Calls Met With Silence
Along with his colleague Dr. Michael Miller of the University of Maryland, Dr. Vogel tried to bring the issue to the forefront 3 years ago by writing an editorial entitled "Cholesterol Goals: Moving from Numbers to Treatment" (Clin. Cardiol. 2009;32:106-8). And 3 years earlier, Dr. Hayward and his associates wrote a review article concluding that "there is clear and compelling evidence that most patients at high risk for cardiovascular disease should be taking at least a moderate dose of a statin if tolerated, even if their natural LDL cholesterol level is low. We could find no published high-quality clinical evidence supporting titration of lipid therapy based on proposed LDL cholesterol targets" (Ann. Intern. Med. 2006;145:520-30).
These publications, and Dr. Krumholz’s letter earlier this year, have been answered with silence in the scientific literature.
VA Takes Tailored Approach
The Veterans Health Administration (VHA) is not waiting for guidelines to make the move to tailored treatment; it has already adopted this approach. Over the past 18 months, the country’s largest integrated health care system providing care to more than 8 million patients a year, has been reviewing the evidence on the role of LDL targets in managing cardiovascular risk, "particularly in light of concerns that performance measures tied too closely to targets might create incentives for overzealous pharmacotherapy that does not improve overall health," said Dr. Joe Francis, head of performance measurement for the VHA.
Courtesy Oscar G. Johnson VA Medical Center
Oscar G. Johnson VA Medical Center
The Department of Veterans Affairs (VA) "determined that the strongest evidence supports treatment with statins as the core objective, independent of LDL target, so we reconfigured our internal performance measures to align with this evidence," he said in an interview. At the VA, lipid management in patients with ischemic heart disease or diabetes mellitus is now considered appropriate if the patient is on at least a moderate dose of a statin drug or the LDL is under 100 mg/dL, he added.
This decision was in line with recommendations issued by the American Heart Association and American College of Cardiology in November 2011, Dr. John Rumsfeld, national director of cardiology for the VA system, pointed out. Both he and Dr. Francis said they hoped that ATP IV will also be consistent with this evidence-based approach. Dr. Rumsfeld emphasized that the VHA performance measures "are not meant to supplant clinical judgment for individual cases where more aggressive treatment may be warranted."
Whether the panel is also headed in this direction could not be determined, as neither the panel chair, Dr. Neil J. Stone of Northwestern University, Chicago, nor the NHLBI press office would comment on the content of the report before its release. ATP IV is being developed simultaneously with updated reports on hypertension guidelines (JNC 8) and obesity guidelines (Obesity 2), which also are expected to be available for public review and comment this year and will be part of an integrated cardiovascular risk reduction guideline, according to the statement.
Dr. Krumholz said that he could not speculate as to what the recommendations will be, "but if they stick to the evidence, then they will transition ... to a different approach." Because of the public comment period after they are released, there will be ample opportunity for discussing and vetting the guidelines before they are finalized. What he considers most important is that "they adhere to the evidence and recognize that a target-based approach could lead to treatments with medicines that are yet unproven with regard to their benefit for patients."
Dr. Vogel suggested that the long delay in the release of ATP IV is an indicator that the panel is incorporating emerging data and likely struggling with the very issues detailed in this article.
The new guidelines, which will be in a draft format available for public review and comment, are expected to be released this summer, according to the National Heart, Lung, and Blood Institute.
None of the experts who contributed to this article had relevant financial disclosures.