56
Views
5
CrossRef citations to date
0
Altmetric
Original Research

Clinical trial simulation methods for estimating the impact of DPP-4 inhibitors on cardiovascular disease

, &
Pages 313-323 | Published online: 05 Jun 2015

References

  • ConcatoJShahNHorwitzRIRandomized, controlled trials, observational studies, and the hierarchy of research designsN Engl J Med2000342251887189210861325
  • Food and Drug Administration Center for Drug Evaluation and Research (CDER)Guidance for Industry Diabetes Mellitus – Evaluating, Cardiovascular Risk in New, Antidiabetic Therapies to Treat Type 2 DiabetesSilver Spring, MD, USAFood and Drug Administration, Center for Drug Evaluation and Research (CDER)2008
  • ByarDPSimonRMFriedewaldWTRandomized clinical trials. Perspectives on some recent ideasN Engl J Med197629527480775331
  • ChanKEThadhaniRLazarusJMHakimRMModeling the 4D Study: statins and cardiovascular outcomes in long-term hemodialysis patients with diabetesClin J Am Soc Nephrol20105585686620338963
  • GerschWEddyDMDongEJrCardia arrhythmia classification: a heart-beat interval-Markov chain approachComput Biomed Res1970343853925471354
  • EddyDMSchlessingerLKahnRClinical outcomes and cost-effectiveness of strategies for managing people at high risk for diabetesAnn Intern Med2005143425126416103469
  • ClarkePMGrayAMBriggsAA model to estimate the lifetime health outcomes of patients with type 2 diabetes: the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model (UKPDS no 68)Diabetologia200447101747175915517152
  • HayesAJLealJGrayAMHolmanRRClarkePMUKPDS outcomes model 2: a new version of a model to simulate lifetime health outcomes of patients with type 2 diabetes mellitus using data from the 30 year United Kingdom Prospective Diabetes Study: UKPDS 82Diabetologia20135691925193323793713
  • KengneAPPatelAColagiuriSThe Framingham and UK Prospective Diabetes Study (UKPDS) risk equations do not reliably estimate the probability of cardiovascular events in a large ethnically diverse sample of patients with diabetes: the Action in Diabetes and Vascular Disease: Preterax and Diamicron-MR Controlled Evaluation (ADVANCE) StudyDiabetologia201053582183120157695
  • PalmerAJRozeSValentineWJThe CORE Diabetes Model: projecting long-term clinical outcomes, costs and cost-effectiveness of interventions in diabetes mellitus (types 1 and 2) to support clinical and reimbursement decision-makingCurr Med Res Opin200420Suppl 1S5S2615324513
  • PalmerAJRozeSValentineWJValidation of the CORE Diabetes Model against epidemiological and clinical studiesCurr Med Res Opin200420Suppl 1S27S4015324514
  • Michigan Model for Diabetes2009 Available from: http://www.med.umich.edu/mdrtc/cores/DiseaseModel/model.htmAccessed April 1, 2015
  • BarhakJIsamanDJYeWLeeDChronic disease modeling and simulation softwareJ Biomed Inform201043579179920558320
  • GrantDFoosVPalmerJLloydAEvansMMcEwanPLong-term validation of the IMS CORE Diabetes Model in Type 1 and Type 2 diabetesPresented at: The 72nd Scientific Sessions of the American Diabetes Association (ADA)June 8–12, 2012Philadelphia, PA, USA
  • WannerCKraneVRufGMarzWRitzERationale and design of a trial improving outcome of type 2 diabetics on hemodialysis. Die Deutsche Diabetes Dialyse Studie InvestigatorsKidney Int Suppl199971S222S22610412782
  • TuttleKRCharting new territory by simulated modeling of a clinical trialClin J Am Soc Nephrol20105575075220360306
  • SciricaBMBhattDLBraunwaldEThe design and rationale of the saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI) 53 studyAm Heart J20111625818825.e81622093196
  • SciricaBMBhattDLBraunwaldESaxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitusN Engl J Med2013369141317132623992601
  • EddyDMSchlessingerLValidation of the Archimedes diabetes modelDiabetes Care200326113102311014578246
  • EddyDMSchlessingerLArchimedes: a trial-validated model of diabetesDiabetes Care200326113093310114578245
  • ArchimedesIncHealthcare ModelingSan Francisco, CAArchimedes, Inc Available from: http://archimedesmodel.com/Accessed April 1, 2015
  • SchlessingerLEddyDMArchimedes: a new model for simulating health care systems – the mathematical formulationJ Biomed Inform2002351375012415725
  • SchuetzCAvan HerickAAlperinPPeskinBHsiaJGandhiSComparing the effectiveness of rosuvastatin and atorvastatin in preventing cardiovascular outcomes: estimates using the Archimedes modelJ Med Econ20121561118112922712873
  • van HerickASchuetzCAAlperinPBullanoMFBaluSGandhiSThe impact of initial statin treatment decisions on cardiovascular outcomes in clinical care settings: estimates using the Archimedes ModelClinicoecon Outcomes Res2012433734723180970
  • MosenzonORazISciricaBMBaseline characteristics of the patient population in the Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes mellitus (SAVOR)-TIMI 53 trialDiabetes Metab Res Rev201329541742623564755
  • EspositoKChiodiniPBellastellaGMaiorinoMIGiuglianoDProportion of patients at HbA1c target <7% with eight classes of antidiabetic drugs in type 2 diabetes: systematic review of 218 randomized controlled trials with 78 945 patientsDiabetes Obes Metab201214322823321958121
  • AltmanDGAndersenPKCalculating the number needed to treat for trials where the outcome is time to an eventBMJ199931972231492149510582940
  • MonamiMLamannaCDesideriCMMannucciEDPP-4 inhibitors and lipids: systematic review and meta-analysisAdv Ther2012291142522215383
  • WhiteWBCannonCPHellerSRAlogliptin after acute coronary syndrome in patients with type 2 diabetesN Engl J Med2013369141327133523992602
  • WeirDLMcAlisterFASenthilselvanAMinhas-SandhuJKEurichDTSitagliptin use in patients with diabetes and heart failure: a population-based retrospective cohort studyJACC Heart Fail20142657358224998080