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PubMed1998

Fumaric acid esters suppress peripheral CD4- and CD8-positive lymphocytes in psoriasis.

BACKGROUND: For severe forms of psoriasis vulgaris, the antipsoriatic fumaric acid esters (FAE) therapy has recently gained increasing acceptance and importance. Until today, there is little knowledge about the mode of action of FAE. However, some evidence exists indicating immunosuppressive effects. OBJECTIVE: The aim of this study was to examine the systemic, particularly the immunological changes in patients suffering from psoriasis treated with FAE over a long period of time, since we expect to see pharmacological effects of FAE at this point. METHODS: This study is based on continuously recorded clinical data and laboratory parameters of 10 patients, who were treated over a period of 12 months with FAE. A quantitative analysis of lymphocytes and their subtypes was carried out by means of flowcytometric methods. RESULTS: 3 months after starting treatment with FAE, a clinical effect with a remission index > 95% was achieved in all 10 patients examined. This remained constant until the end of this study. Focusing on leukopenia, and particularly on lymphopenia as important parameters, these effects were found in all patients. The lymphocyte subpopulations data demonstrated extensive proportionate reductions. Within the T cell fraction a stronger suppression of CD8+ lymphocytes was observed. CONCLUSION: Our investigations of systemic effects of fumaric acid esters demonstrate the suppressive character of this medication. Effects of cell count reduction in leukocyte and lymphocyte numbers over the entire period of 12 months could be observed. The lymphocytic cell count number is obviously linked to the clinical effect.

Administration, Oral↗
PubMed1997

Characterization of partially saturated poly(propylene fumarate) for orthopaedic application.

A partially saturated linear polyester based on poly(propylene fumarate) (PPF) was synthesized for potential application in filling skeletal defects. The synthesis was carried out according to a two-step reaction scheme. Propylene glycol and fumaryl chloride were first combined to form an intermediate fumaric diester. The intermediate was then subjected to a transesterification to form the PPF-based polymer. This method allowed for production of a polymer with a number average molecular weight up to 1500 and a polydispersity index of 2.8 and below. The polymeric backbone structure was investigated through the use of FTIR and NMR. Kinetic studies of the transesterification allowed mapping of the molecular weight increase with reaction time. The final product was also characterized by thermal and solubility analysis.

Bone Cements↗
PubMed1999

Synthesis of poly(propylene fumarate) by acylation of propylene glycol in the presence of a proton scavenger.

To synthesize high molecular weight poly(propylene fumarate) (PPF), fumaryl chloride and propylene glycol were reacted in the presence of potassium carbonate, which serves as a proton scavenger. Transesterification of the resulting low molecular weight oligomer led to a polymer with greater molecular weight than those from previous reaction methods without requiring the use of a catalyst. According to two-dimensional NMR, the backbone structure of this polymer was as expected and contained no byproducts formed by acid catalyzed addition across the fumarate double bond. Kinetic studies of the transesterification showed that the molecular weight reached a final Mn of 4900 (+/-700) and Mw of 9100 (+/-1300) after 16 h, while the polydispersity index remained below 1.8 throughout the reaction. Thus the PPF synthesized by the new method is of higher molecular weight and greater purity than our previously prepared material.

Acylation↗
PubMed1991

Evaluation of the effect of fumaric acid and sodium bicarbonate addition on performance of starter pigs fed diets of different types.

Three growth experiments were conducted to assess the effect of fumaric acid (FA) supplementation on the performance of pigs fed different types of diets. These 4-wk experiments involved 550 crossbred pigs weaned at 30 +/- 3 d of age. Pigs in Exp. 1 were fed either a simple corn-soybean meal (SBM) diet or a 75% corn-SBM, 25% dried skim milk (DSM) diet. Zero, 2, or 3% FA were added to the diets to create a 2 x 3 factorial arrangement of treatments. Supplementing diets with DSM improved gain (P less than .05) and gain/feed (P less than .001). Fumaric acid addition improved efficiency of feed utilization (P less than .01). Experiment 2 was conducted to evaluate the effect of protein source (casein or soy protein concentrate [SPC]) on the response to 3% FA. Sodium bicarbonate (BCB; 2.75%) was added to one diet containing casein and FA to negate the effect of FA on growth performance. Addition of FA improved gain and feed efficiency (P less than .05) during the first 2 wk.(ABSTRACT TRUNCATED AT 250 WORDS)

Animal Feed↗
PubMed1991

Effect of protein source and fumaric acid supplementation on apparent ileal digestibility of nutrients by young pigs.

