title: Impact of long-term therapy with FTY720 or mycophenolate mofetil on cardiac conduction and rhythm in stable adult renal transplant patients.
abstract: The novel immunomodulator FTY720 has been associated with a mild reduction in heart rate (HR) in clinical trials. A total of 421 patients (FTY720, n=94; mycophenolate mofetil [MMF], n=327) underwent 2-day electrocardiogram and 24-h Holter monitoring. Patients had been maintained on cyclosporine plus MMF or FTY720 (2.5 mg and 5.0 mg) for > or =12 months. No significant differences in mean hourly heart rate (HR) over 24 hrs were noted between groups. Bradycardia (HR 35-50 bpm) and sustained bradycardia (HR <50 bpm for >1 min) were more common with MMF than FTY720 (53% vs. 37% and 34% vs. 21%, respectively). Electrocardiogram parameters did not differ significantly between FTY720 and MMF groups, or between FTY720 groups, supporting the absence of a dose-dependent effect. The absence of any clinically significant effect of FTY720 on cardiac rhythm demonstrates that the reduction in HR seen after the first dose does not persist in the maintenance phase.
authors.affiliation: Hospital Clinico y Provincial de Barcelona, Barcelona, Spain. OPPEN@clinic.ub.es
authors.forename: Federico
authors.initials: F
authors.lastname: Oppenheimer
authors.forename: Shamkant
authors.initials: S
authors.lastname: Mulgaonkar
authors.forename: Ronald
authors.initials: R
authors.lastname: Ferguson
authors.forename: Josep
authors.initials: J
authors.lastname: Grinyó
authors.forename: Federico
authors.initials: F
authors.lastname: Juarez
authors.forename: Marek
authors.initials: M
authors.lastname: Ostrowski
authors.forename: Marian
authors.initials: M
authors.lastname: Klinger
authors.forename: Rowan
authors.initials: R
authors.lastname: Walker
authors.forename: Armando
authors.initials: A
authors.lastname: Torres
authors.forename: Ralph
authors.initials: R
authors.lastname: Preiss
authors.forename: Malika
authors.initials: M
authors.lastname: Cremer
authors.forename: Alan
authors.initials: A
authors.lastname: Jardine
mesh_terms: D018674:Adrenergic Antagonists / Q000627:therapeutic use; D000328:Adult; D005260:Female; D000068876:Fingolimod Hydrochloride; D006329:Heart Conduction System / Q000187:drug effects / Q000276:immunology*; D006339:Heart Rate / Q000187:drug effects / Q000502:physiology*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D016030:Kidney Transplantation / Q000276:immunology / Q000502:physiology*; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011409:Propylene Glycols / Q000627:therapeutic use*; D013110:Sphingosine / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D018674:Adrenergic Antagonists; D007166:Immunosuppressive Agents; D011409:Propylene Glycols; D000068876:Fingolimod Hydrochloride; D009173:Mycophenolic Acid; D013110:Sphingosine