Omeprazole Users Research Articles

Different effects of chronic omeprazole use on osteoporotic fractures rate in the elderly.

To investigate the potential association of chronic use of omeprazole with the occurrence of osteoporotic fractures (OF) in community-dwelling elderly subjects. The cohort consisted of community-dwelling residents aged >65 years registered with a large health maintenance organization in Israel between January 2002 and December 2016. Data were retrospectively collected from the electronic medical files on demographics, parameters known to be associated with OF, diagnoses of osteoporotic hip, wrist, and vertebral fractures, and chronic use of omeprazole (>11 prescriptions/year). Time to OF/death/end of study was calculated from the beginning of the study (2002). The risk of fractures in the chronic users of omeprazole was analyzed by multivariate Cox proportional hazard regression model. In total, 46 805 subjects were included (41% men), mean age 83.4±6.4 years, of whom 10 272 (21.9%) were chronic users of omeprazole. During 14 years of follow-up, OF were diagnosed in 414 (4.0%) omeprazole users and 1007 (2.8%) omeprazole nonusers (p < 0.001). In a Cox regression model adjusted for age and gender only, chronic use of omeprazole was associated with a 16% excess of OF. However, when parameters known to be associated with OF were entered into the multivariate Cox regression model, chronic use of omeprazole was not found to be an independent risk factor for OF, either overall (adjusted hazard ratio = 0.965, 95% confidence interval 0.86-1.08, P = .55) or specifically, in the ≥85 years age group (adjusted hazard ration = 0.780, 95% confidence interval 0.635-0.958, P < .05) in which an inverse correlation between omeprazole use and OF, was demonstrated. Chronic use of omeprazole was not associated with the occurrence of OF in elders.

Effect of Esomeprazole on serum creatinine and urea in patients with Peptic Ulcer

Peptic ulcers are best treated by proton pump inhibitors (PPIs), however, other simple gastrointestinal (GIT) disorders should be better treated by other acid neutralizing or anti-secretory agents. Unfortunately, most GIT diseases were reported to be treated by PPIs even though non-indicated cases. The reasons might include ease availability with/without prescription, reduce patient awareness, and overprescription of PPIs by the health care professionals. This study aims to highlight the effect of these drugs on the renal function test. Patients were recruited and enrolled in the study from outpatients private clinics and plasma samples were withdrawn from control healthy, esomeprazole and omeprazole users individuals. Plasma samples were frozen for further analysis, creatinine and urea test were conducted on overall samples and the results were displayed confirming significant dysfunctioning of the renal system from PPIs use. The study concluded that creatinine and urea are higher in a patient on esomeprazole than omeprazole and the control group. The study recommends general awareness of the society about regular use of these medications unless otherwise carefully required.

Type of proton-pump inhibitor and risk of iron deficiency in kidney transplant recipients - results from the TransplantLines Biobank and Cohort Study.

SummaryProton‐pump inhibitors (PPIs) have been associated with iron deficiency (ID) in kidney transplant recipients (KTRs). Gastric acid plays a pivotal role in the intestinal absorption of non‐heme iron, but the pharmacodynamics of PPIs differs in potency of acid suppression. We hypothesized that the risk of ID might be lower in KTRs using a less potent PPI. In a cohort of 724 KTRs from the TransplantLines Biobank and Cohort Study (NCT03272841), PPI use was associated with ID [odds ratio (OR) 2.02; 95% CI 1.36–2.98]. Compared with no PPI use, the point estimate of the odds ratio for risk of ID for pantoprazole (OR 1.55; 95%CI 0.78–3.10) was lower than for esomeprazole and omeprazole (3.58; 95%CI 1.73–7.40 and 1.96; 95%CI 1.31–2.94, respectively). When comparing pantoprazole users with omeprazole users on an equipotent dose (≤20 omeprazole equivalents (OE)/day) omeprazole, but not pantoprazole was associated with ID, although the lack of a significant effect of pantoprazole on the risk of ID could be caused by a lack of power. Furthermore, risk of ID was higher among users of a high PPI dose (≥ 20 OE/day) and OE as continuous variable was also independently associated with ID, indicating that risk of ID is higher while using a more potent PPI. Further investigation seems warranted to confirm whether pantoprazole leads to less ID in KTRs.

Cognition, oxidative stress and vitamin B12 levels evaluation on patients under long-term omeprazole use.

