Therapeutic Research

Background：Few reports describe the epidemiology of severe asthma in Japan. This subanalysis of the ACQUIRE‒2 Study investigated the proportion and clinical characteristics of patients with“uncontrolled”severe asthma in Japan. 　　Methods：ACQUIRE‒2 was a multi‒center, observational study investigating asthma control, asthma symptoms and health‒related quality of life（HRQOL） among asthma patients（≧20 years）being managed by specialists. In this subanalysis, never smokers or smokers with＜10 pack‒years were included. Patients were classified into two groups：“severe asthma”and“mild‒to‒moderate asthma”. The severe asthma group was subdivided into“‘uncontrolled’severe asthma”and“not‘uncontrolled’severe asthma”based on a definition modified from the European Respiratory Society/American Thoracic Society guidelines. Asthma symptoms and HRQOL were evaluated. Results：Of the 870 patients included in the subanalysis, 205（23.6％）patients were confirmed as having severe asthma；among these, 107（12.3％）patients were classified as having“uncontrolled”asthma and 98（11.3％）patients were classified as having not “uncontrolled”asthma. Mean age, duration of asthma, and body mass index were 59.5±16.8 years, 23.2±16.6 years and 23.1±4.5 kg/m2, respectively, in the“uncontrolled” severe asthma group, and 57.2±12.6 years, 20.4±14.2 years and 23.0±4.0 kg/m2, respectively, in the not“uncontrolled”severe asthma group. Among 735 patients with available symptom information, in the“uncontrolled”severe asthma（n＝81）and not “uncontrolled”severe asthma（n＝84）groups, respectively, 60（74.1％）and 39（46.6％） patients experienced daytime asthma symptoms, 61（75.3％）and 33 （39.3％）experienced nighttime asthma symptoms, 22（27.2％）and 7（8.3％） experienced sleep disorders；20（24.7％）and 4（4.8％）experienced activity limitations. Among patients with“uncontrolled” severe asthma, 52.4％ had an asthma control questionnaire（ACQ‒5）score≧1.5；62.1％ of not “uncontrolled” severe asthma patients had a score of ≦0.75. Mean Mini Asthma Quality of Life Questionnaire scores for“uncontrolled”severe asthma and not“uncontrolled”severe asthma patients were 5.1±1.1 and 5.9±0.8, respectively. Conclusions：Among asthma patients managed by specialists in Japan, 12.3％ had “uncontrolled”severe asthma, were symptomatic, and had greater HRQOL impairment, suggesting a need for more effective asthma management options. Trial registration：ClinicalTrials. gov（NCT02640742）

目的：DPP‒4 阻害剤等の血糖降下剤にシュアポスト®（レパグリニド）（以下，本剤）が新たに併用された2 型糖尿病患者を本剤投与開始後1 年間観察し，製造販売後の使用実態下における長期併用時の安全性および有効性を検討することを目的とした特定使用成績調査を実施した。　方法：中央登録方式により，患者背景，本剤の投与状況，DPP‒4 阻害剤等の血糖降下剤の投与状況，有害事象，臨床検査値等について調査した。　結果：DPP‒4 阻害剤併用例の副作用は安全性評価対象症例970 例の4.23％に発現し，主な副作用は低血糖（1.96％）であった。低血糖以外に特徴的な副作用は認められなかった。また，副作用の多くは本剤投与3 ヵ月以内に発現しており，長期投与で副作用の発現割合の著しい増加は認められなかった。DPP‒4 阻害剤併用例の有効性評価対象症例865 例のHbA1c 値は，本剤投与開始前の7.88±1.33％に対し，最終観察時（12 ヵ月後のデータが欠損もしくは本剤投与中止により中途脱落した場合には最後に観察された値で補完）には7.11±1.09％に低下し，最終観察時の変化量は－0.78±1.37％であった。変化量は，本剤投与開始3 ヵ月後は－0.83±1.31％，12 ヵ月後は－0.83±1.30％であり，長期にわたる改善が確認された。　結論：使用実態下での本剤とDPP‒4 阻害剤との長期併用において，新たな安全性の問題点は認められず，本剤の有効性に関しても特に懸念される点は認められなかった。

Background：We have reported on the administration of PARSABIV®（hereinafterreferred to as etelcalcetide）to patients with maintenance hemodialysis with SecondaryHyperparathyroidism.　　Cases：A total of 18 cases, 9 cases of novel administration and 9 cases of switchingfrom cinacalcet were examined. Etelcalcetide dosage（3 times a week for each case）：5mg；16 cases（ new and switching, eight cases of each）, 2.5 mg；2 cases（new andswitching, one case of each）.　　Results：In switching from the cinacalcet to the etelcalcetide, the average levels ofi‒PTH was 188.9 pg/mL before switching, and greatly increased to 200.2 pg/mL after1 month, and 123.2 pg/mL after 3 months. The pre‒dose of cinacalcet in the switchingexample was 25 mg：7 cases, 50 mg：2 cases. Adjusted serum calcium scarcely changed.In the case of new administration of etelcalcetide, the average levels of i‒PTH was 533.3 pg/mL before administration, and 513.1 pg/mL after 1 month, 148.6 pg/mL after 3 months, that is, the effect was also recognized after 3 months. Decrease in dosage, weight loss, side effects, and patient opinion of other drugs were considered. There was no case of discontinuation of administration within 3 months from the start of administration. Conclusion：It has been revealed the tolerance and safety after switching from the 25 mg of cinacalcet to the 5 mg of etelcalcetide. Etelcalcetide is promising for improving the prognosis of patients with secondary hyperparathyroidism.