2024
Association between growth differentiation factor-15 and adverse outcomes among patients with heart failure: A systematic literature review
Javaheri A, Ozcan M, Moubarak L, Smoyer K, Rossulek M, Revkin J, Groarke J, Tarasenko L, Kosiborod M. Association between growth differentiation factor-15 and adverse outcomes among patients with heart failure: A systematic literature review. Heliyon 2024, 10: e35916. PMID: 39229539, PMCID: PMC11369438, DOI: 10.1016/j.heliyon.2024.e35916.Peer-Reviewed Original ResearchGDF-15 concentrationsGrowth differentiation factor 15Differentiation factor 15GDF-15Heart failureMultivariate analysisRenal functionComposite outcomeAdverse outcomesOptimal treatment regimensPredictors of mortalityCardiovascular-related mortalityCross-sectional studyPrognostic roleTreatment regimensClinical risk prediction modelsPoor outcomeRisk prediction modelExercise capacityEligibility criteriaPatientsPRISMA guidelinesMortalityNonfatal outcomesOutcomesThe mortality burden of cachexia or weight loss in patients with colorectal or pancreatic cancer: A systematic literature review
Dunne R, Crawford J, Smoyer K, McRae T, Rossulek M, Revkin J, Tarasenko L, Bonomi P. The mortality burden of cachexia or weight loss in patients with colorectal or pancreatic cancer: A systematic literature review. Journal Of Cachexia Sarcopenia And Muscle 2024, 15: 1628-1640. PMID: 39095951, PMCID: PMC11446707, DOI: 10.1002/jcsm.13510.Peer-Reviewed Original ResearchWeight loss categoriesSystematic literature reviewPancreatic cancerColorectal cancerAssessment of weight changeStatistically significant poorer survivalLoss categoriesUnintentional weight lossRisk of cachexiaWeight lossPoor survivalInternational consensusAssociated with significantly poorer survivalMortality burdenLiterature reviewEligibility criteriaPRISMA guidelinesCancer-associated cachexiaColorectalProgressive functional impairmentClinical practiceFunctional impairmentWasting disordersPoor prognosisWeight changeMortality burden of pre‐treatment weight loss in patients with non‐small‐cell lung cancer: A systematic literature review and meta‐analysis
Bonomi P, Crawford J, Dunne R, Roeland E, Smoyer K, Siddiqui M, McRae T, Rossulek M, Revkin J, Tarasenko L. Mortality burden of pre‐treatment weight loss in patients with non‐small‐cell lung cancer: A systematic literature review and meta‐analysis. Journal Of Cachexia Sarcopenia And Muscle 2024, 15: 1226-1239. PMID: 38650388, PMCID: PMC11294038, DOI: 10.1002/jcsm.13477.Peer-Reviewed Original ResearchNon-small-cell lung cancerInternational consensus criteriaHazard ratioStatistical heterogeneityMeta-analysisWeight lossLung cancerSubgroup analysisPre-treatment weight lossAssociated with inferior survivalImpact of cachexiaKaplan-Meier curvesRandom-effects modelInferior survivalOverall survivalWorse survivalSurvival outcomesHigher mortality riskAdult patientsPoor prognosisClinical decision-makingClinical trialsMultivariate analysisCachexiaIndependent reviewers screened titlesPhase 2 study of the efficacy and safety of ponsegromab in patients with cancer cachexia: PROACC‐1 study design
Groarke J, Crawford J, Collins S, Lubaczewski S, Breen D, Harrington M, Jacobs I, Qiu R, Revkin J, Rossulek M, Saxena A. Phase 2 study of the efficacy and safety of ponsegromab in patients with cancer cachexia: PROACC‐1 study design. Journal Of Cachexia Sarcopenia And Muscle 2024, 15: 1054-1061. PMID: 38500292, PMCID: PMC11154777, DOI: 10.1002/jcsm.13435.Peer-Reviewed Original ResearchPhysical activityPhysical functionPhase 2 studyCancer cachexiaGDF-15 concentrationsGDF-15Unintentional loss of weightLumbar skeletal muscle indexQuality of lifeSkeletal muscle indexBiomarker of cancer cachexiaNon-small-cell lungIncidence of adverse eventsResponse Evaluation CriteriaGrowth differentiation factor 15Safety laboratory testsOpen-label treatmentPlacebo-controlled studyCharacteristics of cachexiaCancer-related cachexiaMetabolic wasting syndromeHuman monoclonal antibodyCancer-relatedDifferentiation factor 15Phase 1 data
2023
A Phase 1b First-In-Patient Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ponsegromab in Participants with Cancer and Cachexia
Crawford J, Calle R, Collins S, Weng Y, Lubaczewski S, Buckeridge C, Wang E, Harrington M, Tarachandani A, Rossulek M, Revkin J. A Phase 1b First-In-Patient Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ponsegromab in Participants with Cancer and Cachexia. Clinical Cancer Research 2023, 30: 489-497. PMID: 37982848, PMCID: PMC10831332, DOI: 10.1158/1078-0432.ccr-23-1631.Peer-Reviewed Original ResearchThe mortality burden of cachexia in patients with non-small cell lung cancer: A meta-analysis.
