Michael Scott Kook1, Susan Simonyi2, Yong Ho Sohn3, Chan Yun Kim4, Ki Ho Park5. 1. Department of Ophthalmology, Asan Medical Centre, 388-1 Pungnap-dong, Songpa-Gu, Seoul, Korea. mskook@amc.seoul.kr. 2. Allergan Singapore Pte, Ltd., Mapletree Business City, Singapore, Singapore. 3. Kim's Eye Hospital, Seoul, Korea. 4. Department of Ophthalmology, Yonsei University, College of Medicine, Seoul, Korea. 5. Department of Ophthalmology, Seoul National University Hospital, Seoul, Korea.
Abstract
PURPOSE: To evaluate the occurrence of hyperemia with, and efficacy of, bimatoprost 0.01 % for patients in Korea previously treated for open-angle glaucoma (OAG; including normal tension glaucoma) or ocular hypertension (OHT). METHODS: In this multicenter, observational study (Asia Pacific Patterns from Early Access of Lumigan 0.01 % in Korea; APPEAL Korea), patients with unachieved target intraocular pressure (IOP) despite previous treatment received bimatoprost 0.01 % daily for 12 weeks. The primary endpoint was incidence of hyperemia and its severity, graded using the standard 5-point photographic scale and grouped as "none to mild" and "moderate to severe". Hyperemia shifts were reported. IOP and adverse events (AEs) were recorded. RESULTS: Of 800 patients (intent-to-treat/safety population), 248 were switched from previous treatment to bimatoprost 0.01 % monotherapy. Hyperemia shifts from baseline at weeks 6 and 12 were unchanged (84.8, 89.8 %), improved (4.4, 4.8 %), or worsened (10.8, 5.4 %), respectively. The shift was significant at week 6 (P < 0.0001). Hyperemia did not worsen significantly in patients previously receiving a prostaglandin analog or prostamide (PGA/PSD). Baseline mean IOP ± SD was 17.0 ± 5.7 mmHg, decreasing to 14.6 ± 3.8 mmHg (P < 0.0001) after 6 weeks, and to 14.7 ± 3.6 mmHg (P < 0.0001) after 12 weeks. Patients switched from PGA or PSD (excluding bimatoprost 0.03 %) to bimatoprost 0.01 % experienced significant IOP reductions from baseline. Treatment-related ocular AEs were reported by 37 patients, the most common being hyperemia (7.3 %). CONCLUSIONS: This subanalysis of the APPEAL Korea study supports use of bimatoprost 0.01 % for previously treated patients with OAG (including normal tension glaucoma) or OHT who did not reach target IOP or were intolerant of previous treatment.
PURPOSE: To evaluate the occurrence of hyperemia with, and efficacy of, bimatoprost 0.01 % for patients in Korea previously treated for open-angle glaucoma (OAG; including normal tension glaucoma) or ocular hypertension (OHT). METHODS: In this multicenter, observational study (Asia Pacific Patterns from Early Access of Lumigan 0.01 % in Korea; APPEAL Korea), patients with unachieved target intraocular pressure (IOP) despite previous treatment received bimatoprost 0.01 % daily for 12 weeks. The primary endpoint was incidence of hyperemia and its severity, graded using the standard 5-point photographic scale and grouped as "none to mild" and "moderate to severe". Hyperemia shifts were reported. IOP and adverse events (AEs) were recorded. RESULTS: Of 800 patients (intent-to-treat/safety population), 248 were switched from previous treatment to bimatoprost 0.01 % monotherapy. Hyperemia shifts from baseline at weeks 6 and 12 were unchanged (84.8, 89.8 %), improved (4.4, 4.8 %), or worsened (10.8, 5.4 %), respectively. The shift was significant at week 6 (P < 0.0001). Hyperemia did not worsen significantly in patients previously receiving a prostaglandin analog or prostamide (PGA/PSD). Baseline mean IOP ± SD was 17.0 ± 5.7 mmHg, decreasing to 14.6 ± 3.8 mmHg (P < 0.0001) after 6 weeks, and to 14.7 ± 3.6 mmHg (P < 0.0001) after 12 weeks. Patients switched from PGA or PSD (excluding bimatoprost 0.03 %) to bimatoprost 0.01 % experienced significant IOP reductions from baseline. Treatment-related ocular AEs were reported by 37 patients, the most common being hyperemia (7.3 %). CONCLUSIONS: This subanalysis of the APPEAL Korea study supports use of bimatoprost 0.01 % for previously treated patients with OAG (including normal tension glaucoma) or OHT who did not reach target IOP or were intolerant of previous treatment.
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