Introduction: This is a prospective, post marketing surveillance study that aims to determine the efficacy and safety of sevelamer carbonate in hyperphosphatemic chronic kidney disease (CKD) patients in the Philippines. Methods: Adult CKD patients with serum phosphorous levels >1.78 mmol/L and whose physician had decided to treat with sevelamer carbonate 800 mg were enrolled in the study and followed-up for a minimum of three visits from baseline within a six-month period. The primary endpoint was the change in serum phosphorous levels from baseline to the sixth month. Adverse events were noted and recorded during the treatment period. Results: There were 233 patients included in the study from five centers in Metro Manila from 2010 to 2013. Of the 233 patients, 199 were on chronic dialysis, 33 were not on dialysis, and 1 had no data. There was a statistically significant (P-value <0.0001) reduction in serum phosphorous levels from baseline after treatment with sevelamer carbonate. There were 16 patients reported to have adverse drug reactions, 13 of whom had serious adverse events (SAE) and three were non-serious. Of the 13 patients with SAEs, only one was possibly/probably related to sevelamer carbonate and all three non-SAEs were possibly/definitely related to sevelamer carbonate. Conclusion The results showed sevelamer carbonate to be effective in lowering serum phosphorous levels and the most common adverse events were related to the gastrointestinal tract (1.4%). There were sixteen patients with adverse events, three of which were non-serious, while 13 were reported to be serious adverse events. Only one was probably related to the drug.
Renal Insufficiency, Chronic ; Hyperphosphatemia ; Sevelamer

Tumoral calcinosis is a rare complication in uremic patients. An in-depth review of published literature suggests that most patients with uremic tumoral calcinosis do not respond to medical treatment. Here, we report the case of a patient on peritoneal dialysis who presented with infected multifocal masses on both hip joints and was successfully treated by medical intervention. The patient was diagnosed with uremic tumoral calcinosis by physical examination and radiologic imaging, and treated with low-calcium dialysis and a non-calcium phosphate binder, sevelamer, without increasing the dose of dialysis. At the 36-month follow-up, the majority of masses had disappeared and the patient was asymptomatic.
Calcinosis* ; Dialysis ; Follow-Up Studies ; Hip Joint ; Humans ; Peritoneal Dialysis* ; Physical Examination ; Sevelamer

Calciphylaxis is a rare, but serious disorder that is usually observed in patients with renal disease and secondary hyperparathyroidism. It is characterized by the ischemic necrosis of the skin, the underlying tissue and other organs, as well as rapid vascular calcification. Prompt diagnosis and management is required because the intractable skin necrosis sometimes causes lethal sepsis. Sevelamer hydrochloride is an ion-exchanging resin that binds phosphates in the gut without increasing the calcium load. Treatment with it may lead to less vascular calcification and better survival for patients with chronic renal disease. Herein we present a case of calciphylaxis with renal failure and the patient improved after treatment with sevelamer hydrochloride therapy.
Calciphylaxis ; Calcium ; Humans ; Hyperparathyroidism, Secondary ; Necrosis ; Phosphates ; Polyamines ; Renal Insufficiency ; Renal Insufficiency, Chronic ; Sepsis ; Skin ; Vascular Calcification ; Sevelamer

BACKGROUND: Sevelamer is associated with reduced complications of chronic kidney disease-mineral bone disorder (CKD-MBD) resulted from hyperphosphatemia, which may contribute mortality, in CKD patients with dialysis. So far clinical outcomes of sevelamer on mortality and risk of cardiovascular mortality related to CKD-MBD are debating. Purpose of this study was to evaluate the effectiveness of sevelamer HCl on mortality of secondary hyperparathyroidism (SHPT), risk of cardiovascular mortality and, frequency of osteopathy in end stage renal disease (ESRD) patients with dialysis. METHODS: We retrospectively reviewed the electronic medical records of 536 patients with ESRD, who were admitted for moderate to severe SHPT, for 36 months. 75 patients who met inclusion criteria were evaluated for the efficacy of sevelamer (mean serum iPTH = 487.5 pg/mL). RESULTS: Sevelamer intervention was not associated with increased three-year survival time compared with non-sevelamers group [average survival month: 30.4 months in sevelamer group, 26.8 months in non-sevelamer group, p = 0.463]. Sevelamer intervention was not associated with significant mortality benefit and cardiovascular mortality benefit as compared to non-sevelamer group [sevelamer group: non-sevelamer group, all-cause mortality (iPTH > 600 pg/mL): 14.3% (1/34): 20% (1/41) p = 0.962, OR = 0.935, 95% CI, 0.058-14.98, heart disease mortality: 6.67% (2/30): 0% (0/32) p = 0.138]. Sevelamer was not associated with significantly lower cumulative incidence of osteopathy compared to non-sevelamer group (sevelamer group: non-sevelamer group, 5.9% (2/34):9.8% (4/41); p = 0.538; OR = 0.578; 95% CI, 0.099-3.367). CONCLUSION: Sevelamer was not associated with decreased all-cause mortality and risk of cardiovascular mortality compared to non-sevelamer group in ESRD patients with SHPT.
Cardiovascular Diseases ; Dialysis* ; Electronic Health Records ; Heart Diseases ; Humans ; Hyperparathyroidism, Secondary ; Hyperphosphatemia ; Incidence ; Kidney Failure, Chronic ; Kidney* ; Mortality ; Retrospective Studies ; Sevelamer*

