Population/regional differences in efficacy of 3 drug categories (antidiabetic, respiratory and psychotropic agents) among East Asians: A retrospective study based on multiregional clinical trials
Aims This study aimed to identify population/regional differences in drug efficacy and the influencing factors among East Asians to be considered when planning multiregional clinical trials (MRCTs) to facilitate rapid drug approval in Asians. Methods A retrospective analysis of efficacy (intergroup...
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| Veröffentlicht in: | British journal of clinical pharmacology 2019-06, Vol.85 (6), p.1270-1282 |
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| container_title | British journal of clinical pharmacology |
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| creator | Sai, Kimie Yoshida, Akiomi Hanatani, Tadaaki Imatoh, Takuya Takeuchi, Masahiro Narukawa, Mamoru Watanabe, Hiroshi Uyama, Yoshiaki Saito, Yoshiro |
| description | Aims
This study aimed to identify population/regional differences in drug efficacy and the influencing factors among East Asians to be considered when planning multiregional clinical trials (MRCTs) to facilitate rapid drug approval in Asians.
Methods
A retrospective analysis of efficacy (intergroup difference in endpoint between control and study drug treatment) among East Asian populations for 3 drug categories, antidiabetic, respiratory and psychotropic agents, was conducted in collaboration with pharmaceutical companies using their MRCT data. Common endpoints by drug category were selected; background factors that commonly affected the endpoints among regions were analysed first; then the population/regional differences were evaluated by the interaction term region‐by‐treatment using an analysis of covariance model after adjusting for background factors.
Results
Among 17 endpoints for eight pharmaceutical products from 3 drug categories, no substantial population/regional differences were detected in the 3 drug categories examined (P > .05), except for haemoglobin A1c change between Japan and Korea for an antidiabetic drug, insulin glulisine (P = .0068). However, no such regional differences were evident in patients with clinically important higher haemoglobin A1c baseline values (majority subgroup). Variability in disease severity at baseline and concomitant drugs were determined to be potential influencing factors for regional differences.
Conclusions
This study suggests that the regional variability in efficacy of these 3 drug categories is not large among East Asians, and reveals the importance of considering background factors when planning MRCTs. Further studies are needed to evaluate regional variability in the efficacy of other drug categories and clarify the factors leading to regional differences in East Asians. |
| doi_str_mv | 10.1111/bcp.13893 |
| format | Article |
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This study aimed to identify population/regional differences in drug efficacy and the influencing factors among East Asians to be considered when planning multiregional clinical trials (MRCTs) to facilitate rapid drug approval in Asians.
Methods
A retrospective analysis of efficacy (intergroup difference in endpoint between control and study drug treatment) among East Asian populations for 3 drug categories, antidiabetic, respiratory and psychotropic agents, was conducted in collaboration with pharmaceutical companies using their MRCT data. Common endpoints by drug category were selected; background factors that commonly affected the endpoints among regions were analysed first; then the population/regional differences were evaluated by the interaction term region‐by‐treatment using an analysis of covariance model after adjusting for background factors.
Results
Among 17 endpoints for eight pharmaceutical products from 3 drug categories, no substantial population/regional differences were detected in the 3 drug categories examined (P > .05), except for haemoglobin A1c change between Japan and Korea for an antidiabetic drug, insulin glulisine (P = .0068). However, no such regional differences were evident in patients with clinically important higher haemoglobin A1c baseline values (majority subgroup). Variability in disease severity at baseline and concomitant drugs were determined to be potential influencing factors for regional differences.
