Analysis of time course and dose effect of tacrolimus on proteinuria in lupus nephritis patients
What is known and objectives Tacrolimus is used to treat patients with lupus nephritis; however, its time course and dose effect on proteinuria in lupus nephritis patients remain unknown. The purpose of this study was to determine the time course and dose effect of tacrolimus on proteinuria in lupus...
Gespeichert in:
| Veröffentlicht in: | Journal of clinical pharmacy and therapeutics 2021-02, Vol.46 (1), p.106-113 |
|---|---|
| Hauptverfasser: | , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 113 |
|---|---|
| container_issue | 1 |
| container_start_page | 106 |
| container_title | Journal of clinical pharmacy and therapeutics |
| container_volume | 46 |
| creator | Chen, Xiao Wang, Dong‐Dong Li, Zhi‐Ping |
| description | What is known and objectives
Tacrolimus is used to treat patients with lupus nephritis; however, its time course and dose effect on proteinuria in lupus nephritis patients remain unknown. The purpose of this study was to determine the time course and dose effect of tacrolimus on proteinuria in lupus nephritis patients via model‐based meta‐analysis (MBMA).
Methods
PubMed, Web of Science, Cochrane Library and ClinicalTrials.gov databases were systematically searched for information on the efficacy of tacrolimus against proteinuria in lupus nephritis patients. Useful data were extracted to build a model for the population studied using a non‐linear mixed‐effect model (NONMEM). This model was applied to simulate time course of tacrolimus on proteinuria using Monte Carlo simulations.
Results
Ten clinical studies that recruited 222 patients with lupus nephritis were included. Based on various diagnostic plots, we found that the established model described the observed data reasonably well. In addition, the typical Emax and ET50 of tacrolimus for 24‐hour proteinuria in lupus nephritis patients were −5.88 g and 0.37 months, respectively. The baseline value of 24‐hour proteinuria affected Emax. No significant dose‐response relationship was observed in the range of tacrolimus concentration used in the present study (3‐10 ng/mL), indicating that the effect of tacrolimus on proteinuria depends on effective concentration range and not the dose. However, the time course relationship was obvious; the efficacy of tacrolimus increased over time, reaching a plateau (80% Emax) at approximately 1.48 months from the beginning of treatment.
What is new and conclusion
When the concentration range of tacrolimus is maintained at 3‐10 ng/mL, at least 1.48 months of treatment is required to achieve a better outcome with regard to proteinuria in lupus nephritis patients.
When the concentration range of tacrolimus is maintained at 3‐10 ng/mL, at least 1.48 months of treatment is required to achieve a better outcome with regard to proteinuria in lupus nephritis patients. |
| doi_str_mv | 10.1111/jcpt.13260 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2446669396</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2446669396</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3930-a04f5629f356697049d861f74abfccb9b92d8e2c048b95532bd76f44581ded9b3</originalsourceid><addsrcrecordid>eNp9kElLAzEYQIMotlYv_gAZ8CLCaLZJJsdSXCnooZ5jJgumzOZkBum_N-1UDx7MJSF5PPI9AM4RvEFx3a51298gghk8AFNEWJZijuAhmELMREo55hNwEsIaQsg4JsdgQrDgVEA8Be_zWpWb4EPSuKT3lU10M3TBJqo2iWniwTpndb97VrprSl8NEa6Ttmt66-uh8yrxdVIObbyvbfvR-T7qWtV7W_fhFBw5VQZ7tt9n4O3-brV4TJcvD0-L-TLVRBCYKkhdxrBwJGNMcEiFyRlynKrCaV2IQmCTW6whzQuRZQQXhjNHaZYjY40oyAxcjd74r8_Bhl5WPmhblqq2zRAkppRFMxEsopd_0HWcOXbYUjzjkGGGI3U9UnHoEDrrZNv5SnUbiaDcdpfb7nLXPcIXe-VQVNb8oj-hI4BG4MuXdvOPSj4vXlej9BuUBY2M</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2475706262</pqid></control><display><type>article</type><title>Analysis of time course and dose effect of tacrolimus on proteinuria in lupus nephritis patients</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><creator>Chen, Xiao ; Wang, Dong‐Dong ; Li, Zhi‐Ping</creator><creatorcontrib>Chen, Xiao ; Wang, Dong‐Dong ; Li, Zhi‐Ping</creatorcontrib><description>What is known and objectives
Tacrolimus is used to treat patients with lupus nephritis; however, its time course and dose effect on proteinuria in lupus nephritis patients remain unknown. The purpose of this study was to determine the time course and dose effect of tacrolimus on proteinuria in lupus nephritis patients via model‐based meta‐analysis (MBMA).
