Efficacy and safety of SBR759, a novel calcium‐free, iron(III)‐based phosphate binder, in Asian patients undergoing hemodialysis: A 12‐week, randomized, open‐label, dose‐titration study <i>versus</i> sevelamer hydrochloride

Chen, Jin‐Bor; Chiang, Shou-Shan; Chen, Hung‐Chun; Obayashi, Seiichi; Nakagawa, Masaki; Hexham, J M; Balfour, Alison; Junge, G.; Akiba, Takashi; Fukagawa, Masafumi

doi:10.1111/j.1440-1797.2011.01509.x

Cited by 26 publications

(30 citation statements)

References 18 publications

(34 reference statements)

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“…Participants and investigators were blinded in three studies 17,18,22 and outcome assessors were blinded in four studies. 15,17,18,22 The number of participants lost to follow-up ranged from 13.1 to 38.1% but did not differ between the treatment and control groups. Only three studies 15,18,22 were analyzed on an intention-to-treat basis.…”

Section: Resultsmentioning

confidence: 99%

“…The remaining 18 full-text articles were reviewed for more detailed assessment, and 10 studies were excluded because of duplicate reports. Finally, 8 studies [15][16][17][18][19][20][21][22] with 2018 participants met our inclusion criteria and were included in our meta-analysis. The selection process for studies included in the systematic review is shown in Figure 1.…”

Section: Resultsmentioning

confidence: 99%

“…Three studies 17,18,22 compared iron-based phosphate binders with placebo, four studies 16,17,19,21 made comparison between iron-based phosphate binders and sevelamer, and one study 20 compared ferric citrate with calcium carbonate. Of the eight included trials, five 15,17,[20][21][22] were conducted in Asia. Two studies 16,17 recruited both hemodialysis and peritoneal dialysis patients and six studies 15,[18][19][20][21][22] included only hemodialysis patients.…”

Section: Resultsmentioning

confidence: 99%

“…Of the eight included trials, five 15,17,[20][21][22] were conducted in Asia. Two studies 16,17 recruited both hemodialysis and peritoneal dialysis patients and six studies 15,[18][19][20][21][22] included only hemodialysis patients. Six studies 15,16,[19][20][21][22] made dietary recommendations or monitored the dietary phosphate intake for the participants.…”

Section: Resultsmentioning

confidence: 99%

“…The mean age of the participants ranged from 52.5 to 62.8 years. Seven studies [15][16][17][18][19]21,22 were parallel randomized controlled trials, while one study 20 was cross-over randomized controlled trial. Three studies 17,18,22 compared iron-based phosphate binders with placebo, four studies 16,17,19,21 made comparison between iron-based phosphate binders and sevelamer, and one study 20 compared ferric citrate with calcium carbonate.…”

Section: Resultsmentioning

confidence: 99%

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Effects and safety of iron-based phosphate binders in dialysis patients: a systematic review and meta-analysis

Zhai

Yang

et al. 2014

Renal Failure

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Aim: To assess the effects and safety of iron-based phosphate binders in adult patients receiving dialysis. Methods: We electronically searched MEDLINE, EMBASE, CENTRAL, and CBM for randomized controlled trials about iron-based phosphate binders in adult dialysis patients. Study quality was assessed using the criteria outlined in the Cochrane Handbook for Systematic Reviews of intervention. Meta-analysis was conducted by RevMan 5.3. Results: Eight studies with 2018 participants were eligible for our meta-analysis. Iron-based phosphate binders were superior to placebo (MD ¼ À2.43 mg/dL, 95% CI: À3.18 to À1.68, p50.00001) and as efficient as sevelamer (MD ¼ 0.04 mg/dL, 95% CI: À0.29 to 0.36, p ¼ 0.83) in reducing serum phosphorus in dialysis patients. No significant differences were found in all adverse events (OR ¼ 1.30, 95% CI: 0.77 to 2.20, p ¼ 0.32) between iron-based phosphate binders and placebo. Iron-based phosphate binders were associated with significant higher serum iron (MD ¼ 9.39 ng/mL, 95% CI 1.48 to 17.30, p ¼ 0.02), higher serum transferring saturation (MD ¼ 6.29%, 95% CI 2.72 to 9.87, p ¼ 0.0006) and lower serum total iron binding capacity (MD ¼ À23.13 mg/dL, 95% CI À35.69 to À10.58, p ¼ 0.0003) in comparison to placebo. Conclusion: Iron-based phosphate binders are as effective as sevelamer and well tolerated for hyperphosphatemia in dialysis patients. Iron-based phosphate binders appear to have a beneficial effect on renal anemia in patients receiving dialysis. Therefore, iron-based phosphate binders may represent a new treatment option for dialysis patients.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Effects and safety of iron-based phosphate binders in dialysis patients: a systematic review and meta-analysis

Zhai

Yang

et al. 2014

Renal Failure

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What If Miró’s Dots and Lines Are Not Simply Dots and Lines?

Guardiola

Baños

2019

JAMA Intern Med

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showed the increased risks of falls related to zolpidem remained present even after adjusting for age. Similarly, we cited several other studies that included adult inpatients of all age groups. It may be reasonable to state that the adverse events associated with sedative-hypnotic medications, or the interventions suggested in these studies, lack ample evidence to extend to younger populations. However, as a corollary, there is also no physiological reason that risks or benefits would reverse in a younger population. Because we are recommending minimizing use of a medication that might increase risks (and is prescribed without appropriate indications in the first place), it is unlikely that deprescribing sedative-hypnotic medications will result in greater harm in younger populations. In fact, given that sedative-hypnotic coingestion is associated with increased lethality of opioid overdoses, it would be reasonable to anticipate harm reduction in any efforts and curb inappropriate sedative-hypnotic prescribing. We would welcome more evidence and study regarding the younger population.Regarding the association of zolpidem with complex and sometimes amnestic behaviors, there is sufficient validation of those adverse effects that a new black-box warning has been issued. 6 However, the cited article focuses on hypnotics in hospitalized patients, and our broad search strategy did not identify publications specifically addressing these complex behaviors in hospitalized patients. Nonetheless, we agree that caution is needed, carefully weighing risks and benefits prior to prescribing zolpidem. Additionally, if it must be prescribed, it should be at the minimal effective and approved dose.

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What If Miro’s Dots and Lines Are Not Simply Dots and Lines?—Reply

Taran

Detsky

2019

JAMA Intern Med

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Efficacy and safety of SBR759, a novel calcium‐free, iron(III)‐based phosphate binder, in Asian patients undergoing hemodialysis: A 12‐week, randomized, open‐label, dose‐titration study versus sevelamer hydrochloride

Abstract: SBR759 showed superior phosphate control with a favorable tolerability profile compared to sevelamer-HCl in hemodialysis patients.

Cited by 26 publications

References 18 publications

Effects and safety of iron-based phosphate binders in dialysis patients: a systematic review and meta-analysis

Effects and safety of iron-based phosphate binders in dialysis patients: a systematic review and meta-analysis

What If Miró’s Dots and Lines Are Not Simply Dots and Lines?

What If Miro’s Dots and Lines Are Not Simply Dots and Lines?—Reply

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