Protonix (Pantoprazole Sodium) - Summary

PROTONIX SUMMARY

The active ingredient in PROTONIX^® (pantoprazole sodium) Delayed-Release Tablets is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1 H -benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C₁₆H₁₄F₂N₃NaO₄S x 1.

PROTONIX^® (pantoprazole sodium) Delayed-Release Tablets are indicated for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those patients who have not healed after 8 weeks of treatment, an additional 8 week course of PROTONIX may be considered.

PROTONIX Delayed-Release Tablets are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in patients with gastroesophageal reflux disease (GERD). Controlled studies did not extend beyond 12 months.

PROTONIX Delayed-Release Tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

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NEWS HIGHLIGHTS

Published Studies Related to Protonix (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.

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Clinical Trials Related to Protonix (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. ReQuest™ 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 (ReQuest™). 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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PATIENT REVIEWS / RATINGS / COMMENTS

Protonix review by 52 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		GERD
Dosage & duration:		40mg taken once a day for the period of 3 months
Other conditions:		hypertension, ulcer
Other drugs taken:		Diovan HCT, Altace
		Reported Results
Benefits:		Within two days, the severe burning pain of the GERD disappeared. At three months of treatment, the pain from the ulcer has receded considerably. Because of the ulcer, however, I still have to be careful not to eat anything too acidic--very fresh pasta sauce with chunks of tomato--or too spicy.
Side effects:		Shortly after starting treatment, I developed diarrhea. It only lasted for a few days, but then I continue to have somewhat pasty stools, with occasional bouts of diarrhea again.
Comments:		I went to the ER with severe burning in the chest. The doctors there suspected either cardiac problems or a blood clot in the lungs. Once they made certain there were no blood clots, and that the EKG and cardiac enzyme levels were normal, they started me on IV protonix. The next day I was switched to pill form of the protonix, and the improvement was amazing. Within thirty-six hours the pain was minimal, and by the third day of treatment, it was virtually gone. Since then, I haven't had any recurrence, and remain on the protonix only because of the ulcer, which is improving, even though at a slower pace. Overall, it's an excellent medication, and had worked wonders for me.

Protonix review by 70 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		acid reflux
Dosage & duration:		20 mg taken once a day for the period of 3 years
Other conditions:		arthritis,shortness of breath
Other drugs taken:		none
		Reported Results
Benefits:		effective in helplng to control acid reflux
Side effects:		none that i know of at the present time.But i donot know what damage it has done if any to any of my internal orgins
Comments:		One tablet once a day

Protonix review by 66 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		gastrointestinal disorder
Dosage & duration:		dont remember (dosage frequency: once daily) for the period of on 2 occasions
Other conditions:		high blood presure
Other drugs taken:		hytrin premerin
		Reported Results
Benefits:		none
Side effects:		On the first occasion I took this drug, I experienced mild tingling and redness of my hands and feet and face. I became somewhat week and faint like . I did not, at the time tie these reactions to the medecation. When I took it on a seperate occasion I experienced extreme tingling, redness and diarea and had to be transported to the hospital where they treated me for toxic shock. passed out
Comments:		Benadril, allegra and other intravenious medication I am not sure of.