Bimatoprost/Timolol Fixed Combination: A 3-month Double-masked, Randomized Parallel Comparison to Its Individual Components in Patients With Glaucoma or Ocular Hypertension
PURPOSETo evaluate the safety and efficacy of a fixed combination (FC) of bimatoprost (BIM) and timolol (TIM) compared with each of the active components for 3 months. PATIENTS AND METHODSTwo double-masked, randomized, multicenter parallel studies of FC (once-daily, mornings), BIM (once-daily, eveni...
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| Veröffentlicht in: | Journal of glaucoma 2008-04, Vol.17 (3), p.211-216 |
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| creator | Brandt, James D Cantor, Louis B Katz, L Jay Batoosingh, Amy L Chou, Connie Bossowska, Izabella |
| description | PURPOSETo evaluate the safety and efficacy of a fixed combination (FC) of bimatoprost (BIM) and timolol (TIM) compared with each of the active components for 3 months.
PATIENTS AND METHODSTwo double-masked, randomized, multicenter parallel studies of FC (once-daily, mornings), BIM (once-daily, evenings), or TIM (twice-daily) were conducted in 1061 patients with glaucoma or ocular hypertension.
RESULTSMean diurnal decreases from baseline intraocular pressure (IOP) at month 3 were 8.1, 7.9, and 6.4 mm Hg for the FC, BIM, and TIM groups, respectively. The proportion of patients with a mean diurnal percent reduction from baseline in IOP of more than 20% across all visits was 81.8% (436/533), 72.1% (191/265), and 49.8% (131/263) for the FC, BIM, and TIM groups, respectively (P |
| doi_str_mv | 10.1097/IJG.0b013e3181507313 |
| format | Article |
| fullrecord | <record><control><sourceid>pubmed_cross</sourceid><recordid>TN_cdi_crossref_primary_10_1097_IJG_0b013e3181507313</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>18414107</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3509-590a24f25fd4e60a54acbea171e87b30ccae65a632ee564430cd965be088cd6e3</originalsourceid><addsrcrecordid>eNpdkO1qFTEQhoMo9kPvQCQX4LaTTbIf_qtHe3qkUJGK_ltmd-dwYrPJkmSt7TV5kaaeQsEfQyYzPC_Dw9gbAScC2vp083l9Aj0ISVI0QkMthXzGDoWWVaEa8eN57kHXBTRle8COYvwJUEJZipfsQDRKKAH1IfvzwUyY_Bx8TKfXZvLWW35uftPIV37qjcNkvHvPz7gsJu_Sjn_0S2-pmDDe0PiOf0U3-sncZ-ALBrSW7AM5YzDRO54836TIN240v8y44H7pHbk8NS4zyfzrv5ucvba4DH5C7gO_GhaLgV_czRQSuZjPeMVebNFGev34HrNv55-uVxfF5dV6szq7LAapoS10C1iqbam3o6IKUCscekJRC2rqXsIwIFUaK1kS6UqpPBnbSvcETTOMFcljpva5Q9YSA227OWRN4a4T0D3I77L87n_5GXu7x-aln2h8gh5tP-XeepsoxBu73FLodoQ27ToAqIRom6IEaEDlb5ELWvkXzQqTvw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Bimatoprost/Timolol Fixed Combination: A 3-month Double-masked, Randomized Parallel Comparison to Its Individual Components in Patients With Glaucoma or Ocular Hypertension</title><source>MEDLINE</source><source>Journals@Ovid Complete</source><creator>Brandt, James D ; Cantor, Louis B ; Katz, L Jay ; Batoosingh, Amy L ; Chou, Connie ; Bossowska, Izabella</creator><creatorcontrib>Brandt, James D ; Cantor, Louis B ; Katz, L Jay ; Batoosingh, Amy L ; Chou, Connie ; Bossowska, Izabella ; Ganfort Investigators Group II</creatorcontrib><description>PURPOSETo evaluate the safety and efficacy of a fixed combination (FC) of bimatoprost (BIM) and timolol (TIM) compared with each of the active components for 3 months.
PATIENTS AND METHODSTwo double-masked, randomized, multicenter parallel studies of FC (once-daily, mornings), BIM (once-daily, evenings), or TIM (twice-daily) were conducted in 1061 patients with glaucoma or ocular hypertension.
