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Kerstin Röhss - One of the best experts on this subject based on the ideXlab platform.

  • Effect of Increasing Esomeprazole and Pantoprazole Doses on Acid Control in Patients with Symptoms of Gastro-Oesophageal Reflux Disease
    Clinical Drug Investigation, 2008
    Co-Authors: Clive Wilder-smith, Anna Backlund, Mia Fjellman, Göran Eckerwall, Tore Lind, Kerstin Röhss
    Abstract:

    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.

  • Pharmacokinetics of Esomeprazole following varying intravenous administration rates.
    Basic & clinical pharmacology & toxicology, 2005
    Co-Authors: Mohammad Niazi, Mohammed Hassan-alin, Henrik Ahlbom, Patrik Bondarov, Anna H Karlsson, Hans Rydholm, Kerstin Röhss
    Abstract:

    There are situations where the use of an oral proton pump inhibitors is not possible. In such situations an intravenous route is the preferred alternative. An intravenous formulation of Esomeprazole has recently been developed. This study was designed to evaluate the pharmacokinetics and tolerability of single-dose intravenous Esomeprazole using different rates of administration. The study was an open randomised, cross-over design in healthy male and female (n = 24). Esomeprazole 40 mg intravenously was administrated as an infusion over 10, 15, 20 or 30 min., or Esomeprazole 20 mg intravenously as an injection over 3 min. There was a wash-out period of at least 6 days between dose regimens. It was demonstrated that increasing the rate of intravenous infusion of Esomeprazole 40 mg resulted in higher Cmax values (geometric means; 5.2-7.6 micromol/l), but the AUC values remained relatively constant (7.1-7.2 micromor/l). As expected Esomeprazole 20 mg administered as a 3 min. intravenous injection had lower Cmax (3.6 micromol/l) and AUC (2.9 micromol.r/l) values than any of the infusions of Esomeprazole 40 mg. Intravenous Esomeprazole was well tolerated in this study. In conclusion, any variation in the infusion rate of Esomeprazole 40 mg intravenously has little effect on the pharmacokinetics of Esomeprazole in healthy volunteers, which provides flexibility in the choice of dosing regimens.

  • Esomeprazole 20mg Provides More Effective Intragastric Acid Control than Maintenance-Dose Rabeprazole, Lansoprazole or Pantoprazole in Healthy Volunteers
    Clinical Drug Investigation, 2004
    Co-Authors: Kerstin Röhss, Clive Wilder-smith, Emma Nauclér, Lennart Jansson
    Abstract:

    Objective A high proportion of patients with gastro-oesophageal reflux disease experience recurrence of symptoms within a year of initial treatment. The key to preventing relapse is an effective maintenance therapy that maintains intragastric pH >4. This study was conducted to compare the effects on intragastric pH of maintenance doses of four proton pump inhibitors: Esomeprazole 20mg, lansoprazole 15mg, rabeprazole 10mg and pantoprazole 20mg. Study participants and methods Three standardised, randomised, two-way crossover studies were performed in a total of 108 Helicobacter pylori-negative healthy subjects. Intragastric pH was monitored on day 5 of once-daily oral dosing. The percentage of time of a 24-hour period with intragastric pH >4 and 24-hour median pH were measured on day 5. Results The mean percentage of time with intragastric pH >4 on day 5 was significantly longer following Esomeprazole 20mg compared with either lansoprazole 15mg (Esomeprazole 50.4% vs lansoprazole 43.0%, p = 0.026), rabeprazole 10mg (Esomeprazole 59.8% vs rabeprazole 51.7%, p = 0.011) or pantoprazole 20mg (Esomeprazole 59.6% vs pantoprazole 39.5%, p < 0.0001). Conclusions Maintenance dose Esomeprazole 20mg provided greater acid control and maintained intragastric pH >4 for a longer period of time than maintenance dose lansoprazole 15mg, rabeprazole 10mg and pantoprazole 20mg in healthy subjects.

  • effect of Esomeprazole 40 mg vs omeprazole 40 mg on 24 hour intragastric ph in patients with symptoms of gastroesophageal reflux disease
    Digestive Diseases and Sciences, 2002
    Co-Authors: Kerstin Röhss, Goran Hasselgren, Hans Hedenstrom
    Abstract:

    Maintenance of intragastric pH > 4 is vital for effective management of gastroesophageal reflux disease (GERD). Esomeprazole 40 mg, the first proton pump inhibitor developed as an optical isomer, demonstrates improved acid inhibition over omeprazole 20 mg. Our aim was to compare Esomeprazole 40 mg with omeprazole 40 mg, once-daily, on intragastric acidity in patients with symptoms of GERD. In this open-label, crossover study, 130 patients with symptoms of GERD received Esomeprazole 40 mg or omeprazole 40 mg once-daily for five days. The 24-hr intragastric pH was monitored on days 1 and 5 of each treatment period. The mean percentage of the 24-hr period with intragastric pH > 4 was significantly greater (P < 0.001) with Esomeprazole 40 mg than with omeprazole 40 mg on days 1 (48.6% vs 40.6%) and 5 (68.4% vs 62.0%). Interpatient variability was significantly less with Esomeprazole than omeprazole. Esomeprazole was well tolerated. In conclusion, Esomeprazole 40 mg provides more effective acid control than twice the standard dose of omeprazole.

  • Pharmacokinetics and pharmacodynamics of Esomeprazole, the S-isomer of omeprazole.
    Alimentary pharmacology & therapeutics, 2001
    Co-Authors: Tommy B. Andersson, Kerstin Röhss, Eva Bredberg, Mohammed Hassan-alin
    Abstract:

    Background Esomeprazole, the S-isomer of omeprazole, is the first proton pump inhibitor developed as a single isomer for the treatment of acid-related diseases. Aim To examine the pharmacokinetics and pharmacodynamics of Esomeprazole. Methods In a crossover study, 12 healthy males received 5, 10 or 20 mg of Esomeprazole, or 20 mg of omeprazole, once daily over 5 days. The pharmacokinetics and effects on pentagastrin-stimulated peak acid output of Esomeprazole and omeprazole were studied on days 1 and 5. Results The area under the curve (AUC) of both Esomeprazole and omeprazole increased from day 1 to day 5. The correlation between acid inhibition and AUC for Esomeprazole could be well described with a sigmoid Emax model. The mean inhibition values of the pentagastrin-stimulated peak acid output on day 1 for 5, 10 and 20 mg of Esomeprazole were 15%, 29% and 46%, respectively; the corresponding day 5 values were 28%, 62% and 90%. The mean inhibition values of the pentagastrin-stimulated peak acid output for omeprazole were 35% (day 1) to 79% (day 5). Conclusions The pharmacokinetics of Esomeprazole are time and dose dependent. There was a good correlation between AUC and effect for Esomeprazole. These data suggest an increased acid inhibitory effect of Esomeprazole compared to omeprazole.

Zheng Sun - One of the best experts on this subject based on the ideXlab platform.

Gillian M. Keating - One of the best experts on this subject based on the ideXlab platform.

  • Intravenous Esomeprazole: a pharmacoeconomic profile of its use in the prevention of recurrent peptic ulcer bleeding.
    PharmacoEconomics, 2011
    Co-Authors: Gillian M. Keating
    Abstract:

    Intravenous Esomeprazole (Nexium) is approved in Europe for the prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers. In a pivotal clinical trial, patients with peptic ulcer bleeding and high-risk stigmata who received intravenous Esomeprazole for 72 hours following endoscopic haemostatic therapy were significantly less likely than those receiving intravenous placebo to experience recurrent peptic ulcer bleeding at days 3, 7 and 30. In addition, the need for repeat endoscopic haemostatic therapy, the total amount of blood transfused and the number of additional hospital days required because of rebleeding were significantly lower in intravenous Esomeprazole recipients than in intravenous placebo recipients. All patients received oral Esomeprazole for 27 days following intravenous study drug administration. Intravenous Esomeprazole was generally well tolerated in the pivotal trial, with infusion-site reactions being among the most commonly reported adverse events. Two pharmacoeconomic analyses conducted from a healthcare payer perspective used decision-tree models with 30-day time horizons to examine the cost effectiveness and cost utility of intravenous Esomeprazole in patients with bleeding peptic ulcers who had undergone endoscopic haemostatic therapy. With regard to the incremental cost per bleed averted, intravenous Esomeprazole was predicted to be dominant in Spain and cost effective in Sweden and the US compared with no intravenous Esomeprazole. Efficacy results and resource utilization data from the pivotal clinical trial were inputted into this model, and the results of the analysis were generally robust to plausible variations in key variables. In the cost-utility analysis, which was conducted in the UK and is available as an abstract and poster, Esomeprazole was considered to be the most cost-effective treatment alternative, compared with omeprazole or pantoprazole. For this analysis, clinical outcomes data were obtained from a systematic review and mixed treatment comparison (given the absence of head-to-head trial data), and utility values were proxied from the literature. In conclusion, intravenous Esomeprazole prevents peptic ulcer rebleeding in patients who have undergone endoscopic haemostatic therapy. Pharmacoeconomic analyses support the use of intravenous Esomeprazole following endoscopic haemostatic therapy in patients with peptic ulcer bleeding and high-risk stigmata.

J Dent - One of the best experts on this subject based on the ideXlab platform.

  • Review article: pharmacology of Esomeprazole and comparisons with omeprazole.
    Alimentary pharmacology & therapeutics, 2003
    Co-Authors: J Dent
    Abstract:

    Plasma concentration measurements have confirmed that the advantageous hepatic metabolism of Esomeprazole results in a greater delivery of acid suppressant to the systemic circulation, compared with an equal dose of omeprazole. Also, this superior delivery has been shown to cause a more consistent and greater suppression of pentagastrin-stimulated gastric acid secretion by Esomeprazole, 20 mg, compared with omeprazole, 20 mg. The superior acid-suppressant properties of Esomeprazole have been revealed by extensive 24-h intragastric pH-monitoring studies. Compared with omeprazole, 20 mg, Esomeprazole, 20 mg and 40 mg, has been shown to give superior outcomes on three key measures of antisecretory effect: (1) consistency amongst individuals; (2) duration over the 24-h cycle; (3) overall impact on pH. As there is a substantial increment of acid control from Esomeprazole, 20 mg, to Esomeprazole, 40 mg, this latter dose is the most appropriate to investigate for modern initial therapy of reflux disease, with the aim of achieving the highest possible response rates in the shortest possible time.

  • Review article: initial therapy of reflux disease with Esomeprazole.
    Alimentary pharmacology & therapeutics, 2003
    Co-Authors: J Dent
    Abstract:

    Large clinical trials in patients with reflux oesophagitis have shown Esomeprazole, 40 mg once daily, to be convincingly superior in the healing of oesophagitis when compared with both omeprazole, 20 mg once daily, and lansoprazole, 30 mg once daily. The greatest advantage for Esomeprazole is with healing of the more severe grades of oesophagitis. Esomeprazole, 40 mg once daily, has also been shown to be significantly superior in the treatment of heartburn. Studies in endoscopy-negative patients, or in both oesophagitis and endoscopy-negative patients, have demonstrated good efficacy for Esomeprazole, with high levels of symptom control achieved in the first 7 days of therapy.

Nicholas J. Talley - One of the best experts on this subject based on the ideXlab platform.

  • one week acid suppression trial in uninvestigated dyspepsia patients with epigastric pain or burning to predict response to 8 weeks treatment with Esomeprazole a randomized placebo controlled study
    Alimentary Pharmacology & Therapeutics, 2007
    Co-Authors: S Van Zanten, Nicholas J. Talley, K Lauritsen, Nimish Vakil, Nigel Flook, Elisabeth Bollingsternevald, Tore Persson, Ewa Bjorck, Larserik Svedberg
    Abstract:

    Summary Background While empiric acid-suppressive therapy for uninvestigated dyspepsia patients with symptoms of epigastric pain or burning is standard practice, it is unknown whether an early response to therapy predicts outcome. Aim To evaluate whether a 1-w acid suppression trial is effective for predicting 8-w response in such patients. Methods Helicobacter pylori-negative patients (aged 18–50 years) in primary care with uninvestigated epigastric pain or burning were randomized to Esomeprazole 40 mg q.d.s. or b.d. for 1w, followed by Esomeprazole 40 mg q.d.s. or placebo for 7w. Each day, patients rated the severity of their symptoms. Results Based on the last 3d, 1-w response rates were 39% (231 of 588) and 43% (258 of 596) with Esomeprazole 40 mg q.d.s. and b.d., respectively. Based on the last 7d, response rates at 4w were 38% (283 of 738) and 25% (93 of 380) for Esomeprazole and placebo, respectively, and 47% (339 of 716) and 34% (124 of 368), respectively, at 8w (both P < 0.001 vs. placebo). The sensitivity and specificity of Esomeprazole treatment were 58% and 70%, respectively, at 8w. Conclusion A 1-w acid suppression trial is of limited clinical value for predicting 8-w response in patients with symptoms of epigastric pain or burning. Esomeprazole provides greater symptom control than placebo at 4w and 8w.

  • randomized controlled trial of Esomeprazole in functional dyspepsia patients with epigastric pain or burning does a 1 week trial of acid suppression predict symptom response
    Alimentary Pharmacology & Therapeutics, 2007
    Co-Authors: Nicholas J. Talley, K Lauritsen, Nimish Vakil, S Van Zanten, Nigel Flook, Elisabeth Bollingsternevald, Tore Persson, Ewa Bjorck, Tore Lind
    Abstract:

    Summary Background Early identification of true responders to acid suppression in functional dyspepsia patients with symptoms of epigastric pain or burning may enable clinicians to optimally tailor treatment. Aim To evaluate whether a 1-w acid suppression trial is useful for identifying true responders in this population. Methods Patients (18–70 years) were randomized to either Esomeprazole 40 mg q.d.s., b.d. or placebo for 1w, and then Esomeprazole 40 mg q.d.s. or placebo for 7w. Epigastric pain and/or burning were recorded on a 4-point scale (0 = none, 3 = severe). Trial-week response was defined as symptom score sum ≤1 on last 3d of therapy; response at 8w was symptom score sum ≤1 over preceding 7d. Results 1-w response rates were 33% (199 of 597), 29% (188 of 629) and 23% (71 of 315) with Esomeprazole q.d.s., Esomeprazole b.d. and placebo, respectively (P = 0.002 for Esomeprazole groups vs. placebo). At 8w, trial week sensitivity and specificity were 46% and 80%, respectively, for Esomeprazole (40 or 80 mg), and 33% and 87%, respectively, for placebo. The positive and negative predictive values for Esomeprazole were 60% and 69%. Conclusion Response to a 1-w acid suppression trial is of limited use for predicting symptom response at 8w in patients with unexplained epigastric pain or burning.

  • Esomeprazole, a new proton pump inhibitor: pharmacological characteristics and clinical efficacy.
    International journal of clinical practice, 2000
    Co-Authors: S Thitiphuree, Nicholas J. Talley
    Abstract:

    Esomeprazole, the S-isomer of omeprazole, is the first proton pump inhibitor synthesised as an optical isomer to become available for clinical use. Esomeprazole is optically stable in humans with negligible inversion to the R-isomer. Esomeprazole has significantly higher oral bioavailability than omeprazole, resulting in greater acid suppression. In clinical studies, 4 weeks' treatment with 40 mg Esomeprazole demonstrated greater healing of all grades of erosive oesophagitis, compared with 20 mg omeprazole (76-82% versus 69-71%) and higher rates of symptom resolution (65-68% versus 58-61%) Furthermore, Esomeprazole maintained healing rates of up to 90% over 6 months in erosive oesophagitis. Comparisons with other proton pump inhibitors in oesophagitis are, as yet, unavailable. In patients with endoscopy-negative gastro-oesophageal reflux disease (GERD), on-demand therapy with Esomeprazole 20 mg has been shown to be very efficacious compared with placebo, and is well tolerated; however, comparisons with other proton pump inhibitors have not been performed. Long-term use of Esomeprazole for up to 12 months in patients with GERD have not raised any significant safety concerns with respect to the development of atrophic gastritis or clinically relevant changes in enterochromaffin-like cells.