Randomized Crossover Study of the Efficacy and Safety of Sevelamer Hydrochloride and Lanthanum Carbonate in Japanese Patients Undergoing Hemodialysis

Therapeutic Apheresis and Dialysis - Tập 16 Số 4 - Trang 341-349 - 2012
Satoshi Kasai1, Kazuto Sato2, Yaeko Murata3, Y Kinoshita2
1Department of Internal Medicine, Japanese Red Cross Ishinomaki Hospital, Ishinomaki, Japan
2Department of Internal Medicine, Japanese Red Cross Ishinomaki Hospital, Ishinomaki
3Department of Blood Purification, Tohoku University Hospital, Sendai, Japan

Tóm tắt

AbstractInsufficient control of serum calcium and phosphate levels in patients undergoing hemodialysis is associated with increased mortality. As commonly used calcium‐containing phosphate binders can cause arterial calcification, newly developed calcium‐free phosphate binders, such as sevelamer hydrochloride (SH) and lanthanum carbonate (LC), have received much attention. We assessed the efficacy and safety of SH and LC treatment in Japanese patients undergoing hemodialysis in a prospective randomized open blinded endpoint (PROBE) crossover study. Forty‐two patients were randomized to receive SH or LC for 13 weeks, with the dosages adjusted every 2 weeks, followed by treatment with the other drug for another 13 weeks. The average daily doses of SH and LC were 2971 ± 1464 mg and 945 ± 449 mg, respectively. The mean dosage ratio of SH to LC was 3.05, which was maintained throughout the treatment period. SH and LC were similarly effective at controlling serum calcium and phosphate levels in the majority of patients (78–93%). A few serious adverse events (AEs) involving the biliary system occurred during the LC treatment period, but they were not considered to be treatment‐induced. Although the incidence of constipation, the most common treatment‐related AE, was higher during the SH period (27% vs. 5%; P < 0.05), no difference was observed in total treatment‐related AEs. This study demonstrates that SH and LC are comparable treatments for controlling serum phosphate and calcium levels, and that both compounds are safe and well‐tolerated in Japanese patients undergoing hemodialysis.

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Tài liệu tham khảo

10.7326/0003-4819-146-3-200702060-00006

10.1053/j.ajkd.2007.11.001

10.1097/01.ASN.0000133041.27682.A2

10.1053/j.ajkd.2008.03.020

National Kidney Foundation, 2003, K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease, Am J Kidney Dis, 42, S1

10.1111/j.1744-9987.2008.00648.x

10.1056/NEJM200005183422003

10.1056/NEJM199102213240804

10.1016/S0140-6736(79)90883-3

10.1016/S0272-6386(97)90009-3

10.1046/j.1523-1755.63.s85.18.x

10.5414/CNP72252

Arenas MD, 2010, A comparative study of 2 new phosphate binders (sevelamer and lanthanum carbonate) in routine clinical practice, J Nephrol, 23, 683

10.1111/j.1744-9987.2010.00868.x

10.1002/jps.20956

10.5414/CNP65191

10.1159/000149239

10.1111/j.1744-9987.2005.00294.x

10.1159/000084653

10.1111/j.1523-1755.2004.09007.x

10.4009/jsdt.43.919

10.1053/j.jrn.2009.10.009

10.1111/j.1523-1755.2005.00281.x

10.1093/ndt/gfl146

10.2165/00003088-200847080-00004

10.1111/j.1744-9987.2010.00898.x

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Therapeutic Apheresis and Dialysis

Tập 16 Số 4

341-349

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