To evaluate the differences concerning cognitive performance, oxidative stress and vitamin B12 levels in omeprazole users under treatment for longer than six months. A case-control study was developed with 44 omeprazole users (OU; 81.8 % female, 66 ± 8.7 years old) and 35 nonusers (NOU; 88.6 % female, 62 ± 8.7 years old). The cognitive ability was assessed through tests approaching attention, memory and executive functions. The vitamin B12 was dosage using a chemiluminescent immunoassay and oxidative stress analysis, based on the evaluation of malondialdehyde, enzymatic activity of extracellular superoxide dismutase, glutathione peroxidase, catalase and the ferric reducing antioxidant power in plasma. A significant increase of the ferric reducing antioxidant power [omeprazole users (OU) group = 1690 µM ± 441 and nonusers (NOU) group = 1308 ± 616; P value=0.002] and a decrease on glutathione peroxidase levels [OU group = 0.534 (0.27-10.63) and NOU group = 71.86 (14.36-173.1); P value=0.006] were found on omeprazole users group, as well as differences on cognitive performance, with impairments on executive functions, automatic and attentional processing. Long-term use of omeprazole is suggested to induce an oxidative stress condition, which causes neurotoxicity and cognitive decline.

Omeprazole use and risk of chronic kidney disease evolution.

In recent years, the use of proton pump inhibitors (PPI), especially omeprazole, has been associated with development of chronic kidney disease (CKD). These drugs are widely used worldwide. Although some studies have found an association between the use of PPI and the onset of acute renal failure and CKD. This study aims to analyze the association between the continuous use of omeprazole and the progression of CKD in adult and elderly individuals. A retrospective cohort study was conducted with patients followed up at a nephrology clinic in Brazil, in 2016 and 2017. Information about clinical and sociodemographic data, health behaviors, and medication use were collected from all patients diagnosed with CKD through consultation of medical charts and the Brazilian health information system (SIS). The participants were allocated into two groups: users and non-users of omeprazole, and the progression of CKD was then evaluated for each group. In the bivariate analysis, the Mann-Whitney U test to compare the quantitative variables between groups, and the Pearson/Fisher two-tailed chi-square test to compare the categorical variables were applied. Multivariate analysis was performed using Cox regression. A total of 199 CKD patients were attended in the polyclinic, and of these, 42.7% were omeprazole users. There was a higher percentage of CKD progression in users (70.6%) compared to non-users (10.5%). The hazard ratio was 7.34 (CI: 3.94-13.71), indicating a higher risk of progression to worse stages of CKD in omeprazole users than in non-users. As for the other variables, no statistically significant difference was found between groups (p > 0.05). An association between omeprazole use and progression of CKD stage was identified, showing a higher risk of disease evolution among omeprazole users.

USO DO OMEPRAZOL: ESTUDO DESCRITIVO DE PACIENTES IDOSOS DE UMA UNIDADE DE SAÚDE DA FAMÍLIA (USF) DE RIBEIRÃO PRETO, SP, BRASIL

O primeiro inibidor da bomba de prótons (IBP) comercializado no mundo foi o omeprazol. É hoje amplamente prescrito na Atenção Básica brasileira. Estudos indicam que o uso a longo prazo pode estar relacionado a efeitos adversos importantes na qualidade de vida do paciente. Assim, o objetivo foi avaliar a prevalência e o perfil clínico de pacientes idosos em uso de omeprazol em uma Unidade de Saúde da Família (USF). Foi realizado um estudo transversal descritivo em que foram avaliados pacientes idosos, usuários de uma USF. Foram incluídos no estudo 100 pacientes idosos. Desses, 35 faziam uso do omeprazol, sendo 10 do sexo masculino e 25 do sexo feminino. A dose de 20 mg diária foi encontrada em 68,6% dos usuários, 91,4% tem prescrição por mais de doze meses e 51,4% não possuíam registro do motivo de uso do omeprazol, 17,1% tinham descrito epigastralgia como justificativa de uso. O omeprazol pode estar sendo prescrito sem uma clara indicação de uso e por tempo de tratamento prolongado, colaborando para o uso inadequado desse medicamento.

The effect of omeprazole and esomeprazole on the maintenance dose of phenprocoumon