Two experiments were conducted to determine the apparent ileal digestibility of DM and N by young pigs fed diets supplemented with different protein sources or organic acids. Pigs were surgically fitted with silicone cannulas at 2 wk of age. Following surgery, pigs were allowed to recuperate with their dams while suckling normally. After weaning at 24 d, pigs were assigned to treatment diets at 28 d of age. A 3-d adjustment and 4-d collection sequence was followed for the duration of the 4-wk experiment. Four treatment diets were fed in each experiment in a weekly rotation until each diet had been fed to each pig. Diet samples and digesta collected through the ileal cannulas were analyzed for chromic oxide (used as an indigestible marker), DM, and N. Pigs in Exp. 1 were fed isolysinic (1.0%) corn-based diets supplemented with casein, soybean meal, soy protein concentrate, or isolated soy protein. Casein addition resulted in improved DM (P less than .001) and N (P less than .05) digestibility but reduced gain (P less than .05) compared with the average of the soy protein sources. Nitrogen from diets formulated with soybean meal was digested more completely (P less than .05) than N from diets based on soy protein concentrate and isolated soy protein. Experiment 2 was an evaluation of the effect of dried skim milk (25%) and fumaric acid (2%) addition on apparent ileal digestibility of N and DM in corn-soybean meal diets. Addition of dried skim milk improved DM (P less than .01) and N (P less than .05) digestibility and daily gain (P less than .001). Fumaric acid supplementation did not affect nutrient digestibility or gain (P greater than .10).

Animal Feed↗
PubMed2004

Methane emissions from beef cattle: Effects of monensin, sunflower oil, enzymes, yeast, and fumaric acid.

Methane emitted from the livestock sector contributes to greenhouse gas (GHG) emissions. Understanding the effects of diet on enteric methane production can help refine GHG emission inventories and identify viable GHG reduction strategies. Our study focused on measuring methane and carbon dioxide emissions, total-tract digestibility, and ruminal fermentation in growing beef cattle fed a diet supplemented with various additives or ingredients. Two experiments, each designed as a 4 x 4 Latin square with 21-d periods, were conducted using 16 Holstein steers (initial BW 311.6 +/- 12.3 kg). In Exp. 1, treatments were control (no additive), monensin (Rumensin, Elanco Animal Health, Indianapolis, IN; 33 mg/kg DM), sunflower oil (400 g/d, approximately 5% of DMI), and proteolytic enzyme (Protex 6-L, Genencor Int., Inc., CA; 1 mL/kg DM). In Exp. 2, treatments were control (no additive), Procreatin-7 yeast (Prince Agri Products, Inc., Quincy, IL; 4 g/d), Levucell SC yeast (Lallemand, Inc., Rexdale, Ontario, Canada; 1 g/d), and fumaric acid (Bartek Ingredients Inc., Stoney Creek, Ontario, Canada; 80 g/d). The basal diet consisted of 75% barley silage, 19% steam-rolled barley grain, and 6% supplement (DM basis). Four large chambers (two animals per chamber) were equipped with lasers and infrared gas analyzers to measure methane and carbon dioxide, respectively, for 3 d each period. Total-tract digestibility was determined using chromic oxide. Approximately 6.5% of the GE consumed was lost in the form of methane emissions from animals fed the control diet. In Exp. 1, sunflower oil decreased methane emissions by 22% (P = 0.001) compared with the control, whereas monensin (P = 0.44) and enzyme had no effect (P = 0.82). However, oil decreased (P = 0.03) the total-tract digestibility of NDF by 20%. When CH(4) emissions were corrected for differences in energy intake, the loss of GE to methane was decreased by 21% (P = 0.002) using oil and by 9% (P = 0.09) using monensin. In Exp. 2, Procreatin-7 yeast (P = 0.72), Levucell SC yeast (P = 0.28), and fumaric acid (P = 0.21) had no effect on methane emissions, although emissions as a percentage of GE intake were 3% (non-significant, P = 0.39) less for steers fed Procreatin-7 yeast compared with the control. This study demonstrates that sunflower oil, ionophores, and possibly some yeast products can be used to decrease the GE lost as methane from cattle, but fiber digestibility is impaired with oil supplementation.

