Potential Formula for the Calculation of Starting and Incremental Insulin Glargine Doses ALOHA Subanalysis 英文参考文献.docVIP
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Potential Formula for the Calculation of Starting and Incremental Insulin Glargine Doses ALOHA Subanalysis 英文参考文献
PotentialFormulafortheCalculationofStartingand
IncrementalInsulinGlargineDoses:ALOHASubanalysis
TakashiKadowaki1*,TetsuyaOhtani2,MasatoOdawara3
1DepartmentofDiabetesandMetabolicDiseases,GraduateSchoolofMedicine,TheUniversityofTokyo,Tokyo,Japan,2sanofi-aventisK.K.,Tokyo,Japan,3Department
ofDiabetology,Metabolism,andEndocrinology,TokyoMedicalUniversity,Tokyo,Japan
Abstract
Background:Pragmaticmethodsfordoseoptimizationarerequiredforthesuccessfulbasalmanagementindailyclinical
practice. To derive a useful formula for calculating recommended glargine doses, we analyzed data from the Add-on
LantusHtoOralHypoglycemicAgents(ALOHA)study,a24-weekobservationofJapanesetype2diabetespatients.
Methodology/PrincipalFindings:Thepatientswhoinitiatedinsulinglargineinbasal-supportedoraltherapy(BOT)regimen
(n=3506)wereanalyzed.ThecorrelationsbetweenaveragechangesinglarginedoseandHbA1cwerecalculated,andits
regression formula was estimated from grouped data categorized by baseline HbA1c levels. Starting doses of the
background-subgroup achieving the HbA1c target with a last-observed dose above the average were compared to an
assumed optimal startingdose of 0.15U/kg/day. The difference in regression lines between background-subgroups was
examined. A formula for determining the optimal starting and titration doses was thereby derived. The correlation
coefficientbetweenchangesindoseandHbA1cwas20.9043.Theestimatedregressionlineformulawas20.9646change
in HbA1c+2.000. A starting dose of 0.15U/kg/day was applicable to all background-subgroups except for patients with
2
retinopathy (0.120U/kg/day) and/or with eGFR,60mL/min/1.73m (0.114U/kg/day). Additionally, women (0.135U/kg/
day)andpatientswithsulfonylureas(0.132U/kg/day)receivedaslightlydecreasedstartingdose.
Conclusions/Significance: We suggest a simplified and pragmatic dose calculation formula for type 2 diabetes patients
startingglargineBOToptimaldailydoseat24weeks = startingdose(0.156weight)+incrementaldose(baselineHbA1c2
targetHbA1
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