title: Renal safety of ibandronate.
abstract: Despite their efficacy in treating complications associated with metastatic bone disease, there are concerns about the potential nephrotoxicity of certain i.v. bisphosphonates for the long-term management of cancer patients. Clinical data suggest, however, that i.v. ibandronate (Bondronat); F. Hoffman-La Roche Ltd., Basel, Switzerland, http://www.roche.com), unlike other bisphosphonates, has a renal safety profile comparable with that of placebo. In a 2-year, phase III study of patients with breast cancer metastatic to bone, the incidence of adverse renal events in patients treated with 6 mg i.v. ibandronate was low and comparable with that of placebo (4% versus 4.5% with placebo). Two-year assessments of time to serum creatinine increase also demonstrated renal safety comparable with that of placebo (patients with creatinine increase: 6% versus 12% with placebo). Long-term (4-year) renal safety of ibandronate was demonstrated in a 2-year extension of the trial. Phase II, open-label studies show that intensive ibandronate dosing does not compromise renal safety in patients with metastatic bone pain from a variety of tumor types. In addition, i.v. ibandronate is well tolerated, with no evidence of renal toxicity in multiple myeloma and urologic cancer patients with existing renal impairment. The potential nephrotoxicity of some bisphosphonates has prompted additional renal safety precautions in product labeling for these agents. The precautions are not, however, contained in the label for ibandronate, which may thus simplify patient management.
authors.affiliation: Department of Haematology, University of Newcastle-Upon-Tyne, R.V.I., Queen Victoria Road, Newcastle-Upon-Tyne, United Kingdom, NE1 4LP. graham.jackson@ncl.ac.uk
authors.forename: Graham H
authors.initials: GH
authors.lastname: Jackson
mesh_terms: D050071:Bone Density Conservation Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000556:secondary; D002986:Clinical Trials as Topic; D004164:Diphosphonates / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D006801:Humans; D000077557:Ibandronic Acid; D007668:Kidney / Q000187:drug effects*; D009101:Multiple Myeloma / Q000188:drug therapy / Q000473:pathology; D051437:Renal Insufficiency / Q000139:chemically induced; D014571:Urologic Neoplasms / Q000188:drug therapy / Q000473:pathology
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D000077557:Ibandronic Acid