Animal Feed↗
PubMed1982

Disposition and metabolism of formoterol fumarate, a new bronchodilator, in rats and dogs.

1. The disposition and metabolism of formoterol fumarate, a highly potent beta 2-adrenoceptor stimulant, were studied in rats and dogs. 2. After oral administration of [3H] formoterol fumarate to dogs, unchanged formoterol accounted for greater than 60% of the plasma radioactivity immediately after dosage; greater than 20% was due to the unchanged drug until 12 h after dosage. In contrast, only 1-3% of the radioactivity was present as unchanged drug in rat plasma. After i.v. dosage, unchanged drug was much higher in both species. The elimination half-life of formoterol was 4-6 h in dogs and 1.7 h in rats. 3. In both species, 36-45% of the dose was excreted in urine and 50-56% in faeces in 72 h, irrespective of the administration route. Biliary excretion after oral dosage amounted to 65 and 31% in rats and dogs, respectively. 4. T.l.c. before and after enzymic hydrolysis revealed that the drug was excreted in urine and bile of rats mostly as a conjugate. Dog urine also contained the conjugate but the unchanged drug was much higher than in rats. The conjugated metabolite was purified from rat urine and identified as the 2-O-glucuronide. The glucuronide was the only metabolite detected in the urine and bile of rats and in the urine of dogs.

Administration, Oral↗
PubMed2006

Efficiency of sodium hypochlorite, fumaric acid, and mild heat in killing native microflora and Escherichia coli O157:H7, Salmonella typhimurium DT104, and Staphylococcus aureus attached to fresh-cut lettuce.

The effect of the disinfectant sodium hypochlorite (NaClO), with or without mild heat (50 degrees C) and fumaric acid, on native bacteria and the foodborne pathogens Staphylococcus aureus, Escherichia coli O157:H7, and Salmonella Typhimurium DT104 attached to iceberg lettuce leaves was examined. The retail lettuce examined consistently harbored 6 to 7 log CFU/g of native bacteria throughout the study period. Inner leaves supported 1 to 2 log CFU/g fewer bacteria than outer leaves. About 70% of the native bacterial flora was removed by washing five times with 0.85% NaCl. S. aureus, E. coli, and Salmonella allowed to attach to lettuce leaves for 5 min were more easily removed by washing than when allowed to attach for 1 h or 2 days, with more S. aureus being removed than E. coli or Salmonella Typhimurium. An increase of time for attachment of pathogens from 5 min to 2 days leads to decreased efficiency of the washing and sanitizing treatment. Treatment with fumaric acid (50 mM for 10 min at room temperature) was the most effective, although it caused browning of the lettuce, with up to a 2-log reduction observed. The combination of 200 ppm of sodium hypochlorite and mild heat treatment at 50 degrees C for 1 min reduced the pathogen populations by 94 to 98% (1.2- to 1.7-log reduction) without increasing browning.

Bacterial Adhesion↗
PubMed1999

[Early phase II study of quetiapine fumarate on schizophrenia].

