Esomeprazole with aspirin offers moderate benefits

<p class="article-intro">Findings from a randomized phase-III-trial show that taking a high dose of the acid-reducing medicine esomeprazole with low dose aspirin for at least seven years can moderately reduce the risk of developing high grade dysplasia or esophageal cancer, or delay death from any cause in people with Barrett’s esophagus.</p> <hr /> <p class="article-content"><p>The ASPECT-trial randomly assigned 2563 people with Barrett&rsquo;s esophagus to four treatment groups: (i) high dose proton pump inhibitor esomeprazole; (ii) high dose esomeprazole with low dose aspirin; (iii) low dose esomeprazole and (iv) low dose esomeprazole with low dose aspirin. The primary endpoint was time to death from any cause, diagnosis of esophageal cancer or diagnosis of high-grade dysplasia. The analysis adjusted for patient&rsquo;s age and duration of Barrett&rsquo;s esophagus.</p> <p>Patients were followed for a median of 8,9 years, and high dose esomeprazole had a statistically significant benefit on the combined endpoint compared to standard dose esomeprazole (p=0,0459). The most effective treatment was high dose esomeprazole with low dose aspirin. <br />Aspirin showed no benefit compared to no aspirin in the primary analysis. However, there was a weak effect when researchers censored for prior NSAID use.</p> <p>The treatments were safe overall, with serious side effects reported in only 1 % of patients. Although both medicines are generally very safe, precautions should be taken before starting this regimen, noted Dr. Jankowski. The most common side effect of proton pump inhibitors is diarrhea. People with heart disease should be aware that these drugs can interact with various heart medications. Other, much more rare risks include Clostridium difficile infection and osteoporosis. The most serious side effects of aspirin include allergic reactions, bleeding in the stomach, and bleeding in the brain. In addition, people who are already taking another non-steroidal anti-inflammatory drug, should not be taking aspirin.</p> <p>Although this was the largest chemoprevention randomized controlled trial in Barrett&rsquo;s esophagus and with the longest follow-up, more research is needed, noted Dr. Jankowski. The research was conducted in only five countries with mostly White populations, so it is not known if this chemoprevention strategy would be as effective in Black and Asian people, as genetic ancestry can affect treatment efficacy. In addition, the researchers would like to follow patients on this study to see if 9-10 years of chemoprevention is even more effective and whether there is an increased risk for side effects with longer treatment.</p> <p><strong>Reference:</strong> <br />Jankowski, J et al.: Chemoprevention of esophageal cancer with esomeprazole and aspirin therapy: Efficacy and safety in the phase III randomized factorial ASPECT trial. ASCO Annual Meeting 2018, abstract #LBA4008</p></p>