カルテオロール塩酸塩/ラタノプロスト配合点眼液（ミケルナ®配合点眼液）の使用実態下における安全性と有効性—特定使用成績調査の最終解析結果報告

The safety and efficacy of carteolol hydrochloride/latanoprost fixed combination（Mikeluna® combination ophthalmic solution）under actual use conditions: Report on the final analysis of specified drug use survey

要約　目的：カルテオロール塩酸塩2％とラタノプロスト0.005％を含有するミケルナ^®配合点眼液（以下，本剤）を，緑内障または高眼圧症の患者に使用実態下で2年間長期投与した際の安全性と有効性を検討した。

対象と方法：全国66施設において，本剤が初めて投与された緑内障または高眼圧症の患者を対象として特定使用成績調査を実施した。2017年4月〜2021年3月に調査票が回収された317例のうち，312例を安全性解析対象，299例を有効性解析対象とした。投与継続率，副作用の発現状況，眼圧の推移，視野障害の悪化有無，視野検査結果および前眼部所見の推移について評価した。

結果：投与継続率は1年後が84.6％，2年後が77.0％で，良好であった。副作用は312例のうち56例（17.95％）に発現し，主なものは視野欠損および角膜障害が各13例，眼瞼炎が5例，眼瞼色素沈着，結膜充血および視野検査異常が各4例，点状角膜炎および霧視が各2例などであった。重篤な副作用に関して，本剤投与以外の要因が考えられないものとして血圧低下と期外収縮が同一症例でみられたが，投与中止により回復した。投与前の眼圧15.3±4.0mmHg（平均±標準偏差）に対して，2年後まで眼圧の下降傾向がみられ，24か月後の下降値は1.7±2.5mmHgで統計学的に有意であった（p＜0.0001）。前眼部所見がみられた割合は投与前20.2％，最終評価時16.0％であり，本剤投与中に低下した。

結論：本剤の2年間の長期投与において投与継続率が良好であり，安全性の面で臨床的に特に問題となる点はみられなかった。また，統計学的に有意な眼圧下降も確認された。

Abstract　Purpose：The safety and efficacy of Mikeluna^® combination ophthalmic solution（hereinafter, this drug）containing carteolol hydrochloride 2％ and latanoprost 0.005％ in patients with glaucoma or ocular hypertension were investigated under actual use conditions for 2 years.

Subjects and methods：Patients with glaucoma or ocular hypertension who received this drug for the first time at 66 medical facilities all over Japan were included in the study. Of the 317 patients whose case report forms were collected between April 2017 and March 2021, 312 were included in the safety analysis and 299 in the efficacy analysis. The rate of treatment continuation, incidence of each adverse drug reaction, intraocular pressure（IOP）reduction, visual field changes, and changes in anterior segment findings were evaluated.

Results（findings）：The persistence of this drug was excellent, with a treatment persistence rate of 84.6％ at 1 year and 77.0％ at 2 years. The incidence of adverse drug reactions was 17.95％（56/312 cases）. The most common adverse drug reactions were visual field defect^＊ and corneal disorder^＊ in 13 cases each, blepharitis^＊ in 5 cases, blepharal pigmentation^＊, conjunctival hyperaemia^＊, and visual field tests abnormal^＊ in 4 cases each, and punctate keratitis^＊ and vision blurred^＊ in 2 cases each. As serious adverse drug reactions for which other factors except for administration of this drug were not reported, extrasystoles and blood pressure decreased were reported in the same case and the patient was recovered after discontinuation of this drug. As for efficacy, with a baseline IOP of 15.3±4.0 mmHg（Mean±SD）, a lowering trend in IOP was observed until 2 years after the treatment, and a statistically significant reduction of 1.7±2.5 mmHg was observed after 24 months of treatment（p＜0.0001）. The percentage of patients with anterior segment findings was 20.2％ at baseline and 16.0％ at the final evaluation. It decreased during administration of this drug.

^＊Aadverse drug reactions were coded using the MedDRA/J（Medical Dictionary for Regulatory Activities Japanese edition）.

Conclusions：The long-term administration of this drug for 2 years showed a good persistence rate. No clinically significant issues were observed in terms of safety, and statistically significant IOP reduction was confirmed.