PMID- 18667837 OWN - NLM STAT- MEDLINE DCOM- 20081118 LR - 20211020 IS - 1660-2110 (Electronic) IS - 1660-8151 (Print) IS - 1660-2110 (Linking) VI - 110 IP - 1 DP - 2008 TI - Long-term efficacy and safety profile of lanthanum carbonate: results for up to 6 years of treatment. PG - c15-23 LID - 10.1159/000149239 [doi] AB - BACKGROUND/AIMS: Lanthanum carbonate (LC, FOSRENOL) is an effective phosphate binder for which tolerability and a safety profile have been reported in haemodialysis patients. Patients from previous studies entered a 2-year extension, enabling assessment of efficacy and safety for up to 6 years of LC monotherapy. METHODS: Patients from four previous trials entered this study. RESULTS: Ninety-three patients started the extension, with 22 entering a sixth year of LC treatment. Two-thirds of all patients received LC doses of 2,250 or 3,000 mg/day. Reductions in serum phosphate and calcium x phosphate product were maintained for up to 6 years. There were no new or unexpected adverse events (AEs), and no increase in the incidence of events with increasing treatment exposure. Over the complete duration of therapy, treatment-related AEs occurred in 25.8% of patients and were primarily gastrointestinal in nature. No clinically relevant changes in liver function tests were observed and there was no evidence of adverse effects on the liver, bone or the central nervous system. CONCLUSIONS: LC monotherapy was effective and well tolerated for up to 6 years with no evidence of safety concerns or increased frequency of AEs. CI - Copyright 2008 S. Karger AG, Basel. FAU - Hutchison, Alastair J AU - Hutchison AJ AD - Manchester Royal Infirmary, Manchester, UK. alastair.hutchison@cmmc.nhs.uk FAU - Barnett, M Edwina AU - Barnett ME FAU - Krause, Rolfdieter AU - Krause R FAU - Kwan, Jonathan T C AU - Kwan JT FAU - Siami, Ghodrat A AU - Siami GA CN - SPD405-309 Lanthanum Study Group LA - eng PT - Clinical Trial PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20080731 PL - Switzerland TA - Nephron Clin Pract JT - Nephron. Clinical practice JID - 101159763 RN - 0 (Phosphates) RN - 27YLU75U4W (Phosphorus) RN - 490D9F069T (lanthanum carbonate) RN - 6I3K30563S (Lanthanum) SB - IM EIN - Nephron Clin Pract. 2008;110(1):c23 MH - Adult MH - Aged MH - Female MH - Follow-Up Studies MH - Humans MH - Hyperphosphatemia/*drug therapy/etiology/metabolism MH - Kidney Failure, Chronic/blood/complications/therapy MH - Lanthanum/administration & dosage/*adverse effects/therapeutic use MH - Male MH - Middle Aged MH - Phosphates/blood/metabolism MH - Phosphorus/blood/metabolism MH - Treatment Outcome PMC - PMC2790759 FIR - Maes, B IR - Maes B FIR - Musselmann, L IR - Musselmann L FIR - Bagnewski, W IR - Bagnewski W FIR - Meyer, E IR - Meyer E FIR - Backs, W IR - Backs W FIR - Schupp, J IR - Schupp J FIR - Krause, R IR - Krause R FIR - Prager, G IR - Prager G FIR - Scholz, R IR - Scholz R FIR - Asmus, G IR - Asmus G FIR - Kirchertz, E J IR - Kirchertz EJ FIR - Bohm, R IR - Bohm R FIR - Cangiano, J IR - Cangiano J FIR - Bradley, J IR - Bradley J FIR - Hutchison, A J IR - Hutchison AJ FIR - Kwan, J IR - Kwan J FIR - Apantaku, F IR - Apantaku F FIR - Barnett, M E IR - Barnett ME FIR - Boren, K IR - Boren K FIR - Kirchner, L IR - Kirchner L FIR - Frederickson, E IR - Frederickson E FIR - Germain, M IR - Germain M FIR - Kaplan, M IR - Kaplan M FIR - Keightley, G IR - Keightley G FIR - Kopyt, N IR - Kopyt N FIR - Locay, H IR - Locay H FIR - Marin, P IR - Marin P FIR - Mawad, H IR - Mawad H FIR - Middleton, J IR - Middleton J FIR - Mosset, R IR - Mosset R FIR - Osorio, F IR - Osorio F FIR - Qami, A IR - Qami A FIR - Siami, G IR - Siami G FIR - Steed, L IR - Steed L FIR - Tokatlian, E IR - Tokatlian E FIR - Weinberg, M IR - Weinberg M FIR - Weise, W IR - Weise W EDAT- 2008/08/01 09:00 MHDA- 2008/11/19 09:00 PMCR- 2008/07/31 CRDT- 2008/08/01 09:00 PHST- 2007/12/21 00:00 [received] PHST- 2008/06/04 00:00 [accepted] PHST- 2008/08/01 09:00 [pubmed] PHST- 2008/11/19 09:00 [medline] PHST- 2008/08/01 09:00 [entrez] PHST- 2008/07/31 00:00 [pmc-release] AID - 000149239 [pii] AID - nec0110-0c15 [pii] AID - 10.1159/000149239 [doi] PST - ppublish SO - Nephron Clin Pract. 2008;110(1):c15-23. doi: 10.1159/000149239. Epub 2008 Jul 31.