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Abstract: FR-OR031

A Randomized Trial of Optimal Phosphate Range for Coronary Artery Calcification in Dialysis Patients

Session Information

Category: Bone and Mineral Metabolism

  • 402 Bone and Mineral Metabolism: Clinical

Authors

  • Isaka, Yoshitaka, Osaka University Graduate School of Medicine, Suita, Japan
  • Hamano, Takayuki, Osaka University Graduate School of Medicine, Suita, Japan
  • Fujii, Hideki, Kobe University Graduate School of Medicine, Kobe, Japan
  • Teramukai, Satoshi, Kyoto Prefectural University of Medicine, Kyoto, Japan
  • Tsujimoto, Yoshihiro, Inoue hospital, Osaka, Japan
  • Tanaka, Ryoichi, Iwate Medical University, Iwate, Japan
  • Tomiyama, Noriyuki, Osaka University Graduate School of Medicine, Suita, Japan
  • Tatsugami, Fuminari, Hiroshima University, Hiroshima, Japan
  • Hayashi, Terumasa, Osaka General Medical Center, Osaka, Japan
  • Yamauchi, Atsushi, Osaka Rosai Hospital, Sakai-city, Japan
  • Tsubakihara, Yoshiharu, Graduate School of Health Care Science, Jikei Institute, Yodogawa-ku, Osaka, Japan
Background

In dialysis patients, mortality risk due to cardiovascular diseases is remarkably high and prognosis is poor; coronary artery calcification (CAC) is considered one of the major contributing factors. It is known that hyperphosphatemia is associated with CAC. Therefore, controlling serum phosphate level could improve the poor prognosis of dialysis patients. However, the optimal phosphate level in dialysis patients remains unknown; hence, this study was planned to compare the effects of two types of non-calcium-based phosphate binders, and examine the effect of strict control of phosphate on CAC.

Methods

Evaluate the new Phosphate Iron-based binder Sucroferric Oxyhydroxide in Dialysis patients with the goal of advancing the practice of E.B.M. (EPISODE) study is a randomized, open-label, multi-center, interventional trial with a two-by-two factorial design (UMIN000023648). We enrolled 160 hemodialysis patients, who were randomized to the sucroferric oxyhydroxide (SO) or lanthanum carbonate (LC) group in order to reduce serum phosphate to two target levels (3.5 - 4.5 mg/dL in strict group and 5.0 - 6.0 mg/dL in standard group) for 12 months. The primary endpoint was percent change in CAC score (% CACS change).

Results

Median CAC score was 840 (IQR 270-2705) at baseline. In 160 dialysis patients, 115 patients were analyzed as full analysis set. There was no significant difference in % CACS change between two phosphate binders (SO; median 12.46% [IQR -2.78-24.12], vs. LC; 13.23% [4.87-30.19], P=0.369) at 12 months. On the contrary, strict phosphate control (achieved phosphate level; 4.98±0.11 mg/dL) significantly suppressed % CACS change (median 7.57% [IQR -1.84-23.93], vs. 20.16% [9.85-30.19], P=0.020) compared with standard control (phosphate level; 5.61±0.11 mg/dL). Strict phosphate control significantly decreased c-terminal FGF23 (-130.31±327.65 pmol/L) compared with standard control (168.69±730.73, P=0.012).Of interest is that therapeutic effect of strict phosphate control was observed even in dialysis patients with baseline-CAC score>1000 (strict; 4.87% [IQR -3.90-4.87], vs, standard; 11.88% [IQR 5.78-21.41], P=0.030).

Conclusion

Strict phosphate control may retard the progression of CAC among dialysis patients.

Funding

  • Commercial Support