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
2009
HCV Response in Patients With End Stage Renal Disease Treated With Combination Pegylated Interferon α-2a and Ribavirin
Hakim W, Sheikh S, Inayat I, Caldwell C, Smith D, Lorber M, Friedman A, Jain D, Bia M, Formica R, Mehal W. HCV Response in Patients With End Stage Renal Disease Treated With Combination Pegylated Interferon α-2a and Ribavirin. Journal Of Clinical Gastroenterology 2009, 43: 477-481. PMID: 19142165, PMCID: PMC3715868, DOI: 10.1097/mcg.0b013e318180803a.Peer-Reviewed Original ResearchConceptsEnd-stage renal diseaseHepatitis C virusCombination therapyRenal diseasePosttreatment rateSide effectsSerious adverse side effectsDose of ribavirinNon-ESRD patientsSafe therapeutic optionEarly virologic responseProspective observational studyMonths of treatmentStage renal diseaseCases of anemiaInitial response rateLength of treatmentInterferon α-2aAdverse side effectsPO weeklyVirologic responseESRD patientsHCV infectionESRD populationHCV response
2002
Evolving role of sirolimus immunosuppression after organ transplantation
Formica R, Friedman A, Lorber M. Evolving role of sirolimus immunosuppression after organ transplantation. Current Opinion In Organ Transplantation 2002, 7: 353-358. DOI: 10.1097/00075200-200212000-00009.Peer-Reviewed Original ResearchCalcineurin inhibitorsOrgan transplantationG1-S phase cell cycle arrestHigher serum creatinine valuesBiologic side effectsSirolimus-treated patientsCalcineurin inhibitor tacrolimusSerum creatinine valuesPivotal clinical trialsReduced rejection ratesPhase cell cycle arrestAllograft arteriosclerosisSirolimus immunosuppressionTriglyceride elevationLymphocele formationSirolimus useReversible thrombocytopeniaSerum cholesterolCreatinine valuesCell cycle arrestClinical trialsSide effectsSirolimusComplex woundsFull dose