PubMed:24531757 JSONTXT

{"project":"PubmedHPO","denotations":[{"id":"T1","span":{"begin":400,"end":408},"obj":"HP_0000501"},{"id":"T2","span":{"begin":465,"end":477},"obj":"HP_0000822"}],"text":"Safety and efficacy of a fixed versus unfixed brinzolamide/timolol combination in Japanese patients with open-angle glaucoma or ocular hypertension.\nBACKGROUND: The purpose of this study was to assess the safety and efficacy of fixed-combination brinzolamide 1%/timolol 0.5% (BRINZ/TIM-FC) compared with concomitant brinzolamide 1% and timolol 0.5% (BRINZ + TIM) in Japanese patients with open-angle glaucoma (primary open-angle, exfoliation, pigmentary) or ocular hypertension.\nMETHODS: This randomized, double-masked, multicenter, parallel-group, positive-control, Phase III study was conducted in Japan and included patients aged ≥20 years. Baseline intraocular pressure was assessed after 4 weeks of treatment with timolol 0.5%. Patients were randomized to twice-daily BRINZ/TIM-FC or BRINZ + TIM for 8 weeks (treatment phase). The primary endpoint was mean intraocular pressure reduction from baseline to week 8 at 11 am, at which time noninferiority of BRINZ/TIM-FC versus BRINZ + TIM was evaluated. Data were analyzed using repeated-measures analysis of covariance and t-tests. Adverse events and ophthalmic/physiologic variables were assessed.\nRESULTS: In total, 319 patients of mean age 64±12 years were enrolled in the treatment phase. BRINZ/TIM-FC and BRINZ + TIM were associated with reductions in mean intraocular pressure from baseline throughout the study (ranges -2.5 to -3.4 mmHg and -2.7 to -3.3 mmHg, respectively). Mean between-group differences in intraocular pressure reduction ranged from 0 to -0.3 mmHg; the upper limit of the 97.5% confidence interval for week 8 at 11 am was \u003c1.1 mmHg, indicating noninferiority of BRINZ/TIM-FC. Treatment-related adverse events were observed in 3% and 12% of patients receiving BRINZ/TIM-FC and BRINZ + TIM, respectively. No substantial changes in other safety parameters were reported.\nCONCLUSION: Twice-daily BRINZ/TIM-FC reduced intraocular pressure by levels similar to concomitant BRINZ + TIM in Japanese patients with open-angle glaucoma or ocular hypertension and was noninferior to BRINZ + TIM. Both treatments were well tolerated."}

{"project":"maxiaofeng52_800_3","denotations":[{"id":"T10","span":{"begin":350,"end":355},"obj":"CI"},{"id":"T11","span":{"begin":316,"end":328},"obj":"CI"},{"id":"T12","span":{"begin":46,"end":58},"obj":"CI"},{"id":"T13","span":{"begin":246,"end":258},"obj":"CI"},{"id":"T14","span":{"begin":336,"end":343},"obj":"CI"},{"id":"T15","span":{"begin":59,"end":66},"obj":"CI"},{"id":"T16","span":{"begin":262,"end":269},"obj":"CI"},{"id":"T17","span":{"begin":719,"end":726},"obj":"CI"},{"id":"T18","span":{"begin":358,"end":361},"obj":"CI"},{"id":"T19","span":{"begin":979,"end":984},"obj":"CI"},{"id":"T20","span":{"begin":987,"end":990},"obj":"CI"},{"id":"T21","span":{"begin":1755,"end":1760},"obj":"CI"},{"id":"T22","span":{"begin":1763,"end":1766},"obj":"CI"},{"id":"T23","span":{"begin":1946,"end":1951},"obj":"CI"},{"id":"T24","span":{"begin":1954,"end":1957},"obj":"CI"},{"id":"T25","span":{"begin":2050,"end":2055},"obj":"CI"},{"id":"T26","span":{"begin":2058,"end":2061},"obj":"CI"},{"id":"T27","span":{"begin":135,"end":147},"obj":"DP"},{"id":"T28","span":{"begin":465,"end":477},"obj":"DP"},{"id":"T29","span":{"begin":2014,"end":2026},"obj":"DP"},{"id":"T30","span":{"begin":116,"end":124},"obj":"DP"},{"id":"T31","span":{"begin":400,"end":408},"obj":"DP"},{"id":"T32","span":{"begin":1995,"end":2003},"obj":"DP"},{"id":"T8","span":{"begin":789,"end":794},"obj":"CI"},{"id":"T9","span":{"begin":797,"end":800},"obj":"CI"},{"id":"T33","span":{"begin":276,"end":281},"obj":"CI"},{"id":"T34","span":{"begin":282,"end":285},"obj":"CI"},{"id":"T35","span":{"begin":286,"end":288},"obj":"CI"},{"id":"T36","span":{"begin":773,"end":778},"obj":"CI"},{"id":"T37","span":{"begin":779,"end