BACKGROUND: High serum phosphate and fibroblast growth factor-23 (FGF-23) levels are well-recognized independent risk factors of mortality and morbidity in patients with chronic kidney diseases (CKDs). Sevelamer, as a phosphate chelating agent, reduces serum phosphate and FGF-23 levels produced by bone osteocytes. This study aimed to determine the best dose at which sevelamer could successfully reduce serum phosphate and FGF-23 levels in rat models of adenine-induced CKD. METHODS: CKD was induced using adenine. Healthy and CKD-induced rats were divided into 6 groups as follows: healthy controls; CKD controls; rats treated with 1%, 2%, and 3% sevelamer for CKDs; and healthy rats administered 3% sevelamer. Biochemical factors and serum FGF-23 levels were measured using spectrophotometry and enzyme-linked immunosorbent assay methods. RESULTS: Serum phosphate levels were best decreased in rats receiving 3% sevelamer in their diet (5.91±1.48 mg/dL vs. 8.09±1.70 mg/dL, P < 0.05) compared with the CKD control rats. A dose-dependent decrease in serum FGF-23 levels was observed, and the most significant results were obtained in rats receiving 3% sevelamer compared with the CKD control rats (142.60±83.95 pg/mL vs. 297.15±131.10 pg/mL, P < 0.01). CONCLUSIONS: Higher sevelamer doses significantly reduced serum phosphate and FGF-23 levels in adenine-induced CKD rats.
Adenine ; Animals ; Diet ; Enzyme-Linked Immunosorbent Assay ; Fibroblast Growth Factors* ; Fibroblasts* ; Humans ; Models, Animal ; Mortality ; Osteocytes ; Phosphates ; Rats ; Renal Insufficiency ; Renal Insufficiency, Chronic ; Risk Factors ; Sevelamer* ; Spectrophotometry

INTRODUCTIONSevelamer hydrochloride (Renagel) is frequently used as a second-line phosphate binder in patients on renal replacement therapy. Many studies have shown that sevelamer can improve vascular calcification, serum uric acid and low-density lipoprotein (LDL) cholesterol levels. The main objectives of this study were to assess the efficacy of sevelamer against calcium-based phosphate binders, as well as its tolerability and side-effect profile.

METHODSThis was a retrospective study that included all patients on renal replacement therapy (between 2008 and 2011) who had previously received calcium-based binders for ≥ 6 months and were subsequently switched to sevelamer. Data collected from the patients' medical records included demographics, as well as renal parameters three months prior to sevelamer treatment, and at three and six months post treatment. The study excluded patients on multiple, concomitant phosphate binders or with functioning renal transplants, and those who were noncompliant or had inadequate follow-up blood investigations.

RESULTSA total of 39 patients were included in the study. No major side effects were reported by any of the patients. There were improvements in calcium, phosphate, uric acid and LDL cholesterol levels at three and six months post-sevelamer treatment.

CONCLUSIONWe found sevelamer to be superior to calcium-based phosphate binders in reducing serum calcium, phosphate, uric acid and LDL cholesterol levels in our patient population with advanced renal bone disease. Sevelamer also appears to be well tolerated with no significant side effects.

Adult ; Bone Diseases ; complications ; Chelating Agents ; therapeutic use ; Female ; Humans ; Hypercalcemia ; drug therapy ; Hyperphosphatemia ; drug therapy ; Kidney Failure, Chronic ; drug therapy ; Male ; Middle Aged ; Phosphates ; chemistry ; Polyamines ; therapeutic use ; Renal Replacement Therapy ; methods ; Retrospective Studies ; Sevelamer ; Treatment Outcome ; Uric Acid ; blood