Methods
PubMed, Web of Science, Cochrane Library and ClinicalTrials.gov databases were systematically searched for information on the efficacy of tacrolimus against proteinuria in lupus nephritis patients. Useful data were extracted to build a model for the population studied using a non‐linear mixed‐effect model (NONMEM). This model was applied to simulate time course of tacrolimus on proteinuria using Monte Carlo simulations.
Results
Ten clinical studies that recruited 222 patients with lupus nephritis were included. Based on various diagnostic plots, we found that the established model described the observed data reasonably well. In addition, the typical Emax and ET50 of tacrolimus for 24‐hour proteinuria in lupus nephritis patients were −5.88 g and 0.37 months, respectively. The baseline value of 24‐hour proteinuria affected Emax. No significant dose‐response relationship was observed in the range of tacrolimus concentration used in the present study (3‐10 ng/mL), indicating that the effect of tacrolimus on proteinuria depends on effective concentration range and not the dose. However, the time course relationship was obvious; the efficacy of tacrolimus increased over time, reaching a plateau (80% Emax) at approximately 1.48 months from the beginning of treatment.
What is new and conclusion
When the concentration range of tacrolimus is maintained at 3‐10 ng/mL, at least 1.48 months of treatment is required to achieve a better outcome with regard to proteinuria in lupus nephritis patients.
When the concentration range of tacrolimus is maintained at 3‐10 ng/mL, at least 1.48 months of treatment is required to achieve a better outcome with regard to proteinuria in lupus nephritis patients.</description><identifier>ISSN: 0269-4727</identifier><identifier>EISSN: 1365-2710</identifier><identifier>DOI: 10.1111/jcpt.13260</identifier><identifier>PMID: 32974902</identifier><language>eng</language><publisher>England: Hindawi Limited</publisher><subject>dose effect ; Dose-Response Relationship, Drug ; Humans ; Immunosuppressive Agents - therapeutic use ; Lupus ; Lupus nephritis ; Lupus Nephritis - drug therapy ; Meta-analysis ; model‐based meta‐analysis ; Nephritis ; Patients ; Population studies ; Proteinuria ; Proteinuria - drug therapy ; Tacrolimus ; Tacrolimus - therapeutic use ; time course ; Treatment Outcome</subject><ispartof>Journal of clinical pharmacy and therapeutics, 2021-02, Vol.46 (1), p.106-113</ispartof><rights>2020 John Wiley & Sons Ltd</rights><rights>2020 John Wiley & Sons Ltd.</rights><rights>Copyright © 2021 John Wiley & Sons Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3930-a04f5629f356697049d861f74abfccb9b92d8e2c048b95532bd76f44581ded9b3</citedby><cites>FETCH-LOGICAL-c3930-a04f5629f356697049d861f74abfccb9b92d8e2c048b95532bd76f44581ded9b3</cites><orcidid>0000-0001-6194-023X</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%2Fjcpt.13260$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fjcpt.13260$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32974902$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chen, Xiao</creatorcontrib><creatorcontrib>Wang, Dong‐Dong</creatorcontrib><creatorcontrib>Li, Zhi‐Ping</creatorcontrib><title>Analysis of time course and dose effect of tacrolimus on proteinuria in lupus nephritis patients</title><title>Journal of clinical pharmacy and therapeutics</title><addtitle>J Clin Pharm Ther</addtitle><description>What is known and objectives
Tacrolimus is used to treat patients with lupus nephritis; however, its time course and dose effect on proteinuria in lupus nephritis patients remain unknown. The purpose of this study was to determine the time course and dose effect of tacrolimus on proteinuria in lupus nephritis patients via model‐based meta‐analysis (MBMA).
Methods
PubMed, Web of Science, Cochrane Library and ClinicalTrials.gov databases were systematically searched for information on the efficacy of tacrolimus against proteinuria in lupus nephritis patients. Useful data were extracted to build a model for the population studied using a non‐linear mixed‐effect model (NONMEM). This model was applied to simulate time course of tacrolimus on proteinuria using Monte Carlo simulations.
