Comparison of efficacy of the phosphate binders nicotinic acid and sevelamer hydrochloride in hemodialysis patients

Abstract

Hyperphosphatemia is a significant risk factor for the development of ectopic calcification and coronary artery diseases in patients on hemodialysis (HD), and must be controlled with the use of phosphate binders. Studies comparing the effects of sevelamer and nicotinic acid, both similar non-calcium and non-aluminum phosphate binders, are not available. In this study, 40 patients on HD with a serum phosphorus level of more than 6 mg/dL were enrolled. After a two week washout period without phosphate binders, the patients were randomly divided into two equal groups (n = 20) and were started on nicotinic acid or sevelamer for a period of four weeks. The dose of nicotinic acid used was 500 mg and that of sevelamer was 1600 mg daily. Blood samples were drawn for the measurement of the total calcium (Ca), phosphorus (P), alkaline phosphatase (ALP), triglyceride (TG), total cholesterol (Chol), high-density lipoprotein (HDL), low-density lipoprotein (LDL), uric acid and parathyroid hormone (PTH). Patients receiving sevelamer showed a significant reduction in serum P level (2.2 ± 0.69 mg/dL; P <0.0001) in comparison with the nicotinic acid group (1.7 ± 1.06 mg/dL; P = 0.004). Reduction in the Ca-P product was significantly different in the two groups; in the sevelamer group, it was 21 ± 7; (P <0.0001) while in the nicotinic acid group, it was 16 ± 11 (P = 0.007). Also, patients on sevelamer showed greater reduction in the mean TG level (38.9 ± 92 mg/dL; P = 0.005). No significant changes were observed in the mean serum Ca, total Chol, HDL, LDL, ALP and iPTH levels in the two study groups. Our short-term study suggests that although nicotinic acid reduced hyperphosphatemia, sevelamer showed higher efficacy in controlling hyperphosphatemia as well as the Ca-P product.

The Therapeutic Effects of Sevelamer on Blood Sugar, HbA1c, Lipid Profile, and hs-CRP in Patients with Diabetic Nephropathy

“…This finding is partially in line with the findings of the study conducted by Ahmadi et al (13) in which they studied hemodialysis patients and found that sevelamer decreases triglycerides levels but does not affect their LDL-C, HDL-C, and total serum cholesterol. However, our finding regarding the patients' lipid profile was inconsistent with the findings of the studies conducted by Chertow et al (14), Shantouf et al (15) and Burke et al (16).…”

The Slo-Niacin Trial: A Randomized Double-Blind Placebo-Controlled Cross-Over Trial of Extended Release Niacin for Phosphate Lowering in Haemodialysis Patients

“…The authors concluded that Sevelamer had greater serum phosphate lowering effect. However, this conclusion was erroneous, because the difference in phosphate reduction between the 2 groups over the treatment period was in fact not statistically significant (p=0.3) [15]. It is, however, of note that the phosphate reduction of 1.7 mg/dl (>0.5 mmol/L) achieved in the Niacin group over a 1 month period [15] is greater than that achieved in this study and Cheng et al's study [9].…”

“…Furthermore, this reduction was achieved with the same total daily dose of Niacin as our study, once again suggesting that low dose therapy may be sufficient. Despite the low dose of Niacin, Ahmadi et al found that the incidence of significant side effects (mainly flushing) prompting study withdrawal was high (25%) [15]. Although not adequately powered to examine this phenomenon, the lower incidence of side effects prompting withdrawal (<10%) in this study, suggests that extended release Niacin may be better tolerated than the immediate release form used by Ahmadi et al [15] None of our patients had hepatotoxicity or GI side effects.…”

“…However, this conclusion was erroneous, because the difference in phosphate reduction between the 2 groups over the treatment period was in fact not statistically significant (p=0.3) [15]. It is, however, of note that the phosphate reduction of 1.7 mg/dl (>0.5 mmol/L) achieved in the Niacin group over a 1 month period [15] is greater than that achieved in this study and Cheng et al's study [9]. Furthermore, this reduction was achieved with the same total daily dose of Niacin as our study, once again suggesting that low dose therapy may be sufficient.…”

“…Ahmadi et al [15] conducted an open-label randomised trial comparing Sevelamer and the immediate release form of Niacin. The authors concluded that Sevelamer had greater serum phosphate lowering effect.…”