Conclusions
This study suggests that the regional variability in efficacy of these 3 drug categories is not large among East Asians, and reveals the importance of considering background factors when planning MRCTs. Further studies are needed to evaluate regional variability in the efficacy of other drug categories and clarify the factors leading to regional differences in East Asians.</description><identifier>ISSN: 0306-5251</identifier><identifier>EISSN: 1365-2125</identifier><identifier>DOI: 10.1111/bcp.13893</identifier><identifier>PMID: 30735569</identifier><language>eng</language><publisher>England: John Wiley and Sons Inc</publisher><subject>Asian Continental Ancestry Group ; Biomarkers - blood ; Blood Glucose - drug effects ; Blood Glucose - metabolism ; Clinical Trials as Topic - methods ; drug development ; effectiveness ; Endpoint Determination ; Female ; Forced Expiratory Volume ; Glycated Hemoglobin A - metabolism ; Health Status Disparities ; Humans ; Hypoglycemic Agents - adverse effects ; Hypoglycemic Agents - therapeutic use ; Lung - drug effects ; Lung - physiopathology ; Male ; Mental Health - ethnology ; Multicenter Studies as Topic - methods ; Original ; Psychotropic Drugs - adverse effects ; Psychotropic Drugs - therapeutic use ; randomised controlled trial ; Research Design ; Respiratory System Agents - adverse effects ; Respiratory System Agents - therapeutic use ; Retrospective Studies ; Risk Assessment ; Risk Factors ; Treatment Outcome</subject><ispartof>British journal of clinical pharmacology, 2019-06, Vol.85 (6), p.1270-1282</ispartof><rights>2019 The British Pharmacological Society</rights><rights>2019 The British Pharmacological Society.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4813-52be9b5d3eb305767aa709e2c23b8b5f977468eb9772761c84c0c247b42932ff3</citedby><cites>FETCH-LOGICAL-c4813-52be9b5d3eb305767aa709e2c23b8b5f977468eb9772761c84c0c247b42932ff3</cites><orcidid>0000-0002-8160-7335 ; 0000-0002-1586-6515</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fbcp.13893$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fbcp.13893$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,776,780,881,1411,1427,27901,27902,45550,45551,46384,46808</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30735569$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sai, Kimie</creatorcontrib><creatorcontrib>Yoshida, Akiomi</creatorcontrib><creatorcontrib>Hanatani, Tadaaki</creatorcontrib><creatorcontrib>Imatoh, Takuya</creatorcontrib><creatorcontrib>Takeuchi, Masahiro</creatorcontrib><creatorcontrib>Narukawa, Mamoru</creatorcontrib><creatorcontrib>Watanabe, Hiroshi</creatorcontrib><creatorcontrib>Uyama, Yoshiaki</creatorcontrib><creatorcontrib>Saito, Yoshiro</creatorcontrib><title>Population/regional differences in efficacy of 3 drug categories (antidiabetic, respiratory and psychotropic agents) among East Asians: A retrospective study based on multiregional clinical trials</title><title>British journal of clinical pharmacology</title><addtitle>Br J Clin Pharmacol</addtitle><description>Aims
This study aimed to identify population/regional differences in drug efficacy and the influencing factors among East Asians to be considered when planning multiregional clinical trials (MRCTs) to facilitate rapid drug approval in Asians.
Methods
A retrospective analysis of efficacy (intergroup difference in endpoint between control and study drug treatment) among East Asian populations for 3 drug categories, antidiabetic, respiratory and psychotropic agents, was conducted in collaboration with pharmaceutical companies using their MRCT data. Common endpoints by drug category were selected; background factors that commonly affected the endpoints among regions were analysed first; then the population/regional differences were evaluated by the interaction term region‐by‐treatment using an analysis of covariance model after adjusting for background factors.
Results
Among 17 endpoints for eight pharmaceutical products from 3 drug categories, no substantial population/regional differences were detected in the 3 drug categories examined (P > .05), except for haemoglobin A1c change between Japan and Korea for an antidiabetic drug, insulin glulisine (P = .0068). However, no such regional differences were evident in patients with clinically important higher haemoglobin A1c baseline values (majority subgroup). Variability in disease severity at baseline and concomitant drugs were determined to be potential influencing factors for regional differences.
