The efficacy and safety of the sucroferric oxyhydroxide (Velphoro®) in hemodialysis patients: results of a prospective randomized controlled trial


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Abstract

The treatment of hyperphosphatemia is the main goal in cure of mineral and bone disorders in patients with ckd. however, the results of the correction of hyperphosphatemia remain unsatisfactory. This is due to the absence of effective and safe medicines. in our prospective randomized controlled trial we evaluated the effects of a 16-week treatment with a new phosphate binder -sucroferric oxyhydroxide (velphoro®) in comparison with sevelamer carbonate (‘sevelamer’) on ckd-mbd parameters in patients on chronic hemodialysis with hyperphosphatemia. materials and methods. after 4-week washout period from previous phosphate binders, 50 stable patients with hyperphosphatemia (P>5,5 mg/dl) were randomized at a 1:1 ratio to receive sucroferric oxyhydroxide (n=25) or sevelamer (n=25) for treatment up to 16 weeks. in all patients levels of p, ca, pth, ferritin, transferrin saturation, hb, fgf-23, crp were monthly evaluated. the dose of both medications was adjusted according to serum phosphate level. results: Phosphate binder therapy of sucroferric oxyhydroxide was associated with a significant decrease in serum phosphate level from 6,8±1,5 to 5,27±0,99 mg/dl (P<0,01); HOWEVER, TREATMENT with sevelamer did not reduce the level of P: 6,32±1,5 vs 6,35±1,9 mg/dl. the number of prescribed tablets was lower in the sucroferric oxyhydroxide group (2,o ±i,5 tab/day, mean ± sd) compared with sevelamer group (6,1±з,2 tab/day, mean±sd). the average intact fibroblast growth factor-23 (fgf-23), pth, transferrin saturation and ferritin levels did not significantly change in both groups. we noted also in velphoro group increase in Hb level from io5,6±15,7 to 111,9±22,з g/l (p<0,05) by the end of the study and simultaneously decrease in crp level by 50% (p<0,01). during the study, 6 patients in the sucroferric oxyhydroxide group and 5 in the sevelamer group dropped out due to dyspeptic symptoms. Conclusions. Sucroferric oxyhydroxide (Velphoro®) is a new more effective phosphate binder with a comparable safety profile to a sevelamer, but with superioir phosphate binding capacity.treatment with velphoro can significantly increase the level of hb and reduce level of inflammation.

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About the authors

Evgeny V. Shutov

Botkin Clinical City Hospital; Russian Medical Academy of Continuous Postgraduate Education

Email: shutov_e_v@mail.ru
Doctor of Medical Sciences, Head of Nephrology Department No. 12; Professor, Head of the Chair of Nephrology and Hemodialysis Moscow, Russia

Galina V. Kotlyarova

Botkin Clinical City Hospital

Ph.D., doctor of the hemodialysis department Moscow, Russia

Ksenia M. Lysenko

Botkin Clinical City Hospital

doctor of the hemodialysis department Moscow, Russia

Galina V. Ryabinskaya

Botkin Clinical City Hospital

Ph.D., Doctor of the Department of Laboratory Diagnostics Moscow, Russia

Sergey V. Lashutin

Botkin Clinical City Hospital

Ph.D., doctor of the hemodialysis department Moscow, Russia

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