The FDA has issued its final assessment of two clinical studies in patients with gastro-esophageal reflux disease (GERD), comparing anti-reflux surgery with AztraZeneca’s Prilosec, or omeprazole, (SOPRAN study) and Nexium (LOTUS study) treatment.
The agency said the studies were designed to assess the effectiveness of treatment with Prilosec or Nexium, or surgery for severe GERD. Participants were randomly assigned to receive treatment with either a drug or surgery. During the studies, cardiovascular events raised a question about whether long-term use of these drugs increases the risk of heart attacks, heart failure, and heart-related sudden death in patients taking either one of the drugs compared to patients who received surgical treatment, the FDA said.
The FDA said it has completed a comprehensive, scientific review of safety data for Prilosec and Nexium. The agency assessed the data gathered from the studies reported on May 29, which was further supported by an additional analysis of 14 comparative studies of Prilosec, four of which were placebo-controlled.
The agency concluded that “although the studies were not specifically conducted to assess the risk of heart problems and patient follow-up was incomplete, they do not suggest an increased risk of heart problems with the use of Prilosec or its newer formulation Nexium.”
In response, AstraZeneca of London said it supports the conclusion made by the FDA that the overall benefit and risk profiles of Prilosec and Nexium remain unchanged.