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UCSF Benioff Children’s Hospital Oakland clinical researchers, in conjunction with other sickle cell centers and scientists at Emmaus Life Sciences Inc., have demonstrated that therapy with L-Glutamine reduced the frequency of pain episodes in both pediatric and adult patients with sickle cell disease (SCD). The results of the 48-week, phase 3 clinical trial are published in the July 19, 2018, issue of New England Journal of Medicine.
The paper, “A Phase 3 Trial of L-Glutamine in Sickle Cell Disease,” documented the effects of taking Endari, a prescription-grade, pharmaceutical form of L-glutamine, as compared to placebo, for 230 patients aged 5 to 58 years of age with sickle cell disease. Endari was approved in July 2017 by the U.S. Food and Drug Administration based on the safety and efficacy data from this study. Glutamine is an amino acid that is involved in several biochemical reactions.
The study showed that whether administered alone or with hydroxyurea, L-glutamine reduced the frequency of sickle cell pain crises by 25 percent (a median of three events per patient in the L-glutamine group and four in the placebo group) and hospitalizations by 33 percent (a median of two hospitalizations in the L-glutamine group and three in the placebo group). Additional findings showed lower cumulative hospital days of 41 percent and a lower incidence of dangerous acute chest syndrome (ACS) by more than 60 percent.
“This study validated research on the safety of pharmaceutical grade L-glutamine which has antioxidant properties that improves the NAD redox potential in sickle cell patients. Safe neutraceuticals are of major importance to the sickle cell community,” said Elliott Vichinsky, MD, director of Hematology/Oncology at the Northern California Sickle Center at UCSF Benioff Children’s Hospital Oakland. “Our clinical trial found that L-glutamine, which does not require any routine laboratory monitoring, decreases pain events in patients by itself or in combination with hydroxyurea. It is a major advance in therapy for sickle …