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Deferasirox is a once-daily, oral iron chelator developed for treating transfusional iron overload. Preclinical studies indicated that the kidney was a potential target organ of toxicity. As patients with sickle cell disease often have abnormal baseline renal function, the primary objective of this randomised, open-label, phase II trial was to evaluate the safety and tolerability of deferasirox in comparison with deferoxamine in this population. Assessment of efficacy, as measured by change in liver iron concentration (LIC) using biosusceptometry, was a secondary objective. A total of 195 adult and paediatric patients received deferasirox (n = 132) or deferoxamine (n = 63). Adverse events most commonly associated with deferasirox were mild, including transient nausea, vomiting, diarrhoea, abdominal pain and skin rash. Abnormal laboratory studies with deferasirox were occasionally associated with mild non-progressive increases in serum creatinine and reversible elevations in liver function tests. Discontinuation rates from deferasirox (11.4%) and deferoxamine (11.1%) were similar. Over 1 year, similar dose-dependent LIC reductions were observed with deferasirox and deferoxamine. Once-daily oral deferasirox has acceptable tolerability and appears to have similar efficacy to deferoxamine in reducing iron burden in transfused patients with sickle cell disease.
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PMID:A randomised comparison of deferasirox versus deferoxamine for the treatment of transfusional iron overload in sickle cell disease. 1723 48

Anatomical change in the anatomy of the gastrointestinal tract after bariatric surgery leads to modification of dietary patterns that have to be adapted to new physiological conditions, either related with the volume of intakes or the characteristics of the macro- and micronutrients to be administered. Restrictive diet after bariatric surgery (basically gastric bypass and restrictive procedures) is done at several steps. The first phase after surgery consists in the administration of clear liquids for 2-3 days, followed by completely low-fat and high-protein content (> 50-60 g/day) liquid diet for 2-4 weeks, normally by means of formula-diets. Soft or grinded diet including very soft protein-rich foods, such as egg, low-calories cheese, and lean meats such as chicken, cow, pork, or fish (red meats are not so well tolerated) is recommended 2-4 weeks after hospital discharge. Normal diet may be started within 8 weeks from surgery or even later. It is important to incorporate hyperproteic foods with each meal, such egg whites, lean meats, cheese or milk. All these indications should be done under the supervision of an expert nutrition professional to always advise the patients and adapting the diet to some special situations (nausea/vomiting, constipation, diarrhea, dumping syndrome, dehydration, food intolerances, overfeeding, etc.). The most frequent vitamin and mineral deficiencies in the different types of surgeries are reviewed, with a special focus on iron, vitamin B12, calcium, and vitamin D metabolism. It should not be forgotten that the aim of obesity surgery is making the patient loose weight and thus post-surgery diet is designed to achieve that goal although without forgetting the essential role that nutritional education has on the learning of new dietary habits contributing to maintain that weight loss over time.
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PMID:[Nutritional implications of bariatric surgery on the gastrointestinal tract]. 1767

This cross-sectional survey sought to document complementary and alternative medicine (CAM) use by Texas midwives, as well as to determine whether licensed direct-entry midwives (LMs) and certified nurse-midwives (CNMs) differed significantly in their patterns of use. All respondents (n = 69) indicated that they used, recommended, or referred their clients for at least one CAM therapy during the preceding year. Ninety percent (90%) of respondents used, recommended, or referred their clients for an herbal remedy (not including homeopathic tinctures). Herbal therapies were among the top three modalities recommended for 7 of 12 (58%) clinical indications. Herbs were the most salient CAM therapy used for cervical ripening (83%), followed closely by use for nausea, vomiting, and hyperemesis (80%), and labor induction (77%). Herbal therapies also constituted 50% or more of the CAM therapies used for the following indications: anemia/iron supplementation (70%), perineal healing (66%), and anxiety/stress/fatigue (50%). LM respondents used, recommended, or referred their clients for a greater number of herbal therapies compared to CNMs. While several of the CAM modalities used or recommended by Texas midwives show potential for clinical benefit, few have been studied sufficiently to determine their efficacy or safety during pregnancy.
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PMID:Herbal and other complementary medicine use by Texas midwives. 1782 10

