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
Large-scale evidence generation and evaluation across a network of databases for type 2 diabetes mellitus (LEGEND-T2DM): a protocol for a series of multinational, real-world comparative cardiovascular effectiveness and safety studies
Khera R, Schuemie MJ, Lu Y, Ostropolets A, Chen R, Hripcsak G, Ryan PB, Krumholz HM, Suchard MA. Large-scale evidence generation and evaluation across a network of databases for type 2 diabetes mellitus (LEGEND-T2DM): a protocol for a series of multinational, real-world comparative cardiovascular effectiveness and safety studies. BMJ Open 2022, 12: e057977. PMID: 35680274, PMCID: PMC9185490, DOI: 10.1136/bmjopen-2021-057977.Peer-Reviewed Original ResearchConceptsLarge-scale Evidence GenerationType 2 diabetes mellitusCardiovascular effectivenessDiabetes mellitusSafety outcomesGlucagon-like peptide-1 receptor agonistsSodium-glucose co-transporter-2 inhibitorsMajor adverse cardiovascular eventsNew-user cohort designPeptide-1 receptor agonistsDipeptidyl peptidase-4 inhibitorsSafety studiesAdverse cardiovascular eventsPrimary cardiovascular outcomePeptidase-4 inhibitorsAnti-hyperglycaemic agentsElectronic health record data sourcesEvidence generationCardiovascular eventsCardiovascular outcomesCardiovascular riskActive comparatorTherapeutic optionsReceptor agonistDrug comparisons
2021
Patterns of Prescribing Sodium-Glucose Cotransporter-2 Inhibitors for Medicare Beneficiaries in the United States
Sangha V, Lipska K, Lin Z, Inzucchi SE, McGuire DK, Krumholz HM, Khera R. Patterns of Prescribing Sodium-Glucose Cotransporter-2 Inhibitors for Medicare Beneficiaries in the United States. Circulation Cardiovascular Quality And Outcomes 2021, 14: e008381. PMID: 34779654, PMCID: PMC9022137, DOI: 10.1161/circoutcomes.121.008381.Peer-Reviewed Original ResearchConceptsType 2 diabetesMedicare beneficiariesSodium-glucose cotransporter 2 inhibitorsLarge randomized clinical trialsMedicare Part D prescriber dataChronic kidney diseaseCotransporter 2 inhibitorsAtherosclerotic cardiovascular diseasePercent of cliniciansRandomized clinical trialsUS Medicare beneficiariesAdvanced practice providersCross-sectional studyKidney outcomesSGLT2i useSulfonylurea prescriptionUnique cliniciansCardiovascular deathMedication classesKidney diseaseLabel indicationsClinical trialsSGLT2iCardiovascular diseasePractice providers
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
Effects of Mobile Text Messaging on Glycemic Control in Patients With Coronary Heart Disease and Diabetes Mellitus
Huo X, Krumholz HM, Bai X, Spatz ES, Ding Q, Horak P, Zhao W, Gong Q, Zhang H, Yan X, Sun Y, Liu J, Wu X, Guan W, Wang X, Li J, Li X, Spertus JA, Masoudi FA, Zheng X. Effects of Mobile Text Messaging on Glycemic Control in Patients With Coronary Heart Disease and Diabetes Mellitus. Circulation Cardiovascular Quality And Outcomes 2019, 12: e005805. PMID: 31474119, DOI: 10.1161/circoutcomes.119.005805.Peer-Reviewed Original ResearchMeSH KeywordsAgedAsian PeopleBiomarkersBlood GlucoseChinaCoronary DiseaseCulturally Competent CareDiabetes MellitusExerciseFemaleGlycated HemoglobinHealth CommunicationHealthy LifestyleHumansHypoglycemic AgentsMaleMedication AdherenceMiddle AgedMotivationPatient Education as TopicRisk Reduction BehaviorSelf CareSingle-Blind MethodTelemedicineText MessagingTime FactorsTreatment OutcomeConceptsCoronary heart diseaseHeart diseaseGlycemic controlIntervention groupUsual careDiabetes mellitusBlood glucosePhysical activityControl groupText message-based interventionBlood pressure controlProportion of patientsRisk factor managementGood glycemic controlSystolic blood pressureBody mass indexText messaging programsText message interventionMobile health interventionsSecondary outcomesBlood pressurePrimary outcomeLDL cholesterolMass indexMedication adherence
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 documentsDrugsDiabetesFDAAAReviewersIs Hemoglobin A1c the Right Outcome for Studies of Diabetes?
