New guidelines issued on heart disease prevention and treatment were a hot topic at the 2013 AHA scientific sessions in Dallas.
Under the new ACC/AHA Practice Guidelines published just prior to AHA, statins are recommended in four large groups: 1) individuals with clinical atherosclerotic vascular disease (ASCVD); 2) diabetics aged 40-75 years with LDL cholesterol (LDLc) 70-189 mg/dL; 3) individuals with primary LDLc >= 190 mg/dL; and 4) people aged 40 – 79 years with estimated 10-year ASCVD risk ≥ 7.5%. This group of individuals for whom statins are now recommended represents more than 30 million Americans, according to practice guidelines task force numbers.
These changes pose some very interesting challenges and questions for practicing physicians and clinicians, and many professionals have already asked me what I think about these new guidelines. After reading the full ACC/AHA expert panel report, my initial observations are that the guidelines are very similar to prior guidelines with regard to treatment of LDLc over 190, people with established ASCVD and people with diabetes. The major change is less focus on LDLc and NHDLc goals, more focus on moderate- to high-dose statin use in all four groups, and lowering the 10-year risk for treatment from 10% to 7.5%.
The new guidelines are less cumbersome but don’t address large numbers of healthy people with strong family histories of ASCVD or primary and secondary prevention populations with dyslipidemia.
As I have discussed in previous commentary on this blog, I’m a firm believer in the prudent use of statins, which have been clinically validated in well-designed, randomized controlled trials to decrease cardiovascular events and all-cause mortality in both men and women in multiple populations. I’m also a big believer in therapeutic lifestyle changes (TLC) to bring cholesterol levels and risk factors under as much control as possible without resorting to drug therapy. The VAP®+ Lipid Panel complements this by being the most accurate and comprehensive lipid test for individualized risk identification and targeted therapy.
We know there are large, unmet cardiovascular risk needs, with people who are low risk (under current guidelines) having events, and people who are high risk having secondary events. Here are a couple of great examples to help demonstrate the dilemma clinicians will now face:
New Guidelines Case #1
I’m treating 60-year-old male patient for whom these new guidelines may underestimate his risk. His medical history includes:
- History of Type 2 diabetes
- CAD and with CABG
- Medication: atorvastatin 40 mg (a potent statin by current guideline recommendations)
- LDLc ~ 130 mg/dL on potent statin therapy
- TG = 200 – 400 mg/dL range
- VAP+ shows HDLc defects (low apoA1, HDLc2, HDLc3) and RLPc defects (high VLDLc3 and IDLc) and LDLc density defects (Pattern B and high LDLp)
With comprehensive and individualized cholesterol testing, a clinician can identify unmet lipid risks (genetic, metabolic and lifestyle driven). The statin must be changed and/or added to. The addition can include lifestyle changes, metabolic management, different potent statin therapy, and the addition of lipid agents that target HDLc, LDLc and RLPc defects. If we are calling for global risk management that individualizes and personalizes care, the VAP+ Lipid Panel is perfect for both accuracy of measurement as well as identification of risk and risk response to treatment.
New Guidelines Case #2
A 66-year-old female visited our practice to establish care and have a physical. She was fit, healthy and presented with no risk factors:
- No CVD
- No diabetes or MetSyn
- LDLc below 190
- BP = 126/70
- BMI < 25
Her family history includes a grandfather who suffered a stroke and heart attack in his 50′s and died, but no other CAD/CVD in her family. The patient was also on no medications. We ran her VAP Lipid Panel, and the results showed:
- TC = 273
- LDLc = 181
- HDLc = 70
- Lp(a)c = 15 (high over 10)
- TG = 111
- CMP and glucose = all normal
ASCVD Risk Score under the “new guidelines” calculator:
- 6.4% with last month’s BP (126)
- < 7.5% 10-year risk
She does not qualify for lipid-based therapy when simply looking at the four defined populations. The new ACC/AHA guidelines are a foundation to inform and consider care. They still allow the clinician to individualize and personalize care. Considering the reality of these guidelines, it’s equally important to remember that cholesterol numbers and comprehensive lipid assessments can 1) actually increase the ability of the clinician to identify hidden risk and 2) better manage the increased population of patients on statin therapy.
Choosing the right test for cholesterol measurement is essential. Clinical research has found the basic lipid panel lacking significantly in accuracy and risk assessment. A recent groundbreaking study in the Journal of the American College of Cardiology compared the accuracy of calculated LDL cholesterol measurement in the traditional basic lipid panel (standard cholesterol test) to directly measured LDL cholesterol in the VAP Lipid Panel. Results of the study, which involved more than 1.3 million U.S. adults, showed the basic lipid panel underestimated risk in 23 percent to 59 percent of patients with Friedewald estimated LDL cholesterol levels below 70 md/dL and triglycerides above 150, which could result in under treatment of high-risk patients.
In summary, the new ACC/AHA guidelines build on the foundation of evidence and have included people with 7.5% 10-year risks to be on statins. The new guidelines:
- Have not been endorsed by the NLA, AACE and many other groups
- Are not a replacement for clinical judgment
- May result in pushback from patients who:
- Will still want to know their cholesterol levels for motivational and informational reasons (genetic lipid risks, lifestyle lipid risks, etc.)
- Inherently mistrust the wholesale recommendation for statin use and the pharmacologic statin industry overall
- Unfortunately, may not fundamentally change clinician behavior
- May ultimately result in less testing and treatment
- Could result in a rise of cholesterol levels in America
- Result in the 10-year model being challenged in its ability to predict risk based largely on age
To summarize, comprehensive ASCVD risk evaluations require an accurate, affordable and comprehensive lipid test. NHDLc and apoB should not be ignored. An accurate LDLc at baseline and monitoring response to moderate or high-dose statin therapy is important. Finally, apoA1, HDLc defects, LDLc density, LDLp, Lp(a) and triglyceride rich remnants provide added value in risk categorization and consideration for global risk care. People with elevations of such are much higher risk in multiple prospective trials presented and published to date.