Patients with thalassemia major requiring regular blood transfusions accumulate iron that is toxic to the heart, liver, and endocrine systems. The following prospective, randomized trial was carried out to determine the effectiveness, in children and young adults, of combined deferiprone (DFP) and deferoxamine (DFO) in reducing transfusional iron overload compared to either drug alone and to assess the safety and tolerability of DFP. Sixty-six patients were randomized into three treatment arms: daily DFP combined with DFO twice weekly; daily DFP only; and DFO only 5 days/week. Fifty-six patients completed the 54 weeks and were assessed by different indices. A significant reduction of liver iron concentration and serum ferritin was observed in all three arms while significant reduction of liver iron score was observed in patients on combination therapy only. Cardiac function did not significantly change in any arm. Compliance improved in patients who received combined therapy. Toxicity of DFP was mild to moderate and acceptable; most commonly, transient arthropathy and nausea/vomiting were observed. Thus, combination therapy has shown to be effective in reducing iron overload in thalassemia patients.
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PMID:Iron chelation in thalassemia: combined or monotherapy? The Egyptian experience. 1835 37

Small bowel tumors are rare, accounting for 1-2% of all gastrointestinal neoplasms. We sought to determine the diagnostic and therapeutic impact of double-balloon enteroscopy (DBE) in patients with small bowel tumors. Between January 2005 and March 2008, 78 patients underwent 96 DBE. All nine patients (seven males; mean age 68 +/- 11.3 years) with small bowel tumors were retrospectively reviewed. Clinical presentation was: mid-gastrointestinal bleeding or iron-deficient anemia (55.6%); abdominal pain (22.2%); nausea/vomiting and abdominal distension (22.2%). Five patients had abnormal findings in previous capsule endoscopy and four in previous radiologic examinations. Route of insertion was exclusively oral and abnormal lesions were detected in all patients (jejunum 8; ileum 1). Biopsies were taken in seven patients and provided definitive histological diagnosis in all except one. There were no complications of DBE. Surgical resection took place in eight patients. Final histologic diagnosis were: primary carcinoma (33.3%), gastrointestinal stromal tumor (GIST) (33.3%), malignant lymphoma (22.2%), and carcinoid tumor (11.1%). Mean follow-up time was 15.4 +/- 12.7 months (range 2-34 months). Six patients were submitted to chemotherapy. Two patients died. Small bowel tumors are common in patients submitted to DBE. Given its safety and diagnostic capabilities, DBE should be considered the gold-standard method in the study of these neoplasms.
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PMID:Double-balloon enteroscopy and small bowel tumors: a South-European single-center experience. 1895 20

Appendiceal carcinoma is a very rare clinical entity, constituting 1% of all colorectal malignancies and 1% of all appendectomy specimens. Appendiceal malignancies often present atypically, thus creating diagnostic challenges. We present a patient with mucinous carcinoma of the appendix who presented with hematuria and abdominal pain. Similar case reports are extremely rare in the literature, while typical presentations of appendiceal carcinoma include abdominal pain, abdominal mass, early satiety, nausea, and iron-deficiency anemia. Initially, the diagnostic investigation in our patient was focused on urinary tract disorders, but ultimately resulted in finding a mucinous appendiceal carcinoma. The carcinoma had invaded the urinary bladder and was disseminated in the peritoneal cavity. Aggressive cytoreductive surgery is the most common therapeutic approach for disseminated tumors, often followed by intraperitoneal chemotherapy. However, treatment should be individualized based on patient-specific parameters, such as the presence of comorbidities, performance status, as well as the presence of metastatic disease. Our patient had optimal cytoreduction with subsequent systemic therapy with 5-fluorouracil, leucovorin, oxaliplatin, and bevacizumab, a monoclonal antibody directed against vascular endothelial growth factor. She completed her treatment regimen without complications and is currently being restaged. An integrative approach is required in the diagnostic investigation and management of appendiceal malignancies.
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PMID:Appendiceal carcinoma: a diagnostic and therapeutic challenge. 1902 Mar 71

In recent years, a growing number of severely obese adolescents and their families have sought out surgical treatment because behavioral or medical therapies were not successful. A number of reports have suggested that bariatric surgery for this patient group is safe and can provide durable weight loss. However, most of these reports have been retrospective studies with short-term outcomes, and more long-term, prospective studies are needed to optimize care for these patients. Evaluation of the severely obese patient for surgery involves multiple factors, including the overall maturity of the patient; joint discussions with the patient and his or her family; a complete medical evaluation; evaluation by a child psychologist or psychiatrist; and a minimum of 6 months of private, interdisciplinary, multifaceted lifestyle preparation. Surgical options are restricted to severely overweight adolescents without endocrine disorders who have achieved puberty and have failed more conservative therapies. The Roux-en-Y gastric bypass is the most commonly performed procedure in adolescents, but the laparoscopic adjustable gastric band procedure is growing in popularity. Postoperatively, patients are evaluated 2 weeks after surgery and then every 1 to 2 months for the first postoperative year; every 2 months to 6 months in the second year, depending on the individual case; and then annually for life. A careful diet plan backed by continuing family support is essential. Short- and long-term complications are similar to those seen in adults, and include bowel obstruction, bleeding, blood clots, nausea, gallstones, hernia, and vitamin and iron deficiencies.
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PMID:Bariatric surgery for the severely obese adolescent. 1908 45

