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PubMed1990

Apparent failure of edetic acid chelation therapy for the treatment of coronary atherosclerosis.

Patients diagnosed with incurable or fatal diseases may seek alternatives to standard medical therapy and spend significant amounts of money for these therapies. One alternative medical therapy, chelation therapy with edetic acid (EDTA), has gained considerable popularity for the alleged treatment of atherosclerotic vascular disease; however, its efficacy for this indication remains unproven and its use is controversial. We present a case in which chelation therapy was unsuccessful in treating coronary atherosclerosis and review reports that substantiate a lack of efficacy using chelation therapy in the treatment of coronary atherosclerosis. Treatment of atherosclerotic-related diseases using chelation therapy should be discouraged by health professionals. Patients should be counseled regarding the risk of improper diagnosis and treatment of their disease.

Aged↗

PubMed1995

Iron chelation therapy.

Iron chelation therapy is essential to prevent death from cardiac toxicity in patients with thalassemia major or other severe refractory anemias who need regular blood transfusions. Iron chelating drugs also have potential for clinical use as antiproliferative agents in neoplastic diseases and to reduce free radical-induced tissue damage in rheumatoid arthritis, anthracycline-induced cardiotoxicity, and reperfusion injury. Experimental data and clinical trials also suggest they may have therapeutic value as adjuncts to antimalarial and anti-Pneumocystis carinii therapy and to reduce aluminum toxicity. There is therefore an urgent need for an orally active, inexpensive iron chelating drug, because desferrioxamine, the only currently widely available iron chelator, must be given parenterally and is expensive, making it unavailable for long-term use in many parts of the world. L1 (also known as deferiprone, 1-2 dimethyl-3-hydroxpyrid-4-one, DMHP, and CP20) has emerged as an orally active iron chelator with comparable efficiency to desferrioxamine in both short- and long-term clinical studies. Adverse side-effects, principally agranulocytosis and arthropathy, have raised doubts about its safety, and further trials are now planned to evaluate the incidence of these and other toxicities. Despite numerous studies, no other orally active agent has been shown in clinical trials to be as effective or as safe as L1.

Cardiomyopathies↗

PubMed1976

Chronic industrial exposure to lead in 63 subjects. II. Evaluation of chelation therapy.

Efficacy of chelation therapy with intravenous calcium disodium edetate, oral Ca EDTA, and oral penicillamine was tested in 63 subjects with chronic minimal industrial exposure to lead. All three agents increased the urinary lead excretion. The effect was greatest with intravenous Ca EDTA, next with oral penicillamine and least with oral Ca EDTA. Symptoms, particularly colicky abdominal pain, improved during the period of chelation therapy. Anaemic subjects showed improvements in haematological parameters. It is recommended that subjects with chronic minimal industrial exposure to lead receive chelation therapy. The relative merits of the three agents are discussed.

Adult↗

PubMed1984

Chelation therapy of atherosclerosis.

Chelation therapy with intravenous injections of edetate disodium is being promoted to the public as a nonsurgical means to treat coronary or other arterial atherosclerosis. The rationale for use, clinical efficacy, and safety are reviewed. Acceptable evidence supporting chelation therapy for atherosclerotic vascular disease is lacking.

Adult↗

PubMed1999

EDTA chelation therapy does not selectively increase chromium losses.

Chelation therapy and supplemental Cr have both been shown to lead to improved blood glucose, lipids, and insulin activity. Chelation therapy leads to the removal of toxic as well as essential metals. To determine if chelation therapy leads to increased urinary Cr losses and altered Cr homeostasis, 2 groups of subjects (1 group that had undergone only 1 or no chelation therapy and 1 group in which all subjects had undergone at least 19 chelation sessions) were evaluated for differences in possible Cr homeostasis based on urinary Cr losses. There were no significant differences in urinary Cr losses between the two groups of subjects and there were no significant increases in urinary Cr losses resulting from chelation therapy. Increases in urinary Cr losses were strongly influenced by supplementation but not chelation therapy.

Aged↗

PubMed1996

Serum neopterin, interleukin-4, and interleukin-6 concentrations in cerebral malaria patients and the effect of iron chelation therapy.

