The [alpha]-glucosidase inhibitor voglibose (AO-128) does not change pharmacodynamics or pharmacokinetics of warfarin
Objective: Voglibose is a new and potent inhibitor of α-glucosidases and is used for the treatment of diabetes mellitus. Since voglibose increases gastrointestinal motility and could thus affect absorption of concomitantly administered drugs, it was investigated whether or not voglibose modifies the...
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Veröffentlicht in: | European journal of clinical pharmacology 1997-10, Vol.53 (2), p.153 |
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creator | Fuder, H Kleist, P Birkel, M Ehrlich, A Emeklibas, S Maslak, W Stridde, E Wetzelsberger, N Wieckhorst, G Lücker, P W |
description | Objective: Voglibose is a new and potent inhibitor of α-glucosidases and is used for the treatment of diabetes mellitus. Since voglibose increases gastrointestinal motility and could thus affect absorption of concomitantly administered drugs, it was investigated whether or not voglibose modifies the pharmacodynamics and pharmacokinetics of warfarin, an oral anticoagulant frequently used in cardiovascular disorders likely to arise in diabetic patients. Methods: Twelve healthy male subjects were given individually adjusted doses of warfarin to reduce prothrombin time (Quick's method) to a value of about 30-40% of the normal range within the first 8 days. Then, the individual maintenance dose, given in the morning, was maintained until day 15. On study days 11-15, voglibose was co-administered per os in a dose of 5mg t.i.d. The prothrombin time was determined on days 10 and 11 (reference) and on days 15 and 16 (test), and the steady-state pharmacokinetic characteristics of the warfarin enantiomers were determined on days 10 (reference) and 15 (test). The ratios test/reference were evaluated according to bioequivalence criteria. Results: The equivalence ratio (test/reference) for the pharmacodynamic parameter prothrombin time was 0.97 and for the pharmacokinetic characteristics AUC^sub 0-24h,τ,ss^: S-(-)-warfarin, 1.05; R-(+)-warfarin, 1.01; and C^sub max,ss^: S-(-)-warfarin, 1.08; R-(+)-warfarin, 1.04. All parameters were within the predetermined accepted range of 0.7-1.43 (pharmacodynamics) or 0.8-1.25 (pharmacokinetics), thus fulfilling equivalence criteria. Conclusions: Voglibose modified neither the pharmacodynamics nor the pharmacokinetics of warfarin under steady-state conditions. Concomitant treatment was well tolerated and has been proven to be safe for further clinical use.[PUBLICATION ABSTRACT] |
doi_str_mv | 10.1007/s002280050355 |
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Since voglibose increases gastrointestinal motility and could thus affect absorption of concomitantly administered drugs, it was investigated whether or not voglibose modifies the pharmacodynamics and pharmacokinetics of warfarin, an oral anticoagulant frequently used in cardiovascular disorders likely to arise in diabetic patients. Methods: Twelve healthy male subjects were given individually adjusted doses of warfarin to reduce prothrombin time (Quick's method) to a value of about 30-40% of the normal range within the first 8 days. Then, the individual maintenance dose, given in the morning, was maintained until day 15. On study days 11-15, voglibose was co-administered per os in a dose of 5mg t.i.d. The prothrombin time was determined on days 10 and 11 (reference) and on days 15 and 16 (test), and the steady-state pharmacokinetic characteristics of the warfarin enantiomers were determined on days 10 (reference) and 15 (test). The ratios test/reference were evaluated according to bioequivalence criteria. Results: The equivalence ratio (test/reference) for the pharmacodynamic parameter prothrombin time was 0.97 and for the pharmacokinetic characteristics AUC^sub 0-24h,τ,ss^: S-(-)-warfarin, 1.05; R-(+)-warfarin, 1.01; and C^sub max,ss^: S-(-)-warfarin, 1.08; R-(+)-warfarin, 1.04. All parameters were within the predetermined accepted range of 0.7-1.43 (pharmacodynamics) or 0.8-1.25 (pharmacokinetics), thus fulfilling equivalence criteria. Conclusions: Voglibose modified neither the pharmacodynamics nor the pharmacokinetics of warfarin under steady-state conditions. Concomitant treatment was well tolerated and has been proven to be safe for further clinical use.