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Title: Health Canada Approves Pediatric Indication for Prevacid (Lansoprazole) for Children with Gastroesophageal Reflux Disease

"Health Canada Approves Pediatric Indication for Prevacid (Lansoprazole) for Children with Gastroesophageal Reflux Disease"

MONTREAL, QC -- February 10, 2005 - Abbott Laboratories, Limited announces that Prevacid® (lansoprazole), a commonly prescribed Proton Pump Inhibitor (PPI) for adults, has now been approved for pediatric gastroesophageal reflux disease (GERD) in Canada. Prevacid (lansoprazole) is now indicated for the short-term treatment of erosive and non-erosive GERD in children between 1 and 17 years of age. GERD is one of the most common oesophageal disorders in children. When stomach contents, such as food and gastric acid, frequently reflux out of the stomach and into the oesophagus, oesophageal tissue damage may occur. Common symptoms in children include regurgitation (spitting up), vomiting, chest pain (heartburn), abdominal pain, feeding resistance and difficulty swallowing. "The symptoms of GERD are uncomfortable for children, and can be disruptive for both the child and his or her family," said Beth Anderson, executive director of the Pediatric/Adolescent Gastro-oesophageal Reflux Association (PAGER). "We encourage parents who suspect their child may be suffering from GERD to approach their doctor and discuss symptoms, diagnosis and treatment options." About GERD GERD is a common physiologic self-limited condition in infants, with half of two-month old infants regurgitating twice a day or more. Only one percent of twelve-month old infants, however, regurgitate at that rate, although a small percentage of infants will develop pathogenic GERD. The management of gastro-oesophageal reflux disease (GERD) continues to garner vast amounts of attention among physicians who care for adults. However, there is an increasing awareness of the fact that this disease, as well as several other lifelong digestive diseases (i.e. Crohn's disease) may actually have their origins in childhood. Pediatric gastroesophageal reflux (GER) is likely to share a similar pathophysiology to adult GER, and mounting evidence from published preliminary data suggests a genetic susceptibility to GER. However, further studies will be necessary to confirm this hypothesis. In children, GER has a distinct presentation from that in adults, with the diagnostic work-up based upon the patient's age as well as their presenting signs and symptoms. Like their adult counterparts, the early detection and treatment of GER in children may result in a better long-term outcome, improved quality of life, and a reduction in overall healthcare burden. While the treatment of GER in infants tends to be conservative (i.e. positioning during feeding and smaller feedings), its management in older children may, depending on the clinical situation, be similar to that of adults and includes lifestyle changes and pharmacological therapy. However, with persistent symptoms, acid suppression is the mainstay of GERD management in both children and adults. Several studies have demonstrated that acid suppression with a proton pump inhibitor is superior to histamine2-receptor antagonists. Among the proton pump inhibitors, lansoprazole has been the subject of published adult studies demonstrating its safety, in addition to its efficacy in a variety of conditions where reduction of acid secretion is required, such as GERD. Clinical results Prevacid lansoprazole is an effective treatment for children with GERD, according to the results of a U.S. multi-centre study conducted in 66 children (1 to 11 years of age) with erosive or non-erosive GERD. Seventy-six percent of children (47/62) experienced improvement in overall GERD symptoms at week 8 or week 12. Among children with erosive oesophagitis, oesophagitis healed in 21 of 27 or 78% of them by 8 weeks, and in all 27 children (100%) at 12 weeks. Indications In adults, Prevacid is indicated for the treatment of heartburn and other symptoms of GERD; the treatment and maintenance of healed reflux oesophagitis, a condition in which stomach acid injures the lining of the oesophagus; treatment of gastric (stomach) ulcers; the treatment and maintenance of healed duodenal ulcers (ulcers found on the first part of the small intestine); treatment of pathological hypersecretory conditions (which involve the overproduction of stomach acid), including Zollinger-Ellison Syndrome; and the healing and risk reduction of the recurrence of gastric ulcers associated with NSAIDs. According to Dr. Robert Issenman, Chief of Pediatric Gastroenterology and Nutrition, McMaster Children's Hospital in Hamilton, Ontario, "The proton pump class of medication is safe and effective treatment for esophagitis due to acid reflux. Current drug formats are convenient for use in pediatric patients and have been specifically tested in patients in this age group. Now that there is a pediatric indication for use, these medications can be used in children with greater confidence." About Prevacid (lansoprazole) Prevacid is the only PPI in Canada that comes in a capsule. Available in 15 mg and 30 mg, dosage is administrated according to the child's weight. For children who have difficulty swallowing capsules, the granules from a Prevacid capsule can be sprinkled on one tablespoon of applesauce or mixed into select juices (such as orange, apple or grape) and swallowed immediately. Contraindications and adverse reactions Prevacid is contraindicated in patients with known hypersensitivity to any component of the formulation. The most frequently reported adverse events in adults include diarrhea and headache. In pediatric GERD patients between the ages of 1 to 11, the most frequently reported adverse events were constipation and headache and between the ages of 12 to 17, headache and abdominal pain. Symptomatic response to therapy does not preclude the presence of serious stomach problems. About Proton Pump Inhibitors (PPIs) PPIs belong to a group of chemically-related compounds which primary function is the inhibition of acid production in the final common metabolic pathway of gastric parietal cells. PPIs are highly selective and effective in their action and are generally well tolerated. These pharmacological features have made the development of PPIs the most significant advancement in the management of peptic-acid-related disorders in the last two decades. SOURCE: Abbott

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