Report of potential interaction between PPIs, clopidogrel

 

The January 2009 issue of GI & Hepatology News (GIHN) featured an article on the potential drug interaction between proton pump inhibitors (PPIs) and clopidogrel.

In the study of interest, researchers retrospectively reviewed 16,000 patients prescribed clopidogrel after percutaneous coronary intervention (PCI) and found that those patients also on a PPI were 1.5 times as likely to suffer from a myocardial infarction, stroke, or be hospitalized for angina as those not on a PPI. A second study mentioned in the GIHN article, a post hoc analysis of the CREDO trial, found a higher rate of ischemic events in patients on a PPI, but this increase was seen whether the patient was on clopidogrel or not. The conflicting data presented a management challenge for cardiologists and gastroenterologists alike.

It is important to note that the chair of the session where these two analyses were presented and subsequent statements from professional societies all suggested that there was no need to change practice … but practice did change. In my own center at the time, a new potential interaction alert was found in the medical record. Some of my patients shunned their PPIs. The findings were of sufficient concern that the Food and Drug Administration added a warning on the labeling of clopidogrel regarding the concomitant use of clopidogrel and omeprazole. One study (PLoS One. 11[1]:e0145504) found a 40% drop in combined clopidogrel-PPI users after this FDA communication.

Multiple subsequent studies, including a large randomized trial, COGENT (N Engl J Med. 2010;363:1909-17), comparing omeprazole with placebo in patients on clopidogrel, found no significant interaction. A consensus document published in December 2010 acknowledged the potential risks from pharmacodynamic studies but suggested that the clinical data were unclear.

This story speaks to the power of research to change practice, the importance of effectively communicating research findings to the public, and the fact that the practice of medicine is often an exercise in balancing conflicting data on behalf of our patients.
 

Ziad Gellad, MD, MPH, is associate professor of medicine in the division of gastroenterology, Duke University Medical Center, Durham, N.C.; a faculty member at the Duke Clinical Research Institute; and an Associate Editor of GI & Hepatology News.

 

The January 2009 issue of GI & Hepatology News (GIHN) featured an article on the potential drug interaction between proton pump inhibitors (PPIs) and clopidogrel.

In the study of interest, researchers retrospectively reviewed 16,000 patients prescribed clopidogrel after percutaneous coronary intervention (PCI) and found that those patients also on a PPI were 1.5 times as likely to suffer from a myocardial infarction, stroke, or be hospitalized for angina as those not on a PPI. A second study mentioned in the GIHN article, a post hoc analysis of the CREDO trial, found a higher rate of ischemic events in patients on a PPI, but this increase was seen whether the patient was on clopidogrel or not. The conflicting data presented a management challenge for cardiologists and gastroenterologists alike.

It is important to note that the chair of the session where these two analyses were presented and subsequent statements from professional societies all suggested that there was no need to change practice … but practice did change. In my own center at the time, a new potential interaction alert was found in the medical record. Some of my patients shunned their PPIs. The findings were of sufficient concern that the Food and Drug Administration added a warning on the labeling of clopidogrel regarding the concomitant use of clopidogrel and omeprazole. One study (PLoS One. 11[1]:e0145504) found a 40% drop in combined clopidogrel-PPI users after this FDA communication.

Multiple subsequent studies, including a large randomized trial, COGENT (N Engl J Med. 2010;363:1909-17), comparing omeprazole with placebo in patients on clopidogrel, found no significant interaction. A consensus document published in December 2010 acknowledged the potential risks from pharmacodynamic studies but suggested that the clinical data were unclear.

This story speaks to the power of research to change practice, the importance of effectively communicating research findings to the public, and the fact that the practice of medicine is often an exercise in balancing conflicting data on behalf of our patients.
 

Ziad Gellad, MD, MPH, is associate professor of medicine in the division of gastroenterology, Duke University Medical Center, Durham, N.C.; a faculty member at the Duke Clinical Research Institute; and an Associate Editor of GI & Hepatology News.

 

The January 2009 issue of GI & Hepatology News (GIHN) featured an article on the potential drug interaction between proton pump inhibitors (PPIs) and clopidogrel.

In the study of interest, researchers retrospectively reviewed 16,000 patients prescribed clopidogrel after percutaneous coronary intervention (PCI) and found that those patients also on a PPI were 1.5 times as likely to suffer from a myocardial infarction, stroke, or be hospitalized for angina as those not on a PPI. A second study mentioned in the GIHN article, a post hoc analysis of the CREDO trial, found a higher rate of ischemic events in patients on a PPI, but this increase was seen whether the patient was on clopidogrel or not. The conflicting data presented a management challenge for cardiologists and gastroenterologists alike.

It is important to note that the chair of the session where these two analyses were presented and subsequent statements from professional societies all suggested that there was no need to change practice … but practice did change. In my own center at the time, a new potential interaction alert was found in the medical record. Some of my patients shunned their PPIs. The findings were of sufficient concern that the Food and Drug Administration added a warning on the labeling of clopidogrel regarding the concomitant use of clopidogrel and omeprazole. One study (PLoS One. 11[1]:e0145504) found a 40% drop in combined clopidogrel-PPI users after this FDA communication.

Multiple subsequent studies, including a large randomized trial, COGENT (N Engl J Med. 2010;363:1909-17), comparing omeprazole with placebo in patients on clopidogrel, found no significant interaction. A consensus document published in December 2010 acknowledged the potential risks from pharmacodynamic studies but suggested that the clinical data were unclear.

This story speaks to the power of research to change practice, the importance of effectively communicating research findings to the public, and the fact that the practice of medicine is often an exercise in balancing conflicting data on behalf of our patients.
 

Ziad Gellad, MD, MPH, is associate professor of medicine in the division of gastroenterology, Duke University Medical Center, Durham, N.C.; a faculty member at the Duke Clinical Research Institute; and an Associate Editor of GI & Hepatology News.