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
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