Nizatidine for the treatment of pediatric gastroesophageal reflux symptoms: An open-label, multiple-dose, randomized, multicenter clinical trial in 210 children

Orenstein, Susan R.; Gremse, David A.; Pantaleon, Carmela; Kling, Douglas; Rotenberg, Keith S.

doi:10.1016/j.clinthera.2005.04.008

Cited by 22 publications

(13 citation statements)

References 11 publications

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“…Até o momento, apenas a cimetidina 25 e a nizatidina 26,27 foram avaliadas em crianças em relação à evolução clínica da DRGE através de estudos controlados e randomizados. A cimetidina apresenta um grande número de interações medicamentosas.…”

Section: Esofagite Erosivaunclassified

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Treatment of gastroesophageal reflux disease

Guimarães¹,

Marguet²,

Camargos³

2006

J Pediatr (Rio J)

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Objective: To review the literature on the treatment of gastroesophageal reflux disease (GERD) with emphasis on pharmacological aspects. To identify particularities of pharmacological treatment of esophageal and extraesophageal manifestations of the disease.Sources: Electronic search of the PubMed/MEDLINE and Cochrane Collaboration databases. Controlled and randomized studies published since 2000 and reviews representing consensus positions and directives published within the last 10 years were identified. Summary of the findings:The drugs currently available for the treatment of GERD do not act in the primary mechanism of the disease, i.e., transitory relaxation of the lower esophageal sphincter. Pharmacological treatment of GERD with symptoms or with esophageal injury is based on the suppression of acid secretion, particularly with proton pump inhibitors. When the hyperreactivity of the lower airways coexists with esophageal GERD symptoms, suppression of acid secretions should be of benefit in managing the respiratory disease in the presence of a causal relationship; however, this is not usual. When esophageal symptoms are not present, esophageal 24-hour pH study should be carried out prior to starting pharmacological treatment for GERD. Improvement of respiratory symptoms may be delayed with relation to esophageal symptoms. It is common for GERD to recur and pharmacological treatment should be repeated or continued indefinitely, depending on clinical presentation of the disease. Conclusions:The strategies that have been proposed for the pharmacological treatment of GERD in children are primarily based on studies of case series or on studies with adults. There have been very few controlled and randomized studies in children. Undertaking a greater number of these studies might reinforce existing aspects or establish new aspects of management.J Pediatr (Rio J). 2006;82(5 Suppl):S133-45: Gastroesophageal reflux, child, drug therapy, esophagitis, respiratory tract diseases, asthma. ResumoObjetivo: Rever a literatura sobre tratamento da doença do refluxo gastroesofágico (DRGE) com ênfase nos aspectos farmacológi-cos. Identificar particularidades do tratamento farmacológico nas manifestações esofágicas e extra-esofágicas da doença.Fontes de dados: Busca eletrônica na base de dados PubMed/ MEDLINE e Cochrane Collaboration. Procurou-se identificar estudos controlados e randomizados publicados a partir de 2000, bem como revisões que representassem consensos e diretrizes publicados nos últimos 10 anos.Síntese dos dados: Nenhuma das drogas atualmente usadas no tratamento da DRGE altera comprovadamente o mecanismo principal da doença, ou seja, os relaxamentos transitórios do esfíncter esofágico inferior. O tratamento farmacológico da DRGE com sintomas ou com lesões esofágicas é baseado na inibição da secreção ácida, em particular pelos inibidores da bomba de prótons (IBP). Nas situações em que a hiper-reatividade das vias aéreas inferiores coexiste com sintomas esofágicos da DRGE, a inibição da secreção ácida deve...

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Section: Esofagite Erosivaunclassified

“…Trinta e dois por cento dos pacientes alcançaram melhora total dos sintomas após 8 semanas de uso da droga 27 . Apesar do número significativo de pacientes envolvidos, esse estudo sugere uma eficácia limitada da droga, ou, mais provavelmente, uma dificuldade em avaliar a DRGE a partir de sintomas clínicos.…”

Section: Esofagite Erosivaunclassified

Treatment of gastroesophageal reflux disease

Guimarães¹,

Marguet²,

Camargos³

2006

J Pediatr (Rio J)

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“…This makes H 2 RAs well suited to "on-demand" use. Another plus for these drugs is that there are pediatric data supporting the use and safety of the H 2 RAs cimetidine, ranitidine, nizatidine, and famotidine in infants and children [27][28][29][30]. Cimetidine tends to be less frequently used in children, as it has more side effects than the others.…”

Section: H 2 Rasmentioning

confidence: 93%

Step-up and step-down approaches to treatment of gastroesophageal reflux disease in children

