1i3 Innovus, Uxbridge, UK 2Universita¨ tsklinik Giessen und Marburg, Standort Marburg, Marburg, Germany 3AstraZeneca, Lund, Sweden Correspondence to: Samuel Aballe´ a, i3 Innovus, Health Economics and Outcomes, Uxbridge, Middlesex UB8 1QG, UK Tel.: + 44 (0)1895 455384 Fax: + 44 (0)1895 520039 Email: samuel.aballea@i3innovus.com Disclosures The study was funded by AstraZeneca. SA and SC are employees of i3Innovus, who received funding from AstraZeneca for consultancy services. CV gave presentations at industry symposia sponsored by ALTANA, AstraZeneca, Aventis, Bayer, Boehringer Ingelheim, GlaxoSmithKline and Merck Darmstadt. CV also received fees for consulting from ATLANA, AstraZeneca, Bayer, Boehringer Ingelheim and GlaxoSmithKline. CV received compensation for consultation time spent on this manuscript. AW was a full-time employee of AstraZeneca at the time of the study and is now employed by Nycomed. Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation. 1870 doi: 10.1111/j.1742-1241.2008.01895.x O R I G I N A L P A P E R A retrospective database study comparing treatment outcomes and cost associated with choice of ﬁxed-dose inhaled corticosteroid ⁄ long-acting b2-agonists for asthma maintenance treatment in Germany S. Aballe´ a,1 S. Cure,1 C. Vogelmeier,2 A. Wire´ n3 OnlineOpen: This article is available free online at www3.interscience.wiley.com S U M M A R Y Aims: This retrospective, observational cohort study aimed to compare treatment outcomes and healthcare costs in the year after initiation of maintenance treat- ment with budesonide ⁄ formoterol or salmeterol ⁄ ﬂuticasone in a German health- care setting. Methods: Data on German asthma patients initiating treatment with budesonide ⁄ formoterol or salmeterol ⁄ ﬂuticasone between June 2001 and June 2005 were obtained from the IMS Disease Analyzer database. The primary out- come was the probability of treatment success, deﬁned according to short-acting b2-agonist prescriptions and switches or addition of controller medications, during the postindex year. A secondary deﬁnition of treatment success included hospitali- sations and oral corticosteroid (OCS) prescriptions. Secondary outcomes included severe asthma exacerbations, deﬁned as ‡1 OCS prescription, asthma-related hos- pitalisation and ⁄ or referral. The effect of treatment on costs was estimated using generalised linear models, adjusting for patient and physician characteristics. Results: There were no signiﬁcant differences between the budesonide ⁄ formoterol (n = 1456) and salmeterol ⁄ ﬂuticasone (n = 982) groups in disease severity mark- ers in the pre-index year. Patients on budesonide ⁄ formoterol had a 44% greater probability of treatment success [odds ratio (OR): 1.44; p = 0.0003] according to the primary deﬁnition and a 26% greater probability (OR: 1.26; p = 0.0119) according to the secondary deﬁnition, fewer severe exacerbations ()33.4%; p = 0.0123) and fewer OCS prescriptions ()31.5%; p = 0.0082) compared with salmeterol ⁄ ﬂuticasone, after controlling for baseline characteristics. Adjusting for covariates, budesonide ⁄ formoterol had a signiﬁcant inverse relationship on asthma-related costs compared with salmeterol ⁄ ﬂuticasone ()13.4%; p < 0.001). Total cost (asthma- and non-asthma-related costs) was 12.6% lower for budeso- nide ⁄ formoterol (p < 0.0001). Conclusion: This study suggests that for patients with chronic asthma in Germany, budesonide ⁄ formoterol rather than salmeter- ol ⁄ ﬂuticasone had a higher likelihood of treatment success, and that budeso- nide ⁄ formoterol is the less costly option. Although the cohorts appeared to be well matched at baseline, the results should be interpreted with caution given the observational nature of the study. What’s known d Clinical studies have shown that, for patients with asthma uncontrolled by low-dose inhaled corticosteroids (ICS), maintenance treatment with ﬁxed-dose combinations of an ICS and a long- acting b2-agonist (LABA) are effective in achieving asthma control and preventing exacerbations. d Retrospective database studies have shown that combination products may increase compliance and treatment outcomes compared with separately administered ICS and LABA. d Recent meta-analyses have indicated that the two most commonly used ﬁxed-dose ICS ⁄ LABA combinations (budesonide ⁄ formoterol and salmeterol ⁄ ﬂuticasone) may not have the same level of efﬁcacy with regard to asthma-related hospitalisations ⁄ emergency room visits, the risk being greater with salmeterol ⁄ ﬂuticasone. What new d This database analysis of ﬁxed-dose ICS ⁄ LABA combinations adds to a growing body of evidence suggesting that there may be efﬁcacy differences between budesonide ⁄ formoterol and salmeterol ⁄ ﬂuticasone. The results suggest that, in a real-life German healthcare setting: d Patients initiating treatment with budesonide ⁄ formoterol had an increased chance of treatment success and reduced exacerbations compared with salmeterol ⁄ ﬂuticasone. d Fixed-dose budesonide ⁄ formoterol is less costly than salmeterol ⁄ ﬂuticasone for the treatment of chronic asthma. Introduction Guidelines published by the Global Initiative for Asthma indicate that asthma control can and should be achieved and maintained in most patients by employing appropriate pharmacotherapy and mini- mising environmental stimuli (1,2). However, this goal is not always met and the majority of patients still remain uncontrolled. In a recent survey of over 2000 adults diagnosed with asthma in ﬁve European countries only 38% of treated patients were well con- trolled, and in Germany this ﬁgure was lower, at 26% (3). Currently, initial treatment generally consists of a ﬁxed low dose of an inhaled corticosteroid (ICS) (200–500 lg beclomethasone dipropionate equiva- lent) with a short-acting b2-agonist (SABA) for ª 2008 Ingenix Pharmaceutical Services (UK) Ltd. Journal compilation ª 2008 Blackwell Publishing Ltd Int J Clin Pract, December 2008, 62, 12, 1870–1879