Cholesterol Guidelines Are Due for an Upgrade

Debates at medical conferences are backed with a lot of evidence and statistics — but that doesn’t mean there can’t be a little fun thrown into the mix. That’s exactly what moderator Christie M. Ballantyne, MD, did when introducing a discussion about the 2013 American College of Cardiology (ACC)/American Heart Association (AHA) cholesterol guidelines.

After unveiling a black and white referee shirt and kicking off the session with a whistle blow (yes, really), Ballantyne, from Baylor College of Medicine in Texas, introduced the discussants. Jennifer G. Robinson, MD, MPH, and Roger S. Blumenthal, MD, weighed in on the guidelines at the 10^th Annual Cardiometabolic Health Congress (CMHC 2015) in Boston, Massachusetts.

The ACC/AHA cholesterol guidelines that were followed before the current ones advised clinicians to initiate statin therapy based on potential for net benefit. It also said to consider adding a nonstatin in selected high-risk patients. The 2013 guidelines lowered the marginal benefit — and people were not happy about it. At the time, researchers didn’t have the proper evidence saying that another medication would benefit patients. Robinson, director of the Prevention Intervention Center at the University of Iowa, thinks that there is a more sophisticated way to go about treatment “instead of just one-size fits all.”

The new paradigm outperforms the National Cholesterol Education Program (NCEP) ATP III. This is mainly due to the fact that NCEP ATP III focuses on LDL-C cut-points, a factor that has proven not to contribute to plaque. On the other hand, the 2013 ACC/AHA guidelines identifies more high risk patients and performed very well based on individual risk.

“You got to maximize statins,” Robinson advised. High risk patients may even benefit from nonstatins, such as those with cardiovascular disease. It’s not about how much you lower cholesterol, but where you start from and you wind up.

To target the condition, temporary therapies can be used until better personalized risk estimation tools are available. “We need an app for people on a station,” Robinson proclaimed, followed with revealing that this is something already in the works, in hopes that it will be able to determine the benefit of adding another drug. Before incorporating another medication to lower risks, physicians should talk to the patient to determine if that’s what they want and the best step.

What’s next? According to Robinson it’s the use of LDL threshold as trigger points. She presented what the LDL-C treatment threshold approach might look like in the next set of guidelines, using the 2013 model as a guide.

1. Maximize statin therapy

2. Emphasize adherence to lifestyle and statin therapy before considering adding a nonstatin

3. Consider adding nonstatins in high-risk patients who might experience a net ASCVD risk reduction benefit from additional LDL-C lowering

• Clinical ASCVD
• Untreated LDL-C ˃ 190 mg/dL
• Diabetes age 40 to 75 years
• Primary prevention of diabetes with ˃ 20% 10-year ASCVD risk

The interesting thing about this debate is that, for the most part, the physicians agree. Before even giving his side, Blumenthal said that he agreed with 90% of what Robinson had to say. However, he pointed out some points that are need of further investigation. Blumenthal, who described himself as somewhat of a traditionalist, pointed out that it’s difficult to assess the LDL reduction that patients present. Each patient needs to be treated separately, a point that Robinson made earlier.

“There is one problem with the guidelines that came in that we didn’t emphasize enough,” Blumenthal, from the Johns Hopkins Hospital in Maryland, drew attention to the third point on the list of potential issues below.

• Clinicians often not able to assess percentage reduction
• Patients who begin prescription with a high LDL-C level may not attain a clinically optimal LDL-C with statin even if expected percent reduction is achieved
• Potential misperception — “lipid levels no longer need to be followed up”
• Discordance with other guidelines may result in clinician and patient confusion

Blumenthal referenced a report in The New England Journal of Medicine that reacted to the analysis, it read, “IMPROVE-IT provides us with important information on the value of lowering LDL-C levels, regardless of the agent used. These data help emphasize the primary of LDL-C lowering as a strategy to prevent CHD.” Blumenthal’s reaction to that reaction? “I would probably say that’s not exactly right.” There is a lot of data out there saying that lowering LDL levels is better. But going about that goal doesn’t have to be primarily with a prescription. Blumenthal suggested that physicians shouldn’t stride to add a second or third medