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Nexium (Esomeprazole Magnesium) - Summary

 
 



NEXIUM SUMMARY

The active ingredient in NEXIUM® (esomeprazolemagnesium) Delayed-Release Capsules is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole-1-yl) magnesium trihydrate, a compound that inhibits gastric acid secretion. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers.

NEXIUM is indicated for the following:

TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD)

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 4-8 weeks of treatment, an additional 4-8 week course of NEXIUM may be considered.

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 treatment of heartburn and other symptoms associated with GERD.

H. PYLORI ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE

Triple Therapy (NEXIUM plus amoxicillin and clarithromycin): NEXIUM, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with 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 Clinical Studies and DOSAGE AND ADMINISTRATION.)

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, Microbiology and the clarithromycin package insert, CLINICAL PHARMACOLOGY, Microbiology.)


See all Nexium indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Nexium (Esomeprazole)

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.

Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD: the LOTUS randomized clinical trial. [2011.05.18]
CONTEXT: Gastroesophageal reflux disease (GERD) is a chronic, relapsing disease with symptoms that have negative effects on daily life. Two treatment options are long-term medication or surgery. OBJECTIVE: To evaluate optimized esomeprazole therapy vs standardized laparoscopic antireflux surgery (LARS) in patients with GERD... CONCLUSION: This multicenter clinical trial demonstrated that with contemporary antireflux therapy for GERD, either by drug-induced acid suppression with esomeprazole or by LARS, most patients achieve and remain in remission at 5 years. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00251927.

Prevention of peptic ulcers with esomeprazole in patients at risk of ulcer development treated with low-dose acetylsalicylic acid: a randomised, controlled trial (OBERON). [2011.05]
OBJECTIVE: To determine whether once-daily esomeprazole 40 mg or 20 mg compared with placebo reduces the incidence of peptic ulcers over 26 weeks of treatment in patients taking low-dose acetylsalicylic acid (ASA) and who are at risk for ulcer development... Conclusions Acid-suppressive treatment with once-daily esomeprazole 40 mg or 20 mg reduces the occurrence of peptic ulcers in patients at risk for ulcer development who are taking low-dose ASA.

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Clinical Trials Related to Nexium (Esomeprazole)

Prevention of Gastric Ulcers [Completed]
Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the prevention of these gastric ulcers with one of the three following treatment groups for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; versus placebo; in patients at risk.

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).

A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® [Active, not recruiting]
Open-label randomized crossover design studies. 60 subjects will be evaluated on Day 1 to compare effects on stomach acid; 30 subjects will continue treatment for 7 days and will have repeat evaluations at Day 7.

Ulcer Prevention II [Completed]
Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the prevention of these gastric ulcers, in patients deemed to be at risk, with either esomeprazole 40 mg once daily; esomeprazole 20 mg once daily.

A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued [Completed]
Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the treatment of these gastric ulcers with one of the three following treatment groups: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily.

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.

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Page last updated: 2013-02-10

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