Three-month, randomized, parallel-group comparison of brimonidine-timolol versus dorzolamide-timolol fixed-combination therapy
ABSTRACT Objective: Fixed combinations of 0.2% brimonidine-0.5% timolol and 2% dorzolamide-0.5% timolol are used to lower intraocular pressure (IOP). The objective of this study was to evaluate the IOP-lowering efficacy and ocular tolerability of brimonidine-timolol compared with dorzolamide-timolol...
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| creator | Nixon, Donald R. Yan, David B. Chartrand, Jean-Pierre Piemontesi, Roberto L. Simonyi, Susan Hollander, David A. |
| description | ABSTRACT
Objective: Fixed combinations of 0.2% brimonidine-0.5% timolol and 2% dorzolamide-0.5% timolol are used to lower intraocular pressure (IOP). The objective of this study was to evaluate the IOP-lowering efficacy and ocular tolerability of brimonidine-timolol compared with dorzolamide-timolol when used as monotherapy or as adjunctive therapy to a prostaglandin analog (PGA) in patients with glaucoma or ocular hypertension.
Study design and methods: Pooled data analysis of two randomized, investigator-masked, 3-month, parallel-group studies with identical protocols (ten sites). In all, 180 patients with open-angle glaucoma or ocular hypertension who were in need of lower IOP received topical brimonidine-timolol BID or dorzolamide-timolol BID as monotherapy (n = 101) or as adjunctive therapy to a PGA (latanoprost, bimatoprost, or travoprost) (n = 79).
Clinical trial registration: The studies are registered with the identifiers NCT00822081 and NCT00822055 at http://www.clinicaltrials.gov.
Main outcome measures: IOP was measured at 10 a.m. (peak effect) at baseline and at months 1 and 3. Tolerability/comfort was evaluated using a patient questionnaire.
Results: There were no statistically significant between-group differences in patient demographics. Most patients were Caucasian, and the mean age was 68 years. There were also no statistically significant differences between treatment groups in baseline IOP. At month 3, the mean (SD) reduction from baseline IOP for patients on fixed-combination monotherapy was 7.7 (4.2) mmHg (32.3%) with brimonidine-timolol versus 6.7 (5.0) mmHg (26.1%) with dorzolamide-timolol (p = 0.040). The mean reduction from PGA-treated baseline IOP for patients on fixed-combination adjunctive therapy was 6.9 (4.8) mmHg (29.3%) with brimonidine-timolol versus 5.2 (3.7) mmHg (23.5%) with dorzolamide-timolol (p = 0.213). Patients on brimonidine-timolol reported less burning (p |
| doi_str_mv | 10.1185/03007990902994041 |
| format | Article |
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Objective: Fixed combinations of 0.2% brimonidine-0.5% timolol and 2% dorzolamide-0.5% timolol are used to lower intraocular pressure (IOP). The objective of this study was to evaluate the IOP-lowering efficacy and ocular tolerability of brimonidine-timolol compared with dorzolamide-timolol when used as monotherapy or as adjunctive therapy to a prostaglandin analog (PGA) in patients with glaucoma or ocular hypertension.
Study design and methods: Pooled data analysis of two randomized, investigator-masked, 3-month, parallel-group studies with identical protocols (ten sites). In all, 180 patients with open-angle glaucoma or ocular hypertension who were in need of lower IOP received topical brimonidine-timolol BID or dorzolamide-timolol BID as monotherapy (n = 101) or as adjunctive therapy to a PGA (latanoprost, bimatoprost, or travoprost) (n = 79).
Clinical trial registration: The studies are registered with the identifiers NCT00822081 and NCT00822055 at http://www.clinicaltrials.gov.
Main outcome measures: IOP was measured at 10 a.m. (peak effect) at baseline and at months 1 and 3. Tolerability/comfort was evaluated using a patient questionnaire.
Results: There were no statistically significant between-group differences in patient demographics. Most patients were Caucasian, and the mean age was 68 years. There were also no statistically significant differences between treatment groups in baseline IOP. At month 3, the mean (SD) reduction from baseline IOP for patients on fixed-combination monotherapy was 7.7 (4.2) mmHg (32.3%) with brimonidine-timolol versus 6.7 (5.0) mmHg (26.1%) with dorzolamide-timolol (p = 0.040). The mean reduction from PGA-treated baseline IOP for patients on fixed-combination adjunctive therapy was 6.9 (4.8) mmHg (29.3%) with brimonidine-timolol versus 5.2 (3.7) mmHg (23.5%) with dorzolamide-timolol (p = 0.213). Patients on brimonidine-timolol reported less burning (p < 0.001), stinging (p < 0.001), and unusual taste (p < 0.001) than patients on dorzolamide-timolol.
