Efficacy, safety, and tolerability of pantoprazole magnesium in the treatment of reflux symptoms in patients with gastroesophageal reflux disease (GERD): a prospective, multicenter, post-marketing observational study.

BACKGROUND: To improve proton pump inhibitor effects, pharmacological modifications have been developed such as the use of enantiomer molecules (e.g., S-omeprazole, S-pantoprazole, or dexlansoprazole), or addition of NaHCO3 (for an immediate release) or magnesium (with a lower absorption for a more sustained effect). OBJECTIVE: The objective of this study was to assess the efficacy, safety, and tolerability of pantoprazole magnesium 40 mg once daily for 4 weeks, on the relief of reflux symptoms in gastroesophageal reflux disease (GERD) patients. METHODS: A phase IV, open-label, prospective, multicenter study was designed. Patients included were prescribed pantoprazole magnesium 40 mg orally once daily for 28±2 days. All patients had a history of persistent or recurrent heartburn and/or acid regurgitation for at least 3 months. Effectiveness and tolerability data obtained from patients who completed a minimum of 4 weeks of pantoprazole magnesium treatment were considered for analysis. RESULTS: The account of baseline characteristics and demographics of GERD symptom intensity was made by analyzing the group of 4,343 patients that fulfilled all inclusion criteria; 54% were females (n=2,345) and 46% (n=1,998) males, with a mean age of 36.2±7.5 years. Severity of symptoms, assessed by the physician using the 4-point Likert scale, reduced by at least 80% from baseline intensity after treatment in the per protocol population. In the case of the intention-to-treat population, the improvement in symptom intensity was 73%. The number of patients that experienced any adverse events was 175/5,027 (3.48%). CONCLUSIONS: Pantoprazole magnesium is a safe, effective, and well-tolerated drug that significantly improves GERD symptoms.

Proton pump inhibitors in gastroesophageal reflux disease: "a custom-tailored therapeutic regimen".

The Montreal Definition and Classification divides Gastroesophageal Reflux Disease (GERD) into esophageal symptomatic syndromes (and with mucosal damage) and extraesophageal syndromes (with acid established association and proposed association). In typical GERD symptoms, an 8-week treatment with PPIs is satisfactory in most cases (> 90%). Response rates to PPIs in GERD are highly variable, as they also rely on an appropriate clinical diagnosis of the disease; endoscopy differentiates the macroscopic GERD phenotype. The non-erosive variety (50-70% prevalence) has a different symptomatic response rate, as gastric acid is not the sole etiology of symptoms. The possible explanations of treatment failure include treatment adherence, PPI metabolism alterations and characteristics, and inadequate diagnosis. Refractory symptoms are related to gastric content neutralization by the chronic use of PPIs.Extraesophageal manifestations are associated with other pathophysiological mechanisms where an autonomic nervous system disturbance gives rise to symptoms. In these clinical entities, the relationship between symptoms and acid needs to be established in order to determine the use of PPIs, or consider other drugs. In other words, so as to "custom-tailor the best-fitting therapy" we need to answer the questions for whom, for what, how and for how long. Finally, PPI safety and tolerability are factors to be considered in elderly patients requiring chronic PPI use, who usually have chronic concomitant illnesses.

"Diseñando un traje a la medida": los inhibidores de la bomba de protones en la enfermedad por reflujo gastroesofágico / Proton pump inhibitors in gastroesophageal reflux disease: "a custom-tailored therapeutic regimen"

