从药物相互作用看二肽基肽酶4抑制剂的个体化治疗选择
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摘要
随着联合用药的日益普遍,药物相互作用(DDI)已成为严峻的临床安全性的问题。作为治疗2型糖尿病新药,目前已在中国上市的5种二肽基肽酶4(DPP4)抑制剂的潜在DDI风险不尽相同。在个体化治疗已成为大势所趋的今天,本文旨在进一步探讨不同DPP4抑制剂DDI风险的差异,以便更好地指导临床用药选择。
Drug-drug interaction( DDI) is becoming a noticeable clinical safety issue as the multi-drug therapy becomes more common. Serve as effective medicines for the treatment of type 2 diabetes,the potential DDI risk of five marketed dipeptidyl-peptidase 4( DDP-4) inhibitors in China is not the same. As the individualized therapy has become the trend in recent years,this article aims to explore the different DDI risk of DPP4 inhibitors to guide clinical drug selection.
Drug-drug interaction( DDI) is becoming a noticeable clinical safety issue as the multi-drug therapy becomes more common. Serve as effective medicines for the treatment of type 2 diabetes,the potential DDI risk of five marketed dipeptidyl-peptidase 4( DDP-4) inhibitors in China is not the same. As the individualized therapy has become the trend in recent years,this article aims to explore the different DDI risk of DPP4 inhibitors to guide clinical drug selection.
引文
[1]母义明.2型糖尿病治疗中的药物相互作用[J].药品评价,2015,12(17):8-14.
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[3]ZHAO Y S,CHEN F,LI L.Are circulating metabolites important in pharmacokinetic drug-drug interactions?A retroanalysis of clinical data[J].Curr Drug Metab,2014,15(8):767-790.
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[7]HUANG S M,STRONG J M,ZHANG L,et al.New era in drug interaction evaluation:US Food and Drug Administration update on CYP enzymes,transporters,and the guidance process[J].J Clin Pharmacol,2008 48(6):662-670.
[8]US FOOD AND DRUG ADMINISTRATION(FDA).Draft guidance for industry:drug interaction studies-study design,data analysis and implications for dosing and labeling,2006[EB/OL].Rockville:FDA,2006-09-08[2019-01-20].http://www.fda.gov/cder/guidance/6695dft.pdf.
[9]US FOOD AND DRUG ADMINISTRATION(FDA).Guidance for industry:drug interaction studies---study design,data analysis,implications for dosing,and labeling recommendations,2012[EB/OL].Rockville:FDA,2012-02-01[2019-01-20].https://www.xenotech.com/regulatorydocuments/2012/2012_guidance.aspx.
[10]KAREN BAXTER,CLAIRE L.Stockley's drug interactions pocket companion 2013[J].J Med Libr Assoc,2014,102(3):221.
[11]LIU Z,FU C,WANG W,et al.Prevalence of chronic complications of type 2 diabetes mellitus in outpatients-a cross-sectional hospital based survey in urban China[J/OL].Health Qual Life Outcomesm,2010,8:62.2010-06-26[2019-01-20].https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2906445/.
[12]INDU R,ADHIKARI A,MAISNAM I,et al.Polypharmacy and comorbidity status in the treatment of type 2 diabetic patients attending a tertiary care hospital:An observational and questionnairebased study[J].Perspect Clin Res,2018,9(3):139-144.
[13]DUMBRECK S,FLYNN A,NAIRN M,et al.Drug-disease and drug-drug interactions:systematic examination of recommendations in 12 UK national clinical guidelines[J/OL].BMJ,2015,350:h949.2015-03-11[2019-01-20].https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4356453/.
[14]MAY M,SCHINDLER C.Clinically and pharmacologically relevant interactions of antidiabetic drugs[J].Ther Adv Endocrinol Metab,2016,7(2):69-83.
[15]DANTON AC,MONTASTRUC F,SOMMET A,et al.Importance of cytochrome P450(CYP450)in adverse drug reactions due to drug-drug interactions:a Pharmaco Vigilance study in France[J].Eur J Clin Pharmacol,2013,69(4):885-888.
[16]MORALES-OLIVAS FJ,ESTAL.Drug-drug interactions.An update[J].Med Clin(Barc),2006,127(7):269-275.
[17]NEBERT D W,WIKVALL K,MILLER W L.Human cytochromes P450 in health and disease[J].Philos Trans R Soc Lond B Biol Sci,2013,368(1612):20120431.
[18]王崇,刘克辛.外排型转运体与CYP450酶所介导的药物相互作用[J].药学学报,2014,49(5):590-595.
