title: Renal safety and pharmacokinetics of ibandronate in multiple myeloma patients with or without impaired renal function.
abstract: In this open-label study, the authors assessed the pharmacokinetics and safety of ibandronate in patients with multiple myeloma and varying renal function. Renal deterioration was graded at baseline depending on creatinine clearance in 4 stages (0: >80; 1: 50-79; 2: 30-49, and 3: <30 mL/min). Patients (n = 40) received intravenous ibandronate 6 mg (30-minute infusion). Ibandronate excretion and serum levels were measured over 24 hours. Serum creatinine, creatinine clearance, and markers of tubular damage were monitored before ibandronate infusion and at 24 and 72 hours following ibandronate infusion. Ibandronate clearance, AUC(0-24), AUC(0-infinity), serum t((1/2)), and C(max) were calculated. There was a significant positive correlation between ibandronate clearance and creatinine clearance (r = 0.858; P < .00001). The AUC for grade 3 renal insufficiency increased by approximately 60% versus grade 0 (P < .01) but was not significantly different between other grades of renal function. The t((1/2)) did not increase significantly, and peak serum levels of ibandronate were similar for the 4 grades of renal function. Serum creatinine, creatinine clearance, and markers of tubular damage did not change significantly within 72 hours of ibandronate infusion. Despite renal function already being compromised in this patient group, there was no evidence of acute nephrotoxicity with ibandronate.
authors.affiliation: Medizinische Klinik A, Klinikum der Stadt, Ludwigshafen, Bremserstrasse 79, 67063 Ludwigshafen, Germany. bergnerr@klilu.de
authors.forename: Raoul
authors.initials: R
authors.lastname: Bergner
authors.forename: Dirk M
authors.initials: DM
authors.lastname: Henrich
authors.forename: Martin
authors.initials: M
authors.lastname: Hoffmann
authors.forename: Andrea
authors.initials: A
authors.lastname: Honecker
authors.forename: Gerd
authors.initials: G
authors.lastname: Mikus
authors.forename: Bettina
authors.initials: B
authors.lastname: Nauth
authors.forename: Dietmar
authors.initials: D
authors.lastname: Nagel
authors.forename: Michael
authors.initials: M
authors.lastname: Uppenkamp
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D050071:Bone Density Conservation Agents / Q000009:adverse effects* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D001847:Bone Diseases / Q000188:drug therapy*; D004164:Diphosphonates / Q000009:adverse effects* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D000077557:Ibandronic Acid; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000150:complications / Q000188:drug therapy*; D051437:Renal Insufficiency / Q000150:complications / Q000503:physiopathology*
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D000077557:Ibandronic Acid