[PUBLICATION ABSTRACT]</description><identifier>ISSN: 0031-6970</identifier><identifier>EISSN: 1432-1041</identifier><identifier>DOI: 10.1007/s002280050355</identifier><language>eng</language><publisher>Heidelberg: Springer Nature B.V</publisher><subject>Anticoagulants ; Drug therapy</subject><ispartof>European journal of clinical pharmacology, 1997-10, Vol.53 (2), p.153</ispartof><rights>Springer-Verlag Berlin Heidelberg 1997</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids></links><search><creatorcontrib>Fuder, H</creatorcontrib><creatorcontrib>Kleist, P</creatorcontrib><creatorcontrib>Birkel, M</creatorcontrib><creatorcontrib>Ehrlich, A</creatorcontrib><creatorcontrib>Emeklibas, S</creatorcontrib><creatorcontrib>Maslak, W</creatorcontrib><creatorcontrib>Stridde, E</creatorcontrib><creatorcontrib>Wetzelsberger, N</creatorcontrib><creatorcontrib>Wieckhorst, G</creatorcontrib><creatorcontrib>Lücker, P W</creatorcontrib><title>The [alpha]-glucosidase inhibitor voglibose (AO-128) does not change pharmacodynamics or pharmacokinetics of warfarin</title><title>European journal of clinical pharmacology</title><description>Objective: Voglibose is a new and potent inhibitor of α-glucosidases and is used for the treatment of diabetes mellitus. Since voglibose increases gastrointestinal motility and could thus affect absorption of concomitantly administered drugs, it was investigated whether or not voglibose modifies the pharmacodynamics and pharmacokinetics of warfarin, an oral anticoagulant frequently used in cardiovascular disorders likely to arise in diabetic patients. Methods: Twelve healthy male subjects were given individually adjusted doses of warfarin to reduce prothrombin time (Quick's method) to a value of about 30-40% of the normal range within the first 8 days. Then, the individual maintenance dose, given in the morning, was maintained until day 15. On study days 11-15, voglibose was co-administered per os in a dose of 5mg t.i.d. The prothrombin time was determined on days 10 and 11 (reference) and on days 15 and 16 (test), and the steady-state pharmacokinetic characteristics of the warfarin enantiomers were determined on days 10 (reference) and 15 (test). The ratios test/reference were evaluated according to bioequivalence criteria. Results: The equivalence ratio (test/reference) for the pharmacodynamic parameter prothrombin time was 0.97 and for the pharmacokinetic characteristics AUC^sub 0-24h,τ,ss^: S-(-)-warfarin, 1.05; R-(+)-warfarin, 1.01; and C^sub max,ss^: S-(-)-warfarin, 1.08; R-(+)-warfarin, 1.04. All parameters were within the predetermined accepted range of 0.7-1.43 (pharmacodynamics) or 0.8-1.25 (pharmacokinetics), thus fulfilling equivalence criteria. Conclusions: Voglibose modified neither the pharmacodynamics nor the pharmacokinetics of warfarin under steady-state conditions. Concomitant treatment was well tolerated and has been proven to be safe for further clinical use.[PUBLICATION ABSTRACT]</description><subject>Anticoagulants</subject><subject>Drug therapy</subject><issn>0031-6970</issn><issn>1432-1041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1997</creationdate><recordtype>article</recordtype><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNqNjT1PxDAQRC0EEuGjpLdEA4VhbceXS4kQiI7mOoROe4mT-Mh5D28C4t9jIeipRnozTyPEhYYbDVDdMoAxSwAH1rkDUejSGqWh1IeiALBaLeoKjsUJ8xZAuxpsIebV4OULjvsBX1U_zg1xaJG9DHEImzBRkh_Uj2FDmV3dPSttlteyJc8y0iSbAWPvZbbTDhtqvyLuQsMya3_sLUQ__bBOfmLqMIV4Jo46HNmf_-apuHx8WN0_qX2i99nztN7SnGKu1vlvUTlT1s7-b_UNyLZSCA</recordid><startdate>19971001</startdate><enddate>19971001</enddate><creator>Fuder, H</creator><creator>Kleist, P</creator><creator>Birkel, M</creator><creator>Ehrlich, A</creator><creator>Emeklibas, S</creator><creator>Maslak, W</creator><creator>Stridde, E</creator><creator>Wetzelsberger, N</creator><creator>Wieckhorst, G</creator><creator>Lücker, P W</creator><general>Springer Nature B.V</general><scope>3V.