Abstract
Objectives:The tolerability and efficacy of lanthanum carbonate has not been studied in the Indian population. This study was, therefore, undertaken to compare the efficacy and tolerability of lanthanum carbonate with calcium acetate in patients with stage 4 chronic kidney disease.Design:A randomized open label two group cross-over study.Materials and Methods:Following Institutional Ethics Committee approval and valid consent, patients with stage 4 chronic kidney disease were randomized to receive either lanthanum carbonate 500mg thrice daily or calcium acetate 667 mg thrice daily for 4 weeks. After a 4-week washout period, the patients were crossed over for another 4 weeks. Serum phosphorous, serum calcium, serum alkaline phosphatase, and serum creatinine were estimated at fixed intervals.Results:Twenty-six patients were enrolled in the study. The mean serum phosphorous concentrations showed a declining trend with lanthanum carbonate (from pre-drug levels of 7.88 ± 1.52 mg/dL-7.14 ± 1.51 mg/dL) and calcium acetate (from pre-drug levels of 7.54 ± 1.39 mg/dL-6.51 ± 1.38 mg/dL). A statistically significant difference was seen when comparing the change in serum calcium produced by these drugs (P < 0.05). Serum calcium levels increased with calcium acetate (from pre-drug levels of 7.01 ± 1.07-7.46 ± 0.74 mg dL), while it decreased with lanthanum carbonate (from pre-drug levels 7.43 ± 0.77-7.14 ± 0.72 mg/dL). The incidence of adverse effects was greater with lanthanum carbonate.Conclusion:Lanthanum carbonate and calcium acetate are equally effective phosphate binders with trends obvious in the first 4 weeks of therapy. The decrease in serum calcium levels with lanthanum carbonate when compared to the increase in serum calcium levels due to calcium acetate is statistically significant. The drawback of lanthanum carbonate is its high cost and relatively higher incidence of adverse events during treatment.
Highlights
Hyperphosphatemia is a universal complication in patients with chronic kidney disease (CKD) when the glomerular filtration rate (GFR) falls below 25 ml/min
Of the six patients who did not complete the study, one patient withdrew during phase I due to adverse effects while on lanthanum carbonate; two patients were withdrawn in phase I due to protocol violation while on calcium acetate; two patients were withdrawn in phase II due to worsening of their renal status while on lanthanum, and one patient was withdrawn in phase II due to worsening of renal status while on calcium acetate
The mean serum phosphorous levels during the intake of lanthanum carbonate decreased from 7.88 ± 1.52mg/dL-7.14 ± 1.51mg/dL, while during calcium acetate treatment it decreased from 7.54 ± 1.39mg/dL-6.51 ± 1.38mg/dL
Summary
Hyperphosphatemia is a universal complication in patients with chronic kidney disease (CKD) when the glomerular filtration rate (GFR) falls below 25 ml/min. It is known to be associated with the development of hyperparathyroidism, renal osteodystrophy, metastatic, and vascular calcification resulting in increased morbidity and mortality.[1,2,3] Elevated calcium × phosphorous product and increased daily intake of calcium are other risk factors for coronary artery calcification.[4] The reduction of serum phosphorus levels in patients with CKD can be achieved through a combination of dietary control, removal by dialysis, and intervention with phosphate binders that prevent the absorption of phosphorus from the intestine. Dietary restriction is not possible beyond a point without risking a negative nitrogen balance.[5] Even regular daily dialysis treatment removes 75% of absorbed phosphorus and not all of the phosphorus ingested.[6] As a result, most CKD patients require phosphate binders to decrease phosphorus absorption from the gastrointestinal tract and maintain the serum phosphorous and calcium × phosphorous product at the recommended levels
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