EBP: Research Application - Article Example

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Efficacy and Safety of Pantoprazole Delayed-release Granules for Oral Suspension in a Placebo-controlled, Treatment-withdrawal Study in Infants 1–11 Months Old with Symptomatic GERD. Newborns and infants commonly encounter gastroesophageal reflux, which is asymptomatic in the majority of patients and is generally considered a physiologic phenomenon, but when it does give rise to symptoms, such as vomiting, dysphagia, hematemesis and anemia, it can be a source of great distress and morbidity for the infants (Winter, et al., 2010)…
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EBP: Research Article Application
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Moreover, it critically analyses the recommendations made by the authors in light of the current guidelines regarding the management of GERD amongst infants. Winter et al. (2010) conducted a multicenter, randomized, treatment-withdrawal study, which concluded that the short term use of proton pump inhibitors such as Pantoprazole was safe and efficacious, demonstrated by the improvement in the weekly GERD symptom score (WGSS), for the management of symptoms of Gastroesophageal Reflux Disease or GERD, as it is commonly referred to as, amongst infants aged 1 to 11 months (Winter, et al., 2010). The findings of this study are important as it is the first multicenter, randomized, placebo-controlled study of its kind to validate the safety and efficacy of Pantoprazole, a proton pump inhibitor (PPI), in the treatment of GERD, which was previously only demonstrated in small clinical trials (Winter, et al., 2010). ...
These findings have important implications in clinical practice as GERD is commonly encountered amongst infants, with almost half of the infants aged 3-4 months displaying symptoms of regurgitation atleast once a day (Vandenplas, et al., 2009), and can have a significant impact on their proper growth and development if left untreated. Since studies have revealed that PPI’s are the best form of acid suppressing therapy and are superior in efficacy to H 2 receptor antagonists, in both alleviating the symptoms of reflux and in promoting healing of esophagitis occurring as a consequence of chronic reflux (Rudolph, et al., 2001), there was a need for a study to validate the safety of this drug amongst infants so that this group of patients can benefit from this treatment too. The findings of this study help in objectively validating the potential benefits and safety of Pantoprazole, since the study design was a randomized, placebo-controlled trial, and thus can be used as an evidence-based resource in administering treatment for GERD amongst infants. The latest guidelines on the treatment of GERD amongst infants are the Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) which were published in 2009 (Vandenplas, et al., 2009). According to these guidelines, although PPI’s are superior to other acid suppressing agents in alleviating the symptoms of reflux and in promoting healing of erosive disease such as esophagitis, there is no particular PPI which has been approved for use amongst infants (Vandenplas, et al., 2009). Since these guidelines were issued prior to the publish of the Read More
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