":782},"obj":"CI"},{"id":"T38","span":{"begin":783,"end":785},"obj":"CI"},{"id":"T39","span":{"begin":959,"end":964},"obj":"CI"},{"id":"T40","span":{"begin":965,"end":968},"obj":"CI"},{"id":"T41","span":{"begin":969,"end":971},"obj":"CI"},{"id":"T42","span":{"begin":1641,"end":1646},"obj":"CI"},{"id":"T43","span":{"begin":1647,"end":1650},"obj":"CI"},{"id":"T44","span":{"begin":1651,"end":1653},"obj":"CI"},{"id":"T45","span":{"begin":1738,"end":1743},"obj":"CI"},{"id":"T46","span":{"begin":1744,"end":1747},"obj":"CI"},{"id":"T47","span":{"begin":1748,"end":1750},"obj":"CI"},{"id":"T48","span":{"begin":1871,"end":1876},"obj":"CI"},{"id":"T49","span":{"begin":1877,"end":1880},"obj":"CI"},{"id":"T50","span":{"begin":1881,"end":1883},"obj":"CI"},{"id":"T51","span":{"begin":1246,"end":1251},"obj":"CI"},{"id":"T52","span":{"begin":1252,"end":1255},"obj":"CI"},{"id":"T53","span":{"begin":1256,"end":1258},"obj":"CI"},{"id":"T54","span":{"begin":1263,"end":1268},"obj":"CI"},{"id":"T55","span":{"begin":1271,"end":1274},"obj":"CI"}],"text":"Safety and efficacy of a fixed versus unfixed brinzolamide/timolol combination in Japanese patients with open-angle glaucoma or ocular hypertension.\nBACKGROUND: The purpose of this study was to assess the safety and efficacy of fixed-combination brinzolamide 1%/timolol 0.5% (BRINZ/TIM-FC) compared with concomitant brinzolamide 1% and timolol 0.5% (BRINZ + TIM) in Japanese patients with open-angle glaucoma (primary open-angle, exfoliation, pigmentary) or ocular hypertension.\nMETHODS: This randomized, double-masked, multicenter, parallel-group, positive-control, Phase III study was conducted in Japan and included patients aged ≥20 years. Baseline intraocular pressure was assessed after 4 weeks of treatment with timolol 0.5%. Patients were randomized to twice-daily BRINZ/TIM-FC or BRINZ + TIM for 8 weeks (treatment phase). The primary endpoint was mean intraocular pressure reduction from baseline to week 8 at 11 am, at which time noninferiority of BRINZ/TIM-FC versus BRINZ + TIM was evaluated. Data were analyzed using repeated-measures analysis of covariance and t-tests. Adverse events and ophthalmic/physiologic variables were assessed.\nRESULTS: In total, 319 patients of mean age 64±12 years were enrolled in the treatment phase. BRINZ/TIM-FC and BRINZ + TIM were associated with reductions in mean intraocular pressure from baseline throughout the study (ranges -2.5 to -3.4 mmHg and -2.7 to -3.3 mmHg, respectively). Mean between-group differences in intraocular pressure reduction ranged from 0 to -0.3 mmHg; the upper limit of the 97.5% confidence interval for week 8 at 11 am was \u003c1.1 mmHg, indicating noninferiority of BRINZ/TIM-FC. Treatment-related adverse events were observed in 3% and 12% of patients receiving BRINZ/TIM-FC and BRINZ + TIM, respectively. No substantial changes in other safety parameters were reported.\nCONCLUSION: Twice-daily BRINZ/TIM-FC reduced intraocular pressure by levels similar to concomitant BRINZ + TIM in Japanese patients with open-angle glaucoma or ocular hypertension and was noninferior to BRINZ + TIM. Both treatments were well tolerated."}

{"project":"wangzhuo19_800_3","denotations":[{"id":"T1","span":{"begin":116,"end":124},"obj":"DP"},{"id":"T2","span":{"begin":400,"end":408},"obj":"DP"},{"id":"T3","span":{"begin":1995,"end":2003},"obj":"DP"},{"id":"T4","span":{"begin":135,"end":147},"obj":"DP"},{"id":"T5","span":{"begin":465,"end":477},"obj":"DP"},{"id":"T6","span":{"begin":2014,"end":2026},"obj":"DP"},{"id":"T7","span":{"begin":246,"end":258},"obj":"CI"},{"id":"T8","span":{"begin":46,"end":58},"obj":"CI"},{"id":"T9","span":{"begin":316,"end":328},"obj":"CI"},{"id":"T10","span":{"begin":262,"end":269},"obj":"CI"},{"id":"T11","span":{"begin":59,"end":66},"obj":"CI"},{"id":"T12","span":{"begin":336,"end":343},"obj":"CI"},{"id":"T13","span":{"begin":719,"end":726},"obj":"CI"},{"id":"T14","span":{"begin":350,"end":355},"obj":"CI"},{"id":"T15","span":{"begin":276,"