Our library of drug research abstracts drawn from the medical literature is updated on a regular schedule, and you can be assured that new protonix research articles will be listed here shortly after becoming available to us.
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Medical research on protonix
Famotidine versus pantoprazole.
Am J Crit Care. 2008 Jul; 17(4): 311-2
Lwin AA, Gerber DR, Ojiako K, Shingala H, Schorr C
Curr Med Res Opin. 2008 Jul; 24(7): 2009-18
van Rensburg C, Berghöfer P, Enns R, Dattani ID, Maritz JF, Gonzalez Carro P, Fischer R, Schwan T
OBJECTIVE: To investigate the efficacy of pantoprazole 20 mg once daily (o.d.) in relieving epigastric pain associated with ulcer-like functional dyspepsia. RESEARCH DESIGN AND METHODS: In this double-blind, placebo-controlled, multicentre study, patients experiencing ulcer-like functional dyspepsia, with epigastric pain as the predominant symptom, were randomised to receive pantoprazole 20 mg or placebo o.d. for 28 days. Primary endpoint was the complete relief (i.e. absence) from epigastric pain after 28 days' treatment. The odds ratio (OR) for pantoprazole/placebo and its 95% confidence intervals (CIs) were determined. Significant superiority of pantoprazole was concluded if the value 1.0 was above this interval. RESULTS: Of 419 patients (intention-to-treat [ITT]) randomised to treatment, 207 received pantoprazole and 212 received placebo. Epigastric pain relief was achieved after 28 days' treatment in 55% of pantoprazole recipients and 45% of placebo recipients (per-protocol [PP]: 58% and 47%, respectively). Pantoprazole demonstrated statistically significant superiority compared with placebo in the ITT (OR: 0.68; 95% CI: 0.46-0.99) and PP populations (OR: 0.64; 95% CI: 0.42-0.98). Pantoprazole was more efficacious than placebo in relieving heartburn and acid regurgitation after 7, 14 and 28 days of treatment. The sum score of gastrointestinal symptoms after 28 days was statistically significantly lower in the pantoprazole than placebo group. Fewer patients receiving concomitant psychotropic medication experienced relief from epigastric pain than those not receiving such medication. Adverse events did not significantly differ between pantoprazole and placebo. CONCLUSIONS: Results of this study suggest that pantoprazole 20 mg is more efficacious than placebo, and is a well-tolerated treatment for relieving epigastric pain in patients with ulcer-like functional dyspepsia. Further research is needed to confirm these findings.
[Efficacy of Levofloxacin-based Triple Therapy as Second-lineHelicobacter pylori Eradication.]
Korean J Gastroenterol. 2008 May; 51(5): 285-90
Jung HS, Shim KN, Baik SJ, Na YJ, Kang MJ, Jung JM, Ha CY, Jung SA, Yoo K
Background/Aims: Bismuth-based quadruple therapy for second-line eradication treatment achieves the eradication rate ranging from 70% to 81% due to antimicrobial resistance and poor compliance. The aim of this study was to compare the eradication rate of levofloxacin-based triple therapy with that of bismuth-based quadruple therapy in second-line Helicobacter pylori (H. pylori) eradication therapy. Methods: Seventy-six outpatients with persistent H. pylori infection after first-line triple therapy were enrolled in this prospective randomized trial. The subjects were randomized to receive levofloxacin 300 mg, amoxicillin 1 g, and pantoprazole 20 mg, given twice daily for 7 days (LAP group), or metronidazole 500 mg twice, tetracycline 500 mg four times, and pantoprazole 20 mg twice, bismuth subcitrate 600 mg twice daily for 7 days (MTPB group). Eradication was confirmed with (13)C-urea breath test or rapid urease test 4 weeks after the cessation of therapy. Results: Among Seventy-six patients initially included, eleven were lost during follow-up. The eradication rates, expressed as intention to treat (ITT) and per protocol (PP) analyses, were 51.6% and 53.3% in the LAP group, and 48.9% and 62.9% in the MTPB group, respectively. There was no significant difference in H. pylori eradication rates between the two groups (p=0.815 by ITT, p=0.437 by PP). LAP regimen was better tolerated than MTPB regimen with lower incidence of side effects (10.0% versus 31.4%, p=0.03). Conclusions: H. pylori eradication rates of levofloxacin-based triple therapy and bismuth-based quadruple therapy were not significantly different in second-line H. pylori eradication therapy, and low incidence of side effects was observed in levofloxacin-based triple therapy.
[The effect of proton pump inhibitor on healing of post-esophageal variceal ligation ulcers]
Korean J Gastroenterol. 2008 Apr; 51(4): 232-40
Boo GB, Oh JC, Lee BJ, Lee DM, Kim YD, Park CG, Kim MW
BACKGROUND/AIMS: Esophageal variceal ligation (EVL) is the most preferable method for controlling variceal bleeding. However, EVL is associated with complications such as hemorrhage, chest pain, dysphagia, and odynophagia due to post-EVL ulcers in the esophageal mucosa. The aim of this study was to assess the effect of proton pump inhibitor (PPI), pantoprazole on the healing of post-EVL ulcers. METHODS: Forty seven patients were randomly allocated into PPI group and control group. Patients in PPI group received 40 mg of pantoprazole intravenously for 3 days after EVL, then 40 mg of oral pantoprazole for 11 days consecutively. Control patients received intravenous and oral placebo. Endoscopic examinations were performed twice at 7+/-2 days and 14+/-2 days after EVL respectively. Clinical outcomes include the size of ulcers, symptoms reported by patients; chest pain, dysphagia, and odynophagia. RESULTS: Forty seven patients completed the 7 days protocol (PPI/control; 25/22), and twenty six patients completed the 14 days protocol (PPI/control; 16/10). Post-EVL ulcers in PPI group were significantly smaller than those in control group (7 days; 98.7 mm2/119.4 m2, 14 days; 32.3 m2/43.8 m2, p 0.05). Nineteen patients (PPI/control; 9/10) did not complete the 14 days protocol due to patients' refusal and adverse outcomes, such as hepatic failure and sepsis with bleeding from post-EVL ulcer occurred in two patients of control group. CONCLUSIONS: PPI treatment following EVL may be effective in healing post-EVL ulcer.
Presse Med. 2008 May 23;
Mouly S, Charlemagne A, Le Jeunne P, Fagnani F
AIMS: Proton pump inhibitors (PPIs) rank third among drug classes in the amount they cost the French health care system annually (more than a billion euros, i.e., 5.7% of community pharmaceutical expenditures, 50% prescribed for gastroesophageal reflux disease (GERD)). METHODS: Data for a representative sample of patients aged 20 years and older, who visited their GP at least once in 2005 for uncomplicated symptomatic GERD came from the Thales database (1200 representative general practitioners (GP) connected to a computerized network) a. RESULTS: In 2005, 122 571 patients (mean age, 56 years, 45% male, 2.6 consultations for GERD) met the inclusion criteria. Extrapolated to the French population, this sample corresponds to 5.7 million people, i.e., 13% of the adult population who visited a GP during the year. PPIs were prescribed as first-line treatment for GERD in 84% of the consultations. Omeprazole, as a proprietary or generic drug, was prescribed most often (79%) and at a full dose (20mg), while other compounds (lansoprazole, pantoprazole, rabeprazole and esomeprazole) were prescribed at half dose in 64% of cases. The extrapolated annual cost of PPIs reimbursed for this indication was 465 million euros (Meuro) at a mean reimbursement level of 73%. Brand-name omeprazole still accounts for 11% of the total cost reimbursed. Complete replacement of brand-name omeprazole by its generic counterpart would reduce costs by 18.35Meuro (-4.3% reimbursed expenditure). The switch from generic full-dose omeprazole to a half dose of other PPIs would allow a further saving of 2.6 (with lansoprazole) to 13.2 Meuro (with pantoprazole). CONCLUSION: A substantial saving in reimbursed pharmaceutical spending in uncomplicated GERD and full compliance with clinical practice recommendations could be achieved by the substitution of less expensive PPIs.
Arzneimittelforschung. 2008; 58(3): 141-8
Mendes FD, Patni AK, Reyer S, Monif T, Moreira LD, Ilha JO, Mendes GD, De Nucci G
OBJECTIVE: To assess the comparative bioavailability of two formulations (40 mg delayed-released [DR] tablet; test and reference) of pantoprazole (CAS 102625-70-7) in healthy volunteers of both sexes, with and without food. METHODS: The study was conducted using an open, randomized, two-period crossover design with a 1-week washout interval, in two groups, with and without food. Plasma samples were obtained for up to 24 h post dose. Plasma pantoprazole concentrations were analyzed by liquid chromatography coupled to tandem mass spectrometry (LC-MS-MS) with positive ion electrospray ionization using multiple reactions monitoring (MRM). From the pantoprazole plasma concentration vs. time curves, the pharmacokinetic parameters AUC(last) and C(max) were obtained, with and without food. RESULTS: The limit of quantification was 5 ng/mL for plasma pantoprazole analysis. The geometric mean and 90% confidence interval CI of test/reference percent ratios were, without and with food, respectively: 104.6540% (90.8616%-120.5401%) and 99.9708% (90.9987%-109.8275%) for C(max), 95.6634% (85.2675%-107.3267%) and 89.3500% (83.6630%-95.4237%) for AUC(last). CONCLUSION: Since the 90% CI for AUC(last) and C(max) ratios were within the 80-125% interval proposed by the US FDA, it was concluded that pantoprazole 40 mg DR tablet (test formulation) with and without food was bioequivalent to the reference 40 mg DR tablet for both the rate and extent of absorption.
Aliment Pharmacol Ther. 2008 May 12;
Calabrese C, Liguori G, Gabusi V, Gionchetti P, Rizzello F, Straforini G, Ramona B, Di Febo G
Background: Comparative studies of proton pump inhibitors (PPIs) have revealed that acid reflux is influenced by PPI treatment, formulations and dosing regimens. Wireless pH capsules have circumvented some of limitations of conventional catheter based pH testing with the additional advantage of 96-hour recording periods. Aim: 4-day monitoring of esophageal pH and related symptoms to clarify the effectiveness of intra-esophageal acid suppression by omeprazole, pantoprazole and lansoprazole in NERD patients. Materials and methods: 24 patients with typical symptoms of GERD were enrolled and underwent upper endoscopy and placement of a wireless pH-capsule. Patients randomly received omeprazole, pantoprazole or lansoprazole for 3 days after the first 24 hours. Symptom-reflux associations were expressed using the symptom index (SI). Results: all patients completed the study. Significant decrease in acid exposure occurred on day 2 and in each successive day in all groups. Pantoprazole and omeprazole are more effective than lansoprazole at inducing a normalization of intra-esophageal acid exposure at day 2 and 3. Significant reduction of SI at day 2. Conclusions: 4-day ambulatory esophageal pH monitoring is feasible and safe. Omeprazole, pantoprazole and lansoprazole have an equivalent potency for normalizing intra-esophageal acid exposure after 3 days of treatment in NERD patients.
Clin Drug Investig. 2008; 28(6): 333-43
Wilder-Smith C, Backlund A, Eckerwall G, Lind T, Fjellman M, Röhss K
BACKGROUND and objective: In patients with gastro-oesophageal reflux disease (GORD), dose escalation or drug switching may be considered in those with symptoms that persist despite standard-dose proton pump inhibitor (PPI) therapy. This study set out to assess whether increasing the dosage of oral esomeprazole and pantoprazole improves acid control in GORD patients, and to compare the pharmacodynamic efficacy of esomeprazole and pantoprazole administered at different dosages. METHODS: This was an open-label, randomized, six-way crossover study that included Helicobacter pylori-negative GORD patients (aged 20-60 years) with 4. Patients were treated with oral once-daily esomeprazole 20 mg, 40 mg and 80 mg, and pantoprazole 20 mg, 40 mg and 80 mg, for 5 days. The main outcome measures were time with intragastric pH >4 over 24 hours, median pH over 24 hours and area under the hydrogen ion versus time curve on day 5 for each treatment period. RESULTS: Dose escalation with both PPIs improved acid control. The proportion of time with intragastric pH >4 (day 5) was 46.7% with esomeprazole 20 mg/day, 58.6% with esomeprazole 40 mg/day, and 65.8% with esomeprazole 80 mg/day; the corresponding percentages with pantoprazole were 28.6%, 36.9% and 44.9%, respectively. On a milligram-per-milligram basis, esomeprazole provided greater acid control than pantoprazole (p < 0.001). CONCLUSION: Dose escalation with oral esomeprazole and pantoprazole improves acid control in patients with GORD, although esomeprazole provides significantly greater acid control on a milligram-per-milligram basis.
A review of esomeprazole in the treatment of gastroesophageal reflux disease (GERD).
Ther Clin Risk Manag. 2007 Aug; 3(4): 653-63
Kalaitzakis E, Björnsson E
Proton-pump inhibitors (PPIs) are the drugs of choice for the treatment of gastroesophageal reflux disease (GERD). Esomeprazole is the latest PPI and was developed as the S-isomer of omeprazole as an attempt to improve its pharmacokinetic properties. Esomeprazole has been reported to have a somewhat higher potency in acid inhibition than other PPIs. Despite some controversy, data from clinical trials and meta-analyses indicate that esomeprazole 40 mg od for up to 8 weeks provided higher rates of healing of erosive GERD and a greater proportion of patients with sustained resolution of heartburn, than omeprazole 20 mg, lansoprazole 30 mg, or pantoprazole 40 mg od. Esomeprazole 20 mg od has also been shown to be more effective in maintaining healing of erosive GERD compared with lansoprazole 15 mg od or pantoprazole 20 mg od. However, it is not clear whether these statistically significant differences are of major clinical importance. Esomeprazole 20 mg od is superior to placebo for treatment of non-erosive reflux disease (NERD) but clinical trials have not shown any significant differences in efficacy between esomeprazole 20 mg and omeprazole 20 mg or pantoprazole 20 mg od. Lastly, although esomeprazole treatment in GERD has been reported to result in improvement of health-related quality of life (QoL) indices, no clinical trials have evaluated the possible differential effects of different PPIs on QoL in GERD.
J Trauma. 2008 May; 64(5): 1202-10
Somberg L, Morris J, Fantus R, Graepel J, Field BG, Lynn R, Karlstadt R
BACKGROUND: This study aimed to assess intermittent intravenous (IV) pantoprazole for control of gastric acid and the possible prevention of upper gastrointestinal (UGI) bleeding in intensive care units (ICU) patients. METHODS: This was a multicenter, randomized, open-label, dose-ranging pilot study of IV pantoprazole (40 mg q24 hour; 40 mg q12 hour; 80 mg q24 hour; 80 mg q12 hour; 80 mg q8 hour) or continuously infused cimetidine (300 mg bolus; 50 mg/h) in patients at risk for UGI bleeding. The primary endpoint was percent time gastric pH >/=4.0. UGI bleeding and pneumonia were measured as secondary endpoints. RESULTS: Two hundred two ICU patients were randomized. Gastric pH was well controlled by all treatments. Gastric pH control improved from day 1 to day 2 in all pantoprazole groups, whereas there was decreased pH control in the cimetidine group. There were no cases of protocol defined UGI bleeding in any treatment group. Adverse event frequency and pneumonia incidence were similar between pantoprazole and cimetidine treated patients. CONCLUSIONS: This pilot study indicates that intermittent IV pantoprazole effectively controls gastric pH and may protect against UGI bleeding in high risk ICU patients without the development of tolerance.