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Nexium (Esomeprazole Magnesium) - Summary

 
 



NEXIUM SUMMARY

Nexium (esomeprazole) is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. It is a proton pump inhibitor.

Healing of Erosive Esophagitis

NEXIUM is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of NEXIUM may be considered.

In infants 1 month to less than 1 year, NEXIUM is indicated for short-term treatment (up to 6 weeks) of erosive esophagitis due to acid-mediated GERD.

Maintenance of Healing of Erosive Esophagitis

NEXIUM is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.

Symptomatic Gastroesophageal Reflux Disease

NEXIUM is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older.

 

H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [ see Dosage and Administration (2) and Clinical Studies (14) ].

In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [ see Clinical Pharmacology (12.4) and the prescribing information for clarithromycin ].

 

NEXIUM is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.

 

 


See all Nexium indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Nexium (Esomeprazole)

Randomised clinical trial: daily pantoprazole magnesium 40 mg vs. esomeprazole 40 mg for gastro-oesophageal reflux disease, assessed by endoscopy and symptoms. [2014]
AIM: To compare the efficacy of pantoprazole-Mg and esomeprazole in GERD... CONCLUSIONS: Pantoprazole-Mg 40 mg was at least as effective as esomeprazole

[Efficacy and safety of esomeprazole, compared with omeprazole, in maintenance therapy for reflux esophagitis -a phase III, multicenter, randomized, double-blind trial-]. [Article in Japanese] [2013]
A multicenter, randomized, double-blind study comparing the efficacy and safety of esomeprazole 20mg/day (E20) and 10mg/day (E10) with omeprazole 10mg/day (O10) for maintenance of remission in patients with healed reflux esophagitis (RE). For RE, at week 24, the estimated Kaplan-Meier recurrence-free rates were 92.0%, 87.5%, and 82.7% in the E20, E10, and O10 groups, respectively...

A combination of esomeprazole and aspirin reduces tissue concentrations of prostaglandin E(2) in patients with Barrett's esophagus. [2012]
CONCLUSIONS: In combination with esomeprazole, short-term administration of

Prospective, randomized, placebo-controlled evaluation of esomeprazole in coronary artery disease patients. EPAC: esomeprazole prevention of atypical chest pains. [2011.06]
BACKGROUND: Coronary artery disease (CAD) patients experience chest pain (CP) from cardiac and non-cardiac etiologies. OBJECTIVE: Proton pump inhibitor (PPI) treatment of CAD patients with atypical CP would result in less CP, as well as fewer emergency room (ER) visits for CP, medical evaluations, and hospitalizations... CONCLUSIONS: Concomitant esomeprazole therapy in CAD patients without active ischemia but with a history of atypical CP reduces number of patients with further CP symptoms and medical office visits for CP. Larger studies are needed to further evaluate PPI treatment on ER CP visits and hospitalizations in this patient population.

Fixed-dose combination of enteric-coated naproxen and immediate-release esomeprazole has comparable efficacy to celecoxib for knee osteoarthritis: two randomized trials. [2011.06]
CONCLUSIONS: Naproxen/esomeprazole magnesium has comparable efficacy to celecoxib for the management of pain associated with osteoarthritis of the knee over 12 weeks.

more studies >>

Clinical Trials Related to Nexium (Esomeprazole)

Nexium Study To Suppress Nausea During Chemotherapy [Terminated]
This study will look at a drug called esomeprazole, the newest PPI, as a way to further reduce the amount of nausea and vomiting seen in breast cancer patients receiving adriamycin or epirubicin chemotherapy. Esomeprazole may help protect the gut lining from the stomach acid and thus lessen the nausea and vomiting. If patients have less stomach sickness, they may be able to enjoy their daily routines much more while they are getting chemotherapy.

