2024
Standard-of-Care Medication Withdrawal in Patients With Obstructive Hypertrophic Cardiomyopathy Receiving Aficamten in FOREST-HCM
Masri A, Choudhury L, Barriales-Villa R, Elliott P, Maron M, Nassif M, Oreziak A, Owens A, Saberi S, Tower-Rader A, Rader F, Garcia-Pavia P, Olivotto I, Nagueh S, Wang A, Heitner S, Jacoby D, Kupfer S, Malik F, Melloni C, Meng L, Wei J, Sherrid M, Abraham T, Investigators F. Standard-of-Care Medication Withdrawal in Patients With Obstructive Hypertrophic Cardiomyopathy Receiving Aficamten in FOREST-HCM. Journal Of The American College Of Cardiology 2024, 84: 1839-1849. PMID: 39477631, DOI: 10.1016/j.jacc.2024.09.002.Peer-Reviewed Original ResearchConceptsObstructive hypertrophic cardiomyopathyKansas City Cardiomyopathy Questionnaire-Clinical Summary ScoreStandard-of-careSOC therapyAdverse eventsDose reductionTherapy withdrawalHypertrophic cardiomyopathyTreatment of obstructive hypertrophic cardiomyopathyPro-B-type natriuretic peptide levelsN-terminal pro-B-type natriuretic peptide levelsTreatment-emergent adverse eventsHigh-sensitivity troponin IOutflow tract gradientEmergent adverse eventsNYHA functional classFirst-line therapyNatriuretic peptide levelsOff-target side effectsSummary scoreControlled clinical trialsMeasures of efficacyClinical measures of efficacyStable doseNo withdrawalsStudy Design and Baseline Characteristics of ALIGN, a Randomized Controlled Study of Atrasentan in Patients With IgA Nephropathy
Heerspink H, Jardine M, Kohan D, Lafayette R, Levin A, Liew A, Zhang H, Noronha I, Trimarchi H, Hou F, Renfurm R, Gray T, Camargo M, Barratt J. Study Design and Baseline Characteristics of ALIGN, a Randomized Controlled Study of Atrasentan in Patients With IgA Nephropathy. Kidney International Reports 2024, 10: 217-226. PMID: 39810771, PMCID: PMC11725817, DOI: 10.1016/j.ekir.2024.10.004.Peer-Reviewed Original ResearchRenin-angiotensin system inhibitorsEndothelin-AStable doseIgA nephropathyEndothelin-A receptor antagonistSodium-glucose cotransporter-2 inhibitorsPlacebo-controlled clinical trialRenin-angiotensin system inhibitor therapyBiopsy-proven IgANBaseline to weekCotransporter-2 inhibitorsMethods Eligibility criteriaKidney function lossRandomized Controlled StudyDouble-blindReceptor antagonistReduce proteinuriaEGFR changeBaseline characteristicsSystem inhibitorsIgAN populationAtrasentanKidney functionKidney inflammationClinical trials
2023
A Phase I Study of Ruxolitinib in Combination with Abemaciclib for Patients with Primary or Post-Polycythemia Vera/Essential Thrombocythemia Myelofibrosis
Bewersdorf J, Derkach A, Masarova L, Pemmaraju N, Stein E, Mauro M, Rampal R, Bose P. A Phase I Study of Ruxolitinib in Combination with Abemaciclib for Patients with Primary or Post-Polycythemia Vera/Essential Thrombocythemia Myelofibrosis. Blood 2023, 142: 6440. DOI: 10.1182/blood-2023-174322.Peer-Reviewed Original ResearchDuration of responseMaximum tolerated doseDose of ruxolitinibCDK4/6 inhibitorsStable doseTolerated doseHormone receptor-positive metastatic breast cancerRisk of progression to acute myeloid leukemiaSymptom scoresPhase I dose-escalation trialProgression to acute myeloid leukemiaTreatment of hormone receptor-positive metastatic breast cancerAbsolute neutrophil count <Cancer CenterCombination of CDK4/6 inhibitorsUS FDAMemorial Sloan Kettering Cancer CenterGrade 1 diarrheaMedian overall survivalPre-study doseDose-limiting toxicityMD Anderson Cancer CenterBone marrow fibrosisNeutrophil count <Platelet count <
2020
Safety of Rimegepant, an Oral CGRP Receptor Antagonist, Plus CGRP Monoclonal Antibodies for Migraine
Berman G, Croop R, Kudrow D, Halverson P, Lovegren M, Thiry A, Conway C, Coric V, Lipton R. Safety of Rimegepant, an Oral CGRP Receptor Antagonist, Plus CGRP Monoclonal Antibodies for Migraine. Headache The Journal Of Head And Face Pain 2020, 60: 1734-1742. PMID: 32799325, PMCID: PMC7496574, DOI: 10.1111/head.13930.Peer-Reviewed Original ResearchConceptsCGRP receptor antagonistSmall molecule CGRP receptor antagonistsTreatment adverse eventsCGRP mAbsAdverse eventsAcute treatmentPreventive treatmentReceptor antagonistCalcitonin gene-related peptide (CGRP) ligandOral CGRP receptor antagonistLong-term safety studiesMonoclonal antibodiesCGRP monoclonal antibodiesMonthly migraine attacksOral acute treatmentSevere pain intensitySerious adverse eventsLarger patient populationPrevious case reportsModerate nasopharyngitisStable doseAminotransferase levelsPain intensityAdditional patientsPreventive regimenA PHASE IIA STUDY REPOSITIONING DESIPRAMINE IN SMALL CELL LUNG CANCER AND OTHER HIGH-GRADE NEUROENDOCRINE TUMORS
