Evaluation of initial dofetilide dosing recommendation based on actual body weight in overweight and obese patients
Summary What is known and objective The dofetilide label recommends using actual body weight (ABW) to calculate the Cockcroft–Gault creatinine clearance (CrCl) for the determination of the initial dose; however, few studies have attempted to evaluate this dosing recommendation in overweight and obes...
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| Veröffentlicht in: | Journal of clinical pharmacy and therapeutics 2015-12, Vol.40 (6), p.635-639 |
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| creator | Cao, D. X. Kohatsu, A. Eng, L. Mei, K. Dinh, J. Mok, I. Moreau, N. Le, A. Shin, J. |
| description | Summary
What is known and objective
The dofetilide label recommends using actual body weight (ABW) to calculate the Cockcroft–Gault creatinine clearance (CrCl) for the determination of the initial dose; however, few studies have attempted to evaluate this dosing recommendation in overweight and obese patients. We evaluated whether the current dofetilide dosing recommendation based on ABW is appropriate in overweight and obese patients.
Methods
This is a retrospective cohort study conducted at two large academic medical centres in the United States on overweight and obese patients (body mass index ≥ 25 kg/m2) who were newly started on dofetilide based on ABW. Patients were categorized into (i) the different‐dose group if their CrCl calculated based on the ideal body weight (IBW) resulted in a lower initial dofetilide dose compared with ABW‐based CrCl and (ii) the same‐dose group if they would have the same initial dose based on IBW and ABW. The primary outcome was dofetilide dose reduction or discontinuation due to prolongation of the corrected QT interval during the first 3 days of dofetilide therapy. Multivariable logistic regression analysis was performed to identify factors predicting the risk of primary outcome.
Results and discussion
Of the 132 patients included in the study, 29 (22·0%) were in the different‐dose group and 40 (30·3%) had the primary outcome. The per cent of patients with the primary outcome was not statistically significantly different between the different‐dose and same‐dose groups (37·9% vs. 28·2%; P = 0·31). Diabetes mellitus was a significant predictor for the primary outcome (odds ratio 2·54; 95% confidence interval 1·05–6·15).
What is new and conclusion
Our study provides the evidence on the safety of the current dofetilide dosing recommendation in overweight and obese populations in clinical practice. Current ABW‐based dofetilide dosing is reasonable in overweight and obese patients.
This study evaluated whether the current dofetilide dosing recommendation based on actual body weight (ABW) is appropriate in overweight and obese patients. In this study, patients were categorized into 1) the different‐dose group if their creatinine clearance (CrCl) calculated based on the ideal body weight (IBW) resulted in a lower initial dofetilide dose compared to ABW‐based CrCl; and 2) the same‐dose group if they would have the same initial dose based on IBW and ABW. The study found that dofetilide dose reduction or discontinuation due to pro |