Bonomi P, Crawford J, Dunne R, Roeland E, Smoyer K, Siddiqui M, McRae T, Rossulek M, Revkin J, Tarasenko L. The mortality burden of cachexia in patients with non-small cell lung cancer: A meta-analysis. Journal Of Clinical Oncology 2023, 41: e24075-e24075. DOI: 10.1200/jco.2023.41.16_suppl.e24075.Peer-Reviewed Original ResearchNon-small cell lung cancerInternational consensus criteriaCell lung cancerOverall survivalSubgroup analysisWeight lossLung cancerStatistical heterogeneityTreatment of NSCLCInferior overall survivalImpact of cachexiaRisk of mortalityFunnel plot analysisHigher mortality riskPrevious weight lossHigh statistical heterogeneitySystematic literature reviewRandom-effects modelBase-case analysisSubstantial publication biasMeta-analysis resultsPoor outcomeMortality burdenCachexiaMortality riskPhase 2 study to assess the efficacy, safety, and tolerability of the GDF-15 inhibitor ponsegromab in patients with cancer cachexia.
Crawford J, Lubaczewski S, Tarachandani A, Harrington M, Weng Y, Qiu R, Collins S, Rossulek M, Revkin J. Phase 2 study to assess the efficacy, safety, and tolerability of the GDF-15 inhibitor ponsegromab in patients with cancer cachexia. Journal Of Clinical Oncology 2023, 41: tps12147-tps12147. DOI: 10.1200/jco.2023.41.16_suppl.tps12147.Peer-Reviewed Original ResearchGDF-15 concentrationsCancer cachexiaPhysical activityBody weightSelective humanized monoclonal antibodyNon-small cell lungGrowth differentiation factor 15Double-blind periodMultifactorial metabolic syndromeSafety laboratory testsUnintended weight lossWeek 12 visitPlacebo-controlled studyOpen-label treatmentPhase 2 studyDifferentiation factor 15Humanized monoclonal antibodyE max modelSkeletal muscle massQuality of lifePrimary endpointSecondary endpointsWeek 72Adverse eventsGDF-15The mortality burden of cachexia in patients with colorectal or pancreatic cancer: A systematic literature review.