The efficacy and safety of quetiapine fumurate in the treatment of patients with schizophrenia were evaluated in an 8-week, multicenter, open-label study. The results of this study which included a total of 54 patients showed good efficacy and safety profile for quetiapine fumarate as seen by the improvement rate (moderate or above in the final global improvement rating) of 49.1% and safety rate (no problem in overall safety rating) of 66.0%. The mean BPRS total score decreased significantly from 55.5 +/- 10.9 points at baseline to 45.4 +/- 13.0 points at the completion of administration. The PANSS scores also showed significant improvement on all scales; the mean scores decreased from 20.7 +/- 6.3 points at baseline to 17.7 +/- 6.9 points at withdrawal or completion of administration on the positive scale, from 27.8 +/- 5.8 points to 24.0 +/- 7.3 points on the negative scale, and from 51.4 +/- 10.1 points to 44.7 +/- 12.4 points on the general psychopathology scale. Although the most frequent adverse reactions were somnolence (18.9%), insomnia (17.0%), nervousness (13.2%), dizziness (13.2%), malaise (13.2%), postural hypotension (11.3%), tachycardia (9.4%), and constipation (9.4%), the incidence of extrapyramidal symptoms was low (11.3%). From these results, quetiapine fumarate was suggested to be highly effective and safe for the treatment of schizophrenia.

Adult↗
PubMed2000

[Immunomodulation with fumaric acid. Systemic therapy in psoriasis].

The treatment of psoriasis vulgaris with fumaric acid esters has been controversial for more than 30 years. Recently the fumaric acid derivatives are marketed antipsoriatics in many European countries. In this paper the clinical efficacy, the side effects as well as the mode of action of these highly potent substances are summarized.

Dermatologic Agents↗
PubMed1997

[Determination of fumaric acid in Sarcandra glabra (Thunb.) Nakai by HPLC].

A method for the determination of fumaric acid in Sarcandra glabra is reported. After the sample was pretreated with an anion exchange resin column, fumaric acid was determined on a Spherisorb C18 column, with methanol-0.02 mol/L monobasic potassium (20:80, pH2.5) as the mobile phase and detected at 210 nm. The method is simple and accurate.

Chromatography, High Pressure Liquid↗
PubMed2003

Enhanced bioactivity of a poly(propylene fumarate) bone graft substitute by augmentation with nano-hydroxyapatite.

The bioactivity of a nano-hydroxyapatite-augmented, bioresorbable bone graft substitute made from the unsaturated polyester, poly(propylene fumarate), was analyzed by evaluating biocompatibility and osteointegration of implants placed into a rat tibial defect. Three groups of eight animals each were evaluated by grouting bone graft substitutes into 3-mm holes that were made into the anteromedial tibial metaphysis of rats. Thus, a total of 24 animals was included in this study. Two different formulations varying as to the type of hydroxyapatite were used: Group 1 - nano-hydroxyapatite, Group 2 - micron-hydroxyapatite, with a Group 3 control defect remaining unfilled. Animals of each of the three groups were sacrificed in groups of eight at postoperative week three. Histologic analysis revealed best superior biocompatibility and osteointegration of bone graft substitutes when nanohydroxyapatite was employed. At three weeks, there was more reactive new bone formation in this group when compared to the micron-hydroxyapatite group. The control group showed incomplete closure of the defect. This study suggested that nano-hydroxyapatite may improve upon the bioactivity of bone implant and repair materials. The model scaffold used in this study, poly(propylene fumarate), appeared to provide an osteoconductive pathway by which bone will grow in faster. Clinical implications of the use potential advantages of nano-hydroxyapatite on bone repair and orthopaedic implant design are discussed.

Absorbable Implants↗
PubMed1992

[The anticarcinogenic effects of fumaric acid on models of carcinogenesis in the esophagus, nervous system and kidney].

Anticarcinogenic effects of the fumaric acid was studied in two rat models of carcinogenesis. Tumors of the esophagus, forestomach, tongue and throat were induced by peroral instillation of 35 mg/kg body weight N-methyl-N-benzylnitrosamine, and neurogenic and renal ones--by transplacental injection of 75 mg/kg body weight N-ethyl-N-nitrosourea. The fumaric acid given in drinking water in the dose of 1 g/l at the postinitiation stage of the carcinogenesis was shown to inhibit the development of esophageal papilloma, brain glioma and mesenchymal tumors of the kidney.