| doi_str_mv | 10.1111/jcpt.12321 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1897371605</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1760856811</sourcerecordid><originalsourceid>FETCH-LOGICAL-c6041-77b30ded129e91062e69746dbb0663309bc5958ac02705d08af2e8b99025301c3</originalsourceid><addsrcrecordid>eNqF0c1u1DAUBWALgei0sOEBUCQ2qFLKtR3b8ZJOf2BUFYSKkNhYTnxTPCTxECct8_Z1ybQLFuCNbem7R7o6hLyicETTebeuN-MRZZzRJ2RBuRQ5UxSekgUwqfNCMbVH9mNcA4BUjD8ne0wmVWi2IPH0xraTHX3os9Bkvvejt23mQoOjb73D9Iy-v84GrEPXYe9mW9mILksPW49TGqiC22a36K9_jCkkCzc47H62T67CiNkmjWI_xhfkWWPbiC939wH5enZ6tfyQX3w6_7h8f5HXEgqaK1VxcOgo06gpSIZSq0K6qgIpOQdd1UKL0tbAFAgHpW0YlpXWwAQHWvMD8nbO3Qzh14RxNJ2PNbat7TFM0dBSK66oBPF_qiSUQpaUJvrmL7oO09CnRZISSjDGS5nU4azqIcQ4YGM2g-_ssDUUzH1r5r4186e1hF_vIqeqQ_dIH2pKgM7g1re4_UeUWS0_Xz2E5vOMjyP-fpyxw08j09rCfLs8N6uTL2LFimPznd8B6iuwig</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1757522386</pqid></control><display><type>article</type><title>Evaluation of initial dofetilide dosing recommendation based on actual body weight in overweight and obese patients</title><source>MEDLINE</source><source>Wiley Journals</source><creator>Cao, D. X. ; Kohatsu, A. ; Eng, L. ; Mei, K. ; Dinh, J. ; Mok, I. ; Moreau, N. ; Le, A. ; Shin, J.</creator><creatorcontrib>Cao, D. X. ; Kohatsu, A. ; Eng, L. ; Mei, K. ; Dinh, J. ; Mok, I. ; Moreau, N. ; Le, A. ; Shin, J.</creatorcontrib><description>Summary
What is known and objective
The dofetilide label recommends using actual body weight (ABW) to calculate the Cockcroft–Gault creatinine clearance (CrCl) for the determination of the initial dose; however, few studies have attempted to evaluate this dosing recommendation in overweight and obese patients. We evaluated whether the current dofetilide dosing recommendation based on ABW is appropriate in overweight and obese patients.
Methods
This is a retrospective cohort study conducted at two large academic medical centres in the United States on overweight and obese patients (body mass index ≥ 25 kg/m2) who were newly started on dofetilide based on ABW. Patients were categorized into (i) the different‐dose group if their CrCl calculated based on the ideal body weight (IBW) resulted in a lower initial dofetilide dose compared with ABW‐based CrCl and (ii) the same‐dose group if they would have the same initial dose based on IBW and ABW. The primary outcome was dofetilide dose reduction or discontinuation due to prolongation of the corrected QT interval during the first 3 days of dofetilide therapy. Multivariable logistic regression analysis was performed to identify factors predicting the risk of primary outcome.
Results and discussion
Of the 132 patients included in the study, 29 (22·0%) were in the different‐dose group and 40 (30·3%) had the primary outcome. The per cent of patients with the primary outcome was not statistically significantly different between the different‐dose and same‐dose groups (37·9% vs. 28·2%; P = 0·31). Diabetes mellitus was a significant predictor for the primary outcome (odds ratio 2·54; 95% confidence interval 1·05–6·15).
What is new and conclusion
Our study provides the evidence on the safety of the current dofetilide dosing recommendation in overweight and obese populations in clinical practice. Current ABW‐based dofetilide dosing is reasonable in overweight and obese patients.
This study evaluated whether the current dofetilide dosing recommendation based on actual body weight (ABW) is appropriate in overweight and obese patients. In this study, patients were categorized into 1) the different‐dose group if their creatinine clearance (CrCl) calculated based on the ideal body weight (IBW) resulted in a lower initial dofetilide dose compared to ABW‐based CrCl; and 2) the same‐dose group if they would have the same initial dose based on IBW and ABW. The study found that dofetilide dose reduction or discontinuation due to prolongation of the corrected QT interval during the first 3 days of dofetilide therapy was not statistically different between the two categories of patients, providing the evidence that current ABW‐based dofetilide dosing is reasonable in overweight and obese patients.