Savient Pharmaceuticals Announces Publication of Pivotal Phase III KRYSTEXXA ...
/ CNW / - Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) announced today that the results of two pivotal KRYSTEXXA ® (pegloticase) Phase III clinical studies in patients with refractory chronic gout (RCG) were published in The Journal of the American Medical Association (JAMA).The data demonstrated that treatment with KRYSTEXXA resulted in significant and lasting reductions in uric acid levels and clinical improvement in a substantial proportion of patients RCG for six months, a time to demonstrate clinical improvement is unique in randomized controlled trials of urate-lowering therapies.The two replicate, randomized, double-blind, placebo-controlled phase III cons were designed to evaluate the efficacy and tolerability of treatment with KRYSTEXXA 8 mg every two weeks or every four weeks compared with placebo for the treatment of RCG patients.Pooled results of these studies have shown that treatment with KRYSTEXXA every two weeks, the Food and Drug Administration (FDA)-approved dose, resulted in a statistically significant and sustained levels of uric acid below 6 mg / dL in 42 percent of patients, compared to zero percent of patients receiving placebo (p <0.001).
In addition, 40 percent of patients with tophus KRYSTEXXA receive every two weeks experienced complete resolution of one or more tophi, which are crystalline deposits of urate in the joints, skin or cartilage, with a visit to the study, compared to seven percent of placebo patients (p = 0.002). A complete response was defined as tophi a 100 percent reduction in the measured area of at least one tophus without growth of any reference or appearance of any new tophi tophus.
"When lowering effective uric acid levels can be achieved with oral medications, gout, many patients progress to a severe form of the condition known as refractory chronic gout, which is characterized by frequent eruptions arthritis, chronic pain, physical disability and poor quality of life, "said." Data from these studies showed that significant and rapid clinical benefits may be included in these severely affected patients during treatment KRYSTEXXA. "
Improved outcomes reported by patients taking office, physical pain and quality of life were also observed in patients treated KRYSTEXXA.
"The availability of KRYSTEXXA brought hope to patients refractory chronic gout who have not responded to conventional therapies and is the first and only treatment approved by the FDA for the RCG," said Chief Executive Officer and President of Savient Pharmaceuticals. "We are proud to have the results of the Phase III clinical program published in prestigious journals with which further demonstrates that KRYSTEXXA represents an important advance in the treatment of this severe and debilitating illness.
G6PD Treatment | High Blood Pressure Diet, Remedies, Medication ...
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G6pd And Medications - Bookshelf
Family medicine, ambulatory care & prevention
The intravascular hemolysis caused by these conditions is particularly worsened by illness, stress, and, with G6PD, some medications. ...Thompson and Thompson genetics in medicine
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SIGNS TO WATCH See signs and symptoms PREVENTION N/A Common Questions and Answers Q: Do I need to follow a special diet or avoid medications if I have G6PD ...Helpful Information Directory
G6PD Deficiency
... someone doesn't have enough of the enzyme G6PD, which protects red blood cells. Certain triggers can lead to anemia in kids who have G6PD deficiency. ...
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G6PD (Glucose-6-Phosphate Dehydrogenase) Deficiency ...
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Overview of G6PD Deficiency
G6PD deficiency is an inherited condition in which the body doesn't have enough of the ... Some kids with G6PD deficiency can tolerate the medications in small amounts; others ...