Six month safety and tolerability of esomeprazole as maintenance therapy in GERD patients with healed erosive esophagitis (EE)

Richter, Joel E.; Johnson, David A.; Magner, David J.; Skammer, Wendy; Spreen, Kathleen

doi:10.1016/s0016-5085(00)81053-7

Cited by 4 publications

(6 citation statements)

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“…The three most common adverse events in patients treated with esomeprazole were respiratory infection (9%), diarrhoea (7%) and headache (7%), but the incidence of these adverse events was not significantly different between esomeprazole and placebo. Changes in laboratory measurements were small and not clinically meaningful 36,40 . Gastrin was increased as expected and plateaued after 2–3 months of esomeprazole treatment.…”

Section: Safetymentioning

confidence: 54%

“…Sixty‐one patients (8%) discontinued treatment due to adverse events, most commonly nausea, abdominal pain and flatulence, comparable to other PPIs 37–39 . In another placebo‐controlled study, 40 688 patients with endoscopically confirmed healed erosive oesophagitis received esomeprazole 40 mg, esomeprazole 20 mg, esomeprazole 10 mg or placebo for up to 6 months. The three most common adverse events in patients treated with esomeprazole were respiratory infection (9%), diarrhoea (7%) and headache (7%), but the incidence of these adverse events was not significantly different between esomeprazole and placebo.…”

Section: Safetymentioning

confidence: 99%

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Esomeprazole, a New Proton Pump Inhibitor: Pharmacological Characteristics and Clinical Efficacy

Thitiphuree

Talley

2000

Int J Clinical Practice

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SUMMARYEsomeprazole, 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.

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Section: Safetymentioning

confidence: 54%

Section: Safetymentioning

confidence: 99%

Esomeprazole, a New Proton Pump Inhibitor: Pharmacological Characteristics and Clinical Efficacy

Thitiphuree

Talley

2000

Int J Clinical Practice

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“…22-27,31, 32 The most common adverse effects reported were headache, abdominal pain, flatulence, and diarrhea, which generally occur with all PPIs (Table 3). 2,14-17,24, 27 One study 27 assessed the safety of 12 months of treatment with esomeprazole.…”

Section: Safety and Tolerabilitymentioning

confidence: 99%

“…Esomeprazole has been evaluated in more than 10 000 patients aged 18-84 years 2 and was well tolerated in all studies. [22][23][24][25][26][27]31,32 The most common adverse effects reported were headache, abdominal pain, flatulence, and diarrhea, which generally occur with all PPIs (Table 3). 2,14-17,24, 27 One study 27 assessed the safety of 12 months of treatment with esomeprazole.…”

Section: Safety and Tolerabilitymentioning

confidence: 99%

Esomeprazole for Acid Peptic Disorders

2002

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“…Unerwünschte Wirkungen waren nicht häufiger als in den Plazebogruppe, und entsprachen dem, was innerhalb eines Jahres in der Bevölkerung zu erwarten ist [19,24,25]. Die Serumgastrinwerte stiegen unter 40 mg Esomeprazol erwartungsgemäû durchschnittlich um 50 pg/ml und unter 20 mg um 20 pg/ml an und erreichten ein Plateau nach 2±3 Monaten (24,25).…”

Section: Sicherheitsprofil Von Esomeprazolunclassified

Chirale Umschaltung (Chiral Switch), ein erfolgreicher Weg zur Entwicklung von Medikamenten: Beispiel Esomeprazol

Creutzfeldt

2000

Z Gastroenterol

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About 25% of common drugs are racemates, i.e. mixtures of their optical or spatial isomers (stereoisomers or enantiomers). Frequently the enantiomers differ in their pharmacokinetics, pharmacodynamics, drug interactions and side effects. Therefore, the pharmaceutical industry, pharmacologists and clinicians are increasingly interested in the development of enantiomers as drugs. Since advances in synthetic and analytical chemistry have provided the tools to produce stereoisomeric drugs, also the authorities recommend and support chiral switch. As example for the therapeutic gain the recent studies with esomeprazole, the first isomeric protonpump inhibitor (iPPI) are summarized and discussed.

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Six month safety and tolerability of esomeprazole as maintenance therapy in GERD patients with healed erosive esophagitis (EE)

Cited by 4 publications

References 0 publications

Esomeprazole, a New Proton Pump Inhibitor: Pharmacological Characteristics and Clinical Efficacy

Esomeprazole, a New Proton Pump Inhibitor: Pharmacological Characteristics and Clinical Efficacy

Esomeprazole for Acid Peptic Disorders

Chirale Umschaltung (Chiral Switch), ein erfolgreicher Weg zur Entwicklung von Medikamenten: Beispiel Esomeprazol

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