Dunne R, Bonomi P, Crawford J, Smoyer K, McRae T, Rossulek M, Revkin J, Tarasenko L. The mortality burden of cachexia in patients with colorectal or pancreatic cancer: A systematic literature review. Journal Of Clinical Oncology 2023, 41: 87-87. DOI: 10.1200/jco.2023.41.4_suppl.87.Peer-Reviewed Original ResearchPancreatic cancerPoor survivalInternational Consensus Diagnostic CriteriaRisk of cachexiaUnintentional weight lossCancer-associated cachexiaSystematic literature reviewConsensus diagnostic criteriaProgressive functional impairmentPoor prognosisColorectal cancerUnivariate analysisMortality burdenFunctional impairmentCachexiaPRISMA guidelinesDiagnostic criteriaEligibility criteriaPatientsClinical practiceRoutine assessmentMultivariate analysisSignificant associationWasting disorderCancer
2022
1616P The mortality burden of cachexia in patients with non-small cell lung cancer: A systematic literature review
Bonomi P, Crawford J, Dunne R, Smoyer K, McRae T, Rossulek M, Revkin J, Tarasenko L. 1616P The mortality burden of cachexia in patients with non-small cell lung cancer: A systematic literature review. Annals Of Oncology 2022, 33: s1281. DOI: 10.1016/j.annonc.2022.07.1919.Peer-Reviewed Original Research1263O Evaluation of weight gain and overall survival of male vs. female patients with advanced non-small cell lung cancer (NSCLC) receiving first-line chemotherapy
Roeland E, Fintelmann F, Yang R, Tarasenko L, McRae T, Revkin J, Bonomi P. 1263O Evaluation of weight gain and overall survival of male vs. female patients with advanced non-small cell lung cancer (NSCLC) receiving first-line chemotherapy. Annals Of Oncology 2022, 33: s1125. DOI: 10.1016/j.annonc.2022.07.1396.Peer-Reviewed Original ResearchReducinG stroke by screening for UndiAgnosed atRial fibrillation in elderly inDividuals (GUARD-AF): Rationale and design of the GUARD-AF randomized trial of screening for atrial fibrillation with a 14-day patch-based continuous ECG monitor
Singer DE, Atlas SJ, Go AS, Lopes RD, Lubitz SA, McManus DD, Revkin JH, Mills D, Crosson LA, Lenane JC, Aronson RS. ReducinG stroke by screening for UndiAgnosed atRial fibrillation in elderly inDividuals (GUARD-AF): Rationale and design of the GUARD-AF randomized trial of screening for atrial fibrillation with a 14-day patch-based continuous ECG monitor. American Heart Journal 2022, 249: 76-85. PMID: 35472303, DOI: 10.1016/j.ahj.2022.04.005.Peer-Reviewed Original ResearchConceptsOral anticoagulant therapyEfficacy end pointSafety end pointUndiagnosed atrial fibrillationAtrial fibrillationEnd pointAF screeningLong-term oral anticoagulant therapyIndividuals age 70 yearsRate of strokeProportion of patientsScreen-detected casesNovel coronavirus disease 2019 (COVID-19) pandemicAge 70 yearsParoxysmal atrial fibrillationCoronavirus disease 2019 (COVID-19) pandemicPrimary care practicesTarget sample sizeDisease 2019 pandemicLong-term screeningElectronic health recordsBleeding outcomesScreening armAF burdenUsual careA RANDOMIZED CLINICAL TRIAL OF SCREENING FOR ATRIAL FIBRILLATION WITH A 14-DAY PATCH MONITOR: ANALYSIS OF ECG RECORDINGS FROM THE GUARD-AF STUDY
Singer D, Atlas S, Go A, Lopes R, Lubitz S, McManus D, Revkin J, Mills D, Crosson L, Lenane J, Aronson R. A RANDOMIZED CLINICAL TRIAL OF SCREENING FOR ATRIAL FIBRILLATION WITH A 14-DAY PATCH MONITOR: ANALYSIS OF ECG RECORDINGS FROM THE GUARD-AF STUDY. Journal Of The American College Of Cardiology 2022, 79: 28. DOI: 10.1016/s0735-1097(22)01019-1.Peer-Reviewed Original Research
2018
Cardiovascular event reduction with PCSK9 inhibition among 1578 patients with familial hypercholesterolemia: Results from the SPIRE randomized trials of bococizumab
