Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0002871 (anemia)
 52,094 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

A prospective, open, multicenter clinical trial was set up to evaluate the potential interaction of ITF 282 with H2-receptor antagonists in patients affected with iron deficiency. Patients treated with H2 blockers and affected with iron deficiency or iron deficient anemia were given one tablet of ITF 282 (60 mg iron) twice daily for 60 days. A second group of iron deficient patients with no anti H2 concurrent treatment were admitted to the same iron treatment, lasting 60 days. To evaluate the outcome of the iron treatment, a comprehensive assessment of laboratory and clinical determinations was adopted in all the patients: special hematology, symptomatology, safety hematology and hematochemistry, urinalysis. Fifty-three patients with iron deficiency and 47 patients affected with overt iron deficient anemia entered the study. After treatment, a significant trend toward the normalization of the main hematologic parameters in both groups was detected. The general tolerability was apparently more favorable in the patients who had also the antiulcer (1 event of diarrhoea) than in those who had ITF 282 alone (2 heartburn, 3 constipation, 2 abdominal pain). There were no indications of subgroups of patients particularly at risk of adverse events, all of which resulted reversible without the need to reduce the dose of medication or to take other medical action. ITF 282 resulted, also when administered together with H2-receptor antagonists, in the expected therapeutic efficacy, with the expected clinical tolerability and biological safety, without signs of possible interaction, negative or positive.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Iron protein succynilate in the treatment of iron deficiency: potential interaction with H2-receptor antagonists. 810 Feb 20

A prospective, controlled, double-blind, double-dummy, multicenter clinical trial was made to assess the efficacy and tolerability of iron-protein-succinylate (ITF 282) in comparison with a well known iron preparation in the treatment of iron deficiency or iron deficient anemia. One thousand and ninety-five patients affected with iron deficiency or overt iron deficient anemia were randomized to receive either two ITF 282 tablets/day (60 mg iron each) or a commercially available ferrous sulphate controlled release tablet (one tablet containing 105 mg iron/day). Five hundred and forty-nine patients received ITF 282; 546 patients were treated with ferrous sulphate. Both treatments lasted 60 days. The treatment outcome was checked by evaluating special hematology, symptomatology, safety hematology and hematochemistry. After two months of treatment, the normalization of the main hematologic parameters in both groups was detected. Although in the first month the reference treatment appears to provide somewhat faster results, at the end of the observation, the values of hematocrit, hemoglobin and ferritin were greater in the ITF 282 group, indicating a more progressive and steady therapeutic effect. The overall clinical rating was significantly in favor of ITF 282, with 78.9% of favorable results vs 67.6%. By dividing the patient population according to pathological conditions (iron deficiency or overt anemia), or according to the etiopathogenesis of the iron deficiency (increased requirement, or increased loss in adults and in the elderly), separate analyses on the treatment outcome were made (and have been included). The general tolerability, although favorable with both treatments, was significantly more favorable with ITF 282. With this medication, 63 patients (11.5%) complained of 69 adverse reactions (25 heartburn, 19 constipation, 25 abdominal pain) vs 141 events reported by 127 patients (26.3%) with the reference medication (33 heartburn, 31 epigastric pain, 23 constipation, 32 abdominal pain, 8 skin rash, 14 nausea). These observations confirm that, although the most modern preparations of ferrous sulphate exhibit a relatively low frequency of adverse events of limited clinical concern, it is nevertheless possible to decrease both the prevalence and the duration of such events without prejudice for the clinical efficacy, with the use of more "physiological" preparations in which the iron is reversibly bound to a protein carrier, thus effectively removing one of the main obstacles to the correct compliance with treatments that must be administered for prolonged periods of time.
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PMID:Iron protein succinylate in the treatment of iron deficiency: controlled, double-blind, multicenter clinical trial on over 1,000 patients. 846 8

