Author + information
- Thomas M. Maddox, MD, MSc∗ (, )
- William J. Oetgen, MD, MBA and
- John S. Rumsfeld, MD, PhD
- ↵∗VA Eastern Colorado Health Care System, Cardiology Section (111B), 1055 Clermont Street, Denver, Colorado 80220
We appreciate the comments made by Dr. Stone and colleagues regarding our paper discussing implications of the 2013 American College of Cardiology/American Heart Association cholesterol guidelines (1).
As Dr. Stone and colleagues correctly point out, the guidelines did not forbid nonstatin lipid-lowering therapies, but rather suggested that clinicians “may consider the addition of a nonstatin cholesterol-lowering therapy” (1). At the time of the guideline release and our paper publication, there were no randomized, controlled trials (RCTs) that had demonstrated cardiovascular (CV) event reduction benefit with nonstatin lipid-lowering medications. Thus, our statements indicating that these nonstatin medications did not have a strong recommendation for CV event reduction and our consequent conclusions suggesting that the guidelines might lead to significant decreases in nonstatin use were consistent with both the most current evidence at the time and the guidelines (2).
We appreciate the added clarification provided by the guideline authors, and note that their stated preference for drugs proven to reduce CV events is especially germane in the wake of the recently released IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial) trial, which demonstrated CV event reduction with ezetimibe (3). This new information, available after the release of both the 2013 guidelines and our paper, will have implications for cholesterol management, and we are currently exploring those in a new analysis of PINNACLE (Practice Innovation and Clinical Excellence) data.
We also recognize that the guidelines recommended low-density lipoprotein cholesterol (LDL-C) testing to assess appropriateness of statin response and medication adherence. However, our paper did not suggest that no LDL-C testing should occur under the new guidelines, but rather that “the new guidelines did not recommend treatment to target LDL-C lipid levels, thus rendering repeated on-treatment testing unnecessary” (italics our own) (2). Under prior guidelines, repeated LDL-C testing to determine whether a particular LDL-C target was achieved took place with regularity, a phenomenon that we demonstrated in our analysis and almost certainly under-reported, given the frequency with which LDL-C levels are checked by primary care providers (who were not included in our analysis). Thus, our conclusion that “the cost and inconvenience of repeated LDL-C testing to titrate statin medication to specific LDL-C targets would be reduced” is consistent with the guidelines (2).
We appreciate the added clarification provided by the guideline authors, and feel that it helps further provide guidance to clinicians seeking to optimize cholesterol management, and its attendant effects on CV event reduction, for their patients.
Please note: Dr. Maddox is supported with a VA Health Services Research and Development career development award. Dr. Oetgen is the Executive Vice President for Science, Education, and Quality of the American College of Cardiology. Dr. Rumsfeld is the Chief Science Officer for the National Cardiovascular Data Registry.
- American College of Cardiology Foundation
- Stone N.J.,
- Robinson J.G.,
- Lichtenstein A.H.,
- et al.
- Maddox T.M.,
- Borden W.B.,
- Tang F.,
- et al.
- ↵Cannon C. IMProved Reduction of Outcomes: Vytorin Efficacy International Trial. 2014. http://www.eas-society.org/fileArchive/IMPROVE%20IT%20-%20PRESENTATION%202014-11-17.pdf. Accessed February 7, 2015.