Comparación del efecto de omeprazol como monoterapia y su combinación con bicarbonato de sodio en el tratamiento de la pirosis moderada a severa: ensayo clínico controlado, aleatorizado y doble ciego / Comparison of the effect of omeprazole monotherapy and its combination with sodium bicarbonate in the treatment of moderate to severe heartburn: a double-blind, randomized controlled clinical trial

Heartburn occurs in 75% of patients with digestive discomfort of any origin and is one of the main symptoms of gastroesophageal reflux disease. Treatment focuses on lifestyle modification and symptomatology management with various drugs; when heartburn is moderate to severe, a proton pump inhibitor is more suitable. Omeprazole (OMZ) combined with sodium bicarbonate (BC) has demonstrated significant and sustained suppression of acid secretion. The objective was to compare the effect of sequential OMZ/BC therapy compared to OMZ monotherapy for the improvement of heartburn in Mexican individuals. The study was a double-blind, randomized, controlled, multicenter clinical study including 277 subjects with moderate to severe heartburn. Patients received 7 days of OMZ/BC and 7 days of OMZ (OMZ/BC7) or 14 days of OMZ (OMZ14). The primary endpoint was defined as the change in the number of days a week that the patient has heartburn, it was evaluated at 14 days. Both treatments reduced time (days) with heartburn by less than 4 days (OMZ14 3.9 vs. 4.2 days OMZ/BC7), as well as duration, number of events and intensity of heartburn. The treatments improved the quality of life, and the control of the symptoms. The proportion of adverse events was lower with OMZ/BC. The non-inferiority of OMZ/BC7 with respect to OMZ14 was verified.

La pirosis se presenta en el 75% de los pacientes con molestias digestivas de cualquier origen y es uno de los principales síntomas de la enfermedad por reflujo gastroesofágico. El tratamiento se enfoca en la modificación del estilo de vida y el manejo de la sintomatología con diversos fármacos; cuando la pirosis es moderada a severa, un inhibidor de la bomba de protones es más adecuado. El omeprazol (OMZ) combinado con bicarbonato de sodio (BC) ha demostrado supresión significativa y sostenida de la secreción ácida. El objetivo fue comparar el efecto de la terapia secuencial de OMZ/BC en comparación con el tratamiento continuo de OMZ para la mejoría de la pirosis en individuos mexicanos. Estudio clínico multicéntrico, doble ciego, controlado, aleatorizado que incluyó 277 sujetos con pirosis moderada a severa. Los pacientes recibieron 7 días de OMZ/BC y 7 días de OMZ (OMZ/BC7) o 14 días de OMZ (OMZ14). La variable primaria fue definida como el cambio del número de días a la semana que el paciente presenta pirosis, se evaluó a los 14 días. Ambos tratamientos redujeron los días con pirosis en menos 4 días (OMZ14 3,9 vs. 4,2 días OMZ/BC7), así como la duración, el número de eventos e intensidad de la pirosis. Los tratamientos mejoraron los indicadores de calidad de vida, y el control del padecimiento. La proporción de eventos adversos fue menor con OMZ/BC. Se comprobó la no-inferioridad de OMZ/BC7 respecto OMZ14.

Hipoparatireoidismo secundário ao uso prolongado de omeprazol em um cão: relato de caso / Secondary hypoparathyroidism to omeprazole prolonged use in a dog: case report

O hipoparatireoidismo, quer seja primário ou secundário, é uma doença rara em cães, causada pela diminuição da secreção de paratormônio pelas paratireoides, que leva a sinais clínicos resultantes da hipocalcemia. O omeprazol vem sendo cada vez mais utilizado na medicina veterinária visando à diminuição na produção de líquor, mas existem poucos estudos sobre os efeitos colaterais relacionados ao uso crônico dessa medicação. Relata-se o caso de um cão macho da raça Yorkshire Terrier, com quatro anos de idade, com sinais clínicos de dor, sendo verificada calcificação em pelve e divertículo renal. Segundo o proprietário, o cão fazia uso de omeprazol há mais de dois anos devido ao histórico de hidrocefalia. Os exames laboratoriais evidenciaram anemia microcítica hipocrômica, hipocalemia, hiperfosfatemia, hipocalcemia, hipomagnesemia e hipercalciúria. A dosagem do paratormônio sérico confirmou o hipoparatireoidismo. Após a suspensão do omeprazol, as alterações encontradas nos exames se normalizaram, confirmando que a causa do hipoparatireoidismo era o uso crônico da medicação.(AU)