</description><identifier>ISSN: 0269-4727</identifier><identifier>EISSN: 1365-2710</identifier><identifier>DOI: 10.1111/jcpt.12321</identifier><identifier>PMID: 26365492</identifier><identifier>CODEN: JCPTED</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject>Adult ; Aged ; Body Mass Index ; Body Weight - physiology ; dofetilide ; Female ; Humans ; initial dosing ; initial dosing, obesity ; Male ; Middle Aged ; obesity ; Obesity - physiopathology ; Overweight - physiopathology ; Phenethylamines - administration & dosage ; Retrospective Studies ; safety ; Sulfonamides - administration & dosage</subject><ispartof>Journal of clinical pharmacy and therapeutics, 2015-12, Vol.40 (6), p.635-639</ispartof><rights>2015 John Wiley & Sons Ltd</rights><rights>2015 John Wiley & Sons Ltd.</rights><rights>Copyright © 2015 John Wiley & Sons Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c6041-77b30ded129e91062e69746dbb0663309bc5958ac02705d08af2e8b99025301c3</citedby><cites>FETCH-LOGICAL-c6041-77b30ded129e91062e69746dbb0663309bc5958ac02705d08af2e8b99025301c3</cites><orcidid>0000-0002-6083-837X</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.12321$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fjcpt.12321$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26365492$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Cao, D. X.</creatorcontrib><creatorcontrib>Kohatsu, A.</creatorcontrib><creatorcontrib>Eng, L.</creatorcontrib><creatorcontrib>Mei, K.</creatorcontrib><creatorcontrib>Dinh, J.</creatorcontrib><creatorcontrib>Mok, I.</creatorcontrib><creatorcontrib>Moreau, N.</creatorcontrib><creatorcontrib>Le, A.</creatorcontrib><creatorcontrib>Shin, J.</creatorcontrib><title>Evaluation of initial dofetilide dosing recommendation based on actual body weight in overweight and obese patients</title><title>Journal of clinical pharmacy and therapeutics</title><addtitle>J Clin Pharm Ther</addtitle><description>Summary
What is known and objective
The dofetilide label recommends using actual body weight (ABW) to calculate the Cockcroft–Gault creatinine clearance (CrCl) for the determination of the initial dose; however, few studies have attempted to evaluate this dosing recommendation in overweight and obese patients. We evaluated whether the current dofetilide dosing recommendation based on ABW is appropriate in overweight and obese patients.
Methods
This is a retrospective cohort study conducted at two large academic medical centres in the United States on overweight and obese patients (body mass index ≥ 25 kg/m2) who were newly started on dofetilide based on ABW. Patients were categorized into (i) the different‐dose group if their CrCl calculated based on the ideal body weight (IBW) resulted in a lower initial dofetilide dose compared with ABW‐based CrCl and (ii) the same‐dose group if they would have the same initial dose based on IBW and ABW. The primary outcome was dofetilide dose reduction or discontinuation due to prolongation of the corrected QT interval during the first 3 days of dofetilide therapy. Multivariable logistic regression analysis was performed to identify factors predicting the risk of primary outcome.
Results and discussion
Of the 132 patients included in the study, 29 (22·0%) were in the different‐dose group and 40 (30·3%) had the primary outcome. The per cent of patients with the primary outcome was not statistically significantly different between the different‐dose and same‐dose groups (37·9% vs. 28·2%; P = 0·31). Diabetes mellitus was a significant predictor for the primary outcome (odds ratio 2·54; 95% confidence interval 1·05–6·15).
What is new and conclusion
Our study provides the evidence on the safety of the current dofetilide dosing recommendation in overweight and obese populations in clinical practice. Current ABW‐based dofetilide dosing is reasonable in overweight and obese patients.