La Clasificación de Montreal divide la enfermedad por reflujo gastro-esofágico (ERGE) en síndromes esofágicos sintomáticos y con daño a la mucosa y en síndromes extraesofágicos con asociación establecida al ácido y asociación propuesta. En síntomas ERGE típicos el tratamiento con inhibidores de la bomba de protones (IBP) es satisfactorio (> 90%) a 8 semanas en la mayoría de los casos. Las tasas de respuesta a los IBP en la ERGE son muy variables; ya que también dependen de un adecuado diagnóstico clínico de la enfermedad; la endoscopia diferencia el fenotipo macroscópico de la ERGE. La variedad no erosiva (prevalencia 50-70%) tiene una tasa de respuesta sintomática diferente ya que el ácido no es causa suficiente para explicar los síntomas. Las posibles explicaciones a la falla al tratamiento son el apego al tratamiento, alteraciones en el metabolismo y características de IBP y diagnóstico inadecuado. Los síntomas refractarios se relacionan con neutralización del contenido por el uso crónico de IBP. Las manifestaciones extraesofágicas se asocian con otros mecanismos fisiopatológicos como la disfunción del sistema nervioso autónomo. En estas entidades es necesario establecer la relación o no con el ácido para determinar el uso con IBP o considerar otros fármacos. Es decir, necesitamos responder a las preguntas en quien, para qué, cómo y por cuánto tiempo, para diseñar un "traje a la medida". Por último, la seguridad y la tolerabilidad a IBP son factores a considerar en pacientes de edad avanzada que requieren su uso crónico y que generalmente tienen enfermedades crónicas concomitantes (AU)

The Montreal Definition and Classification divides Gastroesophageal Reflux Disease (GERD) into esophageal symptomatic syndromes (and with mucosal damage) and extraesophageal syndromes (with acid established association and proposed association). In typical GERD symptoms, an 8-week treatment with PPIs is satisfactory in most cases (> 90%). Response rates to PPIs in GERD are highly variable, as they also rely on an appropriate clinical diagnosis of the disease; endoscopy differentiates the macroscopic GERD phenotype. The non-erosive variety (50-70% prevalence) has a different symptomatic response rate, as gastric acid is not the sole etiology of symptoms. The possible explanations of treatment failure include treatment adherence, PPI metabolism alterations and characteristics, and inadequate diagnosis. Refractory symptoms are related to gastric content neutralization by the chronic use of PPIs. Extraesophageal manifestations are associated with other pathophysiological mechanisms where an autonomic nervous system disturbance gives rise to symptoms. In these clinical entities, the relationship between symptoms and acid needs to be established in order to determine the use of PPIs, or consider other drugs. In other words, so as to "custom-tailor the best-fitting therapy" we need to answer the questions for whom, for what, how and for how long. Finally, PPI safety and tolerability are factors to be considered in elderly patients requiring chronic PPI use, who usually have chronic concomitant illnesses (AU)

[Guidelines for diagnosis and treatment of constipation in Mexico. A) Epidemiology (meta-analysis of the prevalence), pathophysiology and classification]. / Guías de diagnóstico y tratamiento del estreñimiento en México. A) Epidemiología (meta-análisis de la prevalencia), fisiopatología y clasificación.

BACKGROUND: Constipation is a common problem in the general population and its prevalence is based on the diagnostic criteria, the study population and the research methodology for collecting the data. OBJECTIVES AND METHODS: To establish the clinical gudelines for diagnosis and treatment of chronic constipation in Mexico we have reviewed the epidemiological factors of constipation and have conducted meta-analysis according to the 3 available community-based studies from our country. In addition, evidence-based recommendations have been provided. RESULTS: The estimated prevalence of functional constipation in Mexico is 14.4% (95% CI: 12.6-16.6%) according to Rome II and Rome III criteria. Although constipation is present in both genders and all age groups, it is more common among young women with a female to male ratio of 3:1. In our population, 43.6% report using laxatives, teas for stimulating bowel movements or fiber supplements, but only 18.0% did so because they considered themselves as constipated. Also, data from a tertiary referral center in Mexico City suggests that patients with prolonged colonic transit time have lower scores in the physical component of the SF-36 compared to those with chronic constipation and a normal colonic transit time. CONCLUSIONS: Functional constipation is a very common problem in Mexico affecting mainly young women. Laxatives and other related agents are frequently used and this disorder seems to have a negative impact on quality of life.