Lipska KJ, Krumholz HM. Is Hemoglobin A1c the Right Outcome for Studies of Diabetes? JAMA 2017, 317: 1017-1018. PMID: 28125758, PMCID: PMC5350060, DOI: 10.1001/jama.2017.0029.Commentaries, Editorials and Letters
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 feesAssociationPolypharmacy in the Aging Patient: A Review of Glycemic Control in Older Adults With Type 2 Diabetes
Lipska KJ, Krumholz H, Soones T, Lee SJ. Polypharmacy in the Aging Patient: A Review of Glycemic Control in Older Adults With Type 2 Diabetes. JAMA 2016, 315: 1034-1045. PMID: 26954412, PMCID: PMC4823136, DOI: 10.1001/jama.2016.0299.BooksConceptsRandomized clinical trialsIntensive glycemic controlGlycemic controlClinical trialsOlder adultsMicrovascular outcomesTreatment burdenPatient preferencesMost RCTsLarge randomized clinical trialsType 2 diabetes mellitusMajor macrovascular eventsStandard glycemic controlOptimal glycemic controlLower treatment burdenSurrogate end pointsHigh-quality evidenceType 2 diabetesLikelihood of benefitMajority of adultsGlycemic treatmentMacrovascular eventsDiabetes mellitusPatient factorsAging Patient
2014
Comparing Diabetes Medications: Where Do We Set the Bar?
Lipska KJ, Krumholz HM. Comparing Diabetes Medications: Where Do We Set the Bar? JAMA Internal Medicine 2014, 174: 317-318. PMID: 24366351, PMCID: PMC5459364, DOI: 10.1001/jamainternmed.2013.13433.Commentaries, Editorials and Letters
2012
Discontinuation of Antihyperglycemic Therapy After Acute Myocardial Infarction: Medical Necessity or Medical Error?
Lovig KO, Horwitz L, Lipska K, Kosiborod M, Krumholz HM, Inzucchi SE. Discontinuation of Antihyperglycemic Therapy After Acute Myocardial Infarction: Medical Necessity or Medical Error? The Joint Commission Journal On Quality And Patient Safety 2012, 38: 403-407. PMID: 23002492, PMCID: PMC3534988, DOI: 10.1016/s1553-7250(12)38051-3.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionLeft ventricular ejection fractionAntihyperglycemic therapyDiabetic patientsMyocardial infarctionMedical necessityOne-year mortalityDetailed chart reviewVentricular ejection fractionIschemic heart diseaseNational Medicare databaseMedical errorsAcademic medical centerQuality improvement opportunitiesChart reviewClinical characteristicsOlder patientsRecurrent hypoglycemiaEjection fractionMedicare databaseBlood glucoseHeart diseasePrincipal diagnosisCommunity hospitalMedical CenterRole of Intensive Glucose Control in Development of Renal End Points in Type 2 Diabetes Mellitus: Systematic Review and Meta-analysis
Coca SG, Ismail-Beigi F, Haq N, Krumholz HM, Parikh CR. Role of Intensive Glucose Control in Development of Renal End Points in Type 2 Diabetes Mellitus: Systematic Review and Meta-analysis. JAMA Internal Medicine 2012, 172: 761-769. PMID: 22636820, PMCID: PMC3688081, DOI: 10.1001/archinternmed.2011.2230.