Study published in the Journal of the American College of Cardiology
Millions of people around the world take statins to reduce their cholesterol levels and manage heart disease risk factors. A large GE Healthcare retrospective study of electronic medical records found no increased risk of cancer from the use of the medications among the patients studied. The study, “Statins and Risk of Cancer,” was published in July in Journal of the American College of Cardiology (JACC).
Statins, or HMG-CoA reductase inhibitors, are among the most widely prescribed drugs in the United States. The Centers for Disease Control and Prevention (CDC) reports that statin use in the US has grown quickly since they were first introduced in 1987: “the percentage of adults 45 years of age and over using statin drugs has increased from 2% in 1988-1994 to 25% in 2005-2008.”
Paul Cload, Strategic Marketing Leader, Cardiology with GE Healthcare says, “There have been conflicting studies about whether the use of statins is associated with an increased risk of developing cancer. We wanted to see if we could use GE’s comprehensive dataset of electronic medical records to try to answer the question. Key factors that set this study apart are the large size of the dataset, the rigorous study design and the length of time patient records were tracked.”
More than 11 million electronic patient records in the GE Centricity Electronic Medical Records (EMR) database were analyzed after being collected from physicians belonging to MQIC, the Medical Quality Improvement Consortium. Personal identifying information was removed from the data in compliance with privacy laws. Records were divided into two groups of 45, 857 records each, and matched in pairs for more than 30 parameters, such as age, gender, BMI, and high blood pressure, to make them as comparable as possible. On average, matched records were tracked for an average time of 8 years, and 85% were tracked for more than 5 years.
The incidence of cancer in statin patients was 11.37% versus 11.11% in matched, non-statin patients. The difference in cancer incidence between the two groups was not statistically significant. Cload says that the results are groundbreaking because, “If statins were causing cancers, you would expect certain types of cancer to be more prevalent than others, but we found no differences on any of the types of cancer reported in the comprehensive list.”
No study is 100% conclusive; so it is important to keep in mind that results in this study depend on the accuracy of the data as recorded by physicians in patient records, from patients who visited doctors or specialists in their offices. Hospital records were not included. Cload cautions, “While the data is generally representative of the US population, we can’t just take these results and extrapolate them to apply to every American receiving a statin, as we may have underrepresented certain groups.”
Given the size of the dataset and the rigorous study design however, the results are compelling. Cload says that there is enough data in the database to go back and analyze the results by specific statin drug. He sees the statin research as a “proof of concept” study: “If we can do this for statins, we could do this for many other drugs as well, to investigate their safety and efficacy.”
As participation in the Medical Quality Improvement Consortium (MQIC) and numbers of records in the GE Centricity EMR database continue to grow, researchers will be able to harness the power of statistical analysis to help answer more public health questions with greater and greater accuracy.
CONNECT THE DOTS
Learn more about statins and how they can help lower cholesterol. Read more about FDA’s recent recommendation that doctors significantly limit prescribing high doses of a particular kind of statin due to the risk of muscle injury. Importantly, FDA does not want patients to stop taking statins without consulting their doctor. Talk to your doctor if you have questions or concerns. For more information on how electronic medical records (EMRs) can help physicians and their patients, see the GE Healthcare video, EMR by the Numbers.
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