Patient considerations in the management of type 2 diabetes – critical appraisal of dapagliflozin

References

• International Diabetes FederationDiabetes: facts and figures [cited 2013 Nov 16]. Available from: http://www.idf.org/worlddiabetesday/toolkit/gp/facts-figures
   Google Scholar
• American Diabetes AssociationStandards of medical care in diabetes – 2013Diabetes Care201336S11S6623264422
   PubMed Web of Science ®Google Scholar
• InzucchiSEBergenstalRMBuseJBManagement of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)Diabetes Care201235613341379
   Web of Science ®Google Scholar
• American Association of Clinical EndocrinologistsAACE comprehensive diabetes management algorithmEndocr Pract201319232733623598536
   PubMed Web of Science ®Google Scholar
• NicholsGAKimesTMHarpJBKouTDBrodoviczKGGlycemic response and attainment of A1c goals following newly initiated insulin therapy for type 2 diabetesDiabetes Care201235349549722279033
   PubMed Web of Science ®Google Scholar
• OngKLCheungBMWongLYPrevalence, treatment, and control of diagnosed diabetes in the US. National Health and Nutrition Examination Survey. 1999–2004Ann Epidemiol200818322222918201902
   PubMed Web of Science ®Google Scholar
• United Kingdom Prospective Diabetes Study (UKPDS)13: Relative efficacy of randomly allocated diet, sulphonylurea, insulin, or metformin in patients with newly diagnosed non-insulin dependent diabetes followed for three yearsBMJ1995310697283887833731
   PubMed Web of Science ®Google Scholar
• UK prospective diabetes study 16. Overview of 6 years’ therapy of type II diabetes: a progressive disease. UK Prospective Diabetes Study GroupDiabetes19954411124912587589820
   PubMed Web of Science ®Google Scholar
• Actos [package insert]Deerfield, ILTakeda Pharmaceutical2013
   Google Scholar
• Precose [package insert]Wayne, NJBayer Healthcare Pharmaceuticals2011
   Google Scholar
• Byetta [package insert]San Diego, CAAmylin Pharmaceutical2011
   Google Scholar
• Victoza [package insert]Plainsboro, NJNovo Nordisk2013
   Google Scholar
• AstraZeneca, Bristol-Myers Squibb [press release]US FDA acknowledges receipt of resubmission of the new drug application for investigational compound dapagliflozin for the treatment of type 2 diabetes [cited August 1, 2013]MarketWatch The Wall Street Journal7252013 Available from: http://www.marketwatch.com/story/us-fda-acknowledges-receipt-of-resubmission-of-the-new-drug-application-for-investigational-compound-dapagliflozin-for-the-treatment-of-type-2-diabetes-2013-07-25
   Google Scholar
• Farxiga [package insert]Princeton, NJBristol-Myers Squibb2014
   Google Scholar
• MoeOWBaumMBerryCARectorFCJrRenal transport of glucose, amino acids, sodium, chloride, and waterBrennerBMBrenner and Rector’s the KidneyPhiladelphiaWB Saunders1996413452
   Google Scholar
• DeetjenPvon BaeyerHDrexelHRenal glucose transportSeldinDWGiebischGSeldin and Giebisch’s the Kidney2nd edNewYorkRaven Press199228732888
   Google Scholar
• IsajiMSodium-glucose cotransporter inhibitors for diabetesCurr Opin Investig Drugs200784285292
   PubMed Web of Science ®Google Scholar
• JabbourSAGoldsteinBJSodium glucose co-transporter 2 inhibitors: blocking renal tubular reabsorption of glucose to improve glycaemic control in patients with diabetesInt J Clin Pract20086281279128418705823
   PubMed Web of Science ®Google Scholar
• BakrisGLFonsecaVASharmaKWrightEMRenal sodium-glucose transport: role in diabetes mellitus and potential clinical implicationsKidney Int200975121272127719357717
   PubMed Web of Science ®Google Scholar
• ChaoECHenryRRSGLT2 inhibition – a novel strategy for diabetes treatmentNat Rev Drug Discov20109755155920508640
   PubMed Web of Science ®Google Scholar
• NeumillerJWhiteJRCampbellRKSodium-glucose co-transport inhibitors: progress and therapeutic potential in type 2 diabetes mellitusDrugs201070437738520205482
   PubMed Web of Science ®Google Scholar
• Abdul-GhaniMADeFronzoRAInhibition of renal glucose reabsorption: a novel strategy for achieving glucose control in type 2 diabetes mellitusEndocr Pract200814678279018996802
   PubMedGoogle Scholar
• PloskerGLDapagliflozin: a review of its use in type 2 diabetes mellitusDrugs201272172289231223170914
   PubMed Web of Science ®Google Scholar
• VasilakouDKaragiannisTAthanasiadouESodium-glucose cotransporter 2 inhibitors for type 2 diabetes: a systematic review and meta-analysisAnn Intern Med2013159426227424026259
   PubMed Web of Science ®Google Scholar
• EhrenkranzJRLewisNGKahnCRRothJPhlorizin: a reviewDiabetes Metab Res Rev2005211313815624123
   PubMed Web of Science ®Google Scholar
• Forxiga [prescribing information] Available from: http://www.forxiga.eu/prescribing-informationAccessed November 16, 2013
   Google Scholar
• KasichayanulaSLiuXShyuWCLack of pharmacokinetic interaction between dapagliflozin, a novel sodium-glucose transporter 2 inhibitor, and metformin, pioglitazone, glimepiride, or sitagliptin in healthy subjectsDiabetes Obes Metab201113475421114603
   PubMed Web of Science ®Google Scholar
• KasichayanulaSChangMLiuXLack of pharmacokinetic interactions between dapagliflozin and simvastatin, valsartan, warfarin, or digoxinAdv Ther201229216317722271159
   PubMed Web of Science ®Google Scholar
• FerranniniERamosSJSalsaliATangWListJFDapagliflozin in monotherapy in type 2 diabetes patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trialDiabetes Care201033102217222420566676
   PubMed Web of Science ®Google Scholar
• BaileyCJIqbalNT’joenCListJFDapagliflozin monotherapy in drug-naïve patients with diabetes: a randomized-controlled trial of low-dose rangeDiabetes Obes Metab2012141095195922776824
   PubMed Web of Science ®Google Scholar
• BaileyCJGrossJLPietersABastienAListJFEffect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomized, double-blind, placebo-controlled trialLancet201037597332223223320609968
   PubMed Web of Science ®Google Scholar
• BaileyCJGrossJLHennickenDDapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled 102-week trialBMC Med2013114323425012
   PubMed Web of Science ®Google Scholar
• BolinderJLjunggrenOKullbergJEffects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metforminJ Clin Endocrinol Metab20129731020103122238392
   PubMed Web of Science ®Google Scholar
• StrojekKYoonKHHrubaVEffect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: a randomized, 24-week, double-blind, placebo-controlled trialDiabetes Obes Metab2011131092893821672123
   PubMed Web of Science ®Google Scholar
• WildingJPWooVSolerNLong-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulinAnn Intern Med2012156640541522431673
   PubMed Web of Science ®Google Scholar
• RosenstockJVicoMWeiLSalsaliAListJFEffects of dapagliflozin, an SGLT2 inhibitor, on HbA(1c), body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapyDiabetes Care20123571473147822446170
   PubMed Web of Science ®Google Scholar
• JabbourSAHardyESuggJParikhSDapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24 week, multicenter, randomized, double-blind, placebo-controlled studyDiabetes Care1152014 [Epub ahead of print.]
   Web of Science ®Google Scholar
• NauckMADel PratoSMeierJJDapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trialDiabetes Care20113492015202221816980
   PubMed Web of Science ®Google Scholar
• HenryRRMurrayAVMarmolejoMHDapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trialInt J Clin Pract201266544645622413962
   PubMed Web of Science ®Google Scholar
• Bristol-Myers Squibb [press release]New phase III data showed dapa-gliflozin significantly reduced AbA1c compared to placebo at 24 weeks in patients with type 2 diabetes inadequately controlled with the combination of metformin plus sulfonylurea Available from: http://news.bms.com/press-release/rd-news/new-phase-iii-data-showed-dapagliflozin-significantly-reduced-hba1c-compared-p&t=635156160653787526Accessed September 25, 2013
   Google Scholar
• VallonVSharmaKSodium-glucose transport: role in diabetes mellitus and potential clinical implicationsCurr Opin Nephrol Hypertens201019542543120539226
   PubMed Web of Science ®Google Scholar
• KomoroskiBVachharajaniNBoultonDDapagliflozin, a novel SGLT2 inhibitor, induces dose-dependent glycosuria in healthy subjectsClin Pharmacol Ther200985552052619129748
   PubMed Web of Science ®Google Scholar
• US Food and Drug AdministrationFDA briefing document: NDA 202293 dapagliflozin 5 and 10 mg7192011 Available from: http://www.fda.gov/downloads/AdvisoryCommittees/Committees-MeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM262994.pdfAccessed November 12, 2013
   Google Scholar
• Bristol-Myers Squibb, AstraZenecaNDA 202293 dapagliflozin: Endocrinologic and Metabolic Advisory Committee background document7132011 Available from: http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrino-logicandmetabolicdrugsadvisorycommittee/ucm378079.pdfAccessed November 12, 2013
   Google Scholar
• WildingJPNorwoodPT’joenCA study of dapagliflozin in patients with type 2 diabetes receiving high doses of insulin plus insulin sensitizers: applicability of a novel insulin-independent treatmentDiabetes Care20093291656166219528367
   PubMed Web of Science ®Google Scholar
• ListJFWooVMoralesETangWFiedorekFTSodium-glucose cotransport inhibition with dapagliflozin in type 2 diabetesDiabetes Care200932465065719114612
   PubMed Web of Science ®Google Scholar
• SteinJUrinary tract infections more common in diabetics. Renal and Urology News782013 Available from: http://www.renalandurol-ogynews.com/urinary-tract-infections-more-common-in-diabetics/article/302056Accessed January 13, 2014
   Google Scholar
• Adul-GhaniMADeFronzoRADapagliflozin for the treatment of type 2 diabetesExpert Opin Pharmacother201314121695170323800130
   PubMed Web of Science ®Google Scholar
• KasichayanulaSLiuXZhangWInfluence of hepatic impairment on the pharmacokinetics and safety profile of dapagliflozin: an open-label, parallel group, single-dose studyClin Ther201133111798180822030444
   PubMed Web of Science ®Google Scholar
• KomoroskiBVachharajaniNFengYDapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks in patients with type 2 diabetes mellitusClin Pharmacol Ther200985551351919129749
   PubMed Web of Science ®Google Scholar
• Invokana [package insert]Titusville, NJJanssen Pharmaceuticals2014
   Google Scholar