RESULTSMean diurnal decreases from baseline intraocular pressure (IOP) at month 3 were 8.1, 7.9, and 6.4 mm Hg for the FC, BIM, and TIM groups, respectively. The proportion of patients with a mean diurnal percent reduction from baseline in IOP of more than 20% across all visits was 81.8% (436/533), 72.1% (191/265), and 49.8% (131/263) for the FC, BIM, and TIM groups, respectively (P<0.001 for FC vs. BIM and FC vs. TIM). The proportion of patients achieving an IOP of less than 18 mm Hg at all time points was 39.2% (209/533), 28.7% (76/265), and 12.2% (32/263) for the FC, BIM, and TIM groups, respectively (P=0.003 for FC vs. BIM, and P<0.001 for FC vs. TIM). The most commonly reported treatment-related adverse event was conjunctival hyperemia, with the greatest incidence in BIM (38.5%, 102/265), followed by FC (22.7%, 121/533, P<0.0001 vs. BIM) and TIM (6.8%, 18/263; P<0.001 vs. FC).
CONCLUSIONSFC was statistically significantly more effective than BIM or TIM for most comparisons, and safer than BIM with respect to common ocular adverse events. FC represents a convenient, therapeutic advantage over separate bottles.</description><identifier>ISSN: 1057-0829</identifier><identifier>EISSN: 1536-481X</identifier><identifier>DOI: 10.1097/IJG.0b013e3181507313</identifier><identifier>PMID: 18414107</identifier><language>eng</language><publisher>United States: Lippincott Williams & Wilkins, Inc</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Amides - administration & dosage ; Amides - adverse effects ; Antihypertensive Agents - administration & dosage ; Antihypertensive Agents - adverse effects ; Bimatoprost ; Cloprostenol - administration & dosage ; Cloprostenol - adverse effects ; Cloprostenol - analogs & derivatives ; Double-Blind Method ; Drug Combinations ; Female ; Glaucoma, Angle-Closure - drug therapy ; Glaucoma, Open-Angle - drug therapy ; Humans ; Intraocular Pressure - drug effects ; Male ; Middle Aged ; Ocular Hypertension - drug therapy ; Timolol - administration & dosage ; Timolol - adverse effects ; Tonometry, Ocular ; Treatment Outcome</subject><ispartof>Journal of glaucoma, 2008-04, Vol.17 (3), p.211-216</ispartof><rights>2008 Lippincott Williams & Wilkins, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3509-590a24f25fd4e60a54acbea171e87b30ccae65a632ee564430cd965be088cd6e3</citedby><cites>FETCH-LOGICAL-c3509-590a24f25fd4e60a54acbea171e87b30ccae65a632ee564430cd965be088cd6e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781,27905,27906</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18414107$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Brandt, James D</creatorcontrib><creatorcontrib>Cantor, Louis B</creatorcontrib><creatorcontrib>Katz, L Jay</creatorcontrib><creatorcontrib>Batoosingh, Amy L</creatorcontrib><creatorcontrib>Chou, Connie</creatorcontrib><creatorcontrib>Bossowska, Izabella</creatorcontrib><creatorcontrib>Ganfort Investigators Group II</creatorcontrib><title>Bimatoprost/Timolol Fixed Combination: A 3-month Double-masked, Randomized Parallel Comparison to Its Individual Components in Patients With Glaucoma or Ocular Hypertension</title><title>Journal of glaucoma</title><addtitle>J Glaucoma</addtitle><description>PURPOSETo evaluate the safety and efficacy of a fixed combination (FC) of bimatoprost (BIM) and timolol (TIM) compared with each of the active components for 3 months.
PATIENTS AND METHODSTwo double-masked, randomized, multicenter parallel studies of FC (once-daily, mornings), BIM (once-daily, evenings), or TIM (twice-daily) were conducted in 1061 patients with glaucoma or ocular hypertension.
RESULTSMean diurnal decreases from baseline intraocular pressure (IOP) at month 3 were 8.1, 7.9, and 6.4 mm Hg for the FC, BIM, and TIM groups, respectively. The proportion of patients with a mean diurnal percent reduction from baseline in IOP of more than 20% across all visits was 81.8% (436/533), 72.1% (191/265), and 49.8% (131/263) for the FC, BIM, and TIM groups, respectively (P<0.001 for FC vs. BIM and FC vs. TIM). The proportion of patients achieving an IOP of less than 18 mm Hg at all time points was 39.2% (209/533), 28.7% (76/265), and 12.2% (32/263) for the FC, BIM, and TIM groups, respectively (P=0.003 for FC vs. BIM, and P<0.001 for FC vs. TIM). The most commonly reported treatment-related adverse event was conjunctival hyperemia, with the greatest incidence in BIM (38.5%, 102/265), followed by FC (22.7%, 121/533, P<0.0001 vs. BIM) and TIM (6.8%, 18/263; P<0.001 vs. FC).
