CYSTADANE SUMMARY
Cystadane® (betaine anhydrous for oral solution)
Cystadane® (betaine anhydrous for oral solution) is an agent for the treatment of homocystinuria. Cystadane is a white, granular, hygroscopic powder. It contains no ingredients other than anhydrous betaine. Betaine anhydrous powder is very soluble in water, soluble in methanol and ethanol, and sparingly soluble in ether.
Cystadane (betaine anhydrous for oral solution) is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels. Included within the category of homocystinuria are deficiencies or defects in:
- cystathionine beta-synthase (CBS),
- 5,10-methylenetetrahydrofolate reductase (MTHFR),
- cobalamin cofactor metabolism (cbl).
Patient response to Cystadane can be monitored by homocysteine plasma levels (see DOSAGE AND ADMINISTRATION). Response usually occurs within a week and steady state within a month.
Cystadane has been administered concomitantly with vitamin B6 (pyridoxine), vitamin B12 (cobalamin), and folate.
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NEWS HIGHLIGHTS
Published Studies Related to Cystadane (Betaine)
Betaine for nonalcoholic fatty liver disease: Results of a randomized placebo-controlled trial. [2009.08.17]
Based on animal studies and pilot studies in humans, betaine, a methyl donor for the remethylation of homocysteine, may be a therapeutic agent for nonalcoholic steatohepatitis (NASH). We evaluated the safety and efficacy of betaine for patients with NASH and whether betaine positively modified factors postulated to be "second hits" and underlying mechanisms of NASH...
A study of the treatment of Rett syndrome with folate and betaine. [2009.05]
We tested the hypothesis that increasing methyl-group pools might promote transcriptional repression by other methyl-binding proteins or by mutant methyl-CpG-binding protein 2 with altered affinity, ameliorating the clinical features of Rett syndrome.This study should inform future treatment trials regarding balancing participants with specific mutations and comparable severity to minimize selection bias.
Influence of betaine consumption on strenuous running and sprinting in a hot environment. [2008.05]
This investigation evaluated the effects of a nutritional supplement (the organic osmolyte betaine) in rehydration solutions, with and without carbohydrate and electrolytes. Ten male runners ((mean +/- SD) age, 20 +/- 2 years; weight, 70.6 +/- 6.8 kg; maximal aerobic power, 63.5 +/- 4.1 mL O2 x kg(-1) x min(-1)) dehydrated to -2.7% of body weight.
Dietary and supplementary betaine: acute effects on plasma betaine and homocysteine concentrations under standard and postmethionine load conditions in healthy male subjects. [2008.03]
BACKGROUND: Betaine comes from the diet and from choline, and it is associated with vascular disease in some patient groups. Betaine supplementation lowers plasma total homocysteine. OBJECTIVE: We compared the acute effects of dietary and supplementary betaine and choline on plasma betaine and homocysteine under standard conditions and after a methionine load... CONCLUSIONS: Dietary betaine and supplementary betaine acutely increase plasma betaine, and they and choline attenuate the postmethionine load rise in homocysteine concentrations.
Synergistic effects of betaine and conjugated linoleic acid on the growth and carcass composition of growing Iberian pigs. [2008.01]
An experiment was conducted to determine the efficacy of dietary betaine, CLA, or both as growth promotants and carcass modifiers in growing Iberian pigs. Twenty gilts (20 kg of BW) were individually penned and fed barley- and soybean meal-based diets (12% CP, 0.81% Lys, and 14.8 MJ of ME/kg of DM) containing either no added betaine or CLA (control), 0.5% betaine, 1% CLA, or 0.5% betaine + 1% CLA, at 95% of ad libitum energy intake...
Clinical Trials Related to Cystadane (Betaine)
Efficacy of Betaine for Reduction of Urine Oxalate in Patients With Type 1 Primary Hyperoxaluria [Recruiting]
The aim of this study is to assess the efficacy and safety of betaine in reducing urine
oxalate excretion of PHI patients who do not respond fully to VB6.
HYPOTHESIS If effective, betaine could represent a new and safe treatment option for a
subset of Primary Hyperoxaluria Type I patients, particularly those with either partially
Vitamin B6 responsive or Vitamin B6 refractory hyperoxaluria, or those with adverse effects
such as peripheral neuropathy from large doses of VitaminB6.
Pilot Study of Betaine + Combination Antiviral Therapy for Chronic Hepatitis C Genotype 1 Non-Responder/Relapsers [Not yet recruiting]
This is a non-randomized, open-label study examining the safety and efficacy of betaine in
addition to standard anti-viral therapy in genotype 1 hepatitis C non-responders or
relapsers to previous pegylated interferon plus ribavirin. Betaine (20 gm/day) in 2 divided
doses will be added to Peginterferon alpha 2a (180 mcg) plus weight-based Ribavirin (1000 or
1200 mg/day, for body weight < or > 75 kg, respectively, for 48 weeks. Patients must be
diagnosed with chronic hepatitis C, genotype I, and have undergone therapy for hepatitis C
with pegylated interferon plus ribavirin. Subjects will be followed for safety,
tolerability, hepatitis C viral response and the effect on interferon gene signaling in
peripheral blood mononuclear cells during therapy.
Pilot Comparison of Standard Antiviral Therapy With and Without 12 Weeks of Betaine in Genotype 1 Naive Patients [Recruiting]
The primary purpose of the study is to compare the safety and effectiveness of standard
treatment for chronic hepatitis C using peginterferon alpha-2a (Pegasys) and ribavirin
(Copegus) to those same medications plus a dietary supplement called betaine when added for
the first 12 weeks of treatment.
Peginterferon alpha-2a (Pegasys) and ribavirin (Copegus) are approved by the FDA (Food and
Drug Administration) for the treatment of chronic hepatitis C.
Betaine is a dietary supplement and occurs naturally in the body. It is not a medication
regulated by the FDA or an approved drug for chronic hepatitis C.
Chronic Hepatitis C Non-Responder Study With AdoMet and Betaine [Recruiting]
50-60% of patients with chronic hepatitis C are not cured by treatment with pegylated IFNα
plus ribavirin.
Retreatment of non-responders of previous (pegylated) IFNα plus ribavirin therapies with
pegylated IFNα plus ribavirin results in a sustained response in less than 10% of the
patients.
Extensive analysis of IFNα signaling in cells expressing HCV proteins, in transgenic mice
expressing HCV proteins, and in liver biopsies from patients with chronic hepatitis C point
to STAT1 methylation as an important posttranslational modification targeted by HCV to
inhibit IFNα signaling.
STAT1 methylation can be increased and IFNα can be improved by adding AdoMet and betaine.
The study is designed to test the hypothesis that a combination treatment with pegylated
IFNα2b, ribavirin, AdoMet and betaine is superior to the current standard combination
therapy with pegylated IFNα plus ribavirin.
The study is designed to test the hypothesis that a combination treatment with pegylated
IFNα2b, ribavirin, AdoMet and betaine is superior to the current standard combination
therapy with pegylated IFNα plus ribavirin.
Effect of Betaine and Folic Acid on Vascular Function in Healthy Humans [Completed]
The purpose of this study is to determine whether lowering of fasting homocysteine concentrations improves vascular function in healthy volunteers, irrespective of the homocysteine-lowering agent.
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