2024
Comparative Effectiveness of Second-Line Antihyperglycemic Agents for Cardiovascular Outcomes A Multinational, Federated Analysis of LEGEND-T2DM
Khera R, Aminorroaya A, Dhingra L, Thangaraj P, Pedroso Camargos A, Bu F, Ding X, Nishimura A, Anand T, Arshad F, Blacketer C, Chai Y, Chattopadhyay S, Cook M, Dorr D, Duarte-Salles T, DuVall S, Falconer T, French T, Hanchrow E, Kaur G, Lau W, Li J, Li K, Liu Y, Lu Y, Man K, Matheny M, Mathioudakis N, McLeggon J, McLemore M, Minty E, Morales D, Nagy P, Ostropolets A, Pistillo A, Phan T, Pratt N, Reyes C, Richter L, Ross J, Ruan E, Seager S, Simon K, Viernes B, Yang J, Yin C, You S, Zhou J, Ryan P, Schuemie M, Krumholz H, Hripcsak G, Suchard M. Comparative Effectiveness of Second-Line Antihyperglycemic Agents for Cardiovascular Outcomes A Multinational, Federated Analysis of LEGEND-T2DM. Journal Of The American College Of Cardiology 2024, 84: 904-917. PMID: 39197980, DOI: 10.1016/j.jacc.2024.05.069.Peer-Reviewed Original ResearchConceptsGLP-1 RAsSecond-line agentsGLP-1Antihyperglycemic agentsCardiovascular diseaseMACE riskGlucagon-like peptide-1 receptor agonistsSodium-glucose cotransporter 2 inhibitorsPeptide-1 receptor agonistsDipeptidyl peptidase-4 inhibitorsEffects of SGLT2isType 2 diabetes mellitusPeptidase-4 inhibitorsAdverse cardiovascular eventsCox proportional hazards modelsRandom-effects meta-analysisCardiovascular risk reductionTarget trial emulationProportional hazards model
2022
Emulating the GRADE trial using real world data: retrospective comparative effectiveness study
Deng Y, Polley EC, Wallach JD, Dhruva SS, Herrin J, Quinto K, Gandotra C, Crown W, Noseworthy P, Yao X, Lyon TD, Shah ND, Ross JS, McCoy RG. Emulating the GRADE trial using real world data: retrospective comparative effectiveness study. The BMJ 2022, 379: e070717. PMID: 36191949, PMCID: PMC9527635, DOI: 10.1136/bmj-2022-070717.Peer-Reviewed Original ResearchConceptsSecondary outcomesMetformin monotherapyTreatment groupsRetrospective comparative effectiveness studyCox proportional hazards regressionPropensity scoreIncident microvascular complicationsNationwide claims databaseProportional hazards regressionType 2 diabetesComparative effectiveness studiesMacrovascular complicationsMicrovascular complicationsProspective trialAdverse eventsGlycemic controlHospital admissionInsulin glarginePrimary outcomeMedian timeHazards regressionClaims databaseObservational studyInverse propensity scoreEligibility criteria
2021
Physician variation in the de‐adoption of ineffective statin and fibrate therapy
Everhart A, Desai NR, Dowd B, Herrin J, Higuera L, Jeffery MM, Jena AB, Ross JS, Shah ND, Smith LB, Karaca‐Mandic P. Physician variation in the de‐adoption of ineffective statin and fibrate therapy. Health Services Research 2021, 56: 919-931. PMID: 33569804, PMCID: PMC8522575, DOI: 10.1111/1475-6773.13630.Peer-Reviewed Original ResearchMeSH KeywordsAgedDiabetes Mellitus, Type 2Drug Therapy, CombinationDrug UtilizationFemaleFibric AcidsGuideline AdherenceHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypoglycemic AgentsHypolipidemic AgentsLongitudinal StudiesMaleMedicare Part CMiddle AgedPractice Guidelines as TopicPractice Patterns, Physicians'Risk FactorsUnited StatesConceptsMedicare Advantage patientsType 2 diabetic patientsACCORD lipid trialFibrate useAdvantage patientsCommercial patientsPhysician characteristicsLIPID trialFibrate therapyDiabetic patientsPhysician variationDiabetes careType 2 diabetes diagnosisContinuous insurance enrollmentPatient diabetes carePhysician random effectsGlucose-lowering drugsElectronic health record dataHealth record dataReal-world data assetConcurrent statinCardiovascular eventsStatin usersClinical evidenceManagement visitsComparison of Diabetes Medications Used by Adults With Commercial Insurance vs Medicare Advantage, 2016 to 2019
McCoy RG, Van Houten HK, Deng Y, Mandic PK, Ross JS, Montori VM, Shah ND. Comparison of Diabetes Medications Used by Adults With Commercial Insurance vs Medicare Advantage, 2016 to 2019. JAMA Network Open 2021, 4: e2035792. PMID: 33523188, PMCID: PMC7851726, DOI: 10.1001/jamanetworkopen.2020.35792.Peer-Reviewed Original ResearchConceptsSodium-glucose cotransporter 2 inhibitorsDipeptidyl peptidase-4 inhibitorsCommercial insurance beneficiariesMedicare Advantage beneficiariesDPP-4i treatmentGLP-1RAsType 2 diabetesInsurance beneficiariesMedicare AdvantageGlucose levelsGlucagonlike Peptide-1 Receptor AgonistsPeptide-1 receptor agonistsHealth plansCommercial health insurance plansGLP-1RA treatmentRetrospective cohort studyCotransporter 2 inhibitorsInitiation of treatmentPeptidase-4 inhibitorsLow-income patientsSeparate logistic regression modelsAdministrative claims dataCommercial health plansAdjusted annual rateLogistic regression models