Results
Ten clinical studies that recruited 222 patients with lupus nephritis were included. Based on various diagnostic plots, we found that the established model described the observed data reasonably well. In addition, the typical Emax and ET50 of tacrolimus for 24‐hour proteinuria in lupus nephritis patients were −5.88 g and 0.37 months, respectively. The baseline value of 24‐hour proteinuria affected Emax. No significant dose‐response relationship was observed in the range of tacrolimus concentration used in the present study (3‐10 ng/mL), indicating that the effect of tacrolimus on proteinuria depends on effective concentration range and not the dose. However, the time course relationship was obvious; the efficacy of tacrolimus increased over time, reaching a plateau (80% Emax) at approximately 1.48 months from the beginning of treatment.
What is new and conclusion
When the concentration range of tacrolimus is maintained at 3‐10 ng/mL, at least 1.48 months of treatment is required to achieve a better outcome with regard to proteinuria in lupus nephritis patients.
When the concentration range of tacrolimus is maintained at 3‐10 ng/mL, at least 1.48 months of treatment is required to achieve a better outcome with regard to proteinuria in lupus nephritis patients.</description><subject>dose effect</subject><subject>Dose-Response Relationship, Drug</subject><subject>Humans</subject><subject>Immunosuppressive Agents - therapeutic use</subject><subject>Lupus</subject><subject>Lupus nephritis</subject><subject>Lupus Nephritis - drug therapy</subject><subject>Meta-analysis</subject><subject>model‐based meta‐analysis</subject><subject>Nephritis</subject><subject>Patients</subject><subject>Population studies</subject><subject>Proteinuria</subject><subject>Proteinuria - drug therapy</subject><subject>Tacrolimus</subject><subject>Tacrolimus - therapeutic use</subject><subject>time course</subject><subject>Treatment Outcome</subject><issn>0269-4727</issn><issn>1365-2710</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kElLAzEYQIMotlYv_gAZ8CLCaLZJJsdSXCnooZ5jJgumzOZkBum_N-1UDx7MJSF5PPI9AM4RvEFx3a51298gghk8AFNEWJZijuAhmELMREo55hNwEsIaQsg4JsdgQrDgVEA8Be_zWpWb4EPSuKT3lU10M3TBJqo2iWniwTpndb97VrprSl8NEa6Ttmt66-uh8yrxdVIObbyvbfvR-T7qWtV7W_fhFBw5VQZ7tt9n4O3-brV4TJcvD0-L-TLVRBCYKkhdxrBwJGNMcEiFyRlynKrCaV2IQmCTW6whzQuRZQQXhjNHaZYjY40oyAxcjd74r8_Bhl5WPmhblqq2zRAkppRFMxEsopd_0HWcOXbYUjzjkGGGI3U9UnHoEDrrZNv5SnUbiaDcdpfb7nLXPcIXe-VQVNb8oj-hI4BG4MuXdvOPSj4vXlej9BuUBY2M</recordid><startdate>202102</startdate><enddate>202102</enddate><creator>Chen, Xiao</creator><creator>Wang, Dong‐Dong</creator><creator>Li, Zhi‐Ping</creator><general>Hindawi Limited</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>7T5</scope><scope>7TM</scope><scope>7TO</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-6194-023X</orcidid></search><sort><creationdate>202102</creationdate><title>Analysis of time course and dose effect of tacrolimus on proteinuria in lupus nephritis patients</title><author>Chen, Xiao ; Wang, Dong‐Dong ; Li, Zhi‐Ping</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3930-a04f5629f356697049d861f74abfccb9b92d8e2c048b95532bd76f44581ded9b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>dose effect</topic><topic>Dose-Response Relationship, Drug</topic><topic>Humans</topic><topic>Immunosuppressive Agents - therapeutic use</topic><topic>Lupus</topic><topic>Lupus nephritis</topic><topic>Lupus Nephritis - drug therapy</topic><topic>Meta-analysis</topic><topic>model‐based meta‐analysis</topic><topic>Nephritis</topic><topic>Patients</topic><topic>Population studies</topic><topic>Proteinuria</topic><topic>Proteinuria - drug therapy</topic><topic>Tacrolimus</topic><topic>Tacrolimus - therapeutic use</topic><topic>time course</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chen, Xiao</creatorcontrib><creatorcontrib>Wang, Dong‐Dong</creatorcontrib><creatorcontrib>Li, Zhi‐Ping</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of clinical pharmacy and therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chen, Xiao</au><au>Wang, Dong‐Dong</au><au>Li, Zhi‐Ping</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Analysis of time course and dose effect of tacrolimus on proteinuria in lupus nephritis patients</atitle><jtitle>Journal of clinical pharmacy and therapeutics</jtitle><addtitle>J Clin Pharm Ther</addtitle><date>2021-02</date><risdate>2021</risdate><volume>46</volume><issue>1</issue><spage>106</spage><epage>113</epage><pages>106-113</pages><issn>0269-4727</issn><eissn>1365-2710</eissn><abstract>What is known and objectives
Tacrolimus is used to treat patients with lupus nephritis; however, its time course and dose effect on proteinuria in lupus nephritis patients remain unknown. The purpose of this study was to determine the time course and dose effect of tacrolimus on proteinuria in lupus nephritis patients via model‐based meta‐analysis (MBMA).