To determine if iron chelation therapy alters immune responses in children with cerebral malaria, we retrospectively measured mean serum levels of neopterin, interleukin-4 (IL-4), and IL-6 in children who received desferrioxamine B or placebo for three days in addition to quinine-based therapy. Mean levels of neopterin, IL-4, and IL-6 were elevated above the expected normal range on admission. Neopterin correlated significantly with the degree of anemia, IL-4 with the duration of fever prior to admission, and IL-6 with parasite density. Serial measurements of cytokines and neopterin were performed over four days in 39 children, 21 randomized to receive desferrioxamine B and 18 to receive placebo. Mean concentrations of neopterin did not change significantly in either group while levels of IL-4 increased significantly in the placebo group (P = 0.04) but remained unchanged in the desferrioxamine B group. Interleukin-6 concentrations decreased markedly in both groups (P < 0.025). Stable IL-4 levels in children given desferrioxamine B may represent an inhibition of the T helper lymphocyte-2 (TH-2) response resulting from a strengthened TH-1 response associated with iron chelation therapy. Any effect of iron chelation on immunity in the setting of severe malaria will have to be confirmed in future prospective investigations.

Biopterins↗

PubMed1995

New concepts of iron and aluminium chelation therapy with oral L1 (deferiprone) and other chelators. A review.

The introduction of oral chelation therapy with the alpha-ketohydroxypyridine chelator 1,2-dimethyl-3-hydroxypyrid-4-one (L1, INN/BAN: deferiprone) in iron- and aluminium-overloaded patients has been initiated in over 15 countries in the last 7 years. Over 600 patients with various conditions, in 26 centres have received L1, in some cases daily for over 5 years. In the vast majority of iron-loaded patients, doses of 55-100 mg kg-1 of L1 resulted in urinary iron excretion levels greater than those accumulating from transfusions (15-35 mg d-1) and also reduction in serum ferritin and liver iron to near normal levels. Urinary iron excretion was related to the iron load of the patients, as well as the dose and frequency of administration of L1. The L1 appears to mobilize iron mainly from a serum iron pool in excess of transferrin saturation, transferrin-bound iron and tissue iron, mainly but not exclusively from the liver. The order of metal binding by L1 at pH 7.4 is Fe > Cu > A1 > Zn. Aluminium removal from aluminium-loaded renal dialysis patients by L1 was also effective at doses similar to those used for iron-loaded patients. Overall toxic side effects include six cases of reversible agranulocytosis, 0-30% incidence of transient musculoskeletal and joint pains, 0-6% of gastric intolerance and 0-2% zinc deficiency. Deferiprone appears to be as effective as desferrioxamine in iron and aluminium removal and has low toxicity. Its oral efficacy and low cost make it more accessible than desferrioxamine for the vast majority of patients needing iron chelation worldwide. The development of other alpha-ketohydroxypyridines is currently in progress.

Aluminum↗

PubMed2000

Chelation therapy for coronary heart disease: An overview of all clinical investigations.

BACKGROUND: Chelation therapy is popular in the United States. The question of whether it does more good than harm remains controversial. AIM: The aim of this systematic review was to summarize all the clinical evidence for or against the effectiveness and efficacy of chelation therapy for coronary heart disease. METHODS: A thorough search strategy was implemented to retrieve all clinical investigations regardless of whether they were controlled or uncontrolled. RESULTS: The most striking finding is the almost total lack of convincing evidence for efficacy. Numerous case reports and case series were found. The majority of these publications seem to indicate that chelation therapy is effective. Only 2 controlled clinical trials were located. They provide no evidence that chelation therapy is efficacious beyond a powerful placebo effect. CONCLUSION: Given the potential of chelation therapy to cause severe adverse effects, this treatment should now be considered obsolete.

Adult↗

PubMedDate not supplied

Zinc supplementation of chelation therapy in saturnism. Preliminary study.