This study evaluated whether the current dofetilide dosing recommendation based on actual body weight (ABW) is appropriate in overweight and obese patients. In this study, patients were categorized into 1) the different‐dose group if their creatinine clearance (CrCl) calculated based on the ideal body weight (IBW) resulted in a lower initial dofetilide dose compared to ABW‐based CrCl; and 2) the same‐dose group if they would have the same initial dose based on IBW and ABW. The study found that dofetilide dose reduction or discontinuation due to prolongation of the corrected QT interval during the first 3 days of dofetilide therapy was not statistically different between the two categories of patients, providing the evidence that current ABW‐based dofetilide dosing is reasonable in overweight and obese patients.</description><subject>Adult</subject><subject>Aged</subject><subject>Body Mass Index</subject><subject>Body Weight - physiology</subject><subject>dofetilide</subject><subject>Female</subject><subject>Humans</subject><subject>initial dosing</subject><subject>initial dosing, obesity</subject><subject>Male</subject><subject>Middle Aged</subject><subject>obesity</subject><subject>Obesity - physiopathology</subject><subject>Overweight - physiopathology</subject><subject>Phenethylamines - administration & dosage</subject><subject>Retrospective Studies</subject><subject>safety</subject><subject>Sulfonamides - administration & dosage</subject><issn>0269-4727</issn><issn>1365-2710</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqF0c1u1DAUBWALgei0sOEBUCQ2qFLKtR3b8ZJOf2BUFYSKkNhYTnxTPCTxECct8_Z1ybQLFuCNbem7R7o6hLyicETTebeuN-MRZZzRJ2RBuRQ5UxSekgUwqfNCMbVH9mNcA4BUjD8ne0wmVWi2IPH0xraTHX3os9Bkvvejt23mQoOjb73D9Iy-v84GrEPXYe9mW9mILksPW49TGqiC22a36K9_jCkkCzc47H62T67CiNkmjWI_xhfkWWPbiC939wH5enZ6tfyQX3w6_7h8f5HXEgqaK1VxcOgo06gpSIZSq0K6qgIpOQdd1UKL0tbAFAgHpW0YlpXWwAQHWvMD8nbO3Qzh14RxNJ2PNbat7TFM0dBSK66oBPF_qiSUQpaUJvrmL7oO09CnRZISSjDGS5nU4azqIcQ4YGM2g-_ssDUUzH1r5r4186e1hF_vIqeqQ_dIH2pKgM7g1re4_UeUWS0_Xz2E5vOMjyP-fpyxw08j09rCfLs8N6uTL2LFimPznd8B6iuwig</recordid><startdate>201512</startdate><enddate>201512</enddate><creator>Cao, D. X.</creator><creator>Kohatsu, A.</creator><creator>Eng, L.</creator><creator>Mei, K.</creator><creator>Dinh, J.</creator><creator>Mok, I.</creator><creator>Moreau, N.</creator><creator>Le, A.</creator><creator>Shin, J.</creator><general>Blackwell Publishing Ltd</general><general>Hindawi Limited</general><scope>BSCLL</scope><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><scope>7TS</scope><orcidid>https://orcid.org/0000-0002-6083-837X</orcidid></search><sort><creationdate>201512</creationdate><title>Evaluation of initial dofetilide dosing recommendation based on actual body weight in overweight and obese patients</title><author>Cao, D. X. ; Kohatsu, A. ; Eng, L. ; Mei, K. ; Dinh, J. ; Mok, I. ; Moreau, N. ; Le, A. ; Shin, J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c6041-77b30ded129e91062e69746dbb0663309bc5958ac02705d08af2e8b99025301c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Body Mass Index</topic><topic>Body Weight - physiology</topic><topic>dofetilide</topic><topic>Female</topic><topic>Humans</topic><topic>initial dosing</topic><topic>initial dosing, obesity</topic><topic>Male</topic><topic>Middle Aged</topic><topic>obesity</topic><topic>Obesity - physiopathology</topic><topic>Overweight - physiopathology</topic><topic>Phenethylamines - administration & dosage</topic><topic>Retrospective Studies</topic><topic>safety</topic><topic>Sulfonamides - administration & dosage</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Cao, D. X.</creatorcontrib><creatorcontrib>Kohatsu, A.</creatorcontrib><creatorcontrib>Eng, L.</creatorcontrib><creatorcontrib>Mei, K.</creatorcontrib><creatorcontrib>Dinh, J.</creatorcontrib><creatorcontrib>Mok, I.</creatorcontrib><creatorcontrib>Moreau, N.</creatorcontrib><creatorcontrib>Le, A.</creatorcontrib><creatorcontrib>Shin, J.</creatorcontrib><collection>Istex</collection><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><collection>Physical Education Index</collection><jtitle>Journal of clinical pharmacy and therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Cao, D. X.</au><au>Kohatsu, A.</au><au>Eng, L.</au><au>Mei, K.</au><au>Dinh, J.</au><au>Mok, I.</au><au>Moreau, N.</au><au>Le, A.</au><au>Shin, J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of initial dofetilide dosing recommendation based on actual body weight in overweight and obese patients</atitle><jtitle>Journal of clinical pharmacy and therapeutics</jtitle><addtitle>J Clin Pharm Ther</addtitle><date>2015-12</date><risdate>2015</risdate><volume>40</volume><issue>6</issue><spage>635</spage><epage>639</epage><pages>635-639</pages><issn>0269-4727</issn><eissn>1365-2710</eissn><coden>JCPTED</coden><abstract>Summary
