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.)

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NEWS HIGHLIGHTS

Published Studies Related to Nexium (Esomeprazole)

Evaluation of the pharmacokinetic interaction between esomeprazole (40 mg) and acetylsalicylic acid (325 mg) in healthy volunteers. [2009.09]
OBJECTIVE: To evaluate the effect of esomeprazole on the pharmacokinetics of low-dose acetylsalicylic acid (ASA) during repeated co-administration... CONCLUSIONS: There was no pharmacokinetic interaction between esomeprazole (40 mg) and ASA (325 mg) during repeated co-administration in healthy volunteers.

H. pylori eradication prevents the progression of gastric intestinal metaplasia in reflux esophagitis patients using long-term esomeprazole. [2009.07]
OBJECTIVES: This study aimed to determine whether Helicobacter pylori eradication limits the progression of precancerous changes, manifested as intestinal metaplasia (IM), in patients with reflux esophagitis using long-term esomeprazole... CONCLUSIONS: In patients using long-term esomeprazole for reflux esophagitis, screening for and eradicating H. pylori infection are necessary in order to limit the progression or cause the regression of gastric precancerous changes.

Clinical trial: the treatment of gastro-oesophageal reflux disease in primary care--prospective randomized comparison of rabeprazole 20 mg with esomeprazole 20 and 40 mg. [2009.05.01]
BACKGROUND: A trial of empirical PPI therapy is usual practice for most patients with symptoms of gastro-oesophageal reflux disease (GERD) in primary care. AIM: To determine if the 4-week efficacy of rabeprazole 20 mg for resolving heartburn and regurgitation symptoms is non-inferior to esomeprazole 40 mg or 20 mg... CONCLUSIONS: In uninvestigated GERD patients, rabeprazole 20 mg was non-inferior to esomeprazole 40 mg for complete and satisfactory relief of regurgitation and satisfactory relief of heartburn, and not different for complete resolution of heartburn.

Intravenous esomeprazole for prevention of recurrent peptic ulcer bleeding: a randomized trial. [2009.04.07]
BACKGROUND: Use of proton-pump inhibitors in the management of peptic ulcer bleeding is controversial because discrepant results have been reported in different ethnic groups. OBJECTIVE: To determine whether intravenous esomeprazole prevents recurrent peptic ulcer bleeding better than placebo in a multiethnic patient sample... CONCLUSION: High-dose intravenous esomeprazole given after successful endoscopic therapy to patients with high-risk peptic ulcer bleeding reduced recurrent bleeding at 72 hours and had sustained clinical benefits for up to 30 days. PRIMARY FUNDING SOURCE: AstraZeneca Research and Development.

Comparative study of omeprazole, lansoprazole, pantoprazole and esomeprazole for symptom relief in patients with reflux esophagitis. [2009.02.28]
AIM: To clarify whether there is any difference in the symptom relief in patients with reflux esophagitis following the administration of four Proton pump inhibitors (PPIs)... CONCLUSION: Esomeprazole may be more effective than omeprazole, lansoprazole, and pantoprazole for the rapid relief of heartburn symptoms and acid reflux symptoms in patients with reflux esophagitis.

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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.

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PATIENT REVIEWS / RATINGS / COMMENTS

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 37 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Acid Reflux/Chronic Bronchitis
Dosage & duration:		100mg taken daily for the period of 4 months
Other conditions:		Pancreatitis, PND
Other drugs taken:		Advair and a nose spray (the one with the bee on the commercial)
		Reported Results
Benefits:		I found that it did nothing for my acid reflux. Only after I changed how, what and when I ate did I recieve instant relief from both the acid reflux and the chronic bronchitis.
Side effects:		None
Comments:		I was hospitalized for pancreatitis and that's when the coughing started. The pancreatitis subsided but the coughing worsened, especially at night. I was diagnosed with acid reflux and "hyperinflated lungs", whatever that means. The coughing would keep me up all night. I saw both an allergist and a pulmonologist; the allergist prescribed Nexium and the pulmonologist prescribed Advair, the nasal spray with the bee spokesperson, and an inhaler that made me so jittery that I did not sleep for an entire night when I took it. He also prescribed a codeine syrup that make me incredibly sick to my stomach. I hated being on all those meds. I did some research and decided to modify the size and content of my dinner, and eat it earlier in the evening. No more snacking or ice cream after dinner. My symptoms immediately stopped. I took myself off all meds and never went back to those doctors -- I had no need to.

Nexium review by 32 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		acic reflux
Dosage & duration:		one pill taken once a day for the period of 1 year
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		The treatment benefits are that it has stopped the acid from coming up into my esphogus. I also has benefited from further damage to my esphogus from the acid reflux. I do not have bad breath from the acid and i am no longer horse in my throat when i talk alot. The nexxium has stopped my stomach from producing acid.
Side effects:		After about a couple of months i began to experience severe stomach cramping, bloating, and diareaha. My body is now completely depended on the drug and my understanding is that the pill is telling my body not to produce acid which in turn works harder to produce more, which makes since when i have tried to go off of it my acid reflux was 20 times worse. My body has become completely dependent on the drug.
Comments:		The treatment details were that i did not need to change my diet, but to just take one pill every day and that would take care of my issue with my body producing to much acid.