The effect of zinc supplementation of chelation therapy in saturnism was studied in 20 patients hospitalized in the Clinic of Occupational Diseases of the Colentina Hospital. In 10 patients 400 mg/day zinc sulphate in two uptakes was administered concomitantly with the chelation therapy. The other 10 patients received only chelation therapy. The period necessary for the correction of the anemic syndrome was estimated comparatively by studying the evolution of the following parameters: hemoglobin, reticulocytes, red blood cells with basophilic granulations. Zinc supplementation of the chelation therapy had a favourable effect by reducing the necessary period for the correction of anemic syndrome.

Adult↗

PubMed1991

Pituitary function in thalassemic patients and the effect of chelation therapy.

This study examined anterior pituitary function and the effect of chelation therapy in 31 patients with beta-thalassemia/HbE disease. Patients were divided into those receiving chelation therapy by deferoxamine and those receiving no such therapy (control group). Pituitary function studies were repeated in both groups 18 months later. The results showed decreased pituitary responses following stimulation in 22 patients. Among these, gonadotropin and PRL responses were most affected. After 18 months, serum ferritin levels had significantly decreased in the deferoxamine group. PRL and GH responses were improved in 3 patients receiving chelation therapy without changes in other hormone responses. In contrast, no changes in pituitary responses were shown in the control group at the end of follow-up. There were 6 drop-outs (4 in the control and 2 in the deferoxamine group) and 3 deaths (2 in the control and 1 in the deferoxamine group) during 18 months. In conclusion, gonadotropin and PRL deficiencies occur most frequently in thalassemic patients. Chelation therapy for 18 months markedly reduced serum ferritin level and might preserve or improve PRL and GH secretions, but seems to have no beneficial effects on other pituitary hormone reserves.

Adult↗

PubMed1990

Current status of iron chelation therapy with deferoxamine.

Long-term chelation therapy with deferoxamine is an effective and generally safe method for removing excessive iron, preventing iron-induced organ damage and improving survival of patients with transfusion-dependent disorders. The current treatment of iron overload is an important standard against which new forms of therapy, such as oral chelators, should be measured to ensure that their risks and benefits compare favorably with deferoxamine. Until new treatments are available, continuing studies of deferoxamine will help to define its long-term efficacy and toxicity for patients with thalassemia major and other hematologic disorders.

Chelation Therapy↗

PubMed2000

Transfusional iron overload and chelation therapy with deferoxamine and deferiprone (L1).

Iron is essential for all living organisms. Under normal conditions there is no regulatory and rapid iron excretion in humans and body iron levels are mainly regulated from the absorption of iron from the gut. Regular blood transfusions in thalassaemia and other chronic refractory anaemias can result in excessive iron deposition in tissues and organs. This excess iron is toxic, resulting in tissue and organ damage and unless it is removed it can be fatal to those chronically transfused. Iron removal in transfusional iron overload is achieved using chelation therapy with the chelating drugs deferoxamine (DF) and deferiprone (L1). Effective chelation therapy in chronically transfused patients can only be achieved if iron chelators can remove sufficient amounts of iron, equivalent to those accumulated in the body from transfusions, maintaining body iron load at a non-toxic level. In order to maintain a negative iron balance, both chelating drugs have to be administered almost daily and at high doses. This form of administration also requires that a chelator has low toxicity, good compliance and low cost. DF has been a life-saving drug for thousands of patients in the last 40 years. It is mostly administered by subcutaneous infusion (40-60 mg/kg, 8-12 h, 5 days per week), is effective in iron removal and has low toxicity. However, less than 10% of the patients requiring iron chelation therapy worldwide are able to receive DF because of its high cost, low compliance and in some cases toxicity. In the last 10 years we have witnessed the emergence of oral chelation therapy, which could potentially change the prognosis of all transfusional iron-loaded patients. The only clinically available oral iron chelator is L1, which has so far been taken by over 6000 patients worldwide, in some cases daily for over 10 years, with very promising results. L1 was able to bring patients to a negative iron balance at doses of 50-120 mg/kg/day. It increases urinary iron excretion, decreases serum ferritin levels and reduces liver iron in the majority of chronically transfused iron-loaded patients. Despite earlier concerns of possible increased risk of toxicity, all the toxic side effects of L1 are currently considered reversible, controllable and manageable. These include agranulocytosis (0.6%), musculoskeletal and joint pains (15%), gastrointestinal complaints (6%) and zinc deficiency (1%). The incidence of these toxic side effects could in general be reduced by using lower doses of L1 or combination therapy with DF. Combination therapy could also benefit patients experiencing toxicity with DF and those not responding to either chelator alone. The overall efficacy and toxicity of L1 is comparable to that of DF in both animals and humans. Despite the steady progress in iron chelation therapy with DF and L1, further investigations are required for optimising their use in patients by selecting improved dose protocols, by minimising their toxicity and by identifying new applications in other diseases of iron imbalance.

Deferiprone↗

PubMed1997

Iron-chelating therapy and the treatment of thalassemia.

Iron-chelating therapy with deferoxamine in patients with thalassemia major has dramatically altered the prognosis of this previously fatal disease. The successes achieved with deferoxamine, as well as the limitations of this treatment, have stimulated the design of alternative strategies of iron-chelating therapy, including orally active iron chelators. The development of the most promising of these, deferiprone, has progressed rapidly over the last 5 years; data from several trials have provided direct and supportive evidence for its short-term efficacy. At the same time, the toxicity of this agent mandates a careful evaluation of the balance between risk and benefit of deferiprone in patients with thalassemia, in most of whom long-term deferoxamine is safe and efficacious therapy.

Animals↗

PubMed1996

Laboratory evaluation of a new delivery system to improve patient compliance with chelation therapy.

As thalassaemia patients live longer, compliance with chelation therapy becomes more and more of a problem. Teenagers rebel against the continual need for treatment, and young adults with jobs, active social lives and families, find it hard to find the time to prepare and deliver their treatments. In an effort to find a solution to this problem, we evaluated a non-electronic, disposable pump (Infusor 5 ml/h, Baxter Healthcare) to determine its suitability for high dose desferrioxamine (DFO) infusions. We wanted an infusion time of 12 h to support overnight delivery in the patient's home. Because of DFOs viscosity, infusion times vary at different concentrations. We found the optimal prescription for total delivery within 12 h to be a dose of 70 mg/kg x patient's body weight diluted in constant volume of 40 ml of water for injection. Our tests were carried out in vitro and the results show that the 5 ml/h Infusor may be used to deliver high dose DFO chelation therapy within 12 h. The variability of the flow rate, dependent on the concentration of the solution, and the absence of a warning system, are more than compensated for by the simplicity of the pump.

Adolescent↗

PubMed1994

Chelation therapy for intermittent claudication. A double-blind, randomized, controlled trial.

BACKGROUND: The use of repeated intravenous infusions of EDTA, which has become known as "chelation therapy," has been promoted for treating intermittent claudication as well as a wide range of other disorders. Multiple reports of excellent results in large numbers of patients have encouraged the use of this regimen. The lack of well-controlled studies substantiating the benefits of this treatment has limited its use mainly to private clinics. The aim of the study was to assess the benefits of chelation therapy in patients with intermittent claudication. METHODS AND RESULTS: A double-blind, randomized, controlled trial included 32 patients with intermittent claudication who were randomized to a treatment group (15) and a control group (17). Main outcome measures were subjective and measured walking distances and ankle/brachial pulse indices. Other outcome measures included lifestyle and subjective parameters of improvement, cardiac function, ECG, renal function, hematology, blood glucose, and lipid biochemistry. No clinically significant differences in main outcome measures between chelation therapy and placebo groups were detected up to 3 months after treatment. Measures of mood state, activities of daily living, and quality of life factors were not consistently affected by chelation therapy. An equal proportion (13%) of each group thought that they had received the active agent. The proportion of patients showing an improvement in walking distance was not significantly different between the chelation group (60%) and the control group (59%). CONCLUSIONS: Chelation therapy has no significant beneficial effects over placebo in patients with intermittent claudication.

Activities of Daily Living↗

PubMed1978

Experimental lead intoxication in dogs: a comparison of blood lead and urinary delta-aminolevulinic acid following intoxication and chelation therapy.

Intravenous lead administration to dogs produced an acute syndrome of lead intoxication charcterized by depression, vomiting, anorexia and weight loss. The effect of chelation therapy with calcium disodium ethylene diamine tetraacetate, penicillamine or both was determined by serially monitoring changes in blood lead and urine delta-aminolevulinic acid. Following therapy, blood lead values were significantly lower in chelated dogs than non-treated lead exposed dogs on days 7 and 10. Urine delta-aminolevulinic acid at day 7 was significantly higher in untreated lead exposed dogs than in other groups. There was no significant difference in blood lead or urine delta-aminolevulinic acid between lead intoxicated dogs which underwent the indicated chelation therapy protocols. There was, however, a trend for higher urinary delta-aminolevulinic acid excretion in those intoxicated dogs undergoing calcium disodium ethylene diamine tetraacetate therapy as opposed to those undergoing penicilamine therapy. There was no significant correlation between blood lead and urinary delta-aminolevulinic acid previous to lead exposure. However, after lead exposure significant correlation was present at days 4, 7, 10 and 14. Certain lead exposed dogs following chelation therapy were noted to have normal blood lead levels but elevated urinary delta-aminolevulinic acid suggesting that blood lead does not always correlate with metabolic effects of lead in the body. Urinary delta-aminolevulinic acid was therefore recommended as an additional laboratory parameter which improved assessment of lead exposure in dogs, particularly in determining adequacy of chelation therapy.

Aminolevulinic Acid↗

PubMed1989

Rapid removal of excessive iron with daily, high-dose intravenous chelation therapy.

We investigated the value of high-dose intravenous iron chelation therapy with deferoxamine as an alternative to conventional subcutaneous therapy in eight patients receiving regular transfusions who had massive iron stores, including two with clinical heart disease. Six to twelve grams of deferoxamine was infused daily for 12 hours over 12 to 25 months through externalized central venous catheters or implanted reservoirs. Serum ferritin levels decreased by 56% to 99%. Liver iron concentrations, measured by magnetic susceptibility in two patients, were 1234 and 2438 micrograms/gm wet weight (22.1 and 43.6 mumol/gm wet weight) after treatment for 17 and 25 months, respectively. A patient with congestive heart failure and a patient with severe ventricular dysrhythmias no longer required cardiac medication after 12 to 24 months of chelation therapy. Three episodes of bacteremia and three episodes of cellulitis accounted for a catheter-related infection rate of 0.14 per 100 patient-days. The catheter removal rate was 0.20 per 100 patient-days. No patient experienced serious visual, auditory, or other toxicities. We conclude that in some patients receiving regular erythrocyte transfusions, high-dose intravenous chelation therapy with deferoxamine is superior to conventional subcutaneous treatment.

Adolescent↗

PubMed1988

EDTA chelation therapy in chronic degenerative disease.

A retrospective analysis of treatment results from 2870 patients, with various chronic degenerative and age-associated diseases, who were treated with di-sodium magnesium EDTA chelation therapy, suggests that the case against EDTA Chelation Therapy should be re-opened. Using qualitative but never-the-less standardized criteria for improvement, our analysis shows that EDTA Chelation Therapy resulted in "marked" improvement in 76.89% and "good" improvement in 16.56% of patients with ischemic heart disease; also, "marked" improvement in 91% and "good" improvement in 7.6% of patients with peripheral vascular disease and intermittent claudication. In a group of patients with cerebro-vascular and other degenerative cerebral diseases, 24% had "marked" improvement, and 30% had "good" improvement. Of four patients with scleroderma, three had "marked" improvement and one had "good" improvement. Seventy-five percent of all of the patients had "marked" improvement in "geriatric symptomatology of vascular origin". The authors recommend renewed study of EDTA Chelation Therapy. The possibility of a "tomato effect", i.e., a drug which works, but the majority of physicians believe that it doesn't work, needs to be ruled out. A favorable climate needs to be created, in which FDA-approved studies of its usefulness in treating peripheral vascular disease can take place.

Animals↗