2020
Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses
Wallach JD, Wang K, Zhang AD, Cheng D, Grossetta Nardini HK, Lin H, Bracken MB, Desai M, Krumholz HM, Ross JS. Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses. The BMJ 2020, 368: l7078. PMID: 32024657, PMCID: PMC7190063, DOI: 10.1136/bmj.l7078.Peer-Reviewed Original ResearchMeSH KeywordsCardiovascular DiseasesHumansHypoglycemic AgentsInformation DisseminationRandomized Controlled Trials as TopicRisk FactorsRosiglitazoneConceptsIndividual patient-level dataCardiovascular related deathsCardiovascular riskMyocardial infarctionRelated deathsSummary-level dataHeart failureOdds ratioSystematic reviewIncreased cardiovascular riskMore myocardial infarctionsHeart failure eventsCochrane Central RegistryAcute myocardial infarctionMyocardial infarction eventsPatient-level dataRandom-effects modelWeb of ScienceAnalysis of trialsEligible trialsComposite outcomeAdverse eventsContinuity correctionControlled TrialsRosiglitazone treatment
2019
Adoption of New Glucose-Lowering Medications in the U.S.—The Case of SGLT2 Inhibitors: Nationwide Cohort Study
McCoy R, Dykhoff HJ, Sangaralingham L, Ross JS, Karaca-Mandic P, Montori VM, Shah N. Adoption of New Glucose-Lowering Medications in the U.S.—The Case of SGLT2 Inhibitors: Nationwide Cohort Study. Diabetes Technology & Therapeutics 2019, 21: 702-712. PMID: 31418588, PMCID: PMC7207017, DOI: 10.1089/dia.2019.0213.Peer-Reviewed Original ResearchConceptsSodium-glucose cotransporter 2 inhibitorsGlucose-lowering medicationsHeart failureKidney diseaseMyocardial infarctionHigh-quality diabetes careMedicare Advantage insurancePrevalent adverse effectsRenal protective benefitsTreatment-risk paradoxNationwide cohort studyCotransporter 2 inhibitorsGlucose-lowering therapyPrior myocardial infarctionGlucose lowering medicationsChronic diabetes complicationsMultivariable logistic regressionNon-black patientsType 2 diabetesDiabetes type 1Insurance-related factorsCommercial health insuranceAppropriateness of usePrior hypoglycemiaSGLT2i initiation
2017
Association of the FDA Amendment Act with trial registration, publication, and outcome reporting
Phillips AT, Desai NR, Krumholz HM, Zou CX, Miller JE, Ross JS. Association of the FDA Amendment Act with trial registration, publication, and outcome reporting. Trials 2017, 18: 333. PMID: 28720112, PMCID: PMC5516301, DOI: 10.1186/s13063-017-2068-3.Peer-Reviewed Original ResearchConceptsCardiovascular diseaseTRIAL REGISTRATIONFDA approvalNew drugsClinical trial registrationFDA Amendments ActDrug Administration Amendments ActAccessible trial registryClinical trial publicationsTrials RegistryResultsBetween 2005Efficacy trialsFDA reviewersTrial publicationsOutcome reportingMedical literatureReviewer interpretationsTrialsReporting of findingsDiseaseFDA documentsDrugsDiabetesFDAAAReviewers
2016
Trends in Drug Utilization, Glycemic Control, and Rates of Severe Hypoglycemia, 2006–2013
Lipska KJ, Yao X, Herrin J, McCoy RG, Ross JS, Steinman MA, Inzucchi SE, Gill TM, Krumholz HM, Shah ND. Trends in Drug Utilization, Glycemic Control, and Rates of Severe Hypoglycemia, 2006–2013. Diabetes Care 2016, 40: 468-475. PMID: 27659408, PMCID: PMC5360291, DOI: 10.2337/dc16-0985.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedBlood GlucoseComorbidityDiabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsDrug UtilizationFemaleGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInsulinLogistic ModelsMaleMetforminMiddle AgedRetrospective StudiesSulfonylurea CompoundsThiazolidinedionesYoung AdultConceptsGlycemic controlSevere hypoglycemiaOlder patientsDipeptidyl peptidase-4 inhibitorsGlucose-lowering drugsGlucose-lowering medicationsProportion of patientsOverall glycemic controlPeptidase-4 inhibitorsMedicare Advantage patientsSex-standardized ratesType 2 diabetesOverall rateClass of agentsMore comorbiditiesChronic comorbiditiesYounger patientsAdvantage patientsDrug utilizationClaims dataPatientsHypoglycemiaHemoglobin AT2DMComorbiditiesAssociation between payments from manufacturers of pharmaceuticals to physicians and regional prescribing: cross sectional ecological study
