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Here, we present a concise overview of the safety profile of lanthanum carbonate and interim results from a 5\u2010year observational database study (SPD405\u2010404; ClinicalTrials.gov identifier: NCT00567723). The pharmacokinetic paradigms of lanthanum and aluminium are different in that lanthanum is minimally absorbed and eliminated via the hepatobiliary pathway, whereas aluminium shows appreciable absorption and is eliminated by the kidneys. Randomised prospective studies of paired bone biopsies revealed no evidence of accumulation or toxicity in patients treated with lanthanum carbonate. Patients treated with lanthanum carbonate for up to 6\u2009years showed no clinically relevant changes in liver enzyme or bilirubin levels. Lanthanum does not cross the intact blood\u2013brain barrier. The most common adverse effects are mild\/moderate nausea, diarrhoea and flatulence. An interim Kaplan\u2013Meier analysis of SPD405\u2010404 data from the United States Renal Data System revealed that the median 5\u2010year survival was 51.6\u2009months (95% CI: 49.1, 54.2) in patients who received lanthanum carbonate (test group), 48.9\u2009months (95% CI: 47.3, 50.5) in patients treated with other phosphate binders (concomitant therapy control group) and 40.3\u2009months (95% CI: 38.9, 41.5) in patients before the availability of lanthanum carbonate (historical control group). Bone fracture rates were 5.9%, 6.7% and 6.4%, respectively. After more than 850\u2009000 person\u2010years of worldwide patient exposure, there is no evidence that lanthanum carbonate is associated with adverse safety outcomes in patients with end\u2010stage renal disease.<\/jats:p>","DOI":"10.1111\/nep.12864","type":"journal-article","created":{"date-parts":[[2016,8,2]],"date-time":"2016-08-02T18:13:10Z","timestamp":1470161590000},"page":"987-994","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":65,"title":["Lanthanum carbonate: safety data after 10\u2009years"],"prefix":"10.1111","volume":"21","author":[{"given":"Alastair J","family":"Hutchison","sequence":"first","affiliation":[{"name":"Manchester Royal Infirmary and Academic Health Science Centre  Manchester UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosamund J","family":"Wilson","sequence":"additional","affiliation":[{"name":"Spica Consultants  Marlborough UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Svetlana","family":"Garafola","sequence":"additional","affiliation":[{"name":"Shire Pharmacovigilance and Risk Management  Lexington MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John Brian","family":"Copley","sequence":"additional","affiliation":[{"name":"Shire  Lexington MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2016,11,11]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1053\/ajkd.1998.v31.pm9531176"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.ki.5001542"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2004040275"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1523-1755.2005.00185.x"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/ndt\/gfu335"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2008060609"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2011.12.025"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1038\/ki.2013.185"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrneph.2011.112"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1368-5031.2005.00592.x"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.5414\/CNP65191"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1159\/000088932"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1159\/000149239"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1093\/ndt\/gfh693"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.5414\/CNP63461"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1523-1755.63.s85.18.x"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.5414\/CNP62193"},{"key":"e_1_2_6_19_1","first-page":"286","article-title":"Lanthanum carbonate treatment, for up to 6 years, is not associated with adverse effects on the liver in patients with chronic kidney disease Stage 5 receiving hemodialysis","volume":"71","author":"Hutchison AJ","year":"2009","journal-title":"Clin. 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