New Statins Guidelines Will Prevent More Heart Attacks, Stroke But Treat More Who May Not Need Them

Michael J. Pencina, PhD Professor of Biostatistics and Bioinformatics Director of Biostatistics Duke Clinical Research Institute Durham, NC 27710 MedicalResearch.com Interview with:
Michael J. Pencina, PhD
Professor of Biostatistics and Bioinformatics
Director of Biostatistics
Duke Clinical Research Institute
Durham, NC 27710

MedicalResearch.com: What motivated your research?

Dr. Pencina: After the new guidelines were issued last November, we were intrigued by the change in treatment philosophy from that based on cholesterol levels (used by the “old guidelines” known as NCEP ATPIII) to one based on 10-year risk of cardiovascular disease (used by the new AHA-ACC guidelines).  We were curious what the practical consequences of this shift would be.

Furthermore, the media quoted a lot of experts making educated guesses on the impact.  We realized that this question can be answered much more precisely based on the NHANES data.

MedicalResearch.com: What are the main findings of the study?

Dr. Pencina: The new guidelines could result in 49 percent of U.S. adults ages 40-75 being recommended for statin therapy, an increase from 38 percent, or 12.8 million potential new users.

Those most affected by the new recommendations are older men who are not on statins and do not have cardiovascular disease. Under the earlier guidelines, about 30.4 percent of this group of men between the ages of 60-75 were recommended for statin use. With the new guidelines, 87.4 percent of these men would be candidates for the therapy. Similarly for healthy women in this age group, those recommended for preventive statin use are projected to rise from 21.2 percent to 53.6 percent.

MedicalResearch.com: Were any of the findings unexpected?

Dr. Pencina: While we expected a more steep increase in recommendations in the older age group, we were surprised to see that almost all of the increase happens in those 60-75 years of age. In this older age group 77 percent US adults are already taking or are recommended for statins under the new guidelines versus 48 percent under the previous standards. This contrasts with a modest increase from 27 percent to 30 percent among U.S. adults between the ages of 40 and 59.

MedicalResearch.com: What should clinicians and patients take away from your report?

Dr. Pencina: The new guidelines lead to an increased sensitivity (17% more people likely to develop cardiovascular disease events in the next 10 years could be treated) but decreased specificity (9% more people not likely to develop CVD in the next 10 years could be treated). So we will prevent more heart attacks and strokes but treat more people who may not need it.  As the guidelines suggest, it is essential that patients and doctors engage in an informed discussion about the potentials benefits and risks of statins for every individual.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Dr. Pencina: We hope that our publication will stimulate further discussion and research.  First, we hope that our work will increase general awareness of cardiovascular risk.  Moreover, the new guidelines are based on many important assumptions that should be tested in practice.  The benefits of risk-based approach versus lipid level-based approach need to be examined in more depth.  It is also important to see if 10-year risk horizon is adequate.  Whether younger adults with elevated cholesterol should still be treated needs to be determined.  Finally, the safety of long-term statin use should be investigated further.

Citation:

Application of New Cholesterol Guidelines to a Population-Based Sample

Michael J. Pencina, Ph.D., Ann Marie Navar-Boggan, M.D., Ph.D., Ralph B. D’Agostino, Sr., Ph.D., Ken Williams, M.S., Benjamin Neely, M.S., Allan D. Sniderman, M.D., and Eric D. Peterson, M.D., M.P.H.

March 19, 2014DOI: 10.1056/NEJMoa1315665