end":281},"obj":"CI"},{"id":"T16","span":{"begin":773,"end":778},"obj":"CI"},{"id":"T17","span":{"begin":789,"end":794},"obj":"CI"},{"id":"T18","span":{"begin":959,"end":964},"obj":"CI"},{"id":"T19","span":{"begin":979,"end":984},"obj":"CI"},{"id":"T20","span":{"begin":1246,"end":1251},"obj":"CI"},{"id":"T21","span":{"begin":1263,"end":1268},"obj":"CI"},{"id":"T22","span":{"begin":1641,"end":1646},"obj":"CI"},{"id":"T23","span":{"begin":1738,"end":1743},"obj":"CI"},{"id":"T24","span":{"begin":1755,"end":1760},"obj":"CI"},{"id":"T25","span":{"begin":1871,"end":1876},"obj":"CI"},{"id":"T26","span":{"begin":1946,"end":1951},"obj":"CI"},{"id":"T27","span":{"begin":2050,"end":2055},"obj":"CI"},{"id":"T28","span":{"begin":358,"end":361},"obj":"CI"},{"id":"T29","span":{"begin":282,"end":285},"obj":"CI"},{"id":"T30","span":{"begin":779,"end":782},"obj":"CI"},{"id":"T31","span":{"begin":797,"end":800},"obj":"CI"},{"id":"T32","span":{"begin":965,"end":968},"obj":"CI"},{"id":"T33","span":{"begin":987,"end":990},"obj":"CI"},{"id":"T34","span":{"begin":1252,"end":1255},"obj":"CI"},{"id":"T35","span":{"begin":1271,"end":1274},"obj":"CI"},{"id":"T36","span":{"begin":1647,"end":1650},"obj":"CI"},{"id":"T37","span":{"begin":1744,"end":1747},"obj":"CI"},{"id":"T38","span":{"begin":1763,"end":1766},"obj":"CI"},{"id":"T39","span":{"begin":1877,"end":1880},"obj":"CI"},{"id":"T40","span":{"begin":1954,"end":1957},"obj":"CI"},{"id":"T41","span":{"begin":2058,"end":2061},"obj":"CI"},{"id":"T42","span":{"begin":1256,"end":1258},"obj":"CI"},{"id":"T43","span":{"begin":286,"end":288},"obj":"CI"},{"id":"T44","span":{"begin":783,"end":785},"obj":"CI"},{"id":"T45","span":{"begin":969,"end":971},"obj":"CI"},{"id":"T46","span":{"begin":1651,"end":1653},"obj":"CI"},{"id":"T47","span":{"begin":1748,"end":1750},"obj":"CI"},{"id":"T48","span":{"begin":1881,"end":1883},"obj":"CI"}],"text":"Safety and efficacy of a fixed versus unfixed brinzolamide/timolol combination in Japanese patients with open-angle glaucoma or ocular hypertension.\nBACKGROUND: The purpose of this study was to assess the safety and efficacy of fixed-combination brinzolamide 1%/timolol 0.5% (BRINZ/TIM-FC) compared with concomitant brinzolamide 1% and timolol 0.5% (BRINZ + TIM) in Japanese patients with open-angle glaucoma (primary open-angle, exfoliation, pigmentary) or ocular hypertension.\nMETHODS: This randomized, double-masked, multicenter, parallel-group, positive-control, Phase III study was conducted in Japan and included patients aged ≥20 years. Baseline intraocular pressure was assessed after 4 weeks of treatment with timolol 0.5%. Patients were randomized to twice-daily BRINZ/TIM-FC or BRINZ + TIM for 8 weeks (treatment phase). The primary endpoint was mean intraocular pressure reduction from baseline to week 8 at 11 am, at which time noninferiority of BRINZ/TIM-FC versus BRINZ + TIM was evaluated. Data were analyzed using repeated-measures analysis of covariance and t-tests. Adverse events and ophthalmic/physiologic variables were assessed.\nRESULTS: In total, 319 patients of mean age 64±12 years were enrolled in the treatment phase. BRINZ/TIM-FC and BRINZ + TIM were associated with reductions in mean intraocular pressure from baseline throughout the study (ranges -2.5 to -3.4 mmHg and -2.7 to -3.3 mmHg, respectively). Mean between-group differences in intraocular pressure reduction ranged from 0 to -0.3 mmHg; the upper limit of the 97.5% confidence interval for week 8 at 11 am was \u003c1.1 mmHg, indicating noninferiority of BRINZ/TIM-FC. Treatment-related adverse events were observed in 3% and 12% of patients receiving BRINZ/TIM-FC and BRINZ + TIM, respectively. No substantial changes in other safety parameters were reported.\nCONCLUSION: Twice-daily BRINZ/TIM-FC reduced intraocular pressure by levels similar to concomitant BRINZ + TIM in Japanese patients with open-angle glaucoma or ocular hypertension and was noninferior to BRINZ + TIM. Both treatments were well tolerated."}