Results from two clinical trials demonstrate that Esomeprazole ( Nexium ) can reduce upper gastrointestinal ( GI ) symptoms - such as moderate to severe pain, burning and discomfort in the upper abdomen - associated with continuous, daily use of non-steroidal anti-inflammatory drugs ( NSAIDs ), including selective COX-2 inhibitors.

In the trials, Esomeprazole 20 mg and 40 mg significantly improved upper GI symptoms in patients taking NSAIDs, including selective COX-2 inhibitors, versus placebo.

Based on a seven-point patient-assessed scale ( 0 = no pain to 6 = very severe pain ), the average change in pain score among NSAID users over 4 weeks was 2.30 ( 20 mg ) and 2.03 ( 40 mg ) vs. 1.64 ( placebo ) in the first trial ( p<0.001 ), and 2.17 ( 20 mg ) and 2.12 ( 40 mg ) vs. 1.56 ( placebo ) in the second trial ( p<0.001 ).
For patients on COX-2 inhibitors, the mean change was 2.21 and 1.92 vs. 1.64 in the first trial, respectively ( p<0.05 ) and 2.20 and 2.24 vs. 1.58, respectively in the second trial ( p<0.05 ).

Esomeprazole improved symptoms in as early as the second day of treatment and provided significantly faster symptom relief, compared with placebo.

In one trial, 7 consecutive days of symptom relief occurred within an average of 11 and 10 days for patients treated with Esomeprazole 20 mg and 40 mg, respectively, versus 17 days for placebo.

In the other trial, 7 consecutive days of symptom relief occurred within an average of 10 and 11 days for patients treated with Esomeprazole 20 mg and 40 mg, respectively, versus 21 days for placebo.

In addition, over the four-week treatment period, the proportion of symptom-free days was significantly higher for patients treated with Esomeprazole versus placebo in both trials ( 31 percent and 29 percent, vs. 21 percent, and 29 percent and 27 percent, vs. 14 percent in the two trials ).

More patients treated with Esomeprazole ( 20 mg or 40 mg ) also reported improvements on an overall treatment assessment after four weeks of treatment, versus placebo ( 70.6 percent and 56.8 percent for Esomeprazole 20 mg, and 61.1 percent and 54.7 percent for Esomeprazole 40 mg, compared with 47.7 percent and 40.9 percent for placebo in these trials ).

The clinical research trials were two identical, randomized, double-blind, placebo-controlled trials involving a total of 595 and 554 patients, respectively, who were continuous NSAID users and who did not have gastric ulcers, erosive esophagitis or Helicobacter pylori infection.
Approximately one-third of the patients in both trials ( 30 percent, 38 percent ) were taking only selective COX-2 inhibitors.
In the trials, patients received Esomeprazole 20 mg or 40 mg or placebo.

In both trials, the safety profile of Esomeprazole 20 mg and 40 mg among continuous NSAID users was similar to placebo.

Source: American Journal of Gastroenterology, 2005


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