Gastroesophageal reflux (GERD) is a common condition that often occurs without symptoms after meals. In some people, the reflux is related to a problem with the lower esophageal sphincter, a band of muscle fibers that usually closes off the esophagus from the stomach. If this sphincter doesn't close properly, food and liquid can move backward into the esophagus and may cause the symptoms.
Complications
GERD is not a minor disorder. There are several disorders which can result from unmanaged reflux.
• Inflammation of the esophagus
• Stricture
• Esophageal ulcer
• Hoarseness, bronchospasm
• Chronic pulmonary disease
• Barrett's esophagus (a change in the lining of the esophagus that can increase the risk of cancer)
The common forms of treatment are antacids, drugs such as Tagamet, and the most effective, the proton pump inhibitors (ex. Nexium). Now the PPI’s have come under attack as the cause of heart attacks and other heart conditions in the people who are taking them.
This information led the FDA’s to conduct a current analysis of available data concerning Omeprazole (Prilosec) and Esomeprazole (Nexium).
A 14-year study comparing treatment with the drug omeprazole to surgery in patients with severe GERD found that more patients treated with omeprazole had heart attacks, heart failure, and heart-related sudden death than did the patients who had surgery. The difference between the two groups of patients was seen within the first year of the study, and continued over time. A second, still ongoing, study comparing esomeprazole to surgery had five year follow-up information on patients. While the initial data from this study suggested a difference between treatments in the rate of cardiovascular events, an updated report submitted by AstraZeneca 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.
Also, many of the patients who were randomized to the group that was to have surgery withdrew from the study without ever undergoing the surgical procedure. The patients who did undergo surgery tended to be younger, and less likely to have a past history of heart problems or risk factors for heart problems, than those who were treated with one of the drugs. These differences between the two groups of patients could have biased and significantly influenced the safety data from these studies.
Finally, FDA’s preliminary conclusion about the information from these two studies is further supported by an additional analysis of 14 comparative studies of omeprazole, of which four were placebo-controlled. Patients in these studies were treated for up to two years. 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. Although these studies were not specifically conducted to assess the risk of heart problems, and patient follow-up is incomplete, they do not suggest an increased risk of heart problems with the use of omeprazole. FDA will continue its review of all available data.
Based on everything we know now, FDA’s preliminary conclusion is that the observed difference in risk of heart attacks and other heart related problems seen in early analyses of the two small long-term studies is not a true effect.
Prilosec and Nexium are members of a class of drugs called proton pump inhibitors (PPIs) and work by reducing the amount of acid produced by the stomach. Both drugs are used for the treatment of gastroesophageal reflux disease (GERD) including a condition where the lining of the esophagus wears away (erosions), and for maintenance of healing erosions of the esophagus. They are also used for the treatment of ulcers. Prilosec (omeprazole) and Nexium (esomeprazole) are available by prescription. Prilosec is also sold over-the-counter for frequent heartburn.
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