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Vimovo (Esomeprazole Magnesium / Naproxen) - Summary

 
 



Cardiovascular Risk

• Non-Steroidal Anti-inflammatory Drugs (NSAIDs), a component of VIMOVO, may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [see Warnings and Precautions (5.1)].

• VIMOVO is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4), and Warnings and Precautions (5.1)].

Gastrointestinal Risk

• NSAIDs, including naproxen, a component of VIMOVO, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events [see Warnings and Precautions (5.4)].

 

VIMOVO SUMMARY

The active ingredients of VIMOVO are naproxen which is a NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI).

VIMOVO is a combination product that contains naproxen and esomeprazole. It is indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond 6 months.


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NEWS HIGHLIGHTS

Published Studies Related to Vimovo (Esomeprazole / Naproxen)

Impact of a Fixed-Dose Combination of Naproxen and Esomeprazole Magnesium on Serum Thromboxane B(2) Inhibition by Low-Dose Aspirin Over 5 Days in Healthy Adults: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Noninferiority Trial. [2011.11.09]
Background: Low-dose aspirin (LDA) and nonsteroidal anti-inflammatory drugs (NSAIDs) are often used concomitantly; however, some NSAIDs may interfere with LDA antiplatelet activity. OBJECTIVE: We evaluated the impact of coadministered enteric-coated naproxen 500 mg and immediate-release esomeprazole magnesium 20 mg (fixed-dose combination) on LDA-mediated platelet cyclooxygenase (COX)-1 inhibition... CONCLUSIONS: This pilot investigation suggests that LDA coadministered with naproxen/esomeprazole magnesium is noninferior to LDA alone for platelet COX-1 inhibition, as measured by serum TXB(2) concentration, in healthy volunteers. ClinicalTrials.gov identifier: NCT01094483. Copyright (c) 2011 Elsevier HS Journals, Inc. All rights reserved.

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.

Long-term safety of naproxen and esomeprazole magnesium fixed-dose combination: phase III study in patients at risk for NSAID-associated gastric ulcers. [2011.04]
CONCLUSIONS: Based on these outcome measures, long-term treatment with FDC naproxen/esomeprazole is not associated with any new safety issues, including predefined UGI and cardiovascular AEs, in patients requiring NSAID therapy who are at risk of UGI complications.

Clinical trial: the incidence of NSAID-associated endoscopic gastric ulcers in patients treated with PN 400 (naproxen plus esomeprazole magnesium) vs. enteric-coated naproxen alone. [2010]
naproxen 500 mg and immediate-release esomeprazole 20 mg], or EC naproxen... CONCLUSIONS: PN 400 significantly reduces the incidence of gastric ulcers,

A fixed-dose combination of naproxen and esomeprazole magnesium has comparable upper gastrointestinal tolerability to celecoxib in patients with osteoarthritis of the knee: Results from two randomized, parallel-group, placebo-controlled trials. [2011.12]
Abstract Background. Non-steroidal anti-inflammatory drugs are associated with poor upper gastrointestinal (UGI) tolerability and increased ulcer risk, but patient adherence to gastroprotective co-therapy is frequently inadequate.Naproxen/esomeprazole magnesium has comparable UGI tolerability to celecoxib in patients with osteoarthritis.

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Clinical Trials Related to Vimovo (Esomeprazole / Naproxen)

A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA) [Recruiting]
A 6 month study of VIMOVO in adolescents aged 12-16 years with juvenile idiopathic Arthritis (JIA)

Assessment of Pharmacokinetics of a Single Oral Dose of VIMOVO in Healthy Adult Volunteers [Recruiting]

Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty? [Recruiting]
Range from 24% to 44%, with a prevalence of neuropathic-type pain from 6% to 20%-cause impairment in quality of life and functional capacity after total knee arthroplasty(TKA). Duloxetine (cymbalta) is a selective serotonin and nor-epinephrine reuptake inhibitor shown to be effective in treating chronic pain. Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core mood symptoms and help regulate the perception of pain. Its effects on depression and anxiety symptoms, as well as its effect on pain perception, may be due to increasing the activity of serotonin and norepinephrine in the central nervous system. Approved for the acute and maintenance treatment of major depressive disorder, the acute treatment of generalized anxiety disorder, the management of diabetic peripheral neuropathic pain and the management of fibromyalgia, all in adults (18+). Investigators will compare the neuropathic pain following TKA in duloxetine group (n=84) with those in non-duloxetine group (n=84). Investigators will classify the participants in to 2 groups (duloxetine and non-duloxetine group) randomly, and primarily evaluate the degree of neuropathic pain using the S-LANSS pain scale (preoperatively and postoperatively 3 and 6 months). All participants will receive postoperative pain control after TKA using the same pain control regimen except duloxetine.

Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Naprosyn E [Recruiting]
The purpose of the study is to investigate the uptake in the body of naproxen; one of the two active substances in PN400. We also want to show that the body's uptake of naproxen given as PN400 is comparable to that of currently marketed naproxen tablets.

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Reports of Suspected Vimovo (Esomeprazole / Naproxen) Side Effects

Drug Dose Omission (34)Pain (33)OFF Label USE (26)Arthritis (22)Abdominal Discomfort (18)Malaise (18)Drug Ineffective (15)Arthralgia (14)Gastrooesophageal Reflux Disease (12)Dyspnoea (12)more >>


Page last updated: 2013-02-10

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