Nausea and vomiting of pregnancy (NVP) is experienced by the majority of pregnant women, and can negatively affect a women's quality of life. It has been suggested in observational studies that iron-containing prenatal multivitamins may increase the severity of NVP. The objective of this study was to determine whether decreasing iron exposure can mitigate NVP symptoms. Data were collected from a prospective cohort at the Motherisk Program in Toronto. Women (n = 97) seeking advice on managing severe NVP were advised to discontinue prenatal multivitamin administration and switch to folic acid, an adult multivitamin or a children's chewable multivitamin. Two-thirds (63 out of 97) (p < 0.001) of those women qualitatively reported an improvement in NVP symptoms after discontinuation of iron-containing prenatal multivitamins. These findings were verified quantitatively using both the pregnancy-unique quantification of emesis and nausea (PUQE) (p < 0.001) and well-being (p < 0.001) scoring systems. This is the first interventional study showing that discontinuation of iron results in improvement of NVP symptoms. Our data suggest that avoiding iron-containing prenatal multivitamins in the first trimester is effective in improving NVP symptoms in the majority of pregnant women suffering from morning sickness.
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PMID:The effectiveness of discontinuing iron-containing prenatal multivitamins on reducing the severity of nausea and vomiting of pregnancy. 1928 Apr 88

Ferric carboxymaltose (Ferinject(R)), a novel iron complex that consists of a ferric hydroxide core stabilized by a carbohydrate shell, allows for controlled delivery of iron to target tissues. Administered intravenously, it is effective in the treatment of iron-deficiency anaemia, delivering a replenishment dose of up to 1000 mg of iron during a minimum administration time of </=15 minutes. Results of several randomized trials have shown that intravenously administered ferric carboxymaltose rapidly improves haemoglobin levels and replenishes depleted iron stores in various populations of patients with iron-deficiency anaemia, including those with inflammatory bowel disease, heavy uterine bleeding, postpartum iron-deficiency anaemia or chronic kidney disease. It was well tolerated in clinical trials. Ferric carboxymaltose is, therefore, an effective option in the treatment of iron-deficiency anaemia in patients for whom oral iron preparations are ineffective or cannot be administered. Ferric carboxymaltose is a macromolecular ferric hydroxide carbohydrate complex, which allows for controlled delivery of iron within the cells of the reticuloendothelial system and subsequent delivery to the iron-binding proteins ferritin and transferrin, with minimal risk of release of large amounts of ionic iron in the serum. Intravenous administration of ferric carboxymaltose results in transient elevations in serum iron, serum ferritin and transferrin saturation, and, ultimately, in the correction of haemoglobin levels and replenishment of depleted iron stores. The total iron concentration in the serum increased rapidly in a dose-dependent manner after intravenous administration of ferric carboxymaltose. Ferric carboxymaltose is rapidly cleared from the circulation and is distributed primarily to the bone marrow ( approximately 80%) and also to the liver and spleen. Repeated weekly administration of ferric carboxymaltose does not result in accumulation of transferrin iron in patients with iron-deficiency anaemia. Intravenously administered ferric carboxymaltose was effective in the treatment of iron-deficiency anaemia in several 6- to 12-week, randomized, open-label, controlled, multicentre trials in various patient populations, including those with inflammatory bowel disease, heavy uterine bleeding or postpartum iron-deficiency anaemia, and those with chronic kidney disease not undergoing or undergoing haemodialysis. In most trials, patients received either ferric carboxymaltose equivalent to an iron dose of </=1000 mg (or 15 mg/kg in those weighing <66 kg) administered over </=15 minutes (subsequent doses administered at 1-week intervals) or oral ferrous sulfate at a dose equivalent to 65 mg iron three times daily or 100 mg iron twice daily. In one trial, patients with chronic kidney disease undergoing haemodialysis received 200 mg of iron intravenously either as ferric carboxymaltose or iron sucrose administered into the haemodialysis line two to three times weekly. In all trials, ferric carboxymaltose was administered until each patient had received his or her calculated total iron replacement dose. Haemoglobin-related outcomes improved in patients with iron-deficiency anaemia receiving ferric carboxymaltose. Treatment with ferric carboxymaltose was associated with rapid and sustained increases from baseline in haemoglobin levels. Ferric carboxymaltose was considered to be as least as effective as ferrous sulfate with regard to changes from baseline in haemoglobin levels or the proportion of patients achieving a haematopoietic response at various timepoints. In general, improvements in haemoglobin levels were more rapid with ferric carboxymaltose than with ferrous sulfate. In patients with chronic kidney disease undergoing haemodialysis, ferric carboxymaltose was at least as effective as iron sucrose. Ferric carboxymaltose also replenished depleted iron stores and improved health-related quality-of-life (HR-QOL) in patients with iron-deficiency anaemia. Recipients of ferric carboxymaltose demonstrated improvements from baseline in serum ferritin levels and transferrin saturation, as well as improvements from baseline in HR-QOL assessment scores. Ferric carboxymaltose was at least as effective as ferrous sulfate with regard to endpoints related to serum ferritin levels, transferrin saturation and HR-QOL. Ferric carboxymaltose was well tolerated in clinical trials in patients with iron-deficiency anaemia, with most drug-related adverse events considered to be mild to moderate in severity. Commonly reported drug-related adverse events include headache, dizziness, nausea, abdominal pain, constipation, diarrhoea, rash and injection-site reactions. The incidence of drug-related adverse events in patients receiving intravenous ferric carboxymaltose was generally similar to that in patients receiving oral ferrous sulfate. In general, rash and local injection-site reactions were more common with ferric carboxymaltose, whereas gastrointestinal adverse events were more frequent with ferrous sulfate. In patients with chronic kidney disease undergoing haemodialysis, a lower proportion of ferric carboxymaltose than iron sucrose recipients experienced at least one drug-related adverse event.
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PMID:Ferric carboxymaltose: a review of its use in iron-deficiency anaemia. 1940 53