Ridker PM, Rose LM, Kastelein JJP, Santos RD, Wei C, Revkin J, Yunis C, Tardif JC, Shear CL, Investigators S. Cardiovascular event reduction with PCSK9 inhibition among 1578 patients with familial hypercholesterolemia: Results from the SPIRE randomized trials of bococizumab. Journal Of Clinical Lipidology 2018, 12: 958-965. PMID: 29685591, DOI: 10.1016/j.jacl.2018.03.088.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Anti-IdiotypicAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsCardiovascular DiseasesCholesterol, LDLFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHyperlipoproteinemia Type IIMaleMiddle AgedPlacebo EffectProportional Hazards ModelsProprotein Convertase 9Risk FactorsConceptsProprotein convertase subtilisin kexin type 9Major adverse cardiovascular eventsAdverse cardiovascular eventsPCSK9 inhibitionNon-FH patientsFH patientsCardiovascular eventsFamilial hypercholesterolemiaMean (SD) baseline LDL-C levelElevated low-density lipoprotein cholesterolFuture cardiovascular event ratesBaseline LDL-C levelsLow-density lipoprotein cholesterolSubtilisin kexin type 9Cardiovascular event reductionHard cardiovascular eventsHard cardiovascular outcomesPlacebo-controlled dataPrimary prevention patientsCardiovascular event ratesLDL-C reductionProportion of patientsClinical trial programLDL-C levelsIncidence rate ratios
2017
Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab
Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. New England Journal Of Medicine 2017, 376: 1517-1526. PMID: 28304227, DOI: 10.1056/nejmoa1614062.Peer-Reviewed Original ResearchConceptsLDL cholesterol levelsProprotein convertase subtilisin kexin type 9Antidrug antibodiesCholesterol levelsLipoprotein cholesterolLow-density lipoprotein cholesterolSubtilisin kexin type 9Antidrug antibody formationLipid-lowering trialsCommon adverse eventsMajor cardiovascular eventsDensity lipoprotein cholesterolInjection site reactionsTime of enrollmentHumanized monoclonal antibodyCardiovascular eventsStatin therapyAdverse eventsTotal cholesterolMultinational trialTreatment periodBococizumabApolipoprotein BPatientsType 9Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients
Ridker PM, Revkin J, Amarenco P, Brunell R, Curto M, Civeira F, Flather M, Glynn RJ, Gregoire J, Jukema JW, Karpov Y, Kastelein JJP, Koenig W, Lorenzatti A, Manga P, Masiukiewicz U, Miller M, Mosterd A, Murin J, Nicolau JC, Nissen S, Ponikowski P, Santos RD, Schwartz PF, Soran H, White H, Wright RS, Vrablik M, Yunis C, Shear CL, Tardif JC. Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients. New England Journal Of Medicine 2017, 376: 1527-1539. PMID: 28304242, DOI: 10.1056/nejmoa1701488.Peer-Reviewed Original ResearchMeSH KeywordsAntibodiesAntibodies, Monoclonal, HumanizedAnticholesteremic AgentsCardiovascular DiseasesCholesterol, LDLDouble-Blind MethodFemaleFollow-Up StudiesHumansHypercholesterolemiaInjections, SubcutaneousLipidsMaleMiddle AgedPCSK9 InhibitorsProprotein Convertase 9Risk FactorsTreatment FailureConceptsMajor cardiovascular eventsPrimary end pointHigh-risk patientsLDL cholesterol levelsCardiovascular eventsPlacebo groupCholesterol levelsMajor adverse cardiovascular eventsLow-density lipoprotein cholesterolEnd pointSubtilisin kexin type 9Safety of bococizumabAdverse cardiovascular eventsHigh cardiovascular riskNonfatal myocardial infarctionLow-risk patientsInjection site reactionsHumanized monoclonal antibodyDifferent entry criteriaLonger duration trialsShort-duration trialsCardiovascular efficacyNonfatal strokeUrgent revascularizationCardiovascular death
2016
Evaluating bococizumab, a monoclonal antibody to PCSK9, on lipid levels and clinical events in broad patient groups with and without prior cardiovascular events: Rationale and design of the Studies of PCSK9 Inhibition and the Reduction of vascular Events (SPIRE) Lipid Lowering and SPIRE Cardiovascular Outcomes Trials
Ridker PM, Amarenco P, Brunell R, Glynn RJ, Jukema JW, Kastelein JJ, Koenig W, Nissen S, Revkin J, Santos RD, Schwartz PF, Yunis C, Tardif JC, Investigators S. Evaluating bococizumab, a monoclonal antibody to PCSK9, on lipid levels and clinical events in broad patient groups with and without prior cardiovascular events: Rationale and design of the Studies of PCSK9 Inhibition and the Reduction of vascular Events (SPIRE) Lipid Lowering and SPIRE Cardiovascular Outcomes Trials. American Heart Journal 2016, 178: 135-144. PMID: 27502861, DOI: 10.1016/j.ahj.2016.05.010.Peer-Reviewed Original ResearchConceptsCardiovascular outcome trialsOutcome trialsCardiovascular eventsPatient groupAtherogenic lipidsCholesterol levelsHigh-risk primary preventionSubtilisin kexin type 9Hepatic low-density lipoprotein receptorMonoclonal antibodiesAtherogenic cholesterol levelsIncident vascular eventsResidual cholesterol riskSafety of bococizumabVascular event ratesHigh-risk patientsPrior cardiovascular eventsClinical cardiovascular eventsEvident cardiovascular diseaseLDL cholesterol levelsHigh-risk populationHumanized monoclonal antibodyLow-density lipoprotein receptorHigh residual riskBroad patient groupsTraditional and new composite endpoints in heart failure clinical trials: facilitating comprehensive efficacy assessments and improving trial efficiency
Anker SD, Schroeder S, Atar D, Bax JJ, Ceconi C, Cowie MR, Crisp A, Dominjon F, Ford I, Ghofrani H, Gropper S, Hindricks G, Hlatky MA, Holcomb R, Honarpour N, Jukema JW, Kim AM, Kunz M, Lefkowitz M, Le Floch C, Landmesser U, McDonagh TA, McMurray JJ, Merkely B, Packer M, Prasad K, Revkin J, Rosano GM, Somaratne R, Stough WG, Voors AA, Ruschitzka F. Traditional and new composite endpoints in heart failure clinical trials: facilitating comprehensive efficacy assessments and improving trial efficiency. European Journal Of Heart Failure 2016, 18: 482-489. PMID: 27071916, DOI: 10.1002/ejhf.516.Peer-Reviewed Original ResearchConceptsHeart failure clinical trialsComposite endpointClinical trialsNew composite endpointHeart failureHeart failure treatmentEffect of therapyHealth system perspectiveOverall treatment effectRepeat hospitalizationPlanned trialsFunctional statusFailure treatmentOutcome eventsPatient burdenEfficacy assessmentPatient experienceNew treatmentsTrialsAdverse effectsEfficiency of trialsEndpointTrial efficiencyTreatment effectsPrimary measure
2012
Rate of change in carotid intima–media thickness and vascular events
Bots ML, Taylor AJ, Kastelein JJ, Peters SA, Ruijter H, Tegeler CH, Baldassarre D, Stein JH, O’Leary D, Revkin JH, Grobbee DE. Rate of change in carotid intima–media thickness and vascular events. Journal Of Hypertension 2012, 30: 1690-1696. PMID: 22895014, DOI: 10.1097/hjh.0b013e32835644dc.Peer-Reviewed Original ResearchConceptsCarotid intima-media thicknessIntima-media thicknessFuture cardiovascular disease riskCardiovascular disease riskTherapy-induced changesCardiovascular drug developmentDifferent risk profilesVascular eventsPrimary outcomeVascular riskMeta-regression techniquesHeterogeneous efficacyCardiovascular treatmentPharmaceutical interventionsDisease riskRisk profileDrug developmentTrialsEcologic fallacyTreatmentLack of powerRisk
2010
Surrogate endpoints in randomized cardiovascular clinical trials
Domanski M, Pocock S, Bernaud C, Borer J, Geller N, Revkin J, Zannad F. Surrogate endpoints in randomized cardiovascular clinical trials. Fundamental & Clinical Pharmacology 2010, 25: 411-413. PMID: 20698890, DOI: 10.1111/j.1472-8206.2010.00865.x.Peer-Reviewed Original Research
2007
Effects of Torcetrapib in Patients at High Risk for Coronary Events
Barter PJ, Caulfield M, Eriksson M, Grundy SM, Kastelein JJ, Komajda M, Lopez-Sendon J, Mosca L, Tardif JC, Waters DD, Shear CL, Revkin JH, Buhr KA, Fisher MR, Tall AR, Brewer B. Effects of Torcetrapib in Patients at High Risk for Coronary Events. New England Journal Of Medicine 2007, 357: 2109-2122. PMID: 17984165, DOI: 10.1056/nejmoa0706628.Peer-Reviewed Original ResearchConceptsMajor cardiovascular eventsRisk of deathCardiovascular eventsCholesteryl ester transfer proteinLipoprotein cholesterolFirst major cardiovascular eventHigh-density lipoprotein cholesterolLow-density lipoprotein cholesterolEffects of torcetrapibHigh cardiovascular riskNonfatal myocardial infarctionDouble-blind studySystolic blood pressureCoronary heart diseaseRisk of mortalityPlasma lipoprotein levelsEster transfer proteinCoronary eventsCardiac eventsCardiovascular riskUnstable anginaBlood pressurePrimary outcomeSerum potassiumLipoprotein levels