Lanthanumcarbonateversusplaceboformanagementof：碳酸镧与安慰剂的管理.pdfVIP

Hutchison et al. BMC Nephrology 2013, 14:40 /1471-2369/14/40 RESEARCH ARTICLE Open Access Lanthanum carbonate versus placebo for management of hyperphosphatemia in patients undergoing peritoneal dialysis: a subgroup analysis of a phase 2 randomized controlled study of dialysis patients 1,2* 3 4 3 5 Alastair J Hutchison , Maggie Gill , J Brian Copley , Lynne Poole and Rosamund J Wilson Abstract Background: This short-term study assessed the efficacy and safety of lanthanum carbonate in the treatment of hyperphosphatemia in dialysis patients; here, we report a prespecified subgroup analysis of patients undergoing peritoneal dialysis. Methods: Men and women (n = 39) who had received continuous ambulatory peritoneal dialysis for chronic kidney disease for 6 months or more were enrolled in eight renal medicine departments in the United Kingdom. A 2-week washout period was followed by a 4-week dose-titration phase during which patients received lanthanum carbonate titrated up to 2250 mg/day. This was followed by a 4-week, randomized, placebo-controlled, parallel-group phase during which patients continued to receive either lanthanum carbonate at the titrated dose, or a matched dose of placebo. The main outcome measure was control of serum phosphate levels (1.3-1.8 mmol/l) at the end of the parallel-group phase. Results: Serum phosphate was controlled in 3/39 (8%) patients at the beginning of the dose-titration phase (after washout) and in 18/31 (58%) patients treated with lanthanum carbonate at its end. After the parallel-group phase, 60% of lanthanum carbonate-treated patients and 10% of those receiving placebo had controlled serum phosphate. There was no difference in mean (95% confidence interval) se