Fleischman W, Agrawal S, King M, Venkatesh AK, Krumholz HM, McKee D, Brown D, Ross JS. Association between payments from manufacturers of pharmaceuticals to physicians and regional prescribing: cross sectional ecological study. The BMJ 2016, 354: i4189. PMID: 27540015, PMCID: PMC4989280, DOI: 10.1136/bmj.i4189.Peer-Reviewed Original ResearchConceptsHospital referral regionsOral anticoagulantsReferral regionsDiabetes drugsDrug classesGreater prescribingMedicare Part D beneficiariesAdditional daysPart D beneficiariesMedicare Part D prescriptionsCross-sectional analysisSectional ecological studyMedicare Part DPart D prescriptionsManufacturers of pharmaceuticalsPrescribingAnticoagulantsPhysiciansDrugsPart DEducational materialsSectional analysisStudy limitationsConsulting feesAssociationIntensive Treatment and Severe Hypoglycemia Among Adults With Type 2 Diabetes
McCoy RG, Lipska KJ, Yao X, Ross JS, Montori VM, Shah ND. Intensive Treatment and Severe Hypoglycemia Among Adults With Type 2 Diabetes. JAMA Internal Medicine 2016, 176: 969-78. PMID: 27273792, PMCID: PMC5380118, DOI: 10.1001/jamainternmed.2016.2275.Peer-Reviewed Original ResearchConceptsType 2 diabetesHigh clinical complexityRisk-adjusted probabilitySevere hypoglycemiaIntensive treatmentClinical complexityStandard treatmentIntensive glucose-lowering treatmentEnd-stage renal diseasePatient clinical complexityGlucose-lowering medicationsGlucose-lowering treatmentUse of insulinRisk of hypoglycemiaOptumLabs Data WarehouseAdults 18 yearsSerious chronic conditionsEligible patientsHbA1c levelsRenal diseaseHbA1c testEmergency departmentChronic conditionsPractice guidelinesRetrospective analysis
2015
HbA1c overtesting and overtreatment among US adults with controlled type 2 diabetes, 2001-13: observational population based study
McCoy RG, Van Houten HK, Ross JS, Montori VM, Shah ND. HbA1c overtesting and overtreatment among US adults with controlled type 2 diabetes, 2001-13: observational population based study. The BMJ 2015, 351: h6138. PMID: 26646052, PMCID: PMC4673101, DOI: 10.1136/bmj.h6138.Peer-Reviewed Original ResearchConceptsType 2 diabetesGlycemic controlControlled type 2 diabetesNational administrative claims databaseExcessive testingAdministrative claims databaseGood glycemic controlStable glycemic controlStudy patientsTreatment intensificationSevere hypoglycemiaTreatment regimenStudy cohortUS patientsClaims databasePotential overtreatmentUS cohortHypoglycemic drugsInsulin treatmentPatient burdenRetrospective analysisStudy populationUS adultsDiabetes managementObservational population
2014
Use and Out-of-Pocket Costs of Insulin for Type 2 Diabetes Mellitus From 2000 Through 2010
Lipska KJ, Ross JS, Van Houten HK, Beran D, Yudkin JS, Shah ND. Use and Out-of-Pocket Costs of Insulin for Type 2 Diabetes Mellitus From 2000 Through 2010. JAMA 2014, 311: 2331-2333. PMID: 24915266, PMCID: PMC4133975, DOI: 10.1001/jama.2014.6316.Peer-Reviewed Original Research
2012
State Medicaid Programs Did Not Make Use Of Prior Authorization To Promote Safer Prescribing After Rosiglitazone Warning
Ross JS, Jackevicius C, Krumholz HM, Ridgeway J, Montori VM, Alexander GC, Zerzan J, Fan J, Shah ND. State Medicaid Programs Did Not Make Use Of Prior Authorization To Promote Safer Prescribing After Rosiglitazone Warning. Health Affairs 2012, 31: 188-198. PMID: 22232110, PMCID: PMC3319744, DOI: 10.1377/hlthaff.2011.1068.Peer-Reviewed Original ResearchMeSH KeywordsGatekeepingHumansHypoglycemic AgentsMedicaidPrescriptionsRosiglitazoneState GovernmentThiazolidinedionesUnited StatesConceptsState Medicaid programsPreferred drugDrug listPrior authorizationMedicaid programSafety warningsPrior authorization programHigh-cost drugsDiabetes medicationsPrescribing ratesEffective prescribingSafe prescribingMedicaid beneficiariesDiabetes drugsPrescribingState MedicaidHeart attackRosiglitazoneDrug availabilityDrugsAuthorization programPrescriptionMinimal changesMedicationsProviders
2011
Switching From Rosiglitazone: Thinking Outside the Class
Lipska KJ, Ross JS. Switching From Rosiglitazone: Thinking Outside the Class. JAMA 2011, 305: 820-821. PMID: 21304068, DOI: 10.1001/jama.2011.193.Commentaries, Editorials and Letters