Conclusions
This study suggests that the regional variability in efficacy of these 3 drug categories is not large among East Asians, and reveals the importance of considering background factors when planning MRCTs. Further studies are needed to evaluate regional variability in the efficacy of other drug categories and clarify the factors leading to regional differences in East Asians.</description><subject>Asian Continental Ancestry Group</subject><subject>Biomarkers - blood</subject><subject>Blood Glucose - drug effects</subject><subject>Blood Glucose - metabolism</subject><subject>Clinical Trials as Topic - methods</subject><subject>drug development</subject><subject>effectiveness</subject><subject>Endpoint Determination</subject><subject>Female</subject><subject>Forced Expiratory Volume</subject><subject>Glycated Hemoglobin A - metabolism</subject><subject>Health Status Disparities</subject><subject>Humans</subject><subject>Hypoglycemic Agents - adverse effects</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Lung - drug effects</subject><subject>Lung - physiopathology</subject><subject>Male</subject><subject>Mental Health - ethnology</subject><subject>Multicenter Studies as Topic - methods</subject><subject>Original</subject><subject>Psychotropic Drugs - adverse effects</subject><subject>Psychotropic Drugs - therapeutic use</subject><subject>randomised controlled trial</subject><subject>Research Design</subject><subject>Respiratory System Agents - adverse effects</subject><subject>Respiratory System Agents - therapeutic use</subject><subject>Retrospective Studies</subject><subject>Risk Assessment</subject><subject>Risk Factors</subject><subject>Treatment Outcome</subject><issn>0306-5251</issn><issn>1365-2125</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kc1u1DAUhS0EotPCghdAd0mlTseO4_ywQBpGhVaqRBewjmznOjXK2JHtFOX9eDAMAyO6qDdn4e-e-3MIecPoJctvo_R0yXjT8mdkxXgl1gUrxHOyopxWa1EIdkJOY_xOKeOsEi_JCac1F6JqV-TnnZ_mUSbr3SbgkEWO0FtjMKDTGME6QGOslnoBb4BDH-YBtEw4-GAz8E66ZHsrFSarLyBgnGyQyYcFpOthiou-9yn4yWqQA7oUz0HuvRvgSsYE22ili-9hmyszFSfUyT4gxDT3CygZsQfvYD-PyR4H1KN1eaQRUrByjK_IC5MFX__VM_Lt09XX3fX69svnm932dq3LhvF8CYWtEj1Hxamoq1rKmrZY6IKrRgnT1nVZNaiyFnXFdFNqqouyVmXR8sIYfkY-HHynWe2x13mZIMduCnYvw9J5abvHP87ed4N_6CrBeclZNjg_GOi8aQxojrWMdr-j7HKU3Z8oM_v2_2ZH8l92GdgcgB92xOVpp-7j7u5g-QuEJ66s</recordid><startdate>201906</startdate><enddate>201906</enddate><creator>Sai, Kimie</creator><creator>Yoshida, Akiomi</creator><creator>Hanatani, Tadaaki</creator><creator>Imatoh, Takuya</creator><creator>Takeuchi, Masahiro</creator><creator>Narukawa, Mamoru</creator><creator>Watanabe, Hiroshi</creator><creator>Uyama, Yoshiaki</creator><creator>Saito, Yoshiro</creator><general>John Wiley and Sons 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><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-8160-7335</orcidid><orcidid>https://orcid.org/0000-0002-1586-6515</orcidid></search><sort><creationdate>201906</creationdate><title>Population/regional differences in efficacy of 3 drug categories (antidiabetic, respiratory and psychotropic agents) among East Asians: A retrospective study based on multiregional clinical trials</title><author>Sai, Kimie ; Yoshida, Akiomi ; Hanatani, Tadaaki ; Imatoh, Takuya ; Takeuchi, Masahiro ; Narukawa, Mamoru ; Watanabe, Hiroshi ; Uyama, Yoshiaki ; Saito, Yoshiro</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4813-52be9b5d3eb305767aa709e2c23b8b5f977468eb9772761c84c0c247b42932ff3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Asian Continental Ancestry Group</topic><topic>Biomarkers - blood</topic><topic>Blood Glucose - drug effects</topic><topic>Blood Glucose - metabolism</topic><topic>Clinical Trials as Topic - methods</topic><topic>drug development</topic><topic>effectiveness</topic><topic>Endpoint Determination</topic><topic>Female</topic><topic>Forced Expiratory Volume</topic><topic>Glycated Hemoglobin A - metabolism</topic><topic>Health Status Disparities</topic><topic>Humans</topic><topic>Hypoglycemic Agents - adverse effects</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Lung - drug effects</topic><topic>Lung - physiopathology</topic><topic>Male</topic><topic>Mental Health - ethnology</topic><topic>Multicenter Studies as Topic - methods</topic><topic>Original</topic><topic>Psychotropic Drugs - adverse effects</topic><topic>Psychotropic Drugs - therapeutic use</topic><topic>randomised controlled trial</topic><topic>Research Design</topic><topic>Respiratory System Agents - adverse effects</topic><topic>Respiratory System Agents - therapeutic use</topic><topic>Retrospective