Safe use of proton-pump inhibitors.

Proton pump inhibitors (PPIs) are one of the most commonly prescribed drug groups in developed countries. Their approved indications include gastroesophageal reflux disease, peptic ulcer disease, and prophylaxis against NSAID-induced gastroenteropathy in specific scenarios. Since their introduction into clinical practice, their usage has significantly increased, leading to concerns about possible inappropriate prescribing, which can result in a higher risk of side effects and increased economic costs. Consequently, in recent years, literature linking PPIs to various adverse effects has emerged, with some supported by robust evidence, while others are based on lower-quality evidence, requiring cautious interpretation. Among the adverse effects of PPIs, significant ones include an increased risk of fragility fractures, deficiencies in certain micronutrients such as vitamin B12 and magnesium, a higher incidence of enteric infections, especially Clostridioides difficile, complications in cirrhotic patients, and pharmacological interactions with other medications. In clinical practice, it is essential to periodically evaluate the rationale for prescribing these drugs and consider discontinuing them if there is no appropriate indication. Despite PPIs being generally safe medications, it is crucial to be aware of their potential adverse effects and appropriate indications to ensure their proper use.

Limited effectiveness with a 10-day bismuth-containing quadruple therapy (Pylera® ) in third-line recue treatment for Helicobacter pylori infection. A real-life multicenter study.

BACKGROUND: Helicobacter pylori antibiotic resistance is an increasing problem worldwide. Pylera® may be an option as salvage therapy. AIM: To assess the effectiveness, safety, and tolerance of Pylera® as a third-line in clinical practice. MATERIALS AND METHODS: This was a multicenter, observational, prospective database study in four Spanish hospitals. Consecutive H. pylori-infected individuals treated with Pylera® and a proton-pump inhibitor (PPI) were invited to participate if they had failed to respond to PPI-clarithromycin-amoxicillin as first-line and to levofloxacin-amoxicillin-PPI as second-line therapy. Eradication was tested 4-8 weeks after Pylera® using a C13 -urea breath test. Treatment-related adverse effects (TRAEs) were assessed through a questionnaire and by reviewing databases. A questionnaire on patient satisfaction was completed in the last visit. RESULTS: Of 103 subjects fulfilling the selection criteria, 101 were included in the intention-to-treat (ITT) analysis and 97 in the per-protocol (PP) analysis. A 10 day course was prescribed in all patients. Esomeprazole 40 mg b.i.d. was the most used PPI regimen (ITT=94.1%). Ninety-seven individuals (ITT=96.04%) completed more than 90% of the treatment. Overall eradication rates were ITT=80.2% (95% confidence interval [CI]: 72.3%-88.1%) and PP=84.4% (95% CI: 76.8%-91.8%). One or more TRAEs were experienced by 67.3% (95% CI: 57.7%-75.7%), all mild or moderate. TRAEs and the number of pills were the main complaints. CONCLUSION: In an area of high antibiotic resistance to H. pylori, 10-day Pylera® plus double-dose PPI emerged as an alternative as third-line therapy, although not achieving optimal eradication rates. TRAEs were common but were neither severe nor did they condition compliance.

Proton-pump inhibitors adverse effects: a review of the evidence and position statement by the Sociedad Española de Patología Digestiva.

INTRODUCTION: In the last few years a significant number of papers have related the use of proton-pump inhibitors (PPIs) to potential serious adverse effects that have resulted in social unrest. OBJECTIVE: The goal of this paper was to provide a literature review for the development of an institutional position statement by Sociedad Española de Patología Digestiva (SEPD) regarding the safety of long-term PPI use. MATERIAL AND METHODS: A comprehensive review of the literature was performed to draw conclusions based on a critical assessment of the following: a) current PPI indications; b) vitamin B12 deficiency and neurological disorders; c) magnesium deficiency; d) bone fractures; e) enteric infection and pneumonia; f) interactions with thienopyridine derivatives; e) complications in cirrhotic patients. RESULTS: Current PPI indications have remained unchanged for years now, and are well established. A general screening of vitamin B12 levels is not recommended for all patients on a PPI; however, it does seem necessary that magnesium levels be measured at therapy onset, and then monitored in subjects on other drugs that may induce hypomagnesemia. A higher risk for bone fractures is present, even though causality cannot be concluded for this association. The association between PPIs and infection with Clostridium difficile is mild to moderate, and the risk for pneumonia is low. In patients with cardiovascular risk receiving thienopyridines derivatives it is prudent to adequately consider gastrointestinal and cardiovascular risks, given the absence of definitive evidence regardin potential drug-drug interactions; if gastrointestinal risk is found to be moderate or high, effective prevention should be in place with a PPI. PPIs should be cautiously indicated in patients with decompensated cirrhosis. CONCLUSIONS: PPIs are safe drugs whose benefits outweigh their potential side effects both short-term and long-term, provided their indication, dosage, and duration are appropriate.