Riess JW, Jahchan NS, Das M, Koontz M, Kunz PL, Wakelee HA, Schatzberg A, Sage J, Neal JW. A PHASE IIA STUDY REPOSITIONING DESIPRAMINE IN SMALL CELL LUNG CANCER AND OTHER HIGH-GRADE NEUROENDOCRINE TUMORS. Cancer Treatment And Research Communications 2020, 23: 100174. PMID: 32413603, PMCID: PMC7572629, DOI: 10.1016/j.ctarc.2020.100174.Peer-Reviewed Original ResearchSmall cell lung cancerCell lung cancerMetastatic small cell lung cancerRadiographic progression-free survivalHigh-grade neuroendocrine carcinomaMedian overall survivalProgression-free survivalTricyclic antidepressantsClinical trialsLung cancerPrior chemotherapyFree survivalStable doseOverall survivalRadiographic benefitStudy entryNeuroendocrine carcinomaPreclinical modelsAntitumor effectsGrade 1Phase IIa clinical trialDose-escalation clinical trialHigh-grade neuroendocrine tumorsNeurocognitive adverse eventsEscalation clinical trial
2019
Tacrolimus and Indomethacin Are Safe and Effective at Reducing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography in Patients Who Have Undergone Liver Transplantation
Thiruvengadam NR, Forde KA, Chandrasekhara V, Ahmad NA, Ginsberg GG, Khungar V, Kochman ML. Tacrolimus and Indomethacin Are Safe and Effective at Reducing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography in Patients Who Have Undergone Liver Transplantation. Clinical Gastroenterology And Hepatology 2019, 18: 1224-1232.e1. PMID: 31622734, DOI: 10.1016/j.cgh.2019.10.014.Peer-Reviewed Original ResearchConceptsEndoscopic retrograde cholangiopancreatographyRisk of PEPDevelopment of PEPLiver transplantationTrough levelsBiliary complicationsIndomethacin useRectal indomethacinRetrospective studyRetrograde cholangiopancreatographyERCP proceduresOdds ratioMixed-effects multivariable logistic regressionEffectiveness of tacrolimusIncidence of PEPTacrolimus trough levelsCommon adverse eventsChronic kidney diseaseGlomerular filtration rateMultivariable logistic regressionRate of pancreatitisAddition of indomethacinChronic rejectionSevere PEPStable dose
2015
Switching STudy of Kidney TRansplant PAtients with Tremor to LCP‐TacrO (STRATO): an open‐label, multicenter, prospective phase 3b study
Langone A, Steinberg S, Gedaly R, Chan L, Shah T, Sethi K, Nigro V, Morgan J, , Formica R, Barr Y, Brennan D, El‐Amm J, Kozlowski T, Matas A, West‐Thielke P, Kistler K. Switching STudy of Kidney TRansplant PAtients with Tremor to LCP‐TacrO (STRATO): an open‐label, multicenter, prospective phase 3b study. Clinical Transplantation 2015, 29: 796-805. PMID: 26113208, PMCID: PMC4755036, DOI: 10.1111/ctr.12581.Peer-Reviewed Original ResearchConceptsKidney transplant recipientsPhase 3b studyDose reductionKidney transplant patientsPatient Global ImpressionCommon side effectsImmediate-release tacrolimusExtended-release formulationMovement disorder neurologistsFurther dose reductionTransplant recipientsMITT populationStable doseTransplant patientsGlobal ImpressionMarin scaleFahn-TolosaAUC exposureSide effectsPatientsTacrolimusMeaningful improvementsDrug concentrationsSignificant tremorTremor
2012
Ipilimumab in patients with melanoma and brain metastases: an open-label, phase 2 trial
Margolin K, Ernstoff MS, Hamid O, Lawrence D, McDermott D, Puzanov I, Wolchok JD, Clark JI, Sznol M, Logan TF, Richards J, Michener T, Balogh A, Heller KN, Hodi FS. Ipilimumab in patients with melanoma and brain metastases: an open-label, phase 2 trial. The Lancet Oncology 2012, 13: 459-465. PMID: 22456429, DOI: 10.1016/s1470-2045(12)70090-6.Peer-Reviewed Original ResearchConceptsBrain metastasesCohort ACohort BSerum aspartate aminotransferaseDisease controlIntravenous ipilimumabAdverse eventsAdvanced melanomaCohort B.Common grade 3 adverse eventsAspartate aminotransferaseGrade 3 adverse eventsCommon grade 3Drug-related complicationsPhase 2 trialProportion of patientsUnexpected toxic effectsBristol-Myers SquibbStable diseaseCorticosteroid treatmentPrimary endpointStable dosePartial responseWeek 24Complete response
2010
Significant Sirolimus and Dronedarone Interaction in a Kidney Transplant Recipient
Tichy EM, Medwid AJ, Mills EA, Formica RN, Kulkarni S. Significant Sirolimus and Dronedarone Interaction in a Kidney Transplant Recipient. Annals Of Pharmacotherapy 2010, 44: 1338-1341. PMID: 20484171, DOI: 10.1345/aph.1p114.Peer-Reviewed Original ResearchConceptsSignificant pharmacokinetic interactionsTrough concentrationsPharmacokinetic interactionsHorn Drug Interaction Probability ScaleNarrow therapeutic index medicationsDrug Interaction Probability ScaleKidney transplant recipientsPost-kidney transplantDronedarone initiationExcessive immunosuppressionImmunosuppressive regimenIndex medicationSirolimus toxicityTransplant recipientsMycophenolate mofetilStable doseConcurrent administrationAtrial fibrillationSirolimus concentrationsBloody diarrheaTherapeutic misadventureDose reductionClose monitoringDronedaroneSirolimus
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