RESEARCH - Nexium (esomeprazole) for NSAID ulcers

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Esomeprazole for NSAID ulcers

Rheumawire

Jun 7, 2005

Gandey

Nottingham, UK - Two AstraZeneca-funded studies have found that esomeprazole

magnesium (Nexium) cuts gastrointestinal (GI) symptoms in patients on

chronic NSAID therapy, including coxibs [1]. " People who use NSAIDs

regularly are at high risk for upper-GI disturbances, including dyspepsia,

abdominal pain, and heartburn, " Dr Scheiman (University of Michigan,

Ann Arbor) said in a company-issued press release. " Although reducing the

NSAID dosage or discontinuing therapy might ease GI symptoms, these

alterations often are not an option for many patients because of the chronic

nature of their underlying condition. These two trials demonstrate that

Nexium was effective in reducing upper-GI symptoms of patients on chronic

NSAID therapy. "

Led by Dr Hawkey (University Hospital, Nottingham, UK), the study

authors, mostly employees and consultants for AstraZeneca, point out that

proton-pump inhibitors are now well recognized as valuable agents for the

prevention of recurrent ulcer complications in patients using NSAIDs. In the

May 2005 issue of the American Journal of Gastroenterology, they write,

" Other recently reported data have also shown a reduction in the incidence

of ulcer development in patients using selective COX-2 inhibitors as well as

nonselective NSAIDs if they are given esomeprazole. "

But critics say that the product is too expensive. And for the first time,

the US Department of Defense has decided for financial reasons to drop a

licensed medication. " Nexium is not worth the money, period, " Mike

Krensavage, a pharmaceutical industry analyst at Financial

told the Washington Post about the recent decision. " It's pretty dubious to

pay $4 a pill for Nexium when you can get over-the-counter Prilosec for

67¢. "

In their analysis, Hawkey and colleagues evaluate the efficacy,

tolerability, and safety of esomeprazole in treating upper-GI symptoms

associated with continuous NSAID use in a nonulcer population. The

researchers randomized more than 600 patients and studied 550 others from

two multinational, multicenter, double-blind studies, the Nexium

Anti-Inflammatory Symptom Amelioration, protocol SH-NEN-0001 (NASA1) and

Symptom Prevention by Acid Control with Esomeprazole, protocol SH-NEN-0003

(SPACE1) trials. These trials looked at continuous NSAID users free of

gastroduodenal ulcers, erosive esophagitis, and Helicobacter pylori.

Patients were randomized to receive esomeprazole 20 mg or 40 mg or placebo,

once daily, for a period of four weeks. The primary variable was the

patient-reported change in the upper-GI symptom score on a seven-grade

severity scale from the seven days before treatment to the last seven days

in the study.

The researchers found that esomeprazole was associated with highly

significant symptom improvement compared with placebo. " Our data extend the

value of this approach by showing that esomeprazole 20 mg and 40 mg also

reduces upper-GI symptoms in patients using selective COX-2 inhibitors, as

they also do in those using nonselective NSAIDs. "

Hawkey and colleagues point out that the patients included in the study

sought medical attention for upper-GI symptoms, either directly or as a

secondary complaint. They note that patients would therefore have been

motivated to have an endoscopy, because the symptoms could have indicated a

gastroduodenal ulcer. " The resulting study population is not, therefore,

representative of all patients taking NSAIDs or selective COX-2

inhibitorsonly those who are ulcer-free and experiencing upper-abdominal

pain, discomfort, or burning. "

Source

1. Hawkey C, Talley NJ, Yeomans ND, et al. Improvements with

esomeprazole in patients with upper gastrointestinal symptoms taking

non-steroidal antiinflammatory drugs, including selective COX-2 inhibitors.

Am J Gastroenterol 2005; 100:1028-1036.

Not an MD

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org