Consideraciones prácticas en el manejo de los inhibidores de la bomba de protones / Practical considerations in the management of proton-pump inhibitors

Los inhibidores de la bomba de protones (IBP) son uno de los principios activos más prescritos en España. En las últimas décadas se ha observado un sobreuso de estos fármacos tanto a nivel extrahospitalario como hospitalario que ha producido un aumento importante en el gasto sanitario y un incremento en el riesgo de posibles efectos adversos. Es importante que los profesionales sanitarios se ajusten a las indicaciones admitidas y a las dosis correctas para el empleo de estos medicamentos. Existen en el mercado diferentes tipos de IBP: omeprazol, pantoprazol, lansoprazol, rabeprazol y esomeprazol. El omeprazol es el más antiguo y utilizado, siendo también el más barato. Si bien en la mayoría de las indicaciones terapéuticas en las que se emplean estos medicamentos no se describen diferencias entre los distintos IBP en la curación de las enfermedades, el esomeprazol, IBP de última generación, ha demostrado mayor eficacia en la erradicación del H. pylori y en la curación de la esofagitis grave respecto al resto de IBP. En los últimos años el uso de los fármacos genéricos se ha extendido; este tipo de medicamentos presentan la misma biodisponibilidad que los medicamentos originales. En el caso de los IBP, los pocos estudios comparativos disponibles en la literatura entre los fármacos originales y los genéricos no han demostrado diferencias significativas en la eficacia clínica (AU)

Proton-pump inhibitors (PPIs) are one of the most active ingredients prescribed in Spain. In recent decades there has been an overuse of these drugs in both outpatient clinics and hospitals that has lead to a significant increase in healthcare spending and to an increase in the risk of possible side effects. It is important for health professionals to know the accepted indications and the correct doses for the use of these drugs. On the market there are different types of PPI: omeprazole, pantoprazole, lansoprazole, rabeprazole and esomeprazole. Omeprazole is the oldest and most used PPI, being also the cheapest. Although there are no important differences between PPIs in curing diseases, esomeprazole, a new-generation PPI, has proved to be more effective in eradicating H. pylori and in healing severe esophagitis compared to other PPIs. In recent years the use of generic drugs has spread; these drugs have the same bioavailability than the original drugs. In the case of PPIs, the few comparative studies available in the literature between original and generic drugs have shown no significant differences in clinical efficacy (AU)

PPIs: between overuse and underprescription when really necessary.

Hydrochloric acid gastric secretion plays, among its primary physiological foundations, a role as protective barrier against infection with external agents from the diet and also contributes to the digestion of ingested food. However, this secretion is a critical factor shared by a number of highly prevalent diseases involving the upper gastrointestinal tract. Paradigms of such conditions include gastroduodenal peptic ulcer and gastroesophageal reflux disease.

Evidencias e incertidumbres del uso clínico de los inhibidores de la bomba de protones / Evidence and uncertainties on the clinical use of proton pump inhibitors

Los inhibidores de la bomba de protones (IBP) son los fármacos más potentes y eficaces para el control de la secreción ácida gástrica y constituyen uno de los grupos farmacológicos más prescritos en todo el mundo. Estos fármacos han demostrado su eficacia y alta seguridad en la práctica clínica, y en la actualidad son el tratamiento de elección en la enfermedad ulcerosa péptica y la infección por Helicobacter pylori, la enfermedad por reflujo gastroesofágico, la gastropatía por antiinflamatorios no esteroideos y la dispepsia funcional. Sin embargo, a pesar del excelente perfil farmacológico de los IBP actuales, su rapidez de acción puede ser insuficiente en algunas enfermedades, no logran cubrir las 24 h del día de inhibición ácida y, de modo diferente según las distintas moléculas de IBP, presentan una variabilidad interindividual de eficacia antisecretora gástrica en función del polimorfismo genético de metabolización de la isoenzima CYP2C19 del CYP450. Es probable que nuevas generaciones de estos fármacos subsanen estas deficiencias (AU)

Proton pump inhibitors (PPI) are the most potent and effective drugs for the control of gastric acid secretion and constitute one of the most widely prescribed pharmacological groups worldwide. The safety and efficacy of PPI have been demonstrated in clinical practice and these drugs are currently the treatment of choice in peptic ulcer diseases, Helicobacter pylori infection, gastroesophageal reflux disease, nonsteroidal antiinflammatory drug gastropathy and functional dyspepsia. However, despite the excellent pharmacological profile of current PPI, their rapidity of action may be insufficient in some diseases, 24-hour acid inhibition is not always achieved and – to a greater or lesser extent depending on the distinct molecules of the PPI – there is interindividual variability in gastric antisecretory efficacy, depending on genetic polymorphism of CYP2C19, which could affect individual metabolism of the distinct PPI. New generations of these drugs will probably eliminate these deficiencies (AU)

[Chronic urticaria and Helicobacter pylori]. / Urticaria crónica e infección por Helicobacter pylori.

BACKGROUND AND OBJECTIVE: We intended to analyze the influence of Helicobacter pylori eradication on the clinical evolution of patients with chronic idiopathic urticaria. PATIENTS AND METHOD: The evolution of dermatological symptoms after eradication was studied in a group of 55 patients previously diagnosed with chronic idiopathic urticaria who were infected by Helicobacter pylori. RESULTS: There was a partial or complete improvement in 74.6% (CI 95%, 61-85%) of studied patients. We could not demonstrate a statistically significant influence of sex, age or endoscopic lesions on the clinical evolution of urticaria after eradication. CONCLUSIONS: These results suggest a possible usefulness of Helicobacter pylori eradication in some patients with chronic idiopathic urticaria. Controlled and randomized studies are necessary to confirm it.