- Need for Antibiotics Eliminated in 87 Percent of Patients, New Study
PRINCETON, N.J., Aug. 7 /PRNewswire/ -- DEFLUX(R) (non-animal stabilized hyaluronic acid/dextranomer gel), for the treatment of vesicoureteral reflux (VUR) in children, reduced the incidence of recurrent urinary tract infections (UTIs) in children with VUR by 62 percent, according to a study published in the July issue of the Journal of Laparoendoscopic & Advanced Surgical Techniques. DEFLUX also eliminated the need for prophylactic antibiotics in 87 percent of patients. VUR, a malformation of the ureter that causes a backflow of urine from the bladder toward the kidneys, is the most common abnormality of the urinary tract in children. UTIs are the primary indicator of pediatric VUR and if left untreated, may lead to kidney damage.
"The primary goal of VUR treatment in children is to reduce the incidence of UTIs, which over time can lead to long-term health consequences including renal scarring and hypertension," said Kevin P. Moriarty, MD, FACS, FAAP Clinical Associate Professor of Surgery, Tufts University School of Medicine. "In this study we see that DEFLUX is not only effective in resolving VUR, but also in reducing the incidence of UTIs and use of antibiotics, which require long-term compliance and can increase the potential of resistance. These data add to the growing body of evidence supporting DEFLUX as first-line treatment for VUR."
In this prospectively designed study, the charts of 100 children aged one to 17 years with VUR from Baystate Children's Hospital, Tufts University School of Medicine, Springfield, Massachusetts were reviewed. Inclusion criteria included Grades II-IV VUR determined by voiding cystourethrogram (VCUG) with breakthrough UTIs despite prophylactic antibiotics. The frequency of UTIs was recorded before and after treatment with DEFLUX. Success was defined as the resolution of reflux on a three-month postoperative VCUG. All patients were kept on prophylactic antibiotics for three months after DEFLUX injection.
After treatment with DEFLUX, 13 percent of patients (n=13) had recurrent UTIs compared to 75 percent (n=75) before DEFLUX treatment, with a five-fold reduction in the incidence of UTIs per year (0.12 +/- 0.04 (p=0.001) post- treatment versus 0.68 +/- 0.09 pre-treatment). DEFLUX also eliminated the need for prophylactic antibiotics in 87 percent of patients. Of the 13 patients with recurrent UTIs after DEFLUX treatment, eight experienced them when they were no longer taking antibiotics. The overall success rate by ureter of DEFLUX treatment in resolving VUR was 77.4 percent after the first injection and 83.9 percent after a second injection. There were no major intraoperative or postoperative complications.
Additional Study Supports Data
A long-term observational study of 179 children with VUR, published in the November 2006 issue of the Journal of Pediatric Urology, showed that in children successfully treated with DEFLUX 74.9 percent of patients experienced no UTIs in the seven-to-12-year follow-up period after DEFLUX treatment (all experienced at least one UTI before treatment). Additionally, 96.6 percent experienced no febrile UTIs (UTIs accompanied by fever) in the follow-period. Most of the post-treatment UTIs reported occurred more than one year after treatment (82.2 percent). Study participants, treated with DEFLUX between 1993 and 1998, were asked to complete a 21-item questionnaire, with parental assistance if required.
DEFLUX, injected endoscopically where the ureter joins the bladder, is typically administered under general anesthesia as an outpatient procedure. The procedure is quick to perform (approximately 15 minutes) and no incision is required. The majority of VUR patients in the U.S. are managed with either antibiotics or an invasive surgical procedure that, while highly effective, requires hospitalization and carries the risk of significant complications. Prophylactic antibiotics, the current first-line treatment, do not cure VUR and require long-term compliance, increasing the potential for antibiotic resistance.
About Vesicoureteral Reflux (VUR)
Approximately one percent of all children born suffer from VUR, which causes urine to flow backwards from the bladder to the kidneys through one or both of the connecting ureters. In most children, VUR is a birth defect caused by an abnormal connection between the bladder and ureter. Symptoms of VUR include frequent and recurrent urinary tract infections, infrequent or incomplete urination and urgency and frequency. VUR, which tends to run in families, is classified into five grades - I being the mildest and V being the most severe. If a parent has VUR, up to one half of his or her children will also have it, and VUR is 20 percent more likely to occur in the siblings of VUR patients. The average age of diagnosis is one to two years.
DEFLUX is a viscous gel consisting of non-animal stabilized hyaluronic acid and dextranomer, a crosslinked polysaccharide that promotes the natural formation of connective tissue. DEFLUX is indicated for the treatment of children with VUR grades II - IV. The most frequent adverse event seen in clinical trials was urinary tract infections. Other adverse events reported -- ureteral dilatation, nausea, vomiting and abdominal pain -- occurred in approximately 1-3% of patients. Rare cases of postoperative dilatation of the upper urinary tract with or without hydronephrosis leading to temporary placement of a ureteric stent have been reported. DEFLUX is contraindicated in patients with non-functioning kidney(s), hutch diverticuli, ureterocele, active voiding dysfunction, or ongoing urinary tract infection. Since 1998, DEFLUX has been used in more than 40,000 children worldwide. Long-term follow up suggests that up to 70 percent of children treated with DEFLUX need no further treatment for VUR.
DEFLUX is a registered trademark of Q-Med AB. Additional information about DEFLUX and VUR is available at http://www.deflux.com.
Q-Med Scandinavia Inc. is a wholly-owned subsidiary of Q-Med AB.
Q-Med AB is a rapidly growing and profitable biotechnology/medical device company. The company develops, manufactures, markets and sells primarily medical implants for esthetic and medical use. The majority of the products are based on the company's patented technology, NASHA(TM) for the production of stabilized non-animal hyaluronic acid. Sales are made through the company's own subsidiaries or distributors in over 70 countries. Q-Med today has just over 600 co-workers, with approximately 400 at the company's head office and production facility in Uppsala, Sweden. Q-Med AB is listed in the Large Cap segment of the OMX Nordic Exchange in Stockholm.
Q-Med Scandinavia Inc. markets DEFLUX(R), for the treatment of vesicoureteral reflux, VUR, (a malformation of the urinary bladder) in children in the USA.
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