CONCLUSIONSFC was statistically significantly more effective than BIM or TIM for most comparisons, and safer than BIM with respect to common ocular adverse events. FC represents a convenient, therapeutic advantage over separate bottles.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Amides - administration & dosage</subject><subject>Amides - adverse effects</subject><subject>Antihypertensive Agents - administration & dosage</subject><subject>Antihypertensive Agents - adverse effects</subject><subject>Bimatoprost</subject><subject>Cloprostenol - administration & dosage</subject><subject>Cloprostenol - adverse effects</subject><subject>Cloprostenol - analogs & derivatives</subject><subject>Double-Blind Method</subject><subject>Drug Combinations</subject><subject>Female</subject><subject>Glaucoma, Angle-Closure - drug therapy</subject><subject>Glaucoma, Open-Angle - drug therapy</subject><subject>Humans</subject><subject>Intraocular Pressure - drug effects</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Ocular Hypertension - drug therapy</subject><subject>Timolol - administration & dosage</subject><subject>Timolol - adverse effects</subject><subject>Tonometry, Ocular</subject><subject>Treatment Outcome</subject><issn>1057-0829</issn><issn>1536-481X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkO1qFTEQhoMo9kPvQCQX4LaTTbIf_qtHe3qkUJGK_ltmd-dwYrPJkmSt7TV5kaaeQsEfQyYzPC_Dw9gbAScC2vp083l9Aj0ISVI0QkMthXzGDoWWVaEa8eN57kHXBTRle8COYvwJUEJZipfsQDRKKAH1IfvzwUyY_Bx8TKfXZvLWW35uftPIV37qjcNkvHvPz7gsJu_Sjn_0S2-pmDDe0PiOf0U3-sncZ-ALBrSW7AM5YzDRO54836TIN240v8y44H7pHbk8NS4zyfzrv5ucvba4DH5C7gO_GhaLgV_czRQSuZjPeMVebNFGev34HrNv55-uVxfF5dV6szq7LAapoS10C1iqbam3o6IKUCscekJRC2rqXsIwIFUaK1kS6UqpPBnbSvcETTOMFcljpva5Q9YSA227OWRN4a4T0D3I77L87n_5GXu7x-aln2h8gh5tP-XeepsoxBu73FLodoQ27ToAqIRom6IEaEDlb5ELWvkXzQqTvw</recordid><startdate>200804</startdate><enddate>200804</enddate><creator>Brandt, James D</creator><creator>Cantor, Louis B</creator><creator>Katz, L Jay</creator><creator>Batoosingh, Amy L</creator><creator>Chou, Connie</creator><creator>Bossowska, Izabella</creator><general>Lippincott Williams & Wilkins, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>200804</creationdate><title>Bimatoprost/Timolol Fixed Combination: A 3-month Double-masked, Randomized Parallel Comparison to Its Individual Components in Patients With Glaucoma or Ocular Hypertension</title><author>Brandt, James D ; Cantor, Louis B ; Katz, L Jay ; Batoosingh, Amy L ; Chou, Connie ; Bossowska, Izabella</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3509-590a24f25fd4e60a54acbea171e87b30ccae65a632ee564430cd965be088cd6e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Amides - administration & dosage</topic><topic>Amides - adverse effects</topic><topic>Antihypertensive Agents - administration & dosage</topic><topic>Antihypertensive Agents - adverse effects</topic><topic>Bimatoprost</topic><topic>Cloprostenol - administration & dosage</topic><topic>Cloprostenol - adverse effects</topic><topic>Cloprostenol - analogs & derivatives</topic><topic>Double-Blind Method</topic><topic>Drug Combinations</topic><topic>Female</topic><topic>Glaucoma, Angle-Closure - drug therapy</topic><topic>Glaucoma, Open-Angle - drug therapy</topic><topic>Humans</topic><topic>Intraocular Pressure - drug effects</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Ocular Hypertension - drug therapy</topic><topic>Timolol - administration & dosage</topic><topic>Timolol - adverse effects</topic><topic>Tonometry, Ocular</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Brandt, James D</creatorcontrib><creatorcontrib>Cantor, Louis B</creatorcontrib><creatorcontrib>Katz, L Jay</creatorcontrib><creatorcontrib>Batoosingh, Amy