薬理と治療

Abstract

Objectives A clinical experience investigation was conducted in patients with chronic obstructive pulmonary disease（COPD）using Symbicort(R) Turbuhaler(R)（budesonide╱formoterol combination）in order to confirm its long-term safety and efficacy during routine clinical use in the post-marketing phase. Methods Patients were recruited primarily from the internal medicine and respiratory disease departments of medical institutions using the central registration method. Over a 1-year observation period, adverse events were investigated to evaluate safety, and changes in respiratory function test values（FVC, FEV1）, COPD-related clinical questionnaire（CCQ）scores, and COPD exacerbations were investigated to evaluate efficacy. Results Adverse drug reactions（ADRs）were reported in 65（5.8％, 82 events）of the 1123 patients included in the safety population. ADRs reported in ≥3 patients were dysphonia, oropharyngeal discomfort, palpitations, bronchitis, oral candidiasis, pneumonia, and cough. Serious adverse events（AEs）were reported in 84 patients（7.5％, 125 events）; a drug relationship was ruled out for all but 7 serious AEs: pneumonia in 4 patients, and unstable angina, cardiac failure, and compression fracture in one patient each. ADRs possibly related to the pharmacological effect of a beta2 agonist were reported in 13 patients（1.2％, 14 events）, and ADRs possibly related to the pharmacological effect of a corticosteroid were reported in 37 patients（3.3％, 39 events）. Serious cardiovascular AEs were reported in 15 patients（1.3％, 16 events）, and pneumonia-related AEs were reported in 61 patients（5.4％, 74 events）. Statistical significance was reported at all time points（Week 12, Week 26, 1 year, and last patient observation） in terms of mean change from baseline in FVC, FEV1, and CCQ symptom, functional state, mental state, and total scores. COPD exacerbations were reported in 45 patients（4.0％）. Conclusion A clinical experience investigation of Symbicort(R) Turbuhaler(R) during routine long-term use revealed no noteworthy new signals in terms of safety and confirmed efficacy for improving symptoms and lung function.