PMID- 27926986 OWN - NLM STAT- MEDLINE DCOM- 20180307 LR - 20210109 IS - 1398-9995 (Electronic) IS - 0105-4538 (Print) IS - 0105-4538 (Linking) VI - 72 IP - 6 DP - 2017 Jun TI - Long-term safety of icatibant treatment of patients with angioedema in real-world clinical practice. PG - 994-998 LID - 10.1111/all.13103 [doi] AB - The Icatibant Outcome Survey (IOS) is an observational study monitoring safety and effectiveness of icatibant in the real-world setting. We analyzed safety data from 3025 icatibant-treated attacks in 557 patients (enrolled between July 2009 and February 2015). Icatibant was generally well tolerated. Excluding off-label use and pregnancy, 438 patients (78.6%) did not report adverse events (AEs). The remaining 119 (21.4%) patients reported 341 AEs, primarily gastrointestinal disorders (19.6%). Of these, 43 AEs in 17 patients (3.1%) were related to icatibant. Serious AEs (SAEs) occurred infrequently. A total of 143 SAEs occurred in 59 (10.6%) patients; only three events (drug inefficacy, gastritis, and reflux esophagitis) in two patients were considered related to icatibant. Notably, no SAEs related to icatibant occurred in patients with cardiovascular disease, nor in those using icatibant at a frequency above label guidelines. Additionally, no major differences were noted in AEs occurring in on-label vs off-label icatibant users. CI - (c) 2016 The Authors. Allergy Published by John Wiley & Sons Ltd. FAU - Zanichelli, A AU - Zanichelli A AD - Department of Biomedical and Clinical Sciences Luigi Sacco, University of Milan, ASST Fatebenefratelli Sacco, Milan, Italy. FAU - Maurer, M AU - Maurer M AD - Department of Dermatology and Allergy, Charite-Universitatsmedizin Berlin, Berlin, Germany. FAU - Aberer, W AU - Aberer W AD - Department of Dermatology and Venerology, Medical University of Graz, Graz, Austria. FAU - Caballero, T AU - Caballero T AD - Department of Allergy, Hospital La Paz Institute for Health Research (IdiPaz), Biomedical Research Network on Rare Diseases (CIBERER, U754), Madrid, Spain. FAU - Longhurst, H J AU - Longhurst HJ AD - Department of Immunology, Barts Health NHS Trust, London, UK. FAU - Bouillet, L AU - Bouillet L AD - National Reference Centre for Angioedema, Internal Medicine Department, Grenoble University Hospital, Grenoble, France. FAU - Fabien, V AU - Fabien V AD - Shire, Zug, Switzerland at time of data analysis; now with Vifor Pharma, Glattbrugg, Switzerland. FAU - Andresen, I AU - Andresen I AD - Shire, Zug, Switzerland. CN - IOS Study Group LA - eng PT - Journal Article PT - Observational Study DEP - 20170313 PL - Denmark TA - Allergy JT - Allergy JID - 7804028 RN - 0 (Anti-Inflammatory Agents, Non-Steroidal) RN - 7PG89G35Q7 (icatibant) RN - S8TIM42R2W (Bradykinin) SB - IM EIN - Allergy. 2018 Sep;73(9):1929. PMID: 30168183 MH - Adolescent MH - Angioedema/*drug therapy MH - Anti-Inflammatory Agents, Non-Steroidal MH - Bradykinin/adverse effects/*analogs & derivatives/therapeutic use MH - Cardiovascular Diseases MH - Female MH - Gastrointestinal Diseases/chemically induced MH - Humans MH - Male MH - Off-Label Use/standards MH - Time Factors MH - Treatment Outcome PMC - PMC5434903 OTO - NOTNLM OT - angioedema OT - icatibant OT - real-world OT - safety FIR - Grumach, A IR - Grumach A FIR - Bygum, A IR - Bygum A FIR - Blanchard Delaunay, C IR - Blanchard Delaunay C FIR - Boccon-Gibod, I IR - Boccon-Gibod I FIR - Coppere, B IR - Coppere B FIR - Du Thanh, A IR - Du Thanh A FIR - Dzviga, C IR - Dzviga C FIR - Fain, O IR - Fain O FIR - Goichot, B IR - Goichot B FIR - Gompel, A IR - Gompel A FIR - Guez, S IR - Guez S FIR - Jeandel, P IR - Jeandel P FIR - Kanny, G IR - Kanny G FIR - Launay, D IR - Launay D FIR - Maillard, H IR - Maillard H FIR - Martin, L IR - Martin L FIR - Masseau, A IR - Masseau A FIR - Ollivier, Y IR - Ollivier Y FIR - Sobel, A IR - Sobel A FIR - Aygoren-Pursun, E IR - Aygoren-Pursun E FIR - Bas, M IR - Bas M FIR - Bauer, A IR - Bauer A FIR - Bork, K IR - Bork K FIR - Greve, J IR - Greve J FIR - Magerl, M IR - Magerl M FIR - Martinez Saguer, I IR - Martinez Saguer I FIR - Strassen, U IR - Strassen U FIR - Papadopoulou-Alataki, E IR - Papadopoulou-Alataki E FIR - Psarros, F IR - Psarros F FIR - Graif, Y IR - Graif Y FIR - Kivity, S IR - Kivity S FIR - Reshef, A IR - Reshef A FIR - Toubi, E IR - Toubi E FIR - Arcoleo, F IR - Arcoleo F FIR - Bova, M IR - Bova M FIR - Cicardi, M IR - Cicardi M FIR - Manconi, P IR - Manconi P FIR - Marone, G IR - Marone G FIR - Montinaro, V IR - Montinaro V FIR - Triggiani, M IR - Triggiani M FIR - Baeza, L IR - Baeza L FIR - Cabanas, R IR - Cabanas R FIR - Gala Ortiz, G IR - Gala Ortiz G FIR - Guilarte, M IR - Guilarte M FIR - Hernandez, D IR - Hernandez D FIR - Hernando de Larramendi, C IR - Hernando de Larramendi C FIR - Lleonart, R IR - Lleonart R FIR - Lobera, T IR - Lobera T FIR - Marques, L IR - Marques L FIR - Saenz de San Pedro, B IR - Saenz de San Pedro B FIR - Bjorkander, J IR - Bjorkander J FIR - Bethune, C IR - Bethune C FIR - Garcez, T IR - Garcez T EDAT- 2016/12/08 06:00 MHDA- 2018/03/08 06:00 PMCR- 2017/05/17 CRDT- 2016/12/08 06:00 PHST- 2016/11/30 00:00 [accepted] PHST- 2016/12/08 06:00 [pubmed] PHST- 2018/03/08 06:00 [medline] PHST- 2016/12/08 06:00 [entrez] PHST- 2017/05/17 00:00 [pmc-release] AID - ALL13103 [pii] AID - 10.1111/all.13103 [doi] PST - ppublish SO - Allergy. 2017 Jun;72(6):994-998. doi: 10.1111/all.13103. Epub 2017 Mar 13.