L</creatorcontrib><creatorcontrib>Chou, Connie</creatorcontrib><creatorcontrib>Bossowska, Izabella</creatorcontrib><creatorcontrib>Ganfort Investigators Group II</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Journal of glaucoma</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Brandt, James D</au><au>Cantor, Louis B</au><au>Katz, L Jay</au><au>Batoosingh, Amy L</au><au>Chou, Connie</au><au>Bossowska, Izabella</au><aucorp>Ganfort Investigators Group II</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Bimatoprost/Timolol Fixed Combination: A 3-month Double-masked, Randomized Parallel Comparison to Its Individual Components in Patients With Glaucoma or Ocular Hypertension</atitle><jtitle>Journal of glaucoma</jtitle><addtitle>J Glaucoma</addtitle><date>2008-04</date><risdate>2008</risdate><volume>17</volume><issue>3</issue><spage>211</spage><epage>216</epage><pages>211-216</pages><issn>1057-0829</issn><eissn>1536-481X</eissn><abstract>PURPOSETo evaluate the safety and efficacy of a fixed combination (FC) of bimatoprost (BIM) and timolol (TIM) compared with each of the active components for 3 months.
PATIENTS AND METHODSTwo double-masked, randomized, multicenter parallel studies of FC (once-daily, mornings), BIM (once-daily, evenings), or TIM (twice-daily) were conducted in 1061 patients with glaucoma or ocular hypertension.
RESULTSMean diurnal decreases from baseline intraocular pressure (IOP) at month 3 were 8.1, 7.9, and 6.4 mm Hg for the FC, BIM, and TIM groups, respectively. The proportion of patients with a mean diurnal percent reduction from baseline in IOP of more than 20% across all visits was 81.8% (436/533), 72.1% (191/265), and 49.8% (131/263) for the FC, BIM, and TIM groups, respectively (P<0.001 for FC vs. BIM and FC vs. TIM). The proportion of patients achieving an IOP of less than 18 mm Hg at all time points was 39.2% (209/533), 28.7% (76/265), and 12.2% (32/263) for the FC, BIM, and TIM groups, respectively (P=0.003 for FC vs. BIM, and P<0.001 for FC vs. TIM). The most commonly reported treatment-related adverse event was conjunctival hyperemia, with the greatest incidence in BIM (38.5%, 102/265), followed by FC (22.7%, 121/533, P<0.0001 vs. BIM) and TIM (6.8%, 18/263; P<0.001 vs. FC).
CONCLUSIONSFC was statistically significantly more effective than BIM or TIM for most comparisons, and safer than BIM with respect to common ocular adverse events. FC represents a convenient, therapeutic advantage over separate bottles.</abstract><cop>United States</cop><pub>Lippincott Williams & Wilkins, Inc</pub><pmid>18414107</pmid><doi>10.1097/IJG.0b013e3181507313</doi><tpages>6</tpages></addata></record> |
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| ispartof | Journal of glaucoma, 2008-04, Vol.17 (3), p.211-216 |
| issn | 1057-0829 1536-481X |
| language | eng |
| recordid | cdi_crossref_primary_10_1097_IJG_0b013e3181507313 |
| source | MEDLINE; Journals@Ovid Complete |
| subjects | Adult Aged Aged, 80 and over Amides - administration & dosage Amides - adverse effects Antihypertensive Agents - administration & dosage Antihypertensive Agents - adverse effects Bimatoprost Cloprostenol - administration & dosage Cloprostenol - adverse effects Cloprostenol - analogs & derivatives Double-Blind Method Drug Combinations Female Glaucoma, Angle-Closure - drug therapy Glaucoma, Open-Angle - drug therapy Humans Intraocular Pressure - drug effects Male Middle Aged Ocular Hypertension - drug therapy Timolol - administration & dosage Timolol - adverse effects Tonometry, Ocular Treatment Outcome |
| title | Bimatoprost/Timolol Fixed Combination: A 3-month Double-masked, Randomized Parallel Comparison to Its Individual Components in Patients With Glaucoma or Ocular Hypertension |
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