Animals↗
PubMed1992

Sustained improvement in asthma with long-term use of formoterol fumarate.

Inhaled formoterol fumarate, a long acting beta 2 agonist, produces bronchodilatation that is sustained for approximately 12 hours. To determine whether such bronchodilator effects are maintained and asthma control sustained during chronic administration, we monitored airflow indices and clinical control in 112 asthmatic patients who self administered formoterol twice daily for periods ranging from 9 to 12 months. Subjects were recruited immediately following completion of a 3-month double-blind comparison of formoterol, 12 micrograms, bid versus salbutamol, 200 micrograms, qid. Assessments were conducted at baseline, 3, 6, and 9 months, where baseline represents the final visit of the 3-month comparative study. Patients were asked to complete diary cards and twice daily PEFR for a 2-week period before each assessment. Throughout the follow-up study, there was no indication of worsening of asthma control or deteriorating lung function. For the patients who continued to receive formoterol, the previous improvement in asthma control and lung function was maintained at the level reached in the 3-month study. There was an improvement in flow rates and asthma symptoms in the group switched from salbutamol to formoterol by the first clinic visit. This improvement in asthma control and lung function was maintained over the subsequent 6 months. Formoterol was well tolerated during the study period. We conclude that prolonged use of formoterol fumarate twice daily results in sustained improvement in symptoms and flow rates in asthma with no evidence of tachyphylaxis.

Adolescent↗
PubMed2003

Calcium concentration at rat females with osteoporosis after applying calcium fumarate.

The dynamics of total calcium concentration in blood of rat females with osteoporosis caused experimentally after applying it in the form of fumarate was determined. The fumarate was applied in just one dose by the means of stomach tube at the dose of teoporoz_ 4.28 mg of calcium/100 g of body mass. The total calcium concentration in blood was determined: 0; 1; 2; 3; 5 i 7 h after application. It was observed that one hour after application calcium concentration in control group increased by 19.3%, and in the group of animals after ovariectomy it decreased by 6.7% (P < 0.001). After 2 h calcium concentration in both groups returned to its initial state, and after 3 hours three next decrease in relation to initial time by 10% occurred in the control group and by 4% in the group after ovariectomy. Between 4 h and 7 h after administration calcium concentration in both groups of animals was even and it was maintaining at the constant level in the range 2.248-2.172 mM/l.

Animals↗
PubMed2005

[Progress in researches on the synthesis of poly (propylene fumarate) and its crosslinking characteristics].

Poly (propylene fumarate) is an unsaturated linear polyester, which degrades, in the presence of water, into propylene glycol and fumaric acid, and the degradation products can be cleared from the human body by normal metabolic processes. In this paper, different methods of the synthesis of PPF are listed, the crosslinking characteristics of polymerizing composite as well as the mechanical properties of cross-linked composite are discussed, and the potentialities of PPF composite used as particularly degradable polymeric cement for orthopedic application are reviewed.

Biocompatible Materials↗
PubMed1989

[Acute kidney insufficiency in the treatment of psoriasis using fumaric esters].

We describe two patients who developed acute renal failure during therapy with fumaric acid-esters. Histologic findings after renal biopsy in one patient were compatible with the diagnosis of acute tubular necrosis (ATN), and renal function was restored after cessation of the medication. The histologic diagnosis in the other patient was tubulo-interstitial nephritis (TIN), possibly reactive to ATN. The recovery of renal function was incomplete after 9 months. Two other patients had deterioration of renal function and proteinuria during therapy with fumaric acid-esters. The symptoms were completely reversible in one patient after discontinuation of the medication, and incompletely reversible in the other. The literature is reviewed and a comparison is drawn with the maleic acid model in the rat.

Acute Kidney Injury↗