NEWS HIGHLIGHTS
Published Studies Related to Protonix Injection (Pantoprazole)
Comparison of omeprazole and pantoprazole influence on a high 150-mg clopidogrel maintenance dose the PACA (Proton Pump Inhibitors And Clopidogrel Association) prospective randomized study. [2009.09.22]
OBJECTIVES: This study sought to compare the effect of 2 proton pump inhibitors (PPIs) on platelet response to clopidogrel after coronary stenting for non-ST-segment elevation acute coronary syndrome (NSTE ACS). BACKGROUND: Use of omeprazole has been reported to significantly decrease the clopidogrel antiplatelet effect because of cytochrome P450 interaction. Because all PPIs are metabolized by CYP2C19, but to a varying degree, we hypothesized that the reported negative omeprazole-clopidogrel drug interaction may not be caused by a class effect... CONCLUSIONS: The present findings suggest the preferential use of pantoprazole compared with omeprazole in patients receiving clopidogrel to avoid any potential negative interaction with CYP2C19.
Nosocomial pneumonia risk and stress ulcer prophylaxis: a comparison of pantoprazole vs ranitidine in cardiothoracic surgery patients. [2009.08]
BACKGROUND: Stress ulcer prophylaxis (SUP) using ranitidine, a histamine H2 receptor antagonist, has been associated with an increased risk of ventilator-associated pneumonia. The proton pump inhibitor (PPI) pantoprazole is also commonly used for SUP. PPI use has been linked to an increased risk of community-acquired pneumonia. The objective of this study was to determine whether SUP with pantoprazole increases pneumonia risk compared with ranitidine in critically ill patients... CONCLUSION: The use of pantoprazole for SUP was associated with a higher risk of nosocomial pneumonia compared with ranitidine. This relationship warrants further study in a randomized controlled trial.
Recent in vitro findings of negative inotropy of pantoprazole did not translate into clinically relevant effects on left ventricular function in healthy volunteers. [2009.06]
PURPOSE: Reports on cardiac problems with oral proton pump inhibitors have caused extensive safety reviews by the US Food and Drug Administration. We provide additional data on acute cardiac effects of an intravenous application... CONCLUSIONS: Pantoprazole as injection is safe in healthy subjects with respect to cardiac contractile function. However, in view of recent reports of negative inotropy of the drug, further studies in heart failure patients are required.
Effect of preoperative intravenous pantoprazole in elective-surgery patients: a pilot study. [2009.05]
BACKGROUND: This study evaluated the effects of intravenous pantoprazole on gastric volume and acid output in elective-surgical patients... CONCLUSIONS: Intravenous pantoprazole administered prior to anesthesia induction may be efficacious for the reduction of gastric volume and acid output, and for pulmonary aspiration prophylaxis in surgical patients.
Clinical trial: intravenous pantoprazole vs. ranitidine for the prevention of peptic ulcer rebleeding: a multicentre, multinational, randomized trial. [2009.03.01]
BACKGROUND: Controlled pantoprazole data in peptic ulcer bleeding are few. AIM: To compare intravenous (IV) pantoprazole with IV ranitidine for bleeding ulcers... CONCLUSIONS: Outcomes amongst pantoprazole and ranitidine-treated patients were similar; pantoprazole provided benefits in patients with arterial spurting and gastric ulcers.
Clinical Trials Related to Protonix Injection (Pantoprazole)
Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341) [Active, not recruiting]
The aim of the present study is to identify factors (such as symptom patterns and symptom
scores) that influence the response to treatment with pantoprazole using different evaluation
methods (e. g. ReQuestâ„¢ questionnaire, patient and investigator assessment). Pantoprazole will
be administered once daily in the morning at one dose level. The study duration consists of a
treatment period of 8 weeks. The study will provide further data on safety and tolerability
of pantoprazole.
Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Non-Erosive Reflux or Gastroesophageal Reflux Disease (BY1023/DE-004) [Completed]
The aim of the study is to evaluate the effect of pantoprazole on fast symptom reduction in
hospitalized patients with NERD (non-erosive reflux disease) or GERD (gastroesophageal reflux
disease, Los Angeles [LA] Grade A-D). During the study, the patients will complete a
patient-orientated, self-assessed reflux questionnaire (ReQuestâ„¢). The study duration
consists of a treatment period of 7 days ± 3 days. Pantoprazole (tablet) will be administered
once daily in the morning to patients with NERD or GERD at one dose level for each
indication. The study will provide further data on the safety and tolerability of
pantoprazole.
Long-Term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708) [Active, not recruiting]
Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and
esophagus. GERD might occur when the lower esophageal sphincter does not close properly and
stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common
medical disorders, with estimates of up to 50% of adults reporting reflux symptoms. One of
the main symptoms of GERD is heartburn. It occurs when the acidic content from the stomach
touches the lining of the esophagus, causing a burning sensation in the chest or throat.
Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD and peptic ulcers in
a large proportion of patients.
Additionally, long-term treatment with proton pump inhibitors may be needed for patients with
chronic ulcer disease not caused by H. pylori (H. pylori is a stomach-dwelling bacteria which
is often associated with ulcers in the stomach or duodenum).
The aim of the study is to evaluate the long-term effect of pantoprazole in patients with
chronic gastric acid-related complaints. The study duration consists of a 5-year treatment
period. Pantoprazole will be administered once daily. The study will provide further data on
long-term safety, tolerability, and efficacy of pantoprazole.
On-Demand Use of Pantoprazole: Determinants for Chronic Use of Acid Suppressive Medication [Active, not recruiting]
Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-339) [Completed]
Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and
esophagus. GERD occurs when the lower esophageal sphincter does not close properly and
stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common
medical disorders, with estimates of up to 50% of adults reporting symptoms related to
gastric reflux. Proton pump inhibitors (PPI) such as pantoprazole can relieve symptoms of
GERD in a large proportion of patients.
When refluxed stomach acidic content touches the lining of the esophagus, it causes a burning
sensation in the chest or throat. This sensation is often referred to as heartburn. Some
patients have symptoms of GERD without visible destruction of the tissue surface (no visible
changes by endoscopic examination).
The aim of the study is to evaluate the effect of pantoprazole on the complete remission of
GERD. Complete remission is defined as endoscopically confirmed healing and symptom relief
after a maximum of 12-week treatment period. Pantoprazole will be administered once daily in
the morning. Endoscopy will be performed at the start of the study, and then as required
after 4, 8, or 12 weeks. The study will provide further data on safety and tolerability of
pantoprazole.
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