Search

Tommy Tsang Cheung,1,* Tu H Mai,2,* Yen Lin Chia,2 Desmond YH Yap,1 Chi-Ho Lee,1 Cecil Chi-Keung Chen,2 Ying Huang,3 Yuwen Jin,3 James Johnston,4 Viktoria Werkström,5 Yuhui Yao,6 Xiaoyun Ge,7 Wenying Zheng8 1Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong, People’s Republic of China; 2Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, South San Francisco, CA, USA; 3Clinical Pharmacology, R&D China, AstraZeneca, Shanghai, People’s Republic of China; 4Late-stage Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK; 5Late-Stage Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden; 6Respiratory & Immunology, R&D China, AstraZeneca, Shanghai, People’s Republic of China; 7Clinical Safety, R&D China, AstraZeneca, Shanghai, People’s Republic of China; 8Biometrics, R&D China, AstraZeneca, Shanghai, People’s Republic of China*These authors contributed equally to this workCorrespondence: Yen Lin Chia, Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, 701 Gateway Blvd, South San Francisco, CA, 9408, USA, Tel +1 425 5272574, Email yenlin@gmail.comPurpose: Biological therapies targeting eosinophils have been shown to be effective in treating patients with severe eosinophilic asthma. Benralizumab (Fasenra®, AstraZeneca) is a humanized monoclonal antibody binding to the alpha subunit of the interleukin-5 receptor, which rapidly depletes eosinophils via antibody-dependent cellular cytotoxicity. The aim of this Phase 1 study was to assess the safety, tolerability, and pharmacokinetics of benralizumab in healthy Chinese individuals.Materials and Methods: In this randomized, single-blind study (NCT03928262), healthy Chinese adul

Elisabet Ekman1, Staffan Hägg2, Anders Sundström3, Viktoria Werkström11Regional Pharmacovigilance Unit, Clinical Pharmacology, Lund University Hospital, Lund, Sweden; 2Division of Clinical Pharmacology, Linköping University, Linköping, Sweden; 3Centre for Pharmacoepidemiology, Karolinska Institute, Stockholm, SwedenAim: To describe spontaneously reported cases of erectile dysfunction (ED) in association with angiotensin II type I blockers (ARB) and other antihypertensive drugs.Subjects and methods: All spontaneously reported cases of ED submitted to the Swedish Medical Products Agency (MPA) between 1990 and 2006, where at least one antihypertensive drug was the suspected agent, were scrutinized. Patient demographics, drug treatment and adverse reactions were recorded. Using the Bayesian Confidence Propagation Neural Network (BCPNN) method, the information component (IC) was calculated.Results: Among a total of 225 reports of ED, 59 involved antihypertensive drugs including ARB (9 cases) as suspected agents. A positive IC value was found indicating that ED was reported more often in association with antihypertensive drugs classes, except for angiotensin-converting enzyme inhibitors, compared with all other drugs in the database. Positive dechallenge was reported in 43 cases (72%).Discussion: All classes of major antihypertensive drugs including ARB were implicated as suspected agents in cases of ED. Few risk factors were identified. The relatively high reporting of ED in association with ARB is in contrast with previous studies, suggesting that ARB have neither a positive nor any effect on ED. This discrepancy suggests that further studies are warrnted on this potential adverse reaction to ARB.Keywords: adverse drug reaction, spontaneous reporting, antihypertensive drugs, angiotensin II type 1 receptor blockers, erectile dysfunction