A total of 502 children up to the age of 14 years were treated for iron deficiency or overt anemia. ITF 282 was prescribed to 256 children, and a commercially available ferrous polystyrene sulphonate preparation to 246, in a randomized double-blind, double-dummy, ten-center trial. One oral vial of ITF 282 (60 mg iron) was administered once a day to children weighing up to 40 kg; and twice a day to children with body weight equal or superior to 40 kg. In the reference group, oral vials of polystyrene sulphonate (52.5 mg iron) were administered once a day to children weighing up to 40 kg, and twice a day to children weighing 40 kg or more. Treatments lasted 60 days. The treatments' efficacy and tolerability were evaluated taking into consideration: special hematology, symptomatology, safety hematology and hematochemistry, urinalysis. At the end of treatment, the trend was detected to the normalization of the main hematologic parameters in both groups (hemoglobin, hematocrit, ferritin, blood iron, transferrin saturation, MCHC). Although in the first month the reference treatment appears to provide somewhat faster results, significantly greater values of blood iron are observed at the end of the observation in the ITF 282 group, indicating a more progressive and steady therapeutic effect. The overall clinical rating was, although not significant, in favor of ITF 282, with a failure rate of 18.0 vs 24.0%. The general tolerance, although favorable with both treatments, was significantly more favorable with ITF 282. With this medication, 13 patients complained of 13 events (1 heartburn, 6 constipation, 6 abdominal pain) vs 48 events reported by 43 patients with the reference medication (1 heartburn, 2 epigastric pain, 14 constipation, 14 abdominal pain, 3 skin rash, 14 vomiting). These observations confirm that, although the most modern preparations of ferrous ions exhibit a relatively low frequency of adverse events of limited clinical concern, it is nevertheless possible to decrease (with the use of more "physiologic" preparations in which the iron is reversibly bound to a protein carrier) the prevalence and, tendentially, duration and intensity of such events without prejudice for the clinical efficacy. Therefore, the good clinical tolerability of ITF 282 effectively removed one of the main obstacles to the correct compliance with iron treatments (necessarily to be taken long-term), as reduced the risks of undesired events in a particularly susceptible population subgroup, such as children.
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PMID:Controlled, double-blind, multicenter clinical trial of iron protein succinylate in the treatment of iron deficiency in children. 850 Sep 17

Iron proteinsuccinylate (ITF 282, CAS 93615-44-2) is an iron derivative for the oral treatment of iron deficiency anemia. Its efficacy and tolerability have been proved in about 1800 patients, enrolled in 3 multicenter clinical trials. The first aim of this meta-analysis is to verify the increase of hemoglobin (Hb) in these patients (891 treated with ITF282, 644 treated with iron sulphate and 236 treated with iron-polysterene sulphonate). The 3 studies show homogeneous Hb increases. ITF 282 appeared to provide, from time 0 to the 30th day of treatment, a similar or lesser increase in Hb in comparison to the reference drugs, while from the 30th day of treatment to the 60th day its efficacy was always greater than that of the reference medications. The data have been further analyzed by subdividing the patients in three classes, according to the severity of the anemia: basal Hb < or = 9 g/dl, > 9 < or = 11 g/dl, > g/dl. During the 60-day treatment, both ITF 282 and the reference drugs induced the most significant increase in Hb in the patients affected by the most severe anemia. The meta-analytic evaluation of the 3 trials results has been extended to tolerability data. Most side effects were related to the gastrointestinal tract. Their incidence resulted signficantly lower for ITF 282 than that for the reference drugs (9.4% vs. 20.4%, p < 0.01). The comparative sub-analysis of the side effect distribution into the patients populations shows that ITF 282 is definitely better tolerated in pregnant women (relative risk 0.321, p < 0.01). The time course of Hb increases and the tolerability data suggest a different mechanism by which ITF 282 and the reference drugs are effective. Since the main difference between ITF 282 and the reference drugs is the form in which the iron is presented to the gastrointestinal mucosa, it may be supposed that the reference drugs, providing free divalent iron ions for absorption, could induce some kind of irritative condition of the gastrointestinal mucosa, which results in a reduced long-term absorption capacity, as well as in a higher incidence of gastroenteric adverse events. ITF 282, providing protein-bound iron, would not permit the process supposed with divalent iron, thus resulting in prolonged absorption capacity (that is higher hemoglobin recovery) and higher gastrointestinal tolerability.
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PMID:Meta-analysis of efficacy and tolerability data on iron proteinsuccinylate in patients with iron deficiency anemia of different severity. 892 42