The 100 million is the number I heard on CNN the morning of DNAP shareholders meeting. The light went on in my head just then. So, I made a point of asking Gabriel, after the meeting, of what the Statnome status was. He just said they were moving ahead with it. I think the 100 million may be a slight embellishment because the study really only recommended those levels (below 70 LDL) for the high-risk and moderately –high-risk for heart attack individuals. (see study abstract below) However, my point is: a change in guidelines or laws can multiply your market potential overnight.
The same realization happened to me about blood pressure. I went to see Dr. Moskowitz to get on his preventive therapy in April of 2003. I was 54 and healthy. My bp was between 120-130 systolic. He said he would like to see it below 110 but that no other doctor would treat a patient for that if you weren’t over 130 (AMA guidelines). Then validation came along. By May or June, the AMA had published new guidelines creating a category they called “pre-hypertension” between 120 & 130 systolic. They said that a person over 50 who has bp in that range has a 100% chance of having hypertension at some future time. I saw that one change as including a much larger universe of individuals that should be taking ACE inhibitors. . . . . and on top of that, Dr. Moskowitz REALLY knows what he is doing! Thank you Dr. M!
Paul
NCEP Report Implications of Recent Clinical Trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines Scott M. Grundy; James I. Cleeman; C. Noel Bairey Merz; H. Bryan Brewer, Jr; Luther T. Clark; Donald B. Hunninghake*; Richard C. Pasternak; Sidney C. Smith, Jr; Neil J. Stone, for the Coordinating Committee of the National Cholesterol Education Program, Endorsed by the National Heart, Lung, and Blood Institute, American College of Cardiology Foundation, and American Heart Association Abstract The Adult Treatment Panel III (ATP III) of the National Cholesterol Education Program issued an evidence-based set of guidelines on cholesterol management in 2001. Since the publication of ATP III, 5 major clinical trials of statin therapy with clinical end points have been published. These trials addressed issues that were not examined in previous clinical trials of cholesterol-lowering therapy. The present document reviews the results of these recent trials and assesses their implications for cholesterol management. Therapeutic lifestyle changes (TLC) remain an essential modality in clinical management. The trials confirm the benefit of cholesterol-lowering therapy in high-risk patients and support the ATP III treatment goal of low-density lipoprotein cholesterol (LDL-C) <100 mg/dL. They support the inclusion of patients with diabetes in the high-risk category and confirm the benefits of LDL-lowering therapy in these patients. They further confirm that older persons benefit from therapeutic lowering of LDL-C. The major recommendations for modifications to footnote the ATP III treatment algorithm are the following. In high-risk persons, the recommended LDL-C goal is <100 mg/dL, but when risk is very high, an LDL-C goal of <70 mg/dL is a therapeutic option, ie, a reasonable clinical strategy, on the basis of available clinical trial evidence. This therapeutic option extends also to patients at very high risk who have a baseline LDL-C <100 mg/dL. Moreover, when a high-risk patient has high triglycerides or low high-density lipoprotein cholesterol (HDL-C), consideration can be given to combining a fibrate or nicotinic acid with an LDL-lowering drug. For moderately high-risk persons (2+ risk factors and 10-year risk 10% to 20%), the recommended LDL-C goal is <130 mg/dL, but an LDL-C goal <100 mg/dL is a therapeutic option on the basis of recent trial evidence. The latter option extends also to moderately high-risk persons with a baseline LDL-C of 100 to 129 mg/dL. When LDL-lowering drug therapy is employed in high-risk or moderately high-risk persons, it is advised that intensity of therapy be sufficient to achieve at least a 30% to 40% reduction in LDL-C levels. Moreover, any person at high risk or moderately high risk who has lifestyle-related risk factors (eg, obesity, physical inactivity, elevated triglycerides, low HDL-C, or metabolic syndrome) is a candidate for TLC to modify these risk factors regardless of LDL-C level. Finally, for people in lower-risk categories, recent clinical trials do not modify the goals and cutpoints of therapy.
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