Conclusions: Fixed-combination brimonidine-timolol provided the same or greater IOP lowering compared with fixed-combination dorzolamide-timolol. Both fixed-combination medications were safe and well-tolerated. Brimonidine-timolol received higher ratings of ocular comfort than dorzolamide-timolol. The duration of the studies was 3 months, and additional studies will be needed to compare the efficacy and tolerability of brimonidine-timolol and dorzolamide-timolol during long-term treatment.</description><identifier>ISSN: 0300-7995</identifier><identifier>EISSN: 1473-4877</identifier><identifier>DOI: 10.1185/03007990902994041</identifier><identifier>PMID: 19476406</identifier><language>eng</language><publisher>England: Informa UK Ltd</publisher><subject><![CDATA[Adult ; Aged ; Aged, 80 and over ; Antihypertensive Agents - administration & dosage ; Antihypertensive Agents - adverse effects ; Brimonidine ; Brimonidine Tartrate ; Dorzolamide ; Drug Combinations ; Female ; Fixed combination ; Glaucoma ; Humans ; Intraocular pressure ; Intraocular Pressure - drug effects ; Male ; Middle Aged ; Ocular Hypertension - drug therapy ; Ophthalmic Solutions - administration & dosage ; Osmolar Concentration ; Quinoxalines - administration & dosage ; Quinoxalines - adverse effects ; Sulfonamides - administration & dosage ; Sulfonamides - adverse effects ; Thiophenes - administration & dosage ; Thiophenes - adverse effects ; Time Factors ; Timolol ; Timolol - administration & dosage ; Timolol - adverse effects]]></subject><ispartof>Current medical research and opinion, 2009-07, Vol.25 (7), p.1645-1653</ispartof><rights>2009 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted 2009</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c471t-6d729818f1ac4cccb65071040714a932005aa20f3e4e5fa189e1458f413f29df3</citedby><cites>FETCH-LOGICAL-c471t-6d729818f1ac4cccb65071040714a932005aa20f3e4e5fa189e1458f413f29df3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.tandfonline.com/doi/pdf/10.1185/03007990902994041$$EPDF$$P50$$Ginformahealthcare$$H</linktopdf><linktohtml>$$Uhttps://www.tandfonline.com/doi/full/10.1185/03007990902994041$$EHTML$$P50$$Ginformahealthcare$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,59647,59753,60436,60542,61221,61256,61402,61437</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19476406$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nixon, Donald R.</creatorcontrib><creatorcontrib>Yan, David B.</creatorcontrib><creatorcontrib>Chartrand, Jean-Pierre</creatorcontrib><creatorcontrib>Piemontesi, Roberto L.</creatorcontrib><creatorcontrib>Simonyi, Susan</creatorcontrib><creatorcontrib>Hollander, David A.</creatorcontrib><title>Three-month, randomized, parallel-group comparison of brimonidine-timolol versus dorzolamide-timolol fixed-combination therapy</title><title>Current medical research and opinion</title><addtitle>Curr Med Res Opin</addtitle><description>ABSTRACT
Objective: Fixed combinations of 0.2% brimonidine-0.5% timolol and 2% dorzolamide-0.5% timolol are used to lower intraocular pressure (IOP). The objective of this study was to evaluate the IOP-lowering efficacy and ocular tolerability of brimonidine-timolol compared with dorzolamide-timolol when used as monotherapy or as adjunctive therapy to a prostaglandin analog (PGA) in patients with glaucoma or ocular hypertension.
Study design and methods: Pooled data analysis of two randomized, investigator-masked, 3-month, parallel-group studies with identical protocols (ten sites). In all, 180 patients with open-angle glaucoma or ocular hypertension who were in need of lower IOP received topical brimonidine-timolol BID or dorzolamide-timolol BID as monotherapy (n = 101) or as adjunctive therapy to a PGA (latanoprost, bimatoprost, or travoprost) (n = 79).
Clinical trial registration: The studies are registered with the identifiers NCT00822081 and NCT00822055 at http://www.clinicaltrials.gov.
Main outcome measures: IOP was measured at 10 a.m. (peak effect) at baseline and at months 1 and 3. Tolerability/comfort was evaluated using a patient questionnaire.
Results: There were no statistically significant between-group differences in patient demographics. Most patients were Caucasian, and the mean age was 68 years. There were also no statistically significant differences between treatment groups in baseline IOP. At month 3, the mean (SD) reduction from baseline IOP for patients on fixed-combination monotherapy was 7.7 (4.2) mmHg (32.3%) with brimonidine-timolol versus 6.7 (5.0) mmHg (26.1%) with dorzolamide-timolol (p = 0.040). The mean reduction from PGA-treated baseline IOP for patients on fixed-combination adjunctive therapy was 6.9 (4.8) mmHg (29.3%) with brimonidine-timolol versus 5.2 (3.7) mmHg (23.5%) with dorzolamide-timolol (p = 0.213). Patients on brimonidine-timolol reported less burning (p < 0.001), stinging (p < 0.001), and unusual taste (p < 0.001) than patients on dorzolamide-timolol.
