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01.12.2015 | Research article | Ausgabe 1/2015 Open Access

BMC Pulmonary Medicine 1/2015

Prescribing of long-acting beta-2-agonists/inhaled corticosteroids after the SMART trial

BMC Pulmonary Medicine > Ausgabe 1/2015
Marietta Rottenkolber, Rainald Fischer, Luisa Ibáñez, Joan Fortuny, Robert Reynolds, Justyna Amelio, Roman Gerlach, Martin Tauscher, Petra Thürmann, Joerg Hasford, Sven Schmiedl
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s12890-015-0051-x) contains supplementary material, which is available to authorized users.

Competing interests

MR, RF, LI, RG, MT, PT, and JH have no conflicts of interest. SS reports personal fees (Rottapharm Madaus, Cologne, Germany) and reimbursement of travel costs for an investigator meeting (Bayer HealthCare AG, Leverkusen, Germany) outside the submitted work. JF is an employee of Novartis. JA is an employee of Amgen Ltd. RR is an employee and shareholder of Pfizer Inc. JF, JA and RR belong to EFPIA (European Federation of Pharmaceutical Industries and Association) member companies in the IMI JU and costs related to their part in the research were carried by the respective company as in-kind contribution under the IMI JU scheme.

Authors’ contributions

All authors contributed to the study conception and design. Data extraction and raw data analysis and interpretation were performed by MR, SS, RF, RG, MT, and JH. MR and SS wrote the first draft and all authors contributed with critical comments to the final version. All authors have seen and approved the final version.



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.


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.


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.


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.
Additional file 1: Table S1. Annual period prevalence rates per 10,000 persons stratified by compound between 2004 and 2008. Table S2. Number and proportion of patients with an additional COPD diagnosis for the year 2008.
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