</scope><scope>7RV</scope><scope>7TK</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope></search><sort><creationdate>19971001</creationdate><title>The [alpha]-glucosidase inhibitor voglibose (AO-128) does not change pharmacodynamics or pharmacokinetics of warfarin</title><author>Fuder, H ; Kleist, P ; Birkel, M ; Ehrlich, A ; Emeklibas, S ; Maslak, W ; Stridde, E ; Wetzelsberger, N ; Wieckhorst, G ; Lücker, P W</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-proquest_journals_12867524953</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1997</creationdate><topic>Anticoagulants</topic><topic>Drug therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Fuder, H</creatorcontrib><creatorcontrib>Kleist, P</creatorcontrib><creatorcontrib>Birkel, M</creatorcontrib><creatorcontrib>Ehrlich, A</creatorcontrib><creatorcontrib>Emeklibas, S</creatorcontrib><creatorcontrib>Maslak, W</creatorcontrib><creatorcontrib>Stridde, E</creatorcontrib><creatorcontrib>Wetzelsberger, N</creatorcontrib><creatorcontrib>Wieckhorst, G</creatorcontrib><creatorcontrib>Lücker, P W</creatorcontrib><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Neurosciences Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><jtitle>European journal of clinical pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Fuder, H</au><au>Kleist, P</au><au>Birkel, M</au><au>Ehrlich, A</au><au>Emeklibas, S</au><au>Maslak, W</au><au>Stridde, E</au><au>Wetzelsberger, N</au><au>Wieckhorst, G</au><au>Lücker, P W</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The [alpha]-glucosidase inhibitor voglibose (AO-128) does not change pharmacodynamics or pharmacokinetics of warfarin</atitle><jtitle>European journal of clinical pharmacology</jtitle><date>1997-10-01</date><risdate>1997</risdate><volume>53</volume><issue>2</issue><spage>153</spage><pages>153-</pages><issn>0031-6970</issn><eissn>1432-1041</eissn><abstract>Objective: Voglibose is a new and potent inhibitor of α-glucosidases and is used for the treatment of diabetes mellitus. Since voglibose increases gastrointestinal motility and could thus affect absorption of concomitantly administered drugs, it was investigated whether or not voglibose modifies the pharmacodynamics and pharmacokinetics of warfarin, an oral anticoagulant frequently used in cardiovascular disorders likely to arise in diabetic patients. Methods: Twelve healthy male subjects were given individually adjusted doses of warfarin to reduce prothrombin time (Quick's method) to a value of about 30-40% of the normal range within the first 8 days. Then, the individual maintenance dose, given in the morning, was maintained until day 15. On study days 11-15, voglibose was co-administered per os in a dose of 5mg t.i.d. The prothrombin time was determined on days 10 and 11 (reference) and on days 15 and 16 (test), and the steady-state pharmacokinetic characteristics of the warfarin enantiomers were determined on days 10 (reference) and 15 (test). The ratios test/reference were evaluated according to bioequivalence criteria. Results: The equivalence ratio (test/reference) for the pharmacodynamic parameter prothrombin time was 0.97 and for the pharmacokinetic characteristics AUC^sub 0-24h,τ,ss^: S-(-)-warfarin, 1.05; R-(+)-warfarin, 1.01; and C^sub max,ss^: S-(-)-warfarin, 1.08; R-(+)-warfarin, 1.04. All parameters were within the predetermined accepted range of 0.7-1.43 (pharmacodynamics) or 0.8-1.25 (pharmacokinetics), thus fulfilling equivalence criteria. Conclusions: Voglibose modified neither the pharmacodynamics nor the pharmacokinetics of warfarin under steady-state conditions. Concomitant treatment was well tolerated and has been proven to be safe for further clinical use.[PUBLICATION ABSTRACT]</abstract><cop>Heidelberg</cop><pub>Springer Nature B.V</pub><doi>10.1007/s002280050355</doi></addata></record> |
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title | The [alpha]-glucosidase inhibitor voglibose (AO-128) does not change pharmacodynamics or pharmacokinetics of warfarin |
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