The response to vitamin K antagonists (VKAs) is determined by many different factors like age, weight, height, vitamin K intake and genetic polymorphisms [1]. The proton pump inhibitors (PPIs) omeprazole and esomeprazole may enhance the effect of VKAs by inhibition of the hepatic metabolism of coumarins [2]. Some isolated cases have been reported of clinically significant elevated INRs in patients concomitantly using omeprazole and phenprocoumon, a VKA frequently used in Europe [3]. Practical experience suggests an interaction between omeprazole or esomeprazole and phenprocoumon, but scientific evidence is still lacking. Van Schie et al. developed a dosing algorithm including age, gender, height, weight, CYP2C9 and VKORC1 genotypes and amiodarone use and a dosing algorithm without the genotypes to predict the phenprocoumon maintenance dose [4]. Given the possibility that omeprazole use affects the stable phenprocoumon maintenance dose, we examined whether information about its use would improve the predictive value of a dosing algorithm. Data from the pre-EU-PACT study were used to study the effect of omeprazole and esomeprazole on the stable phenprocoumon maintenance dose [4]. More details about this study can be found elsewhere [4]. The main outcome measure of the present study was the mean stable phenprocoumon maintenance dose in mg day−1 in the first stable period after initiation of phenprocoumon therapy. Only patients who reached a stable dose within 1 year were included in the analyses. Multiple linear regression analysis was used to develop a genotype-guided algorithm and a non-genotype-guided algorithm to estimate the square root of the weekly phenprocoumon maintenance dose. We included the same predictive variables used by van Schie et al. [4], but added an extra variable for omeprazole or esomeprazole use. A stable maintenance dose was reached within 1 year by 597 patients. Of these, 46 patients used omeprazole and 18 patients used esomeprazole. On average, non-users required 2.27 mg (SD 0.90) phenprocoumon day−1, significantly higher than the average dose seen in both omeprazole users (1.78 mg day−1, SD 0.73, 95% CI of the difference 0.22, 0.75) and esomeprazole users (1.88 mg day−1, SD 0.52, 95% CI of the difference 0.12, 0.66)). Since the phenprocoumon dose was not significantly different between omeprazole and esomeprazole users (95% CI of the difference −0.47, 0.28), we combined them into one group for inclusion in the algorithm. Five hundred and eighty-seven phenprocoumon users were included in the analysis of the non-genotype-guided algorithm and 559 for the genotype-guided algorithm. Omeprazole/esomeprazole use significantly influenced the phenprocoumon maintenance dose in the genotype-guided algorithm (P= 0.002) and the non-genotype-guided algorithm (P= 0.001) (Table 1). The genotype-guided algorithm was as follows: Table 1 Algorithms to predict stable phenprocoumon maintenance dose SQRT (maintenance dose (mg week−1) = 2.870–0.254 (if CYP2C9*1/*2) – 0.356 (if CYP2C9*1/*3) – 0.431 (if CYP2C9*2/*2) – 0.708 (if CYP2C9*2/*3) – 0.693 (if CYP2C9*3/*3) – 0.594 (if VCORC1 CT) – 1.371 (if VCORC1 TT) – 0.015 × Age (years) + 0.034 (if female) + 0.009 × Weight (kg) + 0.011 × Height (cm) – 0.315 (if amiodarone use) – 0.234 (if omeprazole/esomeprazole use). With this genotype-guided algorithm, 56.7% of dose variation could be explained, 0.8% more than in the study of van Schie et al. [4]. With our non-genotype-guided algorithm, the predictive value was 18.9%, 1.6% more than the algorithm of van Schie et al. [4]. The information obtained in this study could help physicians determine the right phenprocoumon dose for patients. If a patient is already using omeprazole or esomeprazole when phenprocoumon treatment is started, the dosing algorithm can be used to predict the required dose. If a patient starts using omeprazole or esomeprazole during phenprocoumon treatment the dose of phenprocoumon should be lowered. This could help prevent overanticoagulation and thereby reduce the risk of bleeding events when phenprocoumon and omeprazole or esomeprazole are used simultaneously. In this study we observed a lower phenprocoumon dose requirement in omeprazole and esomeprazole users and developed a dosing algorithm using this information. We only demonstrated the effect of omeprazole and esomeprazole. An interaction between phenprocoumon and other PPIs should be investigated in future research.

Comparison of Daily Average Consumption Between Different Proton Pump Inhibitors in Patients with Gastroesophageal Reflux Disease

