Efficacy and safety of pantoprazole 20 mg once daily treatment in patients with ulcer-like functional dyspepsia

Rensburg, Christo van; Berghöfer, Peter; Enns, Robert; Dattani, I. Dan; Maritz, Johannes F; Carro, Pedro González; Fischer, Renate; Schwan, Thomas J.

doi:10.1185/03007990802184545

Cited by 29 publications

(23 citation statements)

References 38 publications

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“…Such a response was not fully unexpected in a study investigating symptomatology partly related to pain, however, being different due to the exogenous trigger of primary pharmacological treatment. Since heartburn and epigastric pain provided hallmark symptoms in our study (table 2), the observed placebo response could resemble responses that have been reported in other studies on heartburn therapies [30] and pain therapies [31]. …”

Section: Discussionsupporting

confidence: 59%

Improvement of Non-Steroidal Anti-Inflammatory Drug-Induced Gastrointestinal Symptoms during Proton Pump Inhibitor Treatment: Are G-Protein β3 Subunit Genotype, Helicobacter pylori Status, and Environmental Factors Response Modifiers?

Holtmann

Rensburg²,

Schwan³

et al. 2011

Digestion

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Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are associated with significant upper and lower gastrointestinal (GI) morbidity. Aim: To determine the efficacy and safety of pantoprazole versus placebo in controlling GI symptoms during treatment with NSAIDs and to evaluate the influence of potential response modifiers. Methods: 800 patients with GI complaints during NSAID treatment were randomized to pantoprazole 20 mg once daily or placebo for 4 weeks in this double-blind, multicenter trial. Assessments included the difference in cumulated overall symptom load of any GI complaint during treatment (primary endpoint), proportion of days without GI symptoms, and influence of risk factors such as gender, age, alcohol consumption, smoking, Helicobacter pylori status, and GNB3 genotype SNP rs5443 (825C>T) on symptom load. Results: At 4 weeks, cumulated overall symptom load was significantly lower in pantoprazole than placebo recipients [p < 0.0001; intent-to-treat (ITT)]; the effect was statistically significant after 7 days’ treatment. Pantoprazole versus placebo recipients had 54 versus 29% of days without GI symptoms (p < 0.0001; ITT). Neither common risk factors nor GNB3 genotype were significantly associated with therapeutic response, while GNB3 825TT versus CT was associated with a significantly higher baseline symptom load (p < 0.05). Conclusion: In the population studied, treatment with the proton pump inhibitor pantoprazole significantly improves GI symptoms during NSAID therapy, irrespective of the risk factors investigated or GNB3 genotype.

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Section: Discussionsupporting

confidence: 59%

Improvement of Non-Steroidal Anti-Inflammatory Drug-Induced Gastrointestinal Symptoms during Proton Pump Inhibitor Treatment: Are G-Protein β3 Subunit Genotype, Helicobacter pylori Status, and Environmental Factors Response Modifiers?

Holtmann

Rensburg²,

Schwan³

et al. 2011

Digestion

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“…Esomeprazole had no significant benefit over placebo on symptom relief at 8 weeks. Van Rensburg et al 49 randomised FD patients to pantoprazole 20 mg or placebo once daily for 4 weeks. They confined their study to FD patients with 'ulcer-like' symptoms.…”