What is known and objective
The dofetilide label recommends using actual body weight (ABW) to calculate the Cockcroft–Gault creatinine clearance (CrCl) for the determination of the initial dose; however, few studies have attempted to evaluate this dosing recommendation in overweight and obese patients. We evaluated whether the current dofetilide dosing recommendation based on ABW is appropriate in overweight and obese patients.
Methods
This is a retrospective cohort study conducted at two large academic medical centres in the United States on overweight and obese patients (body mass index ≥ 25 kg/m2) who were newly started on dofetilide based on ABW. Patients were categorized into (i) the different‐dose group if their CrCl calculated based on the ideal body weight (IBW) resulted in a lower initial dofetilide dose compared with ABW‐based CrCl and (ii) the same‐dose group if they would have the same initial dose based on IBW and ABW. The primary outcome was dofetilide dose reduction or discontinuation due to prolongation of the corrected QT interval during the first 3 days of dofetilide therapy. Multivariable logistic regression analysis was performed to identify factors predicting the risk of primary outcome.
Results and discussion
Of the 132 patients included in the study, 29 (22·0%) were in the different‐dose group and 40 (30·3%) had the primary outcome. The per cent of patients with the primary outcome was not statistically significantly different between the different‐dose and same‐dose groups (37·9% vs. 28·2%; P = 0·31). Diabetes mellitus was a significant predictor for the primary outcome (odds ratio 2·54; 95% confidence interval 1·05–6·15).
What is new and conclusion
Our study provides the evidence on the safety of the current dofetilide dosing recommendation in overweight and obese populations in clinical practice. Current ABW‐based dofetilide dosing is reasonable in overweight and obese patients.
This study evaluated whether the current dofetilide dosing recommendation based on actual body weight (ABW) is appropriate in overweight and obese patients. In this study, patients were categorized into 1) the different‐dose group if their creatinine clearance (CrCl) calculated based on the ideal body weight (IBW) resulted in a lower initial dofetilide dose compared to ABW‐based CrCl; and 2) the same‐dose group if they would have the same initial dose based on IBW and ABW. The study found that dofetilide dose reduction or discontinuation due to prolongation of the corrected QT interval during the first 3 days of dofetilide therapy was not statistically different between the two categories of patients, providing the evidence that current ABW‐based dofetilide dosing is reasonable in overweight and obese patients.</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>26365492</pmid><doi>10.1111/jcpt.12321</doi><tpages>5</tpages><orcidid>https://orcid.org/0000-0002-6083-837X</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of clinical pharmacy and therapeutics, 2015-12, Vol.40 (6), p.635-639 |
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| language | eng |
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| source | MEDLINE; Wiley Journals |
| subjects | Adult Aged Body Mass Index Body Weight - physiology dofetilide Female Humans initial dosing initial dosing, obesity Male Middle Aged obesity Obesity - physiopathology Overweight - physiopathology Phenethylamines - administration & dosage Retrospective Studies safety Sulfonamides - administration & dosage |
| title | Evaluation of initial dofetilide dosing recommendation based on actual body weight in overweight and obese patients |
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