Studies</topic><topic>Risk Assessment</topic><topic>Risk Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sai, Kimie</creatorcontrib><creatorcontrib>Yoshida, Akiomi</creatorcontrib><creatorcontrib>Hanatani, Tadaaki</creatorcontrib><creatorcontrib>Imatoh, Takuya</creatorcontrib><creatorcontrib>Takeuchi, Masahiro</creatorcontrib><creatorcontrib>Narukawa, Mamoru</creatorcontrib><creatorcontrib>Watanabe, Hiroshi</creatorcontrib><creatorcontrib>Uyama, Yoshiaki</creatorcontrib><creatorcontrib>Saito, Yoshiro</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>British journal of clinical pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sai, Kimie</au><au>Yoshida, Akiomi</au><au>Hanatani, Tadaaki</au><au>Imatoh, Takuya</au><au>Takeuchi, Masahiro</au><au>Narukawa, Mamoru</au><au>Watanabe, Hiroshi</au><au>Uyama, Yoshiaki</au><au>Saito, Yoshiro</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Population/regional differences in efficacy of 3 drug categories (antidiabetic, respiratory and psychotropic agents) among East Asians: A retrospective study based on multiregional clinical trials</atitle><jtitle>British journal of clinical pharmacology</jtitle><addtitle>Br J Clin Pharmacol</addtitle><date>2019-06</date><risdate>2019</risdate><volume>85</volume><issue>6</issue><spage>1270</spage><epage>1282</epage><pages>1270-1282</pages><issn>0306-5251</issn><eissn>1365-2125</eissn><abstract>Aims
This study aimed to identify population/regional differences in drug efficacy and the influencing factors among East Asians to be considered when planning multiregional clinical trials (MRCTs) to facilitate rapid drug approval in Asians.
Methods
A retrospective analysis of efficacy (intergroup difference in endpoint between control and study drug treatment) among East Asian populations for 3 drug categories, antidiabetic, respiratory and psychotropic agents, was conducted in collaboration with pharmaceutical companies using their MRCT data. Common endpoints by drug category were selected; background factors that commonly affected the endpoints among regions were analysed first; then the population/regional differences were evaluated by the interaction term region‐by‐treatment using an analysis of covariance model after adjusting for background factors.
Results
Among 17 endpoints for eight pharmaceutical products from 3 drug categories, no substantial population/regional differences were detected in the 3 drug categories examined (P > .05), except for haemoglobin A1c change between Japan and Korea for an antidiabetic drug, insulin glulisine (P = .0068). However, no such regional differences were evident in patients with clinically important higher haemoglobin A1c baseline values (majority subgroup). Variability in disease severity at baseline and concomitant drugs were determined to be potential influencing factors for regional differences.
Conclusions
This study suggests that the regional variability in efficacy of these 3 drug categories is not large among East Asians, and reveals the importance of considering background factors when planning MRCTs. Further studies are needed to evaluate regional variability in the efficacy of other drug categories and clarify the factors leading to regional differences in East Asians.</abstract><cop>England</cop><pub>John Wiley and Sons Inc</pub><pmid>30735569</pmid><doi>10.1111/bcp.13893</doi><tpages>13</tpages><orcidid>https://orcid.org/0000-0002-8160-7335</orcidid><orcidid>https://orcid.org/0000-0002-1586-6515</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Asian Continental Ancestry Group Biomarkers - blood Blood Glucose - drug effects Blood Glucose - metabolism Clinical Trials as Topic - methods drug development effectiveness Endpoint Determination Female Forced Expiratory Volume Glycated Hemoglobin A - metabolism Health Status Disparities Humans Hypoglycemic Agents - adverse effects Hypoglycemic Agents - therapeutic use Lung - drug effects Lung - physiopathology Male Mental Health - ethnology Multicenter Studies as Topic - methods Original Psychotropic Drugs - adverse effects Psychotropic Drugs - therapeutic use randomised controlled trial Research Design Respiratory System Agents - adverse effects Respiratory System Agents - therapeutic use Retrospective Studies Risk Assessment Risk Factors Treatment Outcome |
| title | Population/regional differences in efficacy of 3 drug categories (antidiabetic, respiratory and psychotropic agents) among East Asians: A retrospective study based on multiregional clinical trials |
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