2024
Kidney Outcomes with GLP-1RAs, SGLT2 Inhibitors, DPP-4 Inhibitors, and Sulfonylureas in Type 2 Diabetes and Moderate Cardiovascular Risk
Neumiller J, Herrin J, Swarna K, Polley E, Galindo R, Umpierrez G, Deng Y, Ross J, Mickelson M, McCoy R. Kidney Outcomes with GLP-1RAs, SGLT2 Inhibitors, DPP-4 Inhibitors, and Sulfonylureas in Type 2 Diabetes and Moderate Cardiovascular Risk. Clinical Journal Of The American Society Of Nephrology 2024 DOI: 10.2215/cjn.0000000587.Peer-Reviewed Original ResearchSodium-glucose co-transporter 2 inhibitorsGlucagon-like peptide-1 receptor agonistsSodium-glucose co-transporter 2Dipeptidyl peptidase-4 inhibitorsGlucagon-like peptide-1Dipeptidyl peptidase-4Receptor agonistsPrimary composite outcomeKidney replacement therapyChronic kidney diseaseComposite outcomeSecondary composite outcomeType 2 diabetesGLP-1 receptor agonist therapyCVD riskCardiovascular diseaseModerate CVD riskPrescribed glucose-lowering agentsBaseline CVD riskHigh-risk patientsAssociated with risk reductionCKD stage 3Retrospective observational studyGlucose-lowering agentsModerate cardiovascular riskComparative 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 modelEffectiveness of glucose-lowering medications on cardiovascular outcomes in patients with type 2 diabetes at moderate cardiovascular risk
McCoy R, Herrin J, Swarna K, Deng Y, Kent D, Ross J, Umpierrez G, Galindo R, Crown W, Borah B, Montori V, Brito J, Neumiller J, Mickelson M, Polley E. Effectiveness of glucose-lowering medications on cardiovascular outcomes in patients with type 2 diabetes at moderate cardiovascular risk. Nature Cardiovascular Research 2024, 3: 431-440. PMID: 38846711, PMCID: PMC11156225, DOI: 10.1038/s44161-024-00453-9.Peer-Reviewed Original ResearchAdverse cardiovascular eventsGlucose-lowering medicationsType 2 diabetesCardiovascular diseaseGLP-1RACardiovascular eventsGlucagon-like peptide-1 receptor agonistsSodium-glucose cotransporter 2 inhibitorsPeptide-1 receptor agonistsDipeptidyl peptidase-4 inhibitorsPeptidase-4 inhibitorsRetrospective cohort studyCardiovascular disease risk reductionGlucose-lowering agentsModerate cardiovascular riskCardiovascular risk reductionReceptor agonistsEffects of glucose-lowering medicationsRisk reductionCardiovascular riskCohort studyCardiovascular outcomesHigh riskBaseline riskModerate riskDerivation of an Annualized Claims-Based Major Adverse Cardiovascular Event Estimator in Type 2 Diabetes
McCoy R, Swarna K, Deng Y, Herrin J, Ross J, Kent D, Borah B, Crown W, Montori V, Umpierrez G, Galindo R, Brito J, Mickelson M, Polley E. Derivation of an Annualized Claims-Based Major Adverse Cardiovascular Event Estimator in Type 2 Diabetes. JACC Advances 2024, 3: 100852. PMID: 38939660, PMCID: PMC11198625, DOI: 10.1016/j.jacadv.2024.100852.Peer-Reviewed Original ResearchType 2 diabetesMedicare fee-for-service planClaims-based prediction modelPopulation risk stratificationRisk of Major Adverse Cardiovascular EventsMajor adverse cardiovascular eventsNon-Hispanic whitesFee-for-service plansStudy cohortClinical trials of cardiovascular diseaseCox proportional hazards modelsProportional hazards modelCare populationHealth systemPrimary preventionMedicare AdvantageParticipant identificationPayer levelPharmacy claimsDecentralized clinical trialsHazards modelCardiovascular diseaseRisk predictionMedicarePatient population
2023
Multinational patterns of second line antihyperglycaemic drug initiation across cardiovascular risk groups: federated pharmacoepidemiological evaluation in LEGEND-T2DM
Khera R, Dhingra L, Aminorroaya A, Li K, Zhou J, Arshad F, Blacketer C, Bowring M, Bu F, Cook M, Dorr D, Duarte-Salles T, DuVall S, Falconer T, French T, Hanchrow E, Horban S, Lau W, Li J, Liu Y, Lu Y, Man K, Matheny M, Mathioudakis N, McLemore M, Minty E, Morales D, Nagy P, Nishimura A, Ostropolets A, Pistillo A, Posada J, Pratt N, Reyes C, Ross J, Seager S, Shah N, Simon K, Wan E, Yang J, Yin C, You S, Schuemie M, Ryan P, Hripcsak G, Krumholz H, Suchard M. Multinational patterns of second line antihyperglycaemic drug initiation across cardiovascular risk groups: federated pharmacoepidemiological evaluation in LEGEND-T2DM. BMJ Medicine 2023, 2: e000651. PMID: 37829182, PMCID: PMC10565313, DOI: 10.1136/bmjmed-2023-000651.Peer-Reviewed Original ResearchType 2 diabetes mellitusSecond-line treatmentCardiovascular risk groupsDiabetes mellitusCardiovascular diseaseAntihyperglycaemic drugsLine treatmentRisk groupsObservational Health Data SciencesGlucagon-like peptide-1 receptor agonistsElectronic health recordsSodium-glucose cotransporter 2 inhibitorsCalendar year trendsPeptide-1 receptor agonistsUS databaseOutcomes of patientsCotransporter 2 inhibitorsAdministrative claims databaseSecond-line drugsHealth recordsSodium-glucose cotransporter-2 inhibitorsMedication useMetformin monotherapyGuideline recommendationsOutcome measures
2021
Real-world Cardiovascular Outcomes Associated With Degarelix vs Leuprolide for Prostate Cancer Treatment
Wallach JD, Deng Y, McCoy RG, Dhruva SS, Herrin J, Berkowitz A, Polley EC, Quinto K, Gandotra C, Crown W, Noseworthy P, Yao X, Shah ND, Ross JS, Lyon TD. Real-world Cardiovascular Outcomes Associated With Degarelix vs Leuprolide for Prostate Cancer Treatment. JAMA Network Open 2021, 4: e2130587. PMID: 34677594, PMCID: PMC8536955, DOI: 10.1001/jamanetworkopen.2021.30587.Peer-Reviewed Original ResearchConceptsMajor adverse cardiovascular eventsSecondary end pointsMyocardial infarctionClinical trialsCardiovascular diseaseProstate cancerCardiovascular eventsEnd pointRisk of MACELarge US administrative claims databasePropensity-matched cohort studyUS administrative claims databasePropensity score-matched patientsAdverse cardiovascular eventsPrimary end pointAdministrative claims databaseProportional hazards regressionRandomized clinical trialsAdministrative claims dataTrial eligibility criteriaMedicare Advantage beneficiariesProstate cancer treatmentReal-world evidenceElectronic health recordsCardiovascular outcomesSecond-Line Therapy for Type 2 Diabetes Management: The Treatment/Benefit Paradox of Cardiovascular and Kidney Comorbidities.
McCoy RG, Van Houten HK, Karaca-Mandic P, Ross JS, Montori VM, Shah ND. Second-Line Therapy for Type 2 Diabetes Management: The Treatment/Benefit Paradox of Cardiovascular and Kidney Comorbidities. Diabetes Care 2021, 44: 2302-2311. PMID: 34348996, PMCID: PMC8929191, DOI: 10.2337/dc20-2977.Peer-Reviewed Original ResearchSodium-glucose cotransporter 2 inhibitorsGLP-1RAsHeart failureRelative risk ratiosDPP-4iMyocardial infarctionOlder patientsCerebrovascular diseaseCardiovascular diseaseGlucagon-like peptide-1 receptor agonistsPeptide-1 receptor agonistsDipeptidyl peptidase-4 inhibitorsType 2 diabetes managementDPP-4i therapySecond-line therapyCotransporter 2 inhibitorsPrior myocardial infarctionPeptidase-4 inhibitorsOptumLabs Data WarehouseType 2 diabetesMedicare Advantage beneficiariesMedication classesSGLT2i therapyClinical factorsRisk ratio
2018
Affordability and availability of off-patent drugs in the United States—the case for importing from abroad: observational study
Gupta R, Bollyky TJ, Cohen M, Ross JS, Kesselheim AS. Affordability and availability of off-patent drugs in the United States—the case for importing from abroad: observational study. The BMJ 2018, 360: k831. PMID: 29555641, PMCID: PMC5858606, DOI: 10.1136/bmj.k831.Peer-Reviewed Original ResearchConceptsOff-patent drugsObservational studyRare diseasePrescription drugsPatent drugsStudy drugTotal Medicaid spendingCardiovascular diseaseOrphan drug designationPsychiatric diseasesDrug AdministrationPatient accessInfectious diseasesDiseaseDrug characteristicsEssential medicinesDrugsGeneric versionsGeneric drugsMedicaid spendingNovel tabletRegulatory agenciesFDAUnited StatesTreatment area
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
2011
US Cardiologist Workforce From 1995 To 2007: Modest Growth, Lasting Geographic Maldistribution Especially In Rural Areas
Aneja S, Ross JS, Wang Y, Matsumoto M, Rodgers GP, Bernheim SM, Rathore SS, Krumholz HM. US Cardiologist Workforce From 1995 To 2007: Modest Growth, Lasting Geographic Maldistribution Especially In Rural Areas. Health Affairs 2011, 30: 2301-2309. PMID: 22147857, PMCID: PMC3332098, DOI: 10.1377/hlthaff.2011.0255.Peer-Reviewed Original ResearchConceptsPrimary care physiciansCare physiciansGeographic maldistributionChronic cardiovascular diseaseHospital referral regionsUse of telemedicineCardiology workforceNumber of cardiologistsTotal physician workforceCardiovascular diseaseCardiovascular careReferral regionsElderly populationUS populationTotal physiciansCardiologistsPhysiciansAge sixtyPhysician workforceDisadvantaged areasPercentRural areasPopulationDiseaseVariety of strategiesPrevalence of Inadequate Blood Pressure Control Among Veterans After Acute Ischemic Stroke Hospitalization
Roumie CL, Ofner S, Ross JS, Arling G, Williams LS, Ordin DL, Bravata DM. Prevalence of Inadequate Blood Pressure Control Among Veterans After Acute Ischemic Stroke Hospitalization. Circulation Cardiovascular Quality And Outcomes 2011, 4: 399-407. PMID: 21693725, PMCID: PMC3140571, DOI: 10.1161/circoutcomes.110.959809.Peer-Reviewed Original ResearchConceptsBP controlBlood pressureIschemic strokeStroke patientsLower oddsAcute ischemic stroke hospitalizationsInadequate blood pressure controlHistory of hypertensionPercent of patientsBlood pressure controlElevated blood pressureSystolic blood pressureIschemic stroke hospitalizationsYears of ageHypertension careHypertension historyDischarge dispositionStroke eventsIndex eventStroke hospitalizationsBlack raceBP valuesCardiovascular diseaseNational guidelinesPatients
2010
Beyond insurance coverage: Usual source of care in the treatment of hypertension and hypercholesterolemia. Data from the 2003-2006 National Health and Nutrition Examination Survey
Spatz ES, Ross JS, Desai MM, Canavan ME, Krumholz HM. Beyond insurance coverage: Usual source of care in the treatment of hypertension and hypercholesterolemia. Data from the 2003-2006 National Health and Nutrition Examination Survey. American Heart Journal 2010, 160: 115-121. PMID: 20598981, PMCID: PMC3025407, DOI: 10.1016/j.ahj.2010.04.013.Peer-Reviewed Original ResearchConceptsTreatment of hypertensionNutrition Examination SurveyInsurance statusMedication treatmentExamination SurveyNational HealthUsual sourceAdult Treatment Panel III recommendationsJoint National Committee 7Multivariable logistic regression modelingInsurance coverageSeparate multivariable modelsChronic disease managementLogistic regression modelingHigh-quality careRace/ethnicityCardiovascular diseaseMultivariable modelStratified analysisHypertensionHypercholesterolemiaRegular sourceCareDisease managementIndependent effects