慢性閉塞性肺疾患の気道閉塞性障害に伴う諸症状の緩解を目的に才ーキシス? 9mugタービュヘイラー?を使用した場合の安全性の検討一才ーキシス? 9mug夕ービュヘイラー?使用成績調査結果一

摘要

tive pulmonary disease (COPD) using formoterol (Oxis?) Turbuhaler? 9 jug for the first time to confirm the occurrence of adverse drug reactions (ADRs) during the long-term use of this product for the management of COPD after marketing authorisation. Methods Patients at medical institutions in Japan were registered. With an observation period of12 weeks, we investigated the occurrence of ADRs and serious adverse events (AEs) by SOC/PT; ADRs possibly related to the pharmacological effect of 〃2—agonists; serious cardiovascular AEs; and exacerbation of COPD. Results Of the 369 patients included in the safety population,13 ADRs were seen in11 patients (3.0%). ADRs of decreased appetite and nausea were seen in 2 patients each, and pharyngitis, hyperkalemia, dysgeusia, unstable angina, arrhythmia, palpitations, laryngeal discomfort, malaise and thirst were seen in1patient each. Eighteen serious AEs were observed in 9 patients (2,4%) ， but a causal relationship with the product was ruled out for all serious AEs except decreased appetite and unstable angina, which occurred in1patient each. ADRs reported as possibly related to the pharmacological effect of ^-agonists were non-serious arrhythmia and palpitations, reported in1patient each (0.3%). Serious cardiovascular AEs of unstable angina and myocardial infarction were reported in1patient each (0.3%). One patient (0.3 %) with exacerbation of COPD was reported, but the condition was recovered. Conclusion In this clinical experience investigation, the rate of incidence of ADRs was comparable with that reported in clinical studies conducted prior to product approval, and no noteworthy findings were observed with regard to safety.