Conclusions: Fixed-combination brimonidine-timolol provided the same or greater IOP lowering compared with fixed-combination dorzolamide-timolol. Both fixed-combination medications were safe and well-tolerated. Brimonidine-timolol received higher ratings of ocular comfort than dorzolamide-timolol. The duration of the studies was 3 months, and additional studies will be needed to compare the efficacy and tolerability of brimonidine-timolol and dorzolamide-timolol during long-term treatment.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antihypertensive Agents - administration & dosage</subject><subject>Antihypertensive Agents - adverse effects</subject><subject>Brimonidine</subject><subject>Brimonidine Tartrate</subject><subject>Dorzolamide</subject><subject>Drug Combinations</subject><subject>Female</subject><subject>Fixed combination</subject><subject>Glaucoma</subject><subject>Humans</subject><subject>Intraocular pressure</subject><subject>Intraocular Pressure - drug effects</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Ocular Hypertension - drug therapy</subject><subject>Ophthalmic Solutions - administration & dosage</subject><subject>Osmolar Concentration</subject><subject>Quinoxalines - administration & dosage</subject><subject>Quinoxalines - adverse effects</subject><subject>Sulfonamides - administration & dosage</subject><subject>Sulfonamides - adverse effects</subject><subject>Thiophenes - administration & dosage</subject><subject>Thiophenes - adverse effects</subject><subject>Time Factors</subject><subject>Timolol</subject><subject>Timolol - administration & dosage</subject><subject>Timolol - adverse effects</subject><issn>0300-7995</issn><issn>1473-4877</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kN1KwzAYhoMobk4vwBPpBRhN2nRt0BMZ_sHAk3lcvuXHZqRNSTp1O_DazdhgiLCTJOR7n5fkQeiSkhtKy_yWZIQUnBNOUs4ZYfQIDSkrMszKojhGw80cx0A-QGchLAihacn5KRpQzooxI-Mh-pnVXincuLavrxMPrXSNWSt5nXTgwVpl8Yd3yy4Rrok3Jrg2cTqZexMRI02rcB-P1tnkU_mwDIl0fu0sNEbuR9p8K4ljxdy00JvY0dfKQ7c6RycabFAXu32E3p8eZ5MXPH17fp08TLFgBe3xWBYpL2mpKQgmhJiPc1JQwuLCgGcpITlASnSmmMo10JIryvJSM5rplEudjRDd9grvQvBKV138AfhVRUm1cVn9cxmZqy3TLeeNkntiJy8G7rcB02rnG_hy3sqqh5V1XkeVwoQqO9R_9wevFdi-FuBVtXBL30YfB173C-Ltl4c</recordid><startdate>20090701</startdate><enddate>20090701</enddate><creator>Nixon, Donald R.</creator><creator>Yan, David B.</creator><creator>Chartrand, Jean-Pierre</creator><creator>Piemontesi, Roberto L.</creator><creator>Simonyi, Susan</creator><creator>Hollander, David A.</creator><general>Informa UK Ltd</general><general>Taylor & Francis</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>20090701</creationdate><title>Three-month, randomized, parallel-group comparison of brimonidine-timolol versus dorzolamide-timolol fixed-combination therapy</title><author>Nixon, Donald R. ; Yan, David B. ; Chartrand, Jean-Pierre ; Piemontesi, Roberto L. ; Simonyi, Susan ; Hollander, David A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c471t-6d729818f1ac4cccb65071040714a932005aa20f3e4e5fa189e1458f413f29df3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antihypertensive Agents - administration & dosage</topic><topic>Antihypertensive Agents - adverse effects</topic><topic>Brimonidine</topic><topic>Brimonidine Tartrate</topic><topic>Dorzolamide</topic><topic>Drug Combinations</topic><topic>Female</topic><topic>Fixed combination</topic><topic>Glaucoma</topic><topic>Humans</topic><topic>Intraocular pressure</topic><topic>Intraocular Pressure - drug effects</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Ocular Hypertension - drug therapy</topic><topic>Ophthalmic Solutions - administration & dosage</topic><topic>Osmolar Concentration</topic><topic>Quinoxalines - administration & dosage</topic><topic>Quinoxalines - adverse effects</topic><topic>Sulfonamides - administration & dosage</topic><topic>Sulfonamides - adverse effects</topic><topic>Thiophenes - administration & dosage</topic><topic>Thiophenes - adverse effects</topic><topic>Time Factors</topic><topic>Timolol</topic><topic>Timolol - administration & dosage</topic><topic>Timolol - adverse effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nixon, Donald R.</creatorcontrib><creatorcontrib>Yan, David B.</creatorcontrib><creatorcontrib>Chartrand, Jean-Pierre</creatorcontrib><creatorcontrib>Piemontesi, Roberto L.</creatorcontrib><creatorcontrib>Simonyi, Susan</creatorcontrib><creatorcontrib>Hollander, David A.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Current medical research and opinion</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nixon, Donald R.</au><au>Yan, David B.</au><au>Chartrand, Jean-Pierre</au><au>Piemontesi, Roberto L.</au><au>Simonyi, Susan</au><au>Hollander, David A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Three-month, randomized, parallel-group comparison of brimonidine-timolol versus dorzolamide-timolol fixed-combination therapy</atitle><jtitle>Current medical research and opinion</jtitle><addtitle>Curr Med Res Opin</addtitle><date>2009-07-01</date><risdate>2009</risdate><volume>25</volume><issue>7</issue><spage>1645</spage><epage>1653</epage><pages>1645-1653</pages><issn>0300-7995</issn><eissn>1473-4877</eissn><abstract>ABSTRACT