[19]WESSLER J D,GRIP L T,MENDELL J,et al.The P-glycoprotein transport system and cardiovascular drugs[J].J Am Coll Cardiol,2013,61(25):2495-2502.
[20]戴立波,方平飞,李焕德.P-gp调节对药物代谢动力学及药效学的影响[J].中南药学,2011,9(8):612-615.
[21]NAKANISHI T,TAMAI I.Interaction of drug or food with drug transporters in intestine and liver[J].Curr Drug Metab,2015,16(9):753-764.
[22]ZHOU S F.Structure,function and regulation of P-glycoprotein and its clinical relevance in drug disposition[J].Xenobiotica,2008,38(7-8):802-832.
[23]陈莉明.二肽基肽酶Ⅳ抑制剂类口服降糖药的药化性质和药理活性综合比较分析[J].中国糖尿病杂志,2016,8(8):508-510.
[24]CERIELLO A,SPORTIELLO L,RAFANIELLO C,et al.DPP-4inhibitors:pharmacological differences and their clinical implications[J].Expert Opin Drug Saf,2014,13(Suppl 1):S57-S68.
[25]BAETTA R,CORSINI A.Pharmacology of dipeptidyl peptidase-4inhibitors:similarities and differences[J].Drugs,2011,71(11):1441-1467.
[26]TAKAHASHI A,IHARA M,YAMAZAKI S,et al.Impact of either GLP-1 agonists or DPP-4 inhibitors on pathophysiology of Heart Failure[J].Int Heart J,2015,56(4):372-376.
[27]JANARDHAN S,SASTRY G N.Dipeptidyl peptidase IV inhibitors:A new paradigm in type 2 diabetes treatment[J].Curr Drug Targets,2014,15(6):600-621.
[28]CHEN X W,HE Z X,ZHOU Z W,et al.Clinical pharmacology of dipeptidyl peptidase 4 inhibitors indicated for the treatment of type 2diabetes mellitus[J].Clin Exp Pharmacol Physiol,2015,42(10):999-1024.
[29]EUROPEAN MEDICINES AGENCY(EMA).Janyvia:EPAR-product information[EB/OL].London:EMA,2012-09-25[2019-01-20].http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/000722/WC500039054.pdf
[30]KRISHNA R,BERGMAN A,LARSON P,et al.Effect of a single cyclosporine dose on the single-dose pharmacokinetics of sitagliptin(MK-0431),a dipeptidyl peptidase-4 inhibitor,in healthy male subjects[J].J Clin Pharmacol,2007,47(2):165-174.
[31]SCHEEN A J.Pharmacokinetics of dipeptidylpeptidase-4 inhibitors[J].Diabetes Obes Metab,2010,12(8):648-658.
[32]EUROPEAN MEDICINES AGENCY(EMA).Galvus:EPAR-Scientific discussion[EB/OL].London:EMA,2007-04-04[2019-01-20].http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000771/WC500020330.pdf.
[33]BROWN NJ,BYIERS S,CARR D,et al.Dipeptidyl peptidaseIV inhibitor use associated with increased risk of ACE inhibitorassociated angioedema[J].Hypertension.2009,54(3):516-523.
[34]DHILLON S,WEBER J.Saxagliptin[J].Drugs,2009,69(15):2103-2114.
[35]UPRETI V V,BOULTON D W,LI L,et al.Effect of rifampicin on the pharmacokinetics and pharmacodynamics of saxagliptin,a dipeptidyl peptidase-4 inhibitor,in healthy subjects[J].Br J Clin Pharmacol,2011,72(1):92-102.
[36]ALI S,FONSECA V.Saxagliptin overview:Special focus on safety and adverse effects[J].Expert Opin Drug Saf,2013,12(1):103-109.
[37]US FOOD AND DRUG ADMINISTRATION(FDA).ONGLYZA(saxagliptin)tablets,for oral use[EB/OL].Rockville:FDA,2015-06-11[2019-01-20].https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022350s016lbl.pdf.
[38]GRAEFE-MODY U,RETLICH S,FRIEDRICH C.Clinical pharmacokinetics and pharmacodynamics of linagliptin[J].Clin Pharmacokinet,2012,51(7):411-427.
[39]US FOOD AND DRUG ADMINISTRATION(FDA).JENTADUE-TO(linagliptin and metformin hydrochloride)tablets,for oral use[EB/OL].Rockville:FDA,2017-03-21[2019-01-20].https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201281s017lbl.pdf.
[40]NEUMILLER J J,WOOD L,CAMPBELL R K.Dipeptidyl peptidase-4 inhibitors for the treatment of type 2 diabetes mellitus[J].Pharmacotherapy,2010,30(5):463-484.
[2]STRANDELL J,WAHLIN S.Pharmacodynamic and pharmacokinetic drug interactions reported to Vigi Base,the WHO global individual case safety report database[J].Eur J Clin Pharmacol,2011,67(6):633-641.
[3]ZHAO Y S,CHEN F,LI L.Are circulating metabolites important in pharmacokinetic drug-drug interactions?A retroanalysis of clinical data[J].Curr Drug Metab,2014,15(8):767-790.
[4]NATIONAL CENTER FOR HEALTH STATISTICS.Health,United States,2015:With special feature on socioeconomic status and health[EB/OL].Washington DC:National Center for Health Statistics,2017-06-22[2019-01-20].https://www.cdc.gov/nchs/data/hus/hus15.pdf.
[5]GUTHRIE B,MAKUBATE B,HERNANDEZ-SANTIAGO V,et al.The rising tide of polypharmacy and drug-drug interactions:population database analysis 1995-2010[J/OL].BMC Med,2015,13:74.2015-04-07[2019-01-20].https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4417329/.
[6]LU Y,FIGLER B,HUANG H,et al.Characterization of the mechanism of drug-drug interactions from PubMed using Me SH terms[J/OL].PLoS One,2017,12(4):e0173548.2017-04-19[2019-01-20].https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5396881/.
[7]HUANG S M,STRONG J M,ZHANG L,et al.New era in drug interaction evaluation:US Food and Drug Administration update on CYP enzymes,transporters,and the guidance process[J].J Clin Pharmacol,2008 48(6):662-670.
[8]US FOOD AND DRUG ADMINISTRATION(FDA).Draft guidance for industry:drug interaction studies-study design,data analysis and implications for dosing and labeling,2006[EB/OL].Rockville:FDA,2006-09-08[2019-01-20].http://www.fda.gov/cder/guidance/6695dft.pdf.
[9]US FOOD AND DRUG ADMINISTRATION(FDA).Guidance for industry:drug interaction studies---study design,data analysis,implications for dosing,and labeling recommendations,2012[EB/OL].Rockville:FDA,2012-02-01[2019-01-20].https://www.xenotech.com/regulatorydocuments/2012/2012_guidance.aspx.
[10]KAREN BAXTER,CLAIRE L.Stockley's drug interactions pocket companion 2013[J].J Med Libr Assoc,2014,102(3):221.
[11]LIU Z,FU C,WANG W,et al.Prevalence of chronic complications of type 2 diabetes mellitus in outpatients-a cross-sectional hospital based survey in urban China[J/OL].Health Qual Life Outcomesm,2010,8:62.2010-06-26[2019-01-20].https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2906445/.
[12]INDU R,ADHIKARI A,MAISNAM I,et al.Polypharmacy and comorbidity status in the treatment of type 2 diabetic patients attending a tertiary care hospital:An observational and questionnairebased study[J].Perspect Clin Res,2018,9(3):139-144.
[13]DUMBRECK S,FLYNN A,NAIRN M,et al.Drug-disease and drug-drug interactions:systematic examination of recommendations in 12 UK national clinical guidelines[J/OL].BMJ,2015,350:h949.2015-03-11[2019-01-20].https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4356453/.
[14]MAY M,SCHINDLER C.Clinically and pharmacologically relevant interactions of antidiabetic drugs[J].Ther Adv Endocrinol Metab,2016,7(2):69-83.
[15]DANTON AC,MONTASTRUC F,SOMMET A,et al.Importance of cytochrome P450(CYP450)in adverse drug reactions due to drug-drug interactions:a Pharmaco Vigilance study in France[J].Eur J Clin Pharmacol,2013,69(4):885-888.
[16]MORALES-OLIVAS FJ,ESTAL.Drug-drug interactions.An update[J].Med Clin(Barc),2006,127(7):269-275.
[17]NEBERT D W,WIKVALL K,MILLER W L.Human cytochromes P450 in health and disease[J].Philos Trans R Soc Lond B Biol Sci,2013,368(1612):20120431.
[18]王崇,刘克辛.外排型转运体与CYP450酶所介导的药物相互作用[J].药学学报,2014,49(5):590-595.
[19]WESSLER J D,GRIP L T,MENDELL J,et al.The P-glycoprotein transport system and cardiovascular drugs[J].J Am Coll Cardiol,2013,61(25):2495-2502.
[20]戴立波,方平飞,李焕德.P-gp调节对药物代谢动力学及药效学的影响[J].中南药学,2011,9(8):612-615.
[21]NAKANISHI T,TAMAI I.Interaction of drug or food with drug transporters in intestine and liver[J].Curr Drug Metab,2015,16(9):753-764.
[22]ZHOU S F.Structure,function and regulation of P-glycoprotein and its clinical relevance in drug disposition[J].Xenobiotica,2008,38(7-8):802-832.
[23]陈莉明.二肽基肽酶Ⅳ抑制剂类口服降糖药的药化性质和药理活性综合比较分析[J].中国糖尿病杂志,2016,8(8):508-510.
[24]CERIELLO A,SPORTIELLO L,RAFANIELLO C,et al.DPP-4inhibitors:pharmacological differences and their clinical implications[J].Expert Opin Drug Saf,2014,13(Suppl 1):S57-S68.
[25]BAETTA R,CORSINI A.Pharmacology of dipeptidyl peptidase-4inhibitors:similarities and differences[J].Drugs,2011,71(11):1441-1467.
[26]TAKAHASHI A,IHARA M,YAMAZAKI S,et al.Impact of either GLP-1 agonists or DPP-4 inhibitors on pathophysiology of Heart Failure[J].Int Heart J,2015,56(4):372-376.
[27]JANARDHAN S,SASTRY G N.Dipeptidyl peptidase IV inhibitors:A new paradigm in type 2 diabetes treatment[J].Curr Drug Targets,2014,15(6):600-621.
[28]CHEN X W,HE Z X,ZHOU Z W,et al.Clinical pharmacology of dipeptidyl peptidase 4 inhibitors indicated for the treatment of type 2diabetes mellitus[J].Clin Exp Pharmacol Physiol,2015,42(10):999-1024.
[29]EUROPEAN MEDICINES AGENCY(EMA).Janyvia:EPAR-product information[EB/OL].London:EMA,2012-09-25[2019-01-20].http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/000722/WC500039054.pdf
[30]KRISHNA R,BERGMAN A,LARSON P,et al.Effect of a single cyclosporine dose on the single-dose pharmacokinetics of sitagliptin(MK-0431),a dipeptidyl peptidase-4 inhibitor,in healthy male subjects[J].J Clin Pharmacol,2007,47(2):165-174.
[31]SCHEEN A J.Pharmacokinetics of dipeptidylpeptidase-4 inhibitors[J].Diabetes Obes Metab,2010,12(8):648-658.
[32]EUROPEAN MEDICINES AGENCY(EMA).Galvus:EPAR-Scientific discussion[EB/OL].London:EMA,2007-04-04[2019-01-20].http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000771/WC500020330.pdf.
[33]BROWN NJ,BYIERS S,CARR D,et al.Dipeptidyl peptidaseIV inhibitor use associated with increased risk of ACE inhibitorassociated angioedema[J].Hypertension.2009,54(3):516-523.
[34]DHILLON S,WEBER J.Saxagliptin[J].Drugs,2009,69(15):2103-2114.
[35]UPRETI V V,BOULTON D W,LI L,et al.Effect of rifampicin on the pharmacokinetics and pharmacodynamics of saxagliptin,a dipeptidyl peptidase-4 inhibitor,in healthy subjects[J].Br J Clin Pharmacol,2011,72(1):92-102.
[36]ALI S,FONSECA V.Saxagliptin overview:Special focus on safety and adverse effects[J].Expert Opin Drug Saf,2013,12(1):103-109.
[37]US FOOD AND DRUG ADMINISTRATION(FDA).ONGLYZA(saxagliptin)tablets,for oral use[EB/OL].Rockville:FDA,2015-06-11[2019-01-20].https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022350s016lbl.pdf.
[38]GRAEFE-MODY U,RETLICH S,FRIEDRICH C.Clinical pharmacokinetics and pharmacodynamics of linagliptin[J].Clin Pharmacokinet,2012,51(7):411-427.
[39]US FOOD AND DRUG ADMINISTRATION(FDA).JENTADUE-TO(linagliptin and metformin hydrochloride)tablets,for oral use[EB/OL].Rockville:FDA,2017-03-21[2019-01-20].https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201281s017lbl.pdf.
[40]NEUMILLER J J,WOOD L,CAMPBELL R K.Dipeptidyl peptidase-4 inhibitors for the treatment of type 2 diabetes mellitus[J].Pharmacotherapy,2010,30(5):463-484.