Methods
PubMed, Web of Science, Cochrane Library and ClinicalTrials.gov databases were systematically searched for information on the efficacy of tacrolimus against proteinuria in lupus nephritis patients. Useful data were extracted to build a model for the population studied using a non‐linear mixed‐effect model (NONMEM). This model was applied to simulate time course of tacrolimus on proteinuria using Monte Carlo simulations.
Results
Ten clinical studies that recruited 222 patients with lupus nephritis were included. Based on various diagnostic plots, we found that the established model described the observed data reasonably well. In addition, the typical Emax and ET50 of tacrolimus for 24‐hour proteinuria in lupus nephritis patients were −5.88 g and 0.37 months, respectively. The baseline value of 24‐hour proteinuria affected Emax. No significant dose‐response relationship was observed in the range of tacrolimus concentration used in the present study (3‐10 ng/mL), indicating that the effect of tacrolimus on proteinuria depends on effective concentration range and not the dose. However, the time course relationship was obvious; the efficacy of tacrolimus increased over time, reaching a plateau (80% Emax) at approximately 1.48 months from the beginning of treatment.
What is new and conclusion
When the concentration range of tacrolimus is maintained at 3‐10 ng/mL, at least 1.48 months of treatment is required to achieve a better outcome with regard to proteinuria in lupus nephritis patients.
When the concentration range of tacrolimus is maintained at 3‐10 ng/mL, at least 1.48 months of treatment is required to achieve a better outcome with regard to proteinuria in lupus nephritis patients.</abstract><cop>England</cop><pub>Hindawi Limited</pub><pmid>32974902</pmid><doi>10.1111/jcpt.13260</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0001-6194-023X</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0269-4727 |
| ispartof | Journal of clinical pharmacy and therapeutics, 2021-02, Vol.46 (1), p.106-113 |
| issn | 0269-4727 1365-2710 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2446669396 |
| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | dose effect Dose-Response Relationship, Drug Humans Immunosuppressive Agents - therapeutic use Lupus Lupus nephritis Lupus Nephritis - drug therapy Meta-analysis model‐based meta‐analysis Nephritis Patients Population studies Proteinuria Proteinuria - drug therapy Tacrolimus Tacrolimus - therapeutic use time course Treatment Outcome |
| title | Analysis of time course and dose effect of tacrolimus on proteinuria in lupus nephritis patients |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-24T04%3A15%3A56IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Analysis%20of%20time%20course%20and%20dose%20effect%20of%20tacrolimus%20on%20proteinuria%20in%20lupus%20nephritis%20patients&rft.jtitle=Journal%20of%20clinical%20pharmacy%20and%20therapeutics&rft.au=Chen,%20Xiao&rft.date=2021-02&rft.volume=46&rft.issue=1&rft.spage=106&rft.epage=113&rft.pages=106-113&rft.issn=0269-4727&rft.eissn=1365-2710&rft_id=info:doi/10.1111/jcpt.13260&rft_dat=%3Cproquest_cross%3E2446669396%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2475706262&rft_id=info:pmid/32974902&rfr_iscdi=true |