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedBlood GlucoseDiabetes Mellitus, Type 2Diabetic NephropathiesDisease ProgressionFemaleGlycated HemoglobinHumansHypoglycemic AgentsKidney Failure, ChronicKidney Function TestsMaleMiddle AgedMonitoring, PhysiologicPrognosisRandomized Controlled Trials as TopicRenal DialysisRisk AssessmentSeverity of Illness IndexConceptsIntensive glucose controlRenal end pointsSerum creatinine levelsConventional glucose controlGlucose controlType 2 diabetesRenal diseaseCreatinine levelsEnd pointGlycemic controlSystematic reviewType 2 diabetes mellitusAggressive glycemic controlClinical renal outcomesKidney-related outcomesIntensive glycemic controlRenal outcomesCumulative incidenceDiabetes mellitusRandomized trialsConventional therapyLanguage restrictionsMacroalbuminuriaMicroalbuminuriaType 2State 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
Use of GLP-1 analogues needs great caution
Yudkin JS, Lehman R, Krumholz HM. Use of GLP-1 analogues needs great caution. The BMJ 2011, 342: d1478. PMID: 21385813, DOI: 10.1136/bmj.d1478.Peer-Reviewed Original Research
2010
Responding to an FDA Warning — Geographic Variation in the Use of Rosiglitazone
Shah ND, Montori VM, Krumholz HM, Tu K, Alexander GC, Jackevicius CA. Responding to an FDA Warning — Geographic Variation in the Use of Rosiglitazone. New England Journal Of Medicine 2010, 363: 2081-2084. PMID: 21083379, DOI: 10.1056/nejmp1011042.Peer-Reviewed Original ResearchLicensing drugs for diabetes
Lehman R, Yudkin JS, Krumholz H. Licensing drugs for diabetes. The BMJ 2010, 341: c4805. PMID: 20819887, DOI: 10.1136/bmj.c4805.Peer-Reviewed Original ResearchDiscontinuation of Antihyperglycemic Therapy and Clinical Outcomes After Acute Myocardial Infarction in Older Patients With Diabetes
Lipska KJ, Wang Y, Kosiborod M, Masoudi FA, Havranek EP, Krumholz HM, Inzucchi SE. Discontinuation of Antihyperglycemic Therapy and Clinical Outcomes After Acute Myocardial Infarction in Older Patients With Diabetes. Circulation Cardiovascular Quality And Outcomes 2010, 3: 236-242. PMID: 20354220, DOI: 10.1161/circoutcomes.109.887620.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionAntihyperglycemic therapyAntihyperglycemic agentsOlder patientsMyocardial infarctionMortality rateMultivariable Cox proportional hazards modelsCox proportional hazards modelFrequency of discontinuationGlucose-lowering agentsGlucose-lowering therapyInclusion/exclusion criteriaProportional hazards modelYear of dischargeHigh mortality rateDiabetic regimenFirst rehospitalizationReadmission ratesSecondary outcomesHeart failurePrimary outcomeClinical outcomesMultivariable analysisRetrospective studyIndependent associationA Perspective on the American Heart Association/American College of Cardiology Science Advisory on Thiazolidinedione Drugs and Cardiovascular Risks
Krumholz HM. A Perspective on the American Heart Association/American College of Cardiology Science Advisory on Thiazolidinedione Drugs and Cardiovascular Risks. Circulation Cardiovascular Quality And Outcomes 2010, 3: 221-222. PMID: 20181986, DOI: 10.1161/circoutcomes.110.936070.Peer-Reviewed Original ResearchNo to QOF target of less than 7%, again
Lehman R, Krumholz HM. No to QOF target of less than 7%, again. The BMJ 2010, 340: c985. PMID: 20179124, DOI: 10.1136/bmj.c985.Peer-Reviewed Original Research