stating that LABA should be prescribed to asthma patients only if other medicines, including low-or-medium dose ICS, do not control asthma [8,9,10] and a ‘Black box’ warning on LABA was imposed by the FDA [11,12]. In 2006, it was decided to add warnings similar to those made by the FDA to product labelling of LABA compounds in Germany, too [15]
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