EBP: Research Application - Article Example

Efficacy and Safety of Pantoprazole Delayed-release Granules for Oral Suspension in a Placebo-controlled, Treatment-withdrawal Study in Infants 11Months 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). This paper discusses the findings of the research article “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 (Winter, et al., 2010)” and discusses its practical and clinical implications.

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). Although the use of PPI’s is fairly common amongst adults suffering from GERD, before the publishing of this study, there were concerns regarding the safety of use of PPI’s amongst infants (Winter, et al., 2010). Based on the results of this study, however, it can be established that the PPI Pantoprazole is a safe treatment choice for infants with GERD when used for a period of upto 4 weeks.

Moreover, it can also be concluded that Pantoprazole is efficacious in improving the symptoms of reflux amongst infants. 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 current study, the guideline does not include the findings of this study.

However, these guidelines do advocate the use of PPI’s in infants based on their efficacy and safety profile in adults and children but recommend usage with caution as there is a possibility of drug related adverse effects (Vandenplas, et al., 2009). Conversely, several systemic reviews and studies conducted after this current study was published have found conflicting evidence. A literature review evaluating the safety and efficacy of PPI’s amongst infants conducted by Higginbotham (2010) revealed that PPIs were ineffective in relieving symptoms associated with GERD amongst infants and there was insufficient evidence to conclusively elucidate the safety of these drugs (Higginbotham, 2010).

Similar findings were reported by Van der Pol (2011) who conducted a systemic review and concluded that PPIS were not superior to placebos in the alleviation of symptoms of GERD amongst infants and although the short term use of PPIs amongst infants was safe, there is need for further research to determine the long term safety profile of PPIs for the management of GERD in infants (Van der Pol, Smits, Wijk, Omari, Tabbers, & Benninga, 2011). Thus, in conclusion, while this study advocates the use of PPI for the treatment of GERD symptoms amongst infants, its applicability in clinical situation is limited owing to its inherent shortcoming of having a withdrawl study design (instead of a double blind randomized control trail) which limits the objectivity of the findings.

Moreover, the findings of this study are not supported by other similar studies in this regard and thus this warrants the need for further future research to conclusively determine the role of PPIs such as Pantoprazole in the treatment of GERD amongst infants. References Higginbotham, T. (2010). Effectiveness and safety of proton pump inhibitors in infantile gastroesophageal reflux disease. Annals of Pharmacotherapy , 572-576. Rudolph, C. D., Mazur, L. J., Liptak, G. S., Baker, R. D., Boyle, J. T., Colletti, R. B., et al. (2001). Guidelines for Evaluation and Treatment of Gastroesophageal Reflux in Infants and Children: Recommendations of the North American Society for Pediatric Gastroenterology and Nutrition.

Journal of Pediatric Gastroenterology & Nutrition , 1-31. Van der Pol, R., Smits, M., Wijk, T. v., Omari, M., Tabbers, M., & Benninga, M. (2011). Efficacy of proton-pump inhibitors in children with gastroesophageal reflux disease: a systematic review. Pediatrics , 925-935. Vandenplas, Y., Rudolph, C. D., Lorenzo, C. D., Hassall, E., Liptak, G., Mazur, L., et al. (2009). Pediatric Gastroesophageal Re?ux Clinical Practice Guidelines: Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition(NASPGHAN) and the ESPGHAN.

Journal of Pediatric Gastroenterology and Nutrition , 498-547. Winter, H., Kum-Nji, P., Mahomedy, S. H., Kierkus, J., Hinz, M., Li, H., et al. (2010). 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. Journal of Pediatric Gastroenterology & Nutrition , 609-618.