Viokase 16, Viokase16 Plus Nexium and Nexium Alone [Terminated]
Our primary hypothesis is that the addition of Nexium to Viokase 16 will decrease the chronic abdominal pain in patients with small duct chronic pancreatitis in a superior fashion compared to Viokase 16 plus placebo or to Nexium alone. A secondary hypothesis would be an increase in quality of life. Our objective is to elucidate the role of Nexium in the control of pancreatic pain, quality of life, and narcotic usage alone or when added to Viokase 16. Our endpoints are the reduction of abdominal pain, decreased pain medication usage, decreased ER visits and decreased hospital admissions for abdominal pain.

The Effect of Nexium and Probiotics on Insulin Secretion and Cardiovascular Risk Factors in Patients With Type 2 Diabetes [Completed]

Plasm Gastrin Concentrations in Response to Nexium Administration in Healthy Volunteers [Completed]
This dose response study is proposed to explore the extent to which Nexium increases endogenous gastrin concentrations and to assess whether Nexium treatment may be useful in the setting of islet cell transplantation for type 1 diabetes to expand islet cells in vivo after transplant.

Study Comparing the Effects of Esomeprazole Adminstered Orally and Intravenously on Basal and Pentrigastrin-stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD) [Completed]
The purpose of this study is to examine the effects of Nexium at a dose of 40mg administered orally compared to intravenously on the maximum acid output in subjects with symptoms of Gastroesophageal reflux disease (GERD).

more trials >>

Reports of Suspected Nexium (Esomeprazole) Side Effects

Drug Dose Omission (5400)Gastrooesophageal Reflux Disease (3182)Malaise (2313)Osteoporosis (1667)Dyspepsia (1661)Drug Ineffective (1621)Multiple Fractures (1284)Intentional Drug Misuse (1063)Pain (986)Vomiting (973)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 37 ratings/reviews, Nexium has an overall score of 7.86. The effectiveness score is 8.70 and the side effect score is 9.03. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Nexium review by 43 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   GERD
Dosage & duration:   40 MG taken once a day for the period of 2 years
Other conditions:   Asthma
Other drugs taken:   albuteral as needed
  
Reported Results
Benefits:   Prior to taking Nexium I had continuous GERD. I took every type of antacid over the counter. In addition I had more episodes of Asthma and cystitis. Whenever I had extreme heartburn I would also get the other 2 problems mentioned above.
Side effects:   I have not had any side effects with this medicine, however I worry about it's long-term use and possible future side effects.
Comments:   I was first prescribed this medicine by my family practitioner. In order to get a refill on the medication, I had to go to a GI doctor and be scoped. My GI stated that I could be on this medicine indefinitely. Whenever I forget to take the medicine my GERD returns the next day, along with the other problems.

 

Nexium review by 55 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   ACID REFLUX
Dosage & duration:   100 GMS (dosage frequency: once a day) for the period of 90 DAYS
Other conditions:   NONE
Other drugs taken:   NONE
  
Reported Results
Benefits:   NO MORE HEART BURN OR ACID REFLUX
Side effects:   NO SIDE EFFECTS
Comments:   WAS VERY PLEASED WITH THE RESULTS

 

Nexium review by 56 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   Acid reflux, GERD
Dosage & duration:   40 mg. taken twice a day for the period of 1 week
Other conditions:   Diabetes, Hypertension
Other drugs taken:   Metformin, Verapamil, Lyrica
  
Reported Results
Benefits:   The Nexium was effective in stopping my heart burn.
Side effects:   I had severe side effects. I itched all over, broke out in hives. I had chest pain and swelling of the lips and eyes. I had to immediately take benedril to stop the drug reactions. I felt nausiated for days after the adverse drug reaction.
Comments:   I had been taking Prevacid for years with success and no adverse drug reactions. I had to switch because my insurance would not pay for the Prevacid any more because there was a Generic form of Prevacid. I tried the generic but it was not effective so I was given the prescription for Nexium. The Nexium was effective but I was highly allergic to it.

See all Nexium reviews / ratings >>

Page last updated: 2014-12-01

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