Proton pump inhibitors (PPIs) are recommended as first line treatments for gastroesophageal reflux disease (GERD). Failure to PPIs has been mentioned as a problem in pharmacotherapy of GERD. The present study compared the symptom relief, quality of life (QoL) and adverse drug reactions (ADRs) of omeprazole plus buccal buspirone with that of omeprazole alone. This was a prospective, randomized trial between buccal buspirone (10 mg/d) plus omeprazole (20 mg/d) and omeprazole (20 mg/d) plus placebo administered for 4 weeks to patients with GERD symptoms. Patients who had GERD symptoms enrolled in this study. 67 patients were randomly assigned to either the buspirone plus omeprazole group (n = 33) or the placebo plus omeprazole group (n = 34). Finally, 58 patients completed the study (29 in each group). Treatment response rates in each drug group were evaluated according to the Frequency Scale for the Symptoms of GERD (FFSG). The QoL and ADRs have been also evaluated too. The treatment score rates for symptom relief according to the FFSG were 7. 13 ± 5. 13 in the buspirone group and 15. 34 ± 8. 17 in the placebo group. Regarding FFSG score, there is a significant difference between the groups (p < 0. 0001). QoL were 6. 86 ± 6. 65 and 27. 2 ± 20. 95 in placebo and buspirone group, respectively after four weeks and there is a significant difference in two groups ( p < 0. 0001). The total incidence of ADRs were similar in the buspirone and placebo groups (p = 0. 36). A combination of buccal buspirone plus omeprazole may be a more effective treatment for GERD than omeprazole alone.

Aim: To assess the effects of omeprazole on the human cardiovascular system is the main aim of this study. Background: Omeprazole as a proton pump inhibitor is widely consumed to inhibit gastric acid secretion. Methods: Gene expression profiles of “ human coronary artery endothelial cells” in the absence and presence of omeprazole were downloaded from the Gene Expression Omnibus (GEO) database. The differentially expressed genes (DEGs) interacted as an interactome, and the hub nodes are determined. The DEGs were enriched via gene ontology (GO) analysis. The critical hubs were identified based on the GO findings. Results: Among 103 queried DEGs, 61 individuals were included in the main connected component. CTNNB1, HNRNPA1, SRSF4, TRA2A, SFPQ, and RBM5 genes were identified as critical hub genes. Six clusters of biological terms were introduced as deregulated elements in the presence of omeprazole. Conclusion: In conclusion, long-term consumption of omeprazole may be accompanied with undesirable effects, however more evidence is required.

Omeprazole, a proton pump inhibitor, effectively suppresses the gastric acid secretion in the parietal cells of stomach. Pharmacokinetics and relative bioavailability of generic products of omeprazole were compared with innovator product, Losec. Twelve healthy adult volunteers participated in the study which was conducted according to a randomized, open-label single dose Latin square cross over design. The preparations were compared using area under the plasma concentration – time curve (AUC), peak plasma concentration (Cmax), and time to reach peak plasma concentration (tmax). The two generic capsules proved to be bioequivalent with brand-name omeprazole with regard to the pharmacokinetic parameters Cmax, AUC0-t, AUC0-inf and tmax. Moreover the parametric confidence intervals (90%) for the ratio of the Cmax, AUC0-8 and AUC0-∞ values lie between 0.8-1.2. The test formulations were found bioequivalent to the reference formulation by the one-way ANOVA test procedure. On the basis of these results, the 3 formulations were considered to be bioequivalent. Two subjects demonstrated increase in AUCs and high Cmax after administration of either product which may attribute to the ethnic disposition of omeprazole in these subjects.

Previous studies have reported the efficacy of baclofen in the treatment of Gastroesophageal Reflux Diseases (GERD). The objective of present study is to evaluatethe effect of co-administration of omeprazole 20 mg/d plus sustained Release baclofen (SR baclofen) vs. omeprazole 20 mg/d plus placebo on alleviation of symptoms in patients with a diagnosis of GERD. A prospective, double blind, placebo controlled trial included 60 patients with diagnosis of GERD have been done. Patients were randomly selected to receive either SR baclofen or a placebo in addition to omeprazole 20 mg/d for a period of 2 weeks. Patients were questioned regarding heartburn, regurgitation, chest pain and hoarseness at the base line and after 2 weeks. All patients tolerated the medications and no patients failed to complete the study due to adverse drug reactions. A total of 53 patients completed the study, 25 in SR baclofen and 28 in placebo group. After 2 weeks, 1 patient (4%) in SR baclofen group reported heartburn and regurgitation. However 13 (46.4%) and 15 (53.6%) of patients in the placebo group had heartburn and regurgitation respectively. The analysis of the data shows that there is a significant difference between the two groups in heartburn and regurgitation (p<0.0001, p<0.0001 respectively). Statistical analysis revealed a significant difference in two groups regarding total GERD score (p<0.0001). The results of the present study suggest that a combination of SR baclofen and omeprazole may be a more effective treatment for heartburn and regurgitation than omeprazole alone.

Background: Omeprazole is metabolized predominantly by CYP2C19, a polymorphically expressed enzymes that show marked interindividual and interethnic variation. These variations cause a substantial differences that have been reported in the pharmacokinetics of omeprazole. The aim of the present study was to evaluate the pharmacokinetic parameters of omeprazole in a random Iranian population.Methods: From the 20 subjects, only 17 healthy unrelated individuals of either sex (9 females age range 22-24 years) participated in the study. After an overnight fasting, a sample of blood was collected. The subjects received a single oral dose of 40 mg capsule of omeprazole (losec) and blood samples were taken up to 8 hours. Omeprazole was analyzed by the HPLC method and population pharmacokinetic analysis was performed using population pharmacokinetic modelling software P-Pharm.Results: The mean value for apparent plasma clearance (CL/F) was 20.8±6.9 (L.h-1). The corresponding value for apparent volume of distribution (V/F), and t1/2 beta were 21.6±7.5 (L) and 0.8±0.3 (h), respectively. A comparison of the weight normalized V/F and CL/F of omeprazole between males and females revealed that both parameters were significantly higher in females than males (p≤0.03).Conclusion: These results show a substantial interindividual variability in omeprazole pharmacokinetics and this might affect the therapeutic effects of omeprazole as reported previously.