Objective: Fixed combinations of 0.2% brimonidine-0.5% timolol and 2% dorzolamide-0.5% timolol are used to lower intraocular pressure (IOP). The objective of this study was to evaluate the IOP-lowering efficacy and ocular tolerability of brimonidine-timolol compared with dorzolamide-timolol when used as monotherapy or as adjunctive therapy to a prostaglandin analog (PGA) in patients with glaucoma or ocular hypertension.
Study design and methods: Pooled data analysis of two randomized, investigator-masked, 3-month, parallel-group studies with identical protocols (ten sites). In all, 180 patients with open-angle glaucoma or ocular hypertension who were in need of lower IOP received topical brimonidine-timolol BID or dorzolamide-timolol BID as monotherapy (n = 101) or as adjunctive therapy to a PGA (latanoprost, bimatoprost, or travoprost) (n = 79).
Clinical trial registration: The studies are registered with the identifiers NCT00822081 and NCT00822055 at http://www.clinicaltrials.gov.
Main outcome measures: IOP was measured at 10 a.m. (peak effect) at baseline and at months 1 and 3. Tolerability/comfort was evaluated using a patient questionnaire.
Results: There were no statistically significant between-group differences in patient demographics. Most patients were Caucasian, and the mean age was 68 years. There were also no statistically significant differences between treatment groups in baseline IOP. At month 3, the mean (SD) reduction from baseline IOP for patients on fixed-combination monotherapy was 7.7 (4.2) mmHg (32.3%) with brimonidine-timolol versus 6.7 (5.0) mmHg (26.1%) with dorzolamide-timolol (p = 0.040). The mean reduction from PGA-treated baseline IOP for patients on fixed-combination adjunctive therapy was 6.9 (4.8) mmHg (29.3%) with brimonidine-timolol versus 5.2 (3.7) mmHg (23.5%) with dorzolamide-timolol (p = 0.213). Patients on brimonidine-timolol reported less burning (p < 0.001), stinging (p < 0.001), and unusual taste (p < 0.001) than patients on dorzolamide-timolol.
Conclusions: Fixed-combination brimonidine-timolol provided the same or greater IOP lowering compared with fixed-combination dorzolamide-timolol. Both fixed-combination medications were safe and well-tolerated. Brimonidine-timolol received higher ratings of ocular comfort than dorzolamide-timolol. The duration of the studies was 3 months, and additional studies will be needed to compare the efficacy and tolerability of brimonidine-timolol and dorzolamide-timolol during long-term treatment.</abstract><cop>England</cop><pub>Informa UK Ltd</pub><pmid>19476406</pmid><doi>10.1185/03007990902994041</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
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| ispartof | Current medical research and opinion, 2009-07, Vol.25 (7), p.1645-1653 |
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| source | MEDLINE; Taylor & Francis:Master (3349 titles); Taylor & Francis Medical Library - CRKN |
| subjects | Adult Aged Aged, 80 and over Antihypertensive Agents - administration & dosage Antihypertensive Agents - adverse effects Brimonidine Brimonidine Tartrate Dorzolamide Drug Combinations Female Fixed combination Glaucoma Humans Intraocular pressure Intraocular Pressure - drug effects Male Middle Aged Ocular Hypertension - drug therapy Ophthalmic Solutions - administration & dosage Osmolar Concentration Quinoxalines - administration & dosage Quinoxalines - adverse effects Sulfonamides - administration & dosage Sulfonamides - adverse effects Thiophenes - administration & dosage Thiophenes - adverse effects Time Factors Timolol Timolol - administration & dosage Timolol - adverse effects |
| title | Three-month, randomized, parallel-group comparison of brimonidine-timolol versus dorzolamide-timolol fixed-combination therapy |
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