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Stanford researchers use data mining to show safety of peripheral artery disease treatment

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Every day, doctors across the country take down reams of information about their patients. Those notes are a treasure trove of information about preventive treatments, side effects of drugs and drug interactions. But most of this information has been hard to access - until now.

In the past, researchers who really wanted the data have combed through individual records - which can be hundreds of pages - manually. When I worked as an epidemiologist at the California Department of Public Health, for example, I worked on a large study that looked at prenatal hospital records for infectious disease lab testing – and our team of a dozen researchers took months to go through a few hundred records. It’s not an efficient approach for most diseases medical researchers might want to study. Recently launched national efforts also recognize this limitation and call for turning data from regular doctor visits into data points to figure out what is best for patients.

So when I learned that Nigam Shah, MBBS, PhD, a biomedical informatics professor at Stanford, has been looking at ways to pull out information electronically from clinical notes, my ears perked up.

In a paper published today in the journal PLOS ONE, Shah and co-authors Nicholas Leeper, MD, a Stanford cardiologist and vascular medicine specialist, and Anna Bauer-Mehren, PhD, an informaticist who recently moved from Stanford to Roche Germany, used a new methodology to answer a nagging question about the safety of Cilostazol, the only drug with the American Heart Association’s highest effectiveness rating - Class 1A - for treating the symptoms of peripheral arterial disease, a condition that affects millions of Americans. Regulators fear the drug might have side effects on the cardiovascular system that could lead to death, so the drug has historically carried a “black-box warning.” As a result, the use of this drug has been limited.

Looking at a specialized system that includes health-research data from millions of patients seen at Stanford Hospital over 18 years, the researchers found no evidence that patients with peripheral arterial disease who took Cilostazol suffered the side effects about which doctors were worried, compared with patients who didn’t receive the drug. By querying these records, the researchers identified a subset of patients they felt were at highest risk - a group which is often excluded from company-sponsored trials - and found no evidence of the side effects.

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