Purpose: Numerous randomized clinical trials have shown the benefits of proton pump inhibitors (PPIs) in patients with gastroesophageal reflux disease (GERD). Due to inadequate symptom control of once daily dosing, approximately 12-20% of patients use twice daily dosing of PPIs. The objective of this study was to compare daily average consumption (DACON) among GERD patients treated with different branded and generic PPIs. Methods: We conducted a retrospective database analysis using commercial enrollees from a large U.S. health plan from February 2008 to December 2009. Adult GERD patients with ≥1 medical claim with ICD-9 diagnosis codes 530.1, 530.10-530.12, 530.81, or 787.1, ≥1 PPI Rx claim during the identification period of February 2009 to September 2009, and continuous eligibility for 12 months before and 6 months after the index date were identified. The date of the first PPI Rx claim during the identification period was considered as the index date. DACON was defined as quantity of medication dispensed over the number of days with medication. We controlled for age, gender, region, GERD severity, plan type, pre-index Quan-Charlson comorbidity score (CCI), DACON, and costs and utilization. Results: Among 185,506 GERD patients identified, 2.3% were taking dexlansoprazole, 5.0% lansoprazole, 9.6% esomeprazole, 19.6% rabeprazole, 30.2% pantoprazole, and 33.3% omeprazole at the index date. Over half of the patients (56.47%) were branded PPI users and 43.53% (n=80,749) were generic PPI users at the index date. Patients in the branded PPI group were more likely to be younger (51.32 vs. 52.25 years, p<0.001), female (57.00% vs. 55.36%, p<0.001), reside in the southern part of the United States (57.65% vs. 48.00%, p<0.001), use point-of-service (56.54% vs. 53.06%, p<0.001) and exclusive provider organization (15.32% vs. 12.92%, p<0.001) health plans and had lower CCI (0.81 vs. 0.90, p<0.001) compared to patients in the generic PPI group. The highest DACON was among omeprazole users (1.32), followed by users of lansoprazole (1.20), rabeprazole (1.18), pantoprazole (1.16), esomeprazole (1.15) and dexlansoprazole (1.04). After risk adjustment, branded PPI users had a lower DACON (1.09 vs. 1.28, p<0.001) compared to generic PPI users. Conclusion: There were differences in DACON values between the different PPIs with dexlansoprazole showing the lowest and omeprazole showing the highest DACON. Branded PPI users showed lower DACON compared to generic PPI. The potential impact of reduced DACON on patient adherence, length of treatment and total and GERD-related healthcare resource utilization and costs requires further evaluation. Disclosure: Dr Mody - Employee: Takeda Pharmaceuticals International, Inc. All other authors were contracted research vendors for this study for Takeda Pharmaceuticals international, Inc. This research was supported by an industry grant from Takeda Pharmaceuticals International, Inc. funded this project.

El Cóndor Pasa: Reflections on the Condor Trial

El Cóndor Pasa: Reflections on the Condor Trial

Increase in Vertebral Fracture Risk in Postmenopausal Women Using Omeprazole

Proton pump inhibitors are taken by millions of patients for prevention and treatment of gastroesophageal diseases. Case-control studies have suggested that use of omeprazole is associated with an increased risk of hip fractures. The aim of this prospective study was to assess the risk of vertebral fractures in postmenopausal women using omeprazole. We studied 1,211 postmenopausal women enrolled in the Osteoporosis and Ultrasound Study from the general population. Information on omeprazole and other risk factors for fractures including prevalent fractures and bone mineral density was obtained at baseline. Vertebral fractures were assessed on X-rays obtained at baseline and at the end of the 6-year follow-up and analyzed centrally. At baseline, 5% of this population was using omeprazole. Age-adjusted rates for vertebral fractures were 1.89 and 0.60 for 100 person-years for omeprazole users and nonusers, respectively (P = 0.009). In the multivariate analysis, omeprazole use was a significant and independent predictor of vertebral fractures (RR = 3.50, 95% CI 1.14-8.44). The other predictors were age higher than 65 years (RR = 2.34, 95% CI 1.02-5.34), prevalent vertebral fractures (RR = 3.62, 95% CI 1.63-8.08), and lumbar spine T score </= -2.5 (RR = 2.38, 95% CI 1.03-5.49). Omeprazole use is associated with an increased risk of vertebral fractures in postmenopausal women. Further studies are required to determine the mechanism of the association between the underlying gastric disease, omeprazole use, and risk of osteoporotic fractures.

The risk of acute pancreatitis associated with acid-suppressing drugs.

To assess the risk of acute pancreatitis associated with use of acid-suppressing drugs. We conducted a retrospective cohort study with a nested case-control design within the General Practice Research Database (GPRD) in the United Kingdom. The cohort included 180 178 persons aged 20-74 years, who had received at least one prescription of cimetidine, famotidine, nizatidine, ranitidine, lansoprazole, or omeprazole from January 1992 to September 1997 and who did not have major risk factors for pancreatic diseases. Patients with a computerized medical history compatible with idiopathic acute pancreatitis were validated through review of medical records. For the nested case-control analysis 1000 controls were randomly selected from the study population. We identified 88 potential cases of idiopathic acute pancreatitis. Medical records were available for 86. After review of these records 36 cases of acute pancreatitis were confirmed. Seven cases occurred during nonuse, corresponding to a background incidence rate (IR) of 4.4/100 000 person-years (PY). Six cases occurred during current use of ranitidine (IR 10.5/100 000 PY), five patients were current users of cimetidine (IR 13.9/100 000 PY), and three were current users of omeprazole (IR 7.8/100 000 PY). There were no cases among current users of famotidine, lansoprazole, or nizatidine. Relative risk (RR) compared with nonuse and corrected for age, gender, calendar year and use of medication known to be associated with acute pancreatitis was 1.3 (95% CI: 0.4,4.1) for ranitidine, 2.1 (95% CI: 0.6,7.2) for cimetidine, and 1.1 (95% CI: 0.3,4.6) for omeprazole. The results of this study do not support an association between acute pancreatitis and the use of acid-suppressing drugs, although a substantial increase in risk cannot be excluded with confidence.

Appropriateness of omeprazole prescribing in Quebec's senior population.

Prescribing omeprazole for the treatment of digestive disorders accounts for an important part of the costs in Quebec's drug benefit plan. In July 1993, the Quebec drug program listed omeprazole, with restriction, in its formulary. On January 1, 1994, this restriction was lifted; since then, omeprazole has been listed in the regular provincial formulary. To describe the appropriateness of initial omeprazole prescribing in the ambulatory senior population of Quebec in the 27 months after being listed without restriction. A retrospective population-based cohort study was performed using prescription and medical services claims databases of the Quebec drug program. Data were extracted for elderly patients who received their first omeprazole prescription between July 1, 1994 and March 31, 1996. Among the 47,140 first-time users of omeprazole identified, 7516 (15.9%) had had an endoscopy in the previous six months, 2308 (4.9%) were given an antimicrobial agent and omeprazole simultaneously, and 22,730 (48.2%) received omeprazole after prior use of an H2 receptor antagonist (H2RA) or a prokinetic drug. A total of 26,525 (56.3%) first-time users were prescribed omeprazole based on at least one of the three criteria listed above. Among these users, 729 (2.8%) received an H2RA concurrently with omeprazole. Altogether, 25,796 (54.7%) first-time users received omeprazole appropriately. Although reimbursement for omeprazole prescriptions has not been restricted in Quebec since January 1, 1994, it was prescribed appropriately for elderly patients in the majority of cases studied.

Ocular disorders in users of H2 antagonists and of omeprazole

We have conducted a cohort study of users of omeprazole and H2 antagonists in Italy to investigate whether the peroral use of these drugs may be associated with an increased incidence of ocular disorders leading to loss of vision. We have used the Sistema Informativo Sanitario Regionale (SISR database) in Friuli-Venezia-Giulia to identify all subjects who received at least one prescription for cimetidine, famotidine, niperotidine, nizatidine, omeprazole, ranitidine or roxatidine between 1 January 1991 and 31 December 1994. We have identified all hospital admissions for serious vascular or inflammatory ocular disorders following any such prescription, reviewed and validated all medical records. There were 71,108 users of any of the study drugs, contributing a total of 101,827 person years of observation. Seven cases of serious eye disorders were identified, giving an annual incidence rate of 7/100,000 persons. By comparison to non-users, the incidence rate ratio for current users of all of the study drugs together was 0, with a 95% confidence interval of 0 to 2·1. By comparison to non-users, the incidence rate ratio for past users was 0·47 (95% CI: 0·06–2·4). Our data are consistent with previous studies and add weight to the general impression of the ocular safety of these drugs. © 1998 John Wiley & Sons, Ltd.

Ocular disorders in users of H2 antagonists and of omeprazole.

We have conducted a cohort study of users of omeprazole and H(2) antagonists in Italy to investigate whether the peroral use of these drugs may be associated with an increased incidence of ocular disorders leading to loss of vision. We have used the Sistema Informativo Sanitario Regionale (SISR database) in Friuli-Venezia-Giulia to identify all subjects who received at least one prescription for cimetidine, famotidine, niperotidine, nizatidine, omeprazole, ranitidine or roxatidine between 1 January 1991 and 31 December 1994. We have identified all hospital admissions for serious vascular or inflammatory ocular disorders following any such prescription, reviewed and validated all medical records. There were 71,108 users of any of the study drugs, contributing a total of 101,827 person years of observation. Seven cases of serious eye disorders were identified, giving an annual incidence rate of 7/100,000 persons. By comparison to non-users, the incidence rate ratio for current users of all of the study drugs together was 0, with a 95% confidence interval of 0 to 2.1. By comparison to non-users, the incidence rate ratio for past users was 0.47 (95% CI: 0.06-2.4). Our data are consistent with previous studies and add weight to the general impression of the ocular safety of these drugs.