Primary or secondary hypoparathyroidism is a rare disease in dogs caused by the decreased secretion of parathormone from the parathyroid glands, leading to clinical signs of hypocalcemia. Omeprazole has been increasingly used in veterinary medicine in order to reduce the production of cerebrospinal fluid, but there are few reports of side effects related to its chronic use. We report a case of a four-year-old male Yorkshire terrier with clinical signs of pain, calcification in the pelvis and renal diverticulum. According to the owner, the dog had been receiving omeprazole for over 2 years because of the history of hydrocephalus. Hematological exams revealed hypochromic microcytic anemia, hypokalemia, hyperphosphatemia, hypocalcemia, hypomagnesemia besides hypercalciuria. The determination of serum parathyroid hormone concentrations confirmed hypoparathyroidism. After interrupting omeprazole, the altered features on the exams returned to normal values, confirming that the cause of hypoparathyroidism was the chronic use of the drug.(AU)

Perfil sociodemográfico e clínico de idosos usuários crônicos de omeprazol na rede básica de saúde / Sociodemographic and clinical profile of elderly people chronic users of omeprazole attending the basic health network / Perfil sociodemográfico y clínico de los ancianos usuarios crônicos de omeprazol em la red básica de salud

Objetivo: Descrever o perfil sociodemográfico e clínico de idosos usuários crônicos de omeprazol. Método: Trata-se de um estudo transversal com usuários com idade superior a 60 anos, que retiraram o omeprazol na Farmácia Pública de Panambi/RS. Resultados: Participaram da pesquisa sessenta idosos, com idade média de 67,90 ±5,6 anos. Duas interações graves foram identificadas envolvendo citalopram e clopidogrel. Observou-se a presença nas prescrições de medicamentos que tem a sua absorção alterada pelo uso concomitante com o omeprazol como captopril (25%) e enalapril (16,7%). Conclusão: Dessa forma, evidenciou-se uma população suscetível a riscos que necessita de acompanhamento farmacêutico

Objective: To describe the sociodemographic and clinical profile of elderly chronic omeprazole users. Method: This is a cross-sectional study. Patients aged 60, from the Public Pharmacy of the city of Panambi / RS. Results: A total of 60 elderly chronic omeprazole users participated in the study with an average of 67.90 ± 5.6 years of age. Two serious interactions were identified involving citalopram and clopidogrel. There was the presence in the prescription of drugs that have their absorption altered by concomitant use of omeprazole as captopril (25%) and enalapril (16.7%). Conclusion: Thus, we highlight that there is a population susceptible to risks that needs pharmaceutical monitoring

Objetivo: Describir el perfil sociodemográfico y clínico de los ancianos usuarios crónicos de omeprazol. Método: Es un estudio transversal descriptivo cuantitativo. Participaron en el estudio pacientes con edad igual o mayor de 60 años, usuarios crónicos de omeprazol, y que acudieron al medicamento en la Farmacia Publica de la cuidad de Panambi/RS. Resultados: Participaron de la investigación 60 ancianos 51,7% del sexo femenino, con edad media de 67,90 ±5,6 años, 81,7% relataran alguna comorbilidad, siendo la más prevalente la hipertensión arterial sistémica (61,7%). Los medicamentos que actúan en el tracto alimentar y metabólico fueron los más frecuentes. Se identificaron dos graves interacciones relacionado al citalopram (8,4%) y clopidogrel (1,7%). Se observó en las prescripciones la presencia de medicamentos cuya absorción es alterada por el uso concomitante con el omeprazol, como el captopril (25%) y enalapril (16,7%). Conclusión: De esta forma, se ha evidenciado una populación susceptible a los riesgos y que necesita de acompañamiento farmacéutico