Hassall

2008

Curr Gastroenterol Rep

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The single biggest change in the approach to treating pediatric gastroesophageal reflux disease (GERD) in recent years has been the empiric use of proton pump inhibitors (PPIs) for symptoms suspected to be those of GERD. In other words, PPIs have been used increasingly as a first-line concurrent diagnostic test and treatment before any investigation. Although this approach is useful for some patients, there are a number of caveats about its application to children. In general, these caveats are related to age per se (eg, infancy) and to age-related symptoms and severity of GERD itself. The most important caveats relate to the prescription of empiric PPI therapy in infants--which generally is to be avoided--and to how PPIs are used in older children--specifically, the advisability of empiric trials being of limited duration. Even in children with proven reflux esophagitis, GERD is not chronic and relapsing in all; thus, trials of therapy withdrawal are warranted. In light of many factors, including the burgeoning literature on potential risks of infections in acid-suppressed children and adults, caution with dose and duration of acid-suppressive drugs in children is urged. The role of antireflux surgery is also mentioned.

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“…The current knowledge on children with GERD is mainly drawn from countless case series reports about H2-receptor antagonists date, cimetidine 25 and nizatidine 26,27 are the only H2-receptor antagonists (H2RA) that have been evaluated in controlled and randomized trials with children in terms of GERD outcome. Cimetidine has been known to present a large number of drug interactions.…”

Section: The Young Child With Abdominal Painmentioning

confidence: 99%

“…Thirty two percent of patients achieved complete relief from symptoms after 8 weeks of treatment. 27 Despite the large number of patients involved, the study suggests either a limited efficacy of the drug or most likely the difficulty to assess GERD based on clinical symptoms. Furthermore, regarding drug safety, several adverse effects, such as upper respiratory tract infections, vomiting, diarrhea, pneumonia, dermatitis, fatigue and tremor were recorded.…”

Section: The Young Child With Abdominal Painmentioning

confidence: 99%

Tratamento da doença do refluxo gastroesofágico

Guimarães

Marguet

Camargos

2006

J. Pediatr. (Rio J.)

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Objective: To review the literature on the treatment of gastroesophageal reflux disease (GERD) with emphasis on pharmacological aspects. To identify particularities of pharmacological treatment of esophageal and extraesophageal manifestations of the disease.Sources: Electronic search of the PubMed/MEDLINE and Cochrane Collaboration databases. Controlled and randomized studies published since 2000 and reviews representing consensus positions and directives published within the last 10 years were identified. Summary of the findings:The drugs currently available for the treatment of GERD do not act in the primary mechanism of the disease, i.e., transitory relaxation of the lower esophageal sphincter. Pharmacological treatment of GERD with symptoms or with esophageal injury is based on the suppression of acid secretion, particularly with proton pump inhibitors. When the hyperreactivity of the lower airways coexists with esophageal GERD symptoms, suppression of acid secretions should be of benefit in managing the respiratory disease in the presence of a causal relationship; however, this is not usual. When esophageal symptoms are not present, esophageal 24-hour pH study should be carried out prior to starting pharmacological treatment for GERD. Improvement of respiratory symptoms may be delayed with relation to esophageal symptoms. It is common for GERD to recur and pharmacological treatment should be repeated or continued indefinitely, depending on clinical presentation of the disease. Conclusions:The strategies that have been proposed for the pharmacological treatment of GERD in children are primarily based on studies of case series or on studies with adults. There have been very few controlled and randomized studies in children. Undertaking a greater number of these studies might reinforce existing aspects or establish new aspects of management.J Pediatr (Rio J). 2006;82(5 Suppl):S133-45: Gastroesophageal reflux, child, drug therapy, esophagitis, respiratory tract diseases, asthma. The symptoms of GERD are less common than the symptoms of GER, but, even so, are very prevalent. A prevalence study reported weekly heartburn sensation and acid regurgitation in approximately 2% of children aged 3 to 9 years and in 5% to 8% of 10 to 17 year-olds. REVIEW ARTICLEHeartburn alone was identified in 17.8% of the children in the older age group. 7 In the Western world, the prevalence of GERD among adults has been estimated from 10% to 20%. 5The refluxate may be exclusively acidic or mixed with duodenum-gastric reflux. Acid reflux is easier to identify and consequently the pathophysiology, diagnosis and treatment are better known. The bile reflux is little understood, but it has been related to severe esophagitis. 8 The case of mixed reflux diagnosis is highly problematic, and is one of the limitations of pH studies. There are no specific clinical trials on mixed reflux in the literature. has not specified the classification by age group, and most of the definitions proposed are applicable to adult patients. Notwithstan...

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Nizatidine for the treatment of pediatric gastroesophageal reflux symptoms: An open-label, multiple-dose, randomized, multicenter clinical trial in 210 children

Cited by 22 publications

References 11 publications

Treatment of gastroesophageal reflux disease

Treatment of gastroesophageal reflux disease

Step-up and step-down approaches to treatment of gastroesophageal reflux disease in children

Tratamento da doença do refluxo gastroesofágico

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