PMID- 29061968 OWN - NLM STAT- MEDLINE DCOM- 20180726 LR - 20181113 IS - 2055-1010 (Electronic) IS - 2055-1010 (Linking) VI - 27 IP - 1 DP - 2017 Oct 23 TI - Comprehensive assessment of the safety of olodaterol 5 microg in the Respimat((R)) device for maintenance treatment of COPD: comparison with the long-acting beta(2)-agonist formoterol. PG - 60 LID - 10.1038/s41533-017-0059-1 [doi] LID - 60 AB - This analysis provides a comprehensive clinical assessment of the long-term safety of the licensed dose of olodaterol (5 microg once daily [QD] via Respimat((R)) inhaler) in patients with chronic obstructive pulmonary disease by exploring the occurrence of acknowledged side effects of long-acting beta(2)-agonists as well as those included in the olodaterol and formoterol labels. We analysed pooled data from two replicate, double-blind studies of olodaterol (5 microg QD via Respimat((R))) compared to formoterol (12 microg twice daily [BID]) or placebo over 48 weeks (1222.13, NCT00793624; 1222.14, NCT00796653). Patients could continue their background treatment. The analysis considered adverse events (AEs) typically associated with beta(2)-agonists, including cardiovascular events, as well as administration-related events. Descriptive statistics were provided for the incidence of AEs and aggregated AEs. The analysis included 1379 patients: 460 placebo, 459 olodaterol and 460 formoterol; AEs were reported by 70.9, 71.7 and 69.1% of patients, respectively. Exposure-adjusted incidence rates of cardiac AEs (arrhythmia and myocardial ischaemia) and cough were numerically lower in the olodaterol group than the formoterol group, while nasopharyngitis, throat irritation, metabolism and psychiatric disorders were numerically higher in the olodaterol group. The most frequent event in the olodaterol group was nasopharyngitis (placebo 8.0%; olodaterol 12.9%; formoterol 10.0%). Except for cough (incidence rate ratio of 0.46 [95% confidence interval 0.24, 0.89] in favour of olodaterol), there were no significant differences between active groups. In conclusion, olodaterol 5 microg QD was well tolerated over 48 weeks with a typical beta(2)-agonist safety profile comparable to formoterol 12 microg BID. FAU - Koch, Andrea AU - Koch A AD - Medizinische Klinik und Poliklinik V, Klinikum der Ludwig-Maximilians-Universitat, Munich, Germany. andrea.koch@med.uni-muenchen.de. AD - German Center for Lung Research (DZL), Klinikum der Ludwig-Maximilians-Universitat, Munich, Germany. andrea.koch@med.uni-muenchen.de. FAU - Watz, Henrik AU - Watz H AD - Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany. FAU - Maleki-Yazdi, M Reza AU - Maleki-Yazdi MR AD - Division of Respiratory Medicine, Women's College Hospital, University of Toronto, Toronto, ON, Canada. FAU - Bothner, Ulrich AU - Bothner U AUID- ORCID: 0000-0001-6515-0841 AD - Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. FAU - Tetzlaff, Kay AU - Tetzlaff K AD - Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. FAU - Voss, Florian AU - Voss F AD - Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. FAU - McGarvey, Lorcan AU - McGarvey L AD - Centre for Infection and Immunity, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK. LA - eng PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial DEP - 20171023 PL - England TA - NPJ Prim Care Respir Med JT - NPJ primary care respiratory medicine JID - 101631999 RN - 0 (Adrenergic beta-2 Receptor Agonists) RN - 0 (Benzoxazines) RN - 0 (Bronchodilator Agents) RN - 0 (Delayed-Action Preparations) RN - VD2YSN1AFD (olodaterol) RN - W34SHF8J2K (Formoterol Fumarate) SB - IM MH - Adrenergic beta-2 Receptor Agonists/administration & dosage/*therapeutic use MH - Benzoxazines/administration & dosage/adverse effects/*therapeutic use MH - Bronchodilator Agents/administration & dosage/adverse effects/*therapeutic use MH - Delayed-Action Preparations MH - Double-Blind Method MH - Female MH - Formoterol Fumarate/administration & dosage/adverse effects/*therapeutic use MH - Humans MH - Male MH - Middle Aged MH - *Nebulizers and Vaporizers MH - Pulmonary Disease, Chronic Obstructive/*drug therapy PMC - PMC5653794 COIS- A.K. has received a grant from Actelion Pharmaceuticals and has taken part in congresses for Boehringer Ingelheim, Almirall, Bayer, TEVA, Roche, Actelion and Novartis. H.W. reports personal fees for consulting and compensation for his institution during the conduct of the study from Boehringer Ingelheim related to the submitted work, and participation in advisory boards for Almirall, AstraZeneca, Boehringer Ingelheim and GlaxoSmithKline, in lectures for Almirall, AstraZeneca, Boehringer Ingelheim, BerlinChemie, GlaxoSmithKline, Novartis and Chiesi, and congress travel support from GlaxoSmithKline and Novartis outside the submitted work; his institution has also received compensation for the conduct of clinical studies from Almirall, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Chiesi, Takeda, AB2BIO, Bayer and Intermune outside the submitted work. M.R.M.-Y. declares that he has no competing financial interests. U.B., K.T. and F.V. are employees of Boehringer Ingelheim. L.M. reports personal fees from Applied Clinical Intelligence during the conduct of the study, grants from Asthma UK, NI Chest Heart & Stroke, NC3Rs, British Heart Foundation and Chiesi, travel and subsistence for attendance at scientific meetings from Boehringer Ingelheim, GlaxoSmithKline and Chiesi, and advisory board/consultancy fees from Almirall, NAPP, GlaxoSmithKline and Boehringer Ingelheim outside the submitted work. EDAT- 2017/10/25 06:00 MHDA- 2018/07/27 06:00 PMCR- 2017/10/23 CRDT- 2017/10/25 06:00 PHST- 2017/02/07 00:00 [received] PHST- 2017/09/13 00:00 [accepted] PHST- 2017/08/14 00:00 [revised] PHST- 2017/10/25 06:00 [entrez] PHST- 2017/10/25 06:00 [pubmed] PHST- 2018/07/27 06:00 [medline] PHST- 2017/10/23 00:00 [pmc-release] AID - 10.1038/s41533-017-0059-1 [pii] AID - 59 [pii] AID - 10.1038/s41533-017-0059-1 [doi] PST - epublish SO - NPJ Prim Care Respir Med. 2017 Oct 23;27(1):60. doi: 10.1038/s41533-017-0059-1.