The FDA has issued its conclusions regarding two small long-term clinical studies of patients with severe GERD. In these studies, patients were chosen to either receive treatment with medication (omeprazole [Prilosec] or esomeprazole [Nexium]), or to have surgery to control their gastroesophageal reflux disease.
While early results from the study raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, and heart-related sudden death in those patients taking either one of the drugs compared to patients who received surgery.
The FDA’s preliminary conclusion is that this data does not suggest an increased risk of heart problems.
While the initial data from this study suggested a difference between treatments in the rate of cardiovascular events, an updated report found that the number of patients who experienced heart problems was similar in both treatment groups.
While both of these studies collected safety data, the study protocols did not specify how heart problems, such as heart attacks, were to be defined or documented. As a result, evaluating the information that has been gathered about the safety of either drug in these studies is difficult.
The FDA’s conclusions are further supported by an additional analysis of 14 comparative studies of omeprazole, of which four were placebo-controlled. In these studies, there were fewer heart attacks or other heart problems reported in the patients treated with omeprazole compared to patients that were given a placebo.
