Calciphylaxis in man. A syndrome of tissue necrosis and vascular calcification in 11 patients with chronic renal failure

Gipstein, Robert M.; Coburn, Jack W.; Adams, Donald A.; Lee, David B. N.; Parsa, Khosrow; Sellers, Alvin L.; Suki, Wadi N.; Massry, Shaul G.

doi:10.1001/archinte.136.11.1273

Cited by 146 publications

(108 citation statements)

References 10 publications

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“…H yperphosphatemia is extensively documented as an independent factor associated with increased morbidity in patients with chronic kidney disease (CKD) (1)(2)(3)(4). Epidemiologic studies have demonstrated that elevated serum phosphate is associated with an increased relative risk of death in patients on hemodialysis (5).…”

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confidence: 99%

Iron-Magnesium Hydroxycarbonate (Fermagate)

McIntyre

Pai

Warwick

et al. 2009

Clinical Journal of the American Society of Nephrology

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Background and objectives: This phase II study tested the safety and efficacy of fermagate, a calcium-free iron and magnesium hydroxycarbonate binder, for treating hyperphosphatemia in hemodialysis patients.Design, setting, participants, & measurements: A randomized, double-blind, three-arm, parallel-group study compared two doses of fermagate (1 g three times daily or 2 g three times daily with placebo). Sixty-three patients who had been on a stable hemodialysis regimen for >3 mo were randomized to the treatment phase. Study medication was administered three times daily just before meals for 21 d. The primary endpoint was reduction in serum phosphate over this period.Results: In the intention-to-treat analysis, mean baseline serum phosphate was 2.16 mmol/L. The fermagate 1-and 2-g three-times-daily treatment arms were associated with statistical reductions in mean serum phosphate to 1.71 and 1.47 mmol/L, respectively. Adverse event (AE) incidence in the 1-g fermagate arm was statistically comparable to the placebo group. The 2-g arm was associated with a statistically higher number of patients reporting AEs than the 1-g arm, particularly gastrointestinal AEs, as well as a higher number of discontinuations, complicating interpretation of this dose's efficacy. Both doses were associated with elevations of prehemodialysis serum magnesium levels.Conclusions: The efficacy and tolerability of fermagate were dose dependent. Fermagate showed promising efficacy in the treatment of hyperphosphatemia in chronic hemodialysis patients as compared with placebo in this initial phase II study. The optimal balance between efficacy and tolerability needs to be determined from future dose-titration studies, or fixed-dose comparisons of more doses.

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confidence: 99%

Iron-Magnesium Hydroxycarbonate (Fermagate)

McIntyre

Pai

Warwick

et al. 2009

Clinical Journal of the American Society of Nephrology

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“…Medical calcinosis of peripheral arteries may be extensive in patients with renal disease and secondary hyperparathyroidism, but gangrene in the digits rarely occurs in association with such calcinosis (6). Furthermore, most patients show marked clinical improvement with regressionof pain and some healing of the lesions within the first week after parathyroidectomy (6).…”

Section: Discussionmentioning

confidence: 99%

“…These patients often have radiographic evidence of subperiosteal reabsorption and vascular calcification. Although vascular calcification is not uncommon, lossof digits because of necrosis is rare (6). We describe a patient with Buerger'sdisease and secondary hyperparathyroidism who developed multiple digital necroses as a result of 2 diseases.…”

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confidence: 95%

Buerger's Disease and Secondary Hyperparathyroidism Associated with Chronic Hemodialysis

Fenves¹,

Jordan²,

Solano³

1994

Baylor University Medical Center Proceedings

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“…Acral gangrene also advances rapidly on the distal portion of the digits and toes. Pathological examination reveals small vessel involvement with medial calcification and intimal proliferation in numerous organs, sometimes accompanied by microthrombi (3,4). Because of the rapid onset, progression and infection from the gangrenous regions, sepsis occurs; the risk of death from cerebral, cardiac and intestinal infarction is indeed great.…”

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confidence: 99%

“…There is a report of the prognosis of40 reported cases (male 17, female 23) of calciphylaxis (3)(4)(5). This study found the morbidity progression stopped or there was improvement in 17 of the cases, compared to 23 cases in which there was progression or death.…”

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confidence: 99%

Systemic Calciphylaxis

Maeda

1995

Intern. Med.

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Calciphylaxis in man. A syndrome of tissue necrosis and vascular calcification in 11 patients with chronic renal failure

Cited by 146 publications

References 10 publications

Iron-Magnesium Hydroxycarbonate (Fermagate)

Iron-Magnesium Hydroxycarbonate (Fermagate)

Buerger's Disease and Secondary Hyperparathyroidism Associated with Chronic Hemodialysis

Systemic Calciphylaxis

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