Safety assessment of omeprazole use: a review

ABSTRACT BACKGROUND: Risks regarding hospital admission due to adverse drug reactions and drug interactions from use of omeprazole have been reported. The question guiding the present review was "Which adverse events occur in patients using omeprazole in a Food and Drug Administration-approved and/or off-label manner?" It was also proposed to evaluate the safety of use of omeprazole. DESIGN AND SETTING: Qualitative narrative review with critical evaluation, in a public university. METHODS: The PubMed, SCOPUS, LILACS, SciELO, EMBASE and EBSCO databases were searched on July 31, 2018. Studies evaluating adverse events were screened. RESULTS: 72 articles were included, among which 58 reported on adverse drug events (47, adverse drug reactions; 5, drug interactions; and 6, situations of ineffectiveness). 28 adverse drug reactions not described in compendia and drug leaflets were described in these studies: myocardial infarction (6); stroke (2); spontaneous abortion (1); proliferative changes (1); chills (1); heart failure (1); thrombosis (2); and dementia (1), among others. Severe adverse reactions, for instance cardiac problems, Steven-Johnson syndrome and proliferative changes, were identified. The antiplatelet effects of drugs such as clopidogrel, in patients who underwent heart-related surgery, increased the risk of developing cardiac problems, such as cardiovascular death, myocardial infarction and stroke. In newly transplanted patients, decreased absorption of mycophenolate mofetil occurred, thus leading to rejection of transplanted organs. CONCLUSION: Use of omeprazole should be monitored primarily in patients with heart disorders using antiplatelet agents concomitantly, and in newly transplanted patients using mycophenolic acid, in order to avoid serious adverse reactions.

Um ensaio randomizado duplo-cego e controlado por placebo com probióticos em casos de supercrescimento bacteriano no intestino delgado em crianças tratadas com omeprazol / A double-blind placebo-controlled randomized trial on probiotics in small bowel bacterial overgrowth in children treated with omeprazole

OBJETIVO: Avaliar a incidência de SBID em crianças tratadas com omeprazol e testar se os probióticos influenciam essa incidência. MÉTODOS: Um ensaio duplo-cego controlado por placebo foi realizado em 70 crianças tratadas oralmente, durante 4 semanas, com 20 mg de omeprazol por dia. Desses, 36 indivíduos receberam diária e simultaneamente Lactobacillus rhamnosus R0011 (1,9 x 10(9) cfu) e Lactobacillus acidophillus R0052 (0,1 x 10(9) cfu) (grupo probiótico), enquanto 34 receberam placebo (grupo placebo). O diagnóstico de SBID teve como base o desenvolvimento de sintomas sugestivos em combinação com um teste respiratório com glicose positivo. RESULTADOS: Após um mês de tratamento com IBP, 30% (21/70) apresentaram um teste respiratório positivo sugerindo SBID; desses, 62% foram sintomáticos. Cinco crianças desenvolveram sintomas parecidos com os de SBID, mas apresentaram um teste respiratório negativo; 44 (63%) não apresentavam sintomas e tiveram teste respiratório negativo. Não houve diferença na incidência de testes respiratórios positivos no grupo probiótico em comparação ao grupo placebo (33% em comparação a 26,5%; p: 0,13). CONCLUSÕES: Como houve sintomas sugestivos de SBID em 26% das crianças tratadas com IBP e o teste respiratório com glicose deu resultados anormais em 72% delas, esse efeito colateral deve ser levado em consideração com mais frequência. O probiótico testado não reduziu o risco de desenvolver SBID.

OBJECTIVE:To evaluate the incidence of small bowel bacterial overgrowth (SBBO) in children treated with omeprazole, and to test whether probiotics influence the incidence. METHODS: A double-blinded, placebo-controlled trial was performed in 70 children treated orally during four weeks with 20 mg omeprazole per day. Lactobacillus rhamnosus R0011 (1.9 x 10(9) cfu) and Lactobacillus acidophillus R0052 (0.1 x 10(9) cfu) were simultaneously given daily to 36 subjects (probiotic group), while 34 subjects received placebo (placebo group). The diagnosis of SBBO was based on the development of suggestive symptoms, in combination with a positive glucose breath test. RESULTS: After one month of proton pump inhibitor (PPI) treatment, 30% (21/70) had a positive breath test suggesting SBBO; of these 62% were symptomatic. Five children developed SBBO-like symptoms, but had a negative breath test; and 44 (63%) were symptom free and had a negative breath test. There was no difference in the incidence of positive breath tests in the probiotic versus the placebo group (33% vs 26.5%; p = 0.13). CONCLUSIONS: Since symptoms suggesting SBBO developed in 26% of PPI-treated children, and since the glucose breath test was abnormal in 72% of these, this side-effect should be more frequently considered. The probiotic tested did not decrease the risk to develop SBBO.

Omeprazol y clopidogrel asociado a trombosis de stent / Omeprazole and Clopidogrel associated to stent thrombosis

El clopidogrel es un fármaco empleado en la prevención de complicaciones aterotrombóticas en pacientes que han sufrido infarto de miocardio, así como en terapia combinada con el ácido acetilsalicílico en pacientes que les será colocado stent tras angioplastia transluminar percutánea, por lo cual debe tomarse en cuenta cuando se asocia con omeprazol por su efecto inhibitorio antiagregante del clopidogrel. Se presentó un caso de trombosis aguda de stent como consecuencia de la interacción entre estos medicamentos

Clopidogrel is a drug which is used in the prevention of atherothombotic complications in patients that have suffered from myocardial infarction and in the combined therapy with the acetylsalcylic acid in patients to whom a stent after percutaneous transluminal coronary angioplasty has been placed. The antiaggregant inhibition effect of clopidogrel should be kept in mind when it is associated to omeprazol. Here, we present a clinical case about acute stent thrombosis as a consequence of the interaction of these drugs

Penfigoide ampollar por fármacos: entidad subdiagnosticada? / Drug-Induced Bullous Pemphigoid: an Underdiagnosaed Entity?

El penfigoide ampollar (PA) es una enfermedad infrecuente, de curso crónico y benigno, que aparece en personas de edad avanzada y se caracteriza por la presencia de ampollas subepidérmicas.En términos generales, el diagnóstico de las enfermedades ampollares se basa en las manifestaciones clínicas, los hallazgos histopatológicos y la inmunofluorescencia directa. Si bien la ausencia de alguno de estos métodos puede dificultar el mismo, una adecuada correlación clínico-patológica permite, en la mayoría de los casos, arribar al diagnóstico y realizar el tratamiento apropiado. El PA puede ser causado por fármacos y produce cuadros clínicos similares al PA idiopático. A continuación se presentan dos casos con diagnóstico de penfigoide ampollar por fármacos.

Bullous Pemphigoid is a chronic, infrequent benign disease of the elderly, characterized by the presenceof subepidermal bullae. Diagnosis is based on clinical, histopathological and direct immunofluorescencefindings. Though the absence of any of them hampers the diagnosis, a correct clinico-pathologic correlation is necessary to make the appropriate treatment. Drug induced-BullousPemphigoid presents with identical clinical features as those of the Idiopathic Bullous Pemphigoid.We present two patients with drug-induced Bullous Pemphigoid.

Esomeprazole : un isomere de l'Omeprazole; qui n'apporte rien de nouveau

N. A.

Spontaneous Resolution of Multiple Fundic Gland Polyps after Cessation of Treatment with Omeprazole / 대한소화기학회지

Fundic gland polyps (FGPs) are the most common type of gastric polyps, found primarily in the fundus and body of stomach. Long term use of proton pump inhibitor (PPI) is known to be associated with certain histological changes of the normal gastric mucosa including parietal cell hyperplasia and fundic gland cysts. We experienced a patient who showed spontaneous resolution of multiple FGPs after the cessation of omeprazole. Two years ago, the patient showed only endoscopically confirmed erosive esophagitis without FGPs. Multiple FGPs developed one year after the use of omeprazole and spontaneously disappeared with the cessation of omeprazole.

Experimental model in the qualitative and quantitative assessment of non-Helicobacter gastric microflora under proton pump inhibitors action / Modelo experimental na avaliação qualitativa e quantitativa da microflora gástrica não-Helicobacter sob ação de inibidores de bomba de próton

PURPOSE: To evaluate models of gastric material collection from Wistar rats with and without using proton pump inhibitors(PPIs). METHODS: Twenty-four rats underwent intraperitoneal omeprazol treatment, and other 12 received similar treatment with 0.9 percent saline. All animals underwent collection of gastric material samples, after stomach removal, by either biopsies, or aspirates, or swabs. Samples were bacteriologically processed in order to identify species and strains. Values are described as natural logarithm of colony former units per mL [Ln(CFU/mL)]. Kruskal-Wallis and Mann-Whitney non-parametric tests were used, and p<0.05 was set as statistically significant. RESULTS: Significant difference was not seen for Ln (UFC/mL) values among the three methods of collection irrespective of using or not omeprazol. Also, significant difference was not seen in Ln (UFC/mL) values when comparing a method with each others, either using omeprazol or placebo. A significant increase of bacteria strains occurred when PPI was used, and this was seen on the three ways of collection, mainly in biopsy and swab. CONCLUSION: No difference occurred among the three methods of collecting bacteria samples from stomachs of rats, either when using placebo or omeprazol. A remarkable change is seen on animals bacterial microflora when PPIs are used, and bacteria are better identified when swab and biopsy are used.

OBJETIVO: Avaliar modelos de coleta de material gástrico de ratos da linhagem Wistar, com e sem o uso de inibidores de bomba de próton (IBPs). MÉTODOS: 24 ratos foram submetidos a tratamento com omeprazol intraperitoneal e 12 outros ratos receberam tratamento semelhante com solução salina a 0,9 por cento. Os animais foram submetidos a coleta de amostras de material gástrico, após retirada do estômago, utilizando-se de biópsias, aspirados ou swabs. Os materiais obtidos foram processados bacteriologicamente para identificação de espécimes quanto ao gênero. Os valores são descritos em logaritmo natural das unidades formadoras de colônias por mL [Ln(UFC/mL)]. Utilizou-se os testes não-paramétricos de Kruskal-Wallis e Mann-Whitney, considerando-se p<0,05 como estatisticamente significativo. RESULTADOS: Não se observou diferença significativa da quantidade de Ln(UFC/mL) entre os três métodos de coleta, independente do uso de omeprazol. Também não se observou diferença significativa de Ln(UFC/mL) ao comparar-se os métodos individualmente entre si nas condições de uso de omeprazol ou placebo. Houve aumento significativo da variedade de gêneros de bactérias com o uso de IBP, nos 3 métodos de coleta, sendo isto mais perceptível na biópsia e swab. CONCLUSÃO: Não houve diferença entre os três métodos de coleta de amostras bacterianas de estômago de ratos, tanto em uso de placebo quanto em uso de omeprazol. Nota-se uma mudança evidente da microflora bacteriana nos animais em uso de IBPs, sendo melhor identificado pelos métodos de swab e biópsia.

An open non-comparative clinical study for the evaluation of safety and efficacy of esomeprazole in patients of reflux oesophagitis in Indian population.

The proton pump inhibitors have consistently been shown to be far more effective than the others are in gastro-oesophageal reflux disease (GERD) as proton pump inhibitors (PPIs) block the final and rate-limiting step of parietal acid production. The primary objective of the study was to assess the efficacy and tolerability of esomeprazole 40 mg given once a day for 4 weeks in patients with reflux oesophagitis. An open, non-comparative study was done with 103 patients in 4 centres with endoscopic erosive oesophagitis. Symptoms of reflux oesophagitis such as heartburn/retrosternal pain and regurgitation recorded on a 4-point scale, dysphagia being marked as present or absent. Oesophagitis was graded as 5-point scale. There was a significant decrease in mean score of heartburn (60.8% and 86%), retrosternal pain (60.84% and 86.75%), mean score of regurgitation (65% and 90%) at second and fourth week respectively. Global assessment of overall symptoms by patients showed complete resolution of symptoms in 86.4% patients at week 4. At the end of treatment 93 out of 103 patients showed complete healing, 13.6% of total cases had side effects. Esomeprazole was found effective and safe in the treatment of GERD.

Alteraçoes no teste ultra-rápido da urease e no exame anatomopatológico para Helicobacter pylori induzidas por drogas anti-secretoras / Changes in ultrarapid urease test and histopathological examination for Helicobacter pylori by antisecretory drugs

One of the major problems when evaluating dyspeptic patients at public hospitals is the large interval between the consultation and the endoscopy, leading to the prescription of antisecretory drugs, what can be responsible for false results on examinations. AIM: To evaluate changes in ultrarapid urease test and histopathological examination for Helicobacter pylori by antisecretory drugs. METHODS: In a prospective double-blind study, 50 patients with dyspeptic complaints and endoscopic diagnosis of peptic ulcer, erosive gastritis, esophagitis or duodenitis, with a positive urease test, were randomized to a 7-day course of treatment with either omeprazole 20 mg or ranitidine 300 mg a day. Before and after treatment, two biopsy specimens each were obtained from the antrum and corpus and an ultrarapid urease test and a histopathological examination for Helicobacter pylori were performed. RESULTS: There were no significant changes in the results of ultrarapid urease test and histopathological examination for Helicobacter pylori after treatment with ranitidine. With omeprazole, we observed a decrease in positive results in ultrarapid urease test and histopathological examination for Helicobacter pylori in the antrum, but not in the corpus. CONCLUSION: Omeprazole, used for 7 days, can lead to negative results in ultrarapid urease test and histopathological examination for Helicobacter pylori in the antrum, and should not be employed in patients before the endoscopy is performed.

Esophageal candidiasis following omeprazole therapy: a report of two cases.

Esophageal candidiasis was diagnosed at endoscopy in two patients receiving omeprazole therapy. There was no clinical evidence of immunosuppression or any obstructive lesion in the esophagus. There was prompt response of oral ketoconazole. These cases suggest that marked acid reduction may predispose to esophageal candidial infection.

Acidosis metabólica con el uso simultaneo de acetazolamida y omeprazol / Metabolic acidosis with the use simultaneous of acetazolamide and omeprazole

Se describe un caso donde la asociación medicamentosa estuvo acompañada de acidosis metabólica, que persistió con la omisión de la primera, y desapareció de inmediato al omitir el Omeprazol. Se destaca esta interacción de drogas. En la revisión bibliográfica no se encontró caso similar

Enfermedad ulcerosa clorhidropéptica no complicada. Perspectivas y praxis terapéuticas / Clorhydropeptic ulcerous disease without complications: Therapeutic perspective and praxis

La mayoría de las úlceras clorhidropéptica cicatriza cuando se reduce adecuadamente la acción agresora ácida durante una fracción de las 24 horas del día: (a) neutralizando en el lumen de la secreción; (b) actuando sobre receptores en las membranas de las células parietales. Los antagonistas del receptor-2 de la histmina en dosis nocturna única reducen el tiempo total de cicatrización de 90 por ciento de las úlceras duodenales y gástricas a 6 y 8 semanas promediales, respectivamente. La vida media de eliminación es corta, no se acumulan y los efectos colaterales, cuya incidencia real con dosis habituales es muy baja, son reversibles. Los antiácidos ( hidróxido de aluminio ) y bloquedores del receptor-1 de la muscarina ( pirenzepina ) son alternativas de segunda línea en la estrategia terapeútica general. Omeprazol, un bloqueador de la bomba de protones, se acumula intracelularmente y alcanza niveles de inhibición casi total; por ello mismo se restrige su uso a determinados problemas clínicos graves y sólo durante lapsos breves. Bismuto coloidal y sucralfato se adhieren a la base de la úlcera y promueven su curación eficazmente. Prostaglandina E2 y sus análogos combinan la acción antisecretora con la " citoprotección " directa: su indicación principal es la prevención de recurrencias de lesiones gástricas en pacientes bajo tratamiento obligado con anti-inflamatorios no esteroideos. Dosis moderadas de bloqueadores del receptor H2 durante periodos hasta de 2 años disminuyen apreciablemente las recurrencias de la enfermedad ulcerosa común. El tratamiento quirúrgico es apreciable a casos precisos