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Hyaluronic Acid/Dextranomer Gel Nearly Twice as Effective as Antibiotics for Preventing Urinary Tract Infections in Children With Vesicoureteral Reflux

Study Presented at American Academy of Pediatrics Annual Conference

ATLANTA, GA -- November 20, 2006 -- Deflux® (non-animal stabilized hyaluronic acid/dextranomer gel), for the treatment of vesicoureteral reflux (VUR) in children, is nearly twice as effective as prophylactic antibiotics in lowering rates of VUR-related urinary tract infections (UTIs), according to a study presented today at the American Academy of Pediatrics 2006 National Conference and Exhibition in Atlanta. Overall, patients taking antibiotics were 79 percent more likely to develop a UTI than those taking Deflux.

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. VUR increases the risk of kidney infection and scarring, and, in the long term, can lead to irreversible kidney damage and high blood pressure. Riccabona M. Management of recurrent urinary tract infection and vesicoureteral reflux in children. Curr Opin Urol. 2000;10:25-28. Lenaghan D, Whitaker JG, Jensen F, Stephens FD. The natural history of reflux and long-term effects of reflux on the kidney. J Urol. 1976;115:728-730. International Reflux Study Committee. Medical versus surgical treatment of primary vesicoureteral reflux: report of the International Reflux Study Committee. Pediatrics. 1981;67:392-400. Bailey RR, Lynn KL, Robson RA. End-stage reflux nephropathy. Ren Fail. 1994;16:27-35. As many as 42 percent of children with VUR taking prophylactic antibiotics will have a UTI within five years. Wheeler D, Vimalachandra D, Hodson EM, et al. Antibiotics and surgery for vesicoureteric reflux: a meta-analysis of randomized controlled trials. Arc Dis Child. 2003;88:688-694.

"The significantly higher rate of UTIs in the antibiotic group compared to those treated with Deflux demonstrates an additional advantage of Deflux over long-term antibiotic prophylaxis, and suggests that Deflux should be considered first-line treatment for VUR-related UTIs," said Terry Hensle, MD, Director of Pediatric Urology, Children's Hospital of New York Presbyterian. "Unlike antibiotics, Deflux treats the actual cause of VUR, not just the UTI, and does not require compliance with a strict and potentially long-lasting dosage regimen that may impact quality of life for children and their parents."

The study retrospectively analyzed the administrative claims of 188 VUR patients aged 10 and younger (140 prescribed antibiotics; 48 treated with Deflux), using the nationally representative PharMetrics Integrated Medical and Pharmaceutical database, for six months prior to and one year after treatment with either prophylactic antibiotics or Deflux. Up to three patients in the antibiotic group were matched to every one Deflux-treated patient by pre-period age, gender, antibiotic charges and use of specialty care.

Urinary tract infections were observed in 25 percent of the Deflux-treated patients versus 45 percent of the patients treated prophylactically with antibiotics (p=0.025). Patients treated with prophylactic antibiotics were 79 percent more likely to develop a UTI than patients treated with Deflux (p=0.028), after controlling for background covariates. Deflux-treated children experienced a lower average number of UTIs than those taking prophylactic antibiotics (.42 versus.69, respectively).

Although they are commonly used prophylactically in children with VUR, antibiotics are not approved by the U.S. Food and Drug Administration (FDA) for this indication. Deflux is the only FDA-approved treatment for VUR. VUR treatment guidelines target reducing the number of UTIs in VUR patients.

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. Puri P, Chertin B, Velayudham M, Dass L, Colhoun E. Treatment of vesicoureteral reflux by endoscopic injection of dextranomer/hyaluronic acid copolymer: preliminary results. J Urol. 2003;170:1541-1544. Kirsch AJ, Perez-Brayfield M, Smith EA, Scherz HC. The modified sting procedure to correct vesicoureteral reflux: improved results with submucosal implantation within the intramural ureter. J Urol. 2004;171:2413-2416. 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. Heidenreich A, Ozgur E, Becker T, Haupt G. Surgical management of vesicoureteral reflux in pediatric patients. World J Urol. 2004;22:96-106. Elder JS, Peters CA, Arant BS, Jr, et al. Pediatric Vesicoureteral Reflux Guidelines Panel summary report on the management of primary vesicoureteral reflux in children. J Urol. 1997;157:1846-1851. Prophylactic antibiotics, the current first-line treatment, do not cure VUR and require long-term compliance, increasing the potential for antibiotic resistance.

In a study where parents were explained all treatment options for their child's VUR, nearly 80 percent of parents preferred treatment with Deflux over prolonged antibiotic prophylaxis or open surgery. Data on file. http://deflux.com/Templates/Page.aspx?id=278

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 constipation. 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 50 percent more likely to occur in the siblings of VUR patients. The average age of diagnosis is one to two years.

About Deflux
Deflux is a copolymer between 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 at approximately 1-3% in 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, duplicated ureters, 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 Scandinavia, Inc.


SOURCE: Q-Med Scandinavia Inc.

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