A Randomized Trial of the Impact of Ferric Citrate on Erythropoietin and Intravenous Iron Use in Patients Receiving Dialysis.

INTRODUCTION: Ferric citrate (FC) is an FDA-approved iron-based phosphate binder for adults with dialysis-dependent chronic kidney disease. This study investigated the impact of FC as the primary phosphate-lowering therapy on utilization of erythropoiesis-stimulating agents (ESAs) and intravenous (IV) iron. METHODS: In this randomized, open-label, active-controlled, multicenter study (NCT04922645), patients on dialysis and receiving ESAs were randomized to receive FC or remain on standard of care (SOC) phosphate-lowering therapy for up to 6 months. Primary endpoints were the difference in change from baseline to efficacy evaluation period (EEP) in mean monthly ESA and IV iron doses. Secondary endpoints included treatment differences in hemoglobin, phosphate, TSAT, and ferritin levels. RESULTS: Two hundred nine patients were randomized to FC and had a day 1 dosing visit (n = 103) or SOC (n = 106). The two groups had similar baseline laboratory characteristics; however, atherosclerotic CV disease, peripheral vascular disease, and congestive heart failure were more common in the SOC group. The mean treatment difference in ESA monthly dose was -30.8 µg (FC vs. SOC; p = 0.02). An absolute though non-statistically significant change in mean monthly IV iron dose of -37.2 mg (p = 0.17) was observed with FC. Mean hemoglobin, TSAT, and ferritin all increased from baseline to the EEP with FC versus SOC. Serious adverse events occurred in 28% of patients receiving FC versus 37% in those receiving SOC. CONCLUSIONS: In patients receiving dialysis, treatment with FC as compared to remaining on SOC phosphate binders resulted in reductions in mean monthly ESA and IV iron dose.

An Arterial Anastomosis Stenosis Used in Lieu of Banding to Prevent Dialysis Access Steal Syndrome.

A 69-year-old Native American female with a past medical history of end-stage renal disease presented to our rural outpatient dialysis access center. One and a half years prior, the patient's arteriovenous fistula was banded due to venous steal syndrome and now demonstrated an abnormal bruit with decreased blood flow during dialysis. On arteriogram, she was found to have a 90% narrowing of her previously banded cephalic vein along with stenosis of the arterial anastomosis and subclavian vein. Balloon angioplasty was performed on the subclavian vein stenosis, and the banded cephalic vein was ruptured. However, the arterial anastomosis stenosis was left untreated due to the patient's previous venous steal syndrome.

Saw palmetto-induced pancreatitis.

Saw palmetto is a frequently used botanical agent in benign prostatic enlargement (BPH). Although it has been reported to cause cholestatic hepatitis and many medical conditions, Saw palmetto has not been implicated in acute pancreatitis. We report a case of a probable Saw palmetto induced acute hepatitis and pancreatitis. A 55-year-old reformed alcoholic, sober for greater than 15 years, presented with severe non-radiating epigastric pain associated with nausea and vomiting. His only significant comorbidity is BPH for which he intermittently took Saw palmetto for about four years. Physical examination revealed normal vital signs, tender epigastrium without guarding or rebound tenderness. Cullen and Gray Turner signs were negative. Complete blood count and basic metabolic profile were normal. Additional laboratory values include a serum amylase: 2,152 mmol/L, lipase: 39,346 mmol/L, serum triglyceride: 38 mmol/L, AST: 1265, ALT: 1232 and alkaline phosphatase was 185. Abdominal ultrasound and magnetic resonance cholangiography revealed sludge without stones. A hepatic indole diacetic acid scan was negative. Patient responded clinically and biochemically to withdrawal of Saw palmetto. Two similar episodes of improvements followed by recurrence were noted with discontinuations and reinstitution of Saw Palmetto. Simultaneous and sustained response of hepatitis and pancreatitis to Saw palmetto abstinence with reoccurrence on reinstitution strongly favors drug effect. "Natural" medicinal preparations are therefore not necessarily safe and the importance of detailed medication history (including "supplements") cannot be over emphasized.

Assessing compliance of cardiologists with the national cholesterol education program (NCEP) III guidelines in an ambulatory care setting.

INTRODUCTION: The NCEP III -ATP guidelines provide clear clinical directives for lipid management especially statins therapy in appropriate patient groups. Compliance of primary care physicians with these guidelines especially in ambulatory care settings has been shown to be poor. The compliance of cardiologist to these guidelines is less documented. METHODS: A retrospective chart review of 386 patients managed in a large urban cardiology practice was undertaken. Patients with documented contraindications to use of statins were excluded from the study. Only patients with two or more years of follow-up in the practice were included. Demographic variables and medical history including CAD or its equivalent and its major risk factors were identified. The proportion of patients on statins and adequacy of statins therapy were recorded. The lipid profiles of all patients were also analyzed. RESULTS: Fifteen patients with documented contraindications to statins therapy including persistent/severe LFT abnormalities, allergies, and gastrointestinal intolerance were excluded. A total of 371 patients were included in the analysis. The mean age for patients in the study was 65 years (range: 42-84). 236 (64%) were males while 141 (36%) were females. 161 (43%) patients were on statins while 210 (57%) weren't. 88 (62%) of females were on stain compared to 116 (49%) of males (p = 0.001). 68% of patients below the age of 50 yrs were not on statins compared with 55% of those greater than 50 yrs (p = 0.01). 38% of patients on statins therapy had sub-optimal lipid profile despite greater than two years of therapy. No statistically significant differences in race and use of satins were noted. CONCLUSION: This study demonstrates a higher than expected prevalence of sub-optimal management of dyslipidemia among patients with established coronary heart disease without contraindications to statins managed by cardiologists. Cardiology and primary care practices require similar comprehensive routine lipid management program that is assiduously maintained and evaluated at both in-patient and out patient settings to ensure most patients receive optimal therapy with statins and other lipid lowering agents.