Ferumoxytol is an intravenous iron preparation for treatment of the anemia of chronic kidney disease (CKD). It is a carbohydrate-coated, superparamagnetic iron oxide nanoparticle. Because little free iron is present in the preparation, doses of 510 mg have been administered safely in as little as 17 seconds. Two prospective, randomized studies compared two doses of ferumoxytol 510 mg given in 5 +/- 3 days with 3 weeks of oral iron 200 mg/day (as ferrous fumarate) in anemic patients with CKD. One study enrolled 304 patients with stages 1-5 CKD (predialysis), and the other study enrolled 230 patients with stage 5D CKD (undergoing hemodialysis). In both studies, a greater increase in hemoglobin level from baseline to end of study (day 35) was noted in patients who received ferumoxytol compared with those who received oral iron (mean +/- SD 0.82 +/- 1.24 vs 0.16 +/- 1.02 g/dl in patients with stages 1-5 CKD and 1.02 +/- 1.13 vs 0.46 +/- 1.06 g/dl in patients with stage 5D CKD, p<0.001). A greater proportion of both predialysis and hemodialysis patients who received ferumoxytol had hemoglobin level increases from baseline of 1 g/dl or more compared with those who received oral iron (p<0.001). In a prospective, double-blind, crossover study of more than 700 patients with CKD stages 1-5D that compared the safety of ferumoxytol with normal saline injection, the rates of treatment-related adverse events were 5.2% and 4.5%, respectively. Serious treatment-related adverse events were seen in one patient in each treatment group. The most common adverse events with ferumoxytol occurred at the injection site (bruising, pain, swelling, erythema). Dizziness, nausea, pruritus, headache, and fatigue occurred in less than 2% of patients receiving ferumoxytol, with a similar frequency noted after administration of normal saline. In short-term studies, intravenous ferumoxytol was safely and rapidly administered, and was more effective than oral iron therapy in increasing hemoglobin levels in anemic patients with CKD. Long-term clinical trials with clinical outcomes and studies comparing ferumoxytol with other parenteral iron agents will help define the role of ferumoxytol in treating the anemia of CKD.
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PMID:Ferumoxytol: a new intravenous iron preparation for the treatment of iron deficiency anemia in patients with chronic kidney disease. 2003 Apr 75


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