SUMMARY
Each 100 mL of R-Gene® 10 (10% Arginine Hydrochloride Injection, USP) for intravenous use contains 10 g of L-Arginine Hydrochloride, USP in Water for Injection, USP. L-arginine is a naturally occurring amino acid.
R-Gene® 10 is indicated as an intravenous stimulant to the pituitary for the release of human growth hormone in patients where the measurement of pituitary reserve for HGH can be of diagnostic usefulness. It can be used as a diagnostic aid in such conditions as panhypopituitarism, pituitary dwarfism, chromophobe adenoma, postsurgical craniopharyngioma, hypophysectomy, pituitary trauma, acromegaly, gigantism and problems of growth and stature.
If the insulin hypoglycemia test has indicated a deficiency of pituitary reserve for HGH, a test with R-Gene® 10 is advisable to confirm the negative response. This can be done after a waiting period of one day. As patients may not respond to R-Gene® 10 (10% Arginine Hydrochloride Injection, USP) during the first test, the unresponsive patient should be tested again to confirm the negative result. A second test can be performed after a waiting period of one day. Some patients who respond to R-Gene® 10 do not respond to insulin and vice versa. The rate of false positive responses for R-Gene® 10 is approximately 32%, and the rate of false negatives is approximately 27%.
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NEWS HIGHLIGHTS
Published Studies Related to Arginine Injection
Concomitant treatment with oral L-arginine improves the efficacy of surgical angiogenesis in patients with severe diffuse coronary artery disease: the Endothelial Modulation in Angiogenic Therapy randomized controlled trial. [2008.04]
OBJECTIVE: Endothelial dysfunction and decreased nitric oxide bioavailability may explain why therapeutic angiogenesis and cell therapy have mostly failed in humans. Building from previous large animal work, the Phase I Endothelial Modulation in Angiogenic Therapy trial tested the hypothesis that L-arginine, a nitric oxide donor, may be safe and effective in potentiating surgical angiogenesis in humans... CONCLUSION: To our knowledge, this is the first study to examine concomitant substrate modification in patients undergoing new biosurgical therapies by using vascular endothelial growth factor angiogenesis. The results suggest safety and efficacy. Concomitant endothelial modulation with L-arginine not only has the potential to make angiogenesis effective but also may have implications for cell therapy trials.
Effect of tilarginine acetate in patients with acute myocardial infarction and cardiogenic shock: the TRIUMPH randomized controlled trial. [2007.04.18]
CONTEXT: Cardiogenic shock complicating acute myocardial infarction (MI) remains a common and lethal disorder despite aggressive use of early revascularization. Systemic inflammation, including expression of inducible nitric oxide synthase (NOS) and generation of excess nitric oxide, is believed to contribute to the pathogenesis and inappropriate vasodilatation of persistent cardiogenic shock. Preliminary, single-center studies suggested a beneficial effect of NOS inhibition on hemodynamics, renal function, and survival in patients with cardiogenic shock. OBJECTIVE: To examine the effects of an isoform-nonselective NOS inhibitor in patients with MI and refractory cardiogenic shock despite establishment of an open infarct artery... CONCLUSIONS: Tilarginine, 1-mg/kg bolus and 5-hour infusion, did not reduce mortality rates in patients with refractory cardiogenic shock complicating MI despite an open infarct artery. Early mortality rates in this patient group are high. Further research is needed to develop effective therapies for patients with cardiogenic shock following acute MI. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00112281
Effects of vitamin E and L-arginine on cardiopulmonary function and ascites parameters in broiler chickens reared under subnormal temperatures. [2006.12]
Two experiments were conducted to evaluate the effects of arginine (Arg) and vitamin E (VE) on ascites (pulmonary hypertension syndrome) parameters, nitric oxide synthase (NOS) activity, and cardiopulmonary performance after an acute challenge with epinephrine (Epi)...
[Analysis of the influence on the prognosis and safety of arginine in patients with severe trauma and burns--a multi-center randomized double blinded, placebo controlled, clinical trail in 86 patients] [2006.08]
CONCLUSION: Oral feeding of arginine is beneficial in enhancing wound healing, reduction of hospital stay days in severe trauma patients and with little side-effects, but it is not beneficial to improve the prognosis of severe burn patients. Maybe this is due to inadequate number of case involved in the study.
Asymmetric dimethylarginine causes hypertension and cardiac dysfunction in humans and is actively metabolized by dimethylarginine dimethylaminohydrolase. [2003.08.01]
CONCLUSIONS: This study defines the cardiovascular effects of a systemic increase in ADMA in humans. These are similar to changes seen in diseases associated with ADMA accumulation. Finally, our data also indicate that ADMA is metabolized by DDAHs extensively in humans in vivo.
Clinical Trials Related to Arginine Injection
Arginine Malaria Trial: Study of Adjunctive Arginine in Falciparum Malaria [Completed]
Acute falciparum malaria is associated with low plasma arginine and impaired nitric oxide
(NO) production. Both are associated with poor outcome. This study will examine the safety
and effect of escalating doses of arginine in falciparum malaria. It will determine whether
arginine can increase NO production and have an effect on NO-dependent physiological
measurements. The hypothesis is that arginine: will be safe in falciparum malaria; will
return plasma arginine concentration to normal/supranormal levels; will increase systemic and
exhaled NO; reduces oxidant stress; and improves a number of NO-dependent physiological
measures of relevance to malaria.
Effect of Creatine and L-Arginine on Endothelial Function [Completed]
The study is a double blind 2x2 factorial study. Patients with coronary disease will be
randomly be assigned to L-arginine (9 g/day), creatine 21 g/d, both, or neither dietary
supplement. The function of the endothelium will be tested using ultrasound before and after
each treatment. These studies will help us understand why the endothelium is abnormal in
patients with coronary artery disease and how L-arginine is acting on endothelial function.
L-Arginine Supplementation and Exercise; L-Arginine Supplementation and Renal Function [Completed]
Effectiveness of Arginine as a Treatment for Sickle Cell Anemia [Completed]
Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited genetic disease
that can cause intense pain episodes. This study will evaluate the effectiveness of the
nutritional supplement arginine at improving blood cell function and disease symptoms in
people with SCD.
L-Arginine Treatment for Severe Vascular Fetal Intrauterine Growth Restriction: a Randomized Double Bind Controlled Trial (L Arginine in IUGR) [Terminated]
Although there is a strong rationale to supplement gravid patients suffering intrauterine
growth restriction (IUGR) or preeclampsia with Arginine or other nitric oxide donors,
evidence in the literature has been inconclusive. The current study was designed to determine
whether oral treatment with L-Arginine, a nitric oxide (NO) donor, would enhance birth weight
and/or decrease neonatal morbidity in pregnancies with severe vascular intrauterine growth
restriction (IUGR).
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Page last updated: 2008-06-22
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