Posted by medconsumers on May 17, 2010
Americans take way too many heartburn drugs. They take them for inappropriate reasons, at higher than necessary doses, and for longer than necessary periods of time. Indicted is the potent class of drugs called proton pump inhibitors sold under multiple brand names like Nexium, Prevacid, Prilosec and generic names like omeprazole. Overuse of these drugs that suppress stomach acid can increase the risk of bone fracture and a potentially fatal hospital-acquired infection called Clostridium difficile. These are some of the findings from studies published in the current issue of Archives of Internal Medicine, which also provides guidance re who should and who should not be taking these drugs.
Increases in fractures of the forearm, spine, arm or wrist were shown in a study of women who took PPIs and were followed for nearly eight years. The increases were described as “modest” by editorialist Mitchell H. Katz, MD, San Francisco Department of Public Health, who added, “But increases of common conditions due to commonly used medications add up to a lot of morbidity on a population level.” Dr. Katz was speaking of the “staggering 113.4 million prescriptions for PPIs filled yearly in the U.S.” This study did not find an increase in the risk of hip fracture which had been shown in previous population studies of PPI users. The exact reason for PPI-related fractures is unknown, but researchers suspect that suppression of stomach acid may interfere with calcium absorption.
The increases in the risk of Clostridium difficile infection shown in the second PPI study were “not at all modest,” according to Dr. Katz. Apparently, stomach acid protects against infections, especially those as life-threatening as C. difficile. This infection is a serious threat in hospitals and is found increasingly in the community. This study was done in over 101,000 people discharged from hospitals over a five-year period.
The researchers found that as the level of stomach acid suppression increased, so did the risk of C. difficile infection. In other words, the increase in those who suffered a C. difficile was clearly related to PPI dose. Hospital patients who received a daily PPI showed a 53% increase in the risk of C. difficile compared to those who did not. The increase climbed to 95% in those who received a PPI more than once a day. The risk was the highest in the patients over age 80 given high PPI doses and in patients given antibiotics. This is not the first time that antibiotics were shown to be counterproductive in a hospital setting. Overuse of PPIs in hospital patients has been noted in an earlier study. (For ways to protect yourself from a hospital-acquired infection, click here.)
Bleeding Peptic Ulcers
Now for the prevailing medical wisdom about high-dose PPI protection against upper gastrointestinal bleeding. This time, it’s not just one study but a review of seven high-quality clinical trials with a total of 1,157 participants. The participants had been treated for peptic ulcers and the PPIs were given afterwards to reduce their risk of rebleeding.
The standard treatment, based on multiple studies, is high-dose PPI given as continuous infusions over a 72-hour period. However, the reviewers pointed out that “no concrete evidence” has shown that high-doses were better than lower doses. They searched the medical literature and found seven high-quality studies that compared people with bleeding peptic ulcers given either high-dose PPIs or a lower dose of PPIs. The conclusion: “High-dose PPIs do not further reduce the rates of rebleeding.”
These PPI studies are part of the newly announced “Less is More” series that will be a regular feature of Archives of Internal Medicine, a journal published by the American Medical Association. The series is a direct response to the “more is better” American approach to medical care. The series will continue to focus attention on “the overuse of medical care [that] may result in harm and in which less care is likely to result in better care.” Between 53 percent and 69 percent of proton pump inhibitor prescriptions are prescribed for inappropriate indications.
How to tell when PPI use is appropriate
Too many people are taking PPIs for garden-variety heartburn (and no ulcers or esophagitis), aka persistant indigestion, largely due to the aggressive promotion of these drugs to doctors and the general public (remember the “purple pill” campaign?). The Archives of Internal Medicine’s new series is aimed at doctors, but it provides guidance for people taking PPIs as well.
Conditions inappropriately treated with PPIs: heartburn in the absence of ulcer disease, esophagitis, or severe gastroesophageal reflux disease (GERD). PPIs clearly alleviate these conditions but the risks of chronic use are too high to justify. Alternatives are dietary changes and/or switching to less risky heartburn drugs.
Conditions appropriately treated with PPIs: Erosive and ulcerative esophagitis, Barrett esophagus, Zollinger-Ellison syndrome, GERD, the short-term treatment of ulcer disease; as part ISSN 2155-1480of a combination regimen for Helicobacter pylori eradication, and the prevention of ulcers due to chronic use of non-steroidal, anti-inflammatory drugs (e.g, Tylenol, aspirin, ibuprofen, etc).
Maryann Napoli, Center for Medical Consumers©