Section: Proton Pump Inhibitors (Ppis)mentioning

confidence: 99%

Review article: current treatment options and management of functional dyspepsia

Lacy

Talley

Locke

et al. 2012

Aliment Pharmacol Ther

193

143

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SUMMARY Background Functional dyspepsia (FD), a common functional gastrointestinal disorder, is defined by the Rome III criteria as symptoms of epigastric pain or discomfort (prevalence in FD of 89–90%), postprandial fullness (75–88%), and early satiety (50–82%) within the last 3 months with symptom onset at least 6 months earlier. Patients cannot have any evidence of structural disease to explain symptoms and predominant symptoms of gastroesophageal reflux are exclusionary. Symptoms of FD are non-specific and the pathophysiology is diverse, which explains in part why a universally effective treatment for FD remains elusive. Aim To present current management options for the treatment of FD (therapeutic gain/response rate noted when available). Results The utility of Helicobacter pylori eradication for the treatment of FD is modest (6–14% therapeutic gain), while the therapeutic efficacy of proton pump inhibitors (PPI) (7–10% therapeutic gain), histamine-type-2-receptor antagonists (8–35% therapeutic gain), prokinetic agents (18–45%), tricyclic antidepressants (TCA) (response rates of 64–70%), serotonin reuptake inhibitors (no better than placebo) is limited and hampered by inadequate data. This review discusses dietary interventions and analyses studies involving complementary and alternative medications, and psychological therapies. Conclusions A reasonable treatment approach based on current evidence is to initiate therapy with a daily PPI in H. pylori-negative FD patients. If symptoms persist, a therapeutic trial with a tricyclic antidepressant may be initiated. If symptoms continue, the clinician can possibly initiate therapy with an antinociceptive agent, a prokinetic agent, or some form of complementary and alternative medications, although evidence from prospective studies to support this approach is limited.

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“…Several randomized controlled studies suggested that the efficacy of PPI therapy for FD is limited, and it may be confined to those patients who have co-existing EPS (Talley et al 1998;Blum et al 2000;Bolling-Sternevald et al 2002;Wong et al 2002;Peura et al 2004). One randomized control study compared PPI therapy to a placebo in FD patients with ulcer-like symptoms (van Rensburg et al 2008). In their selected patient population, PPI therapy had a modest but statistically significant advantage over the placebo.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of Acotiamide in Combination with Esomeprazole for Functional Dyspepsia Refractory to Proton-Pump Inhibitor Monotherapy

Kishino¹,

Kitagawa

Sunamura

2014

Tohoku J. Exp. Med.

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Functional dyspepsia (FD) is a gastroduodenal disorder that presents as postprandial fullness, early satiation, or epigastric burning despite no evidence of a structural disease. Proton pump inhibitors (PPIs) are often the first choice for treating FD. However, some patients need additional medication because of residual symptoms despite a certain level of benefit from the PPI. For these patients, a combination of PPI and other agents has a possibly more beneficial effect than changing their medication. This study aimed to evaluate the efficacy of an initial PPI followed by combination therapy with PPI and acotiamide in FD patients with residual symptoms after an initial PPI. We enrolled 105 patients who started an initial PPI (20 mg of esomeprazole once a day). Twenty-three patients with residual symptoms received 100 mg of acotiamide, a cholinesterase inhibitor, three times a day with esomeprazole as a combination therapy for 2 weeks. The symptoms were evaluated using the modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (mFSSG). Eighteen of 23 patients (78%) achieved an overall improvement in symptoms. Almost all FD-related symptoms statistically improved after the combination therapy, with an improvement in the mFSSG score relevant to the postprandial distress syndrome and epigastric pain syndrome. The symptoms improved regardless of age, sex, and the pre-combination therapy score of the mFSSG. Our findings suggest that the combination therapy of acotiamide and PPI may be effective in selected FD patients with insufficient improvement with an initial PPI. However, welldesigned trials are required to confirm the efficacy.

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Efficacy and safety of pantoprazole 20 mg once daily treatment in patients with ulcer-like functional dyspepsia

Cited by 29 publications

References 38 publications

Improvement of Non-Steroidal Anti-Inflammatory Drug-Induced Gastrointestinal Symptoms during Proton Pump Inhibitor Treatment: Are G-Protein β3 Subunit Genotype, Helicobacter pylori Status, and Environmental Factors Response Modifiers?

Improvement of Non-Steroidal Anti-Inflammatory Drug-Induced Gastrointestinal Symptoms during Proton Pump Inhibitor Treatment: Are G-Protein β3 Subunit Genotype, Helicobacter pylori Status, and Environmental Factors Response Modifiers?

Review article: current treatment options and management of functional dyspepsia

Efficacy of Acotiamide in Combination with Esomeprazole for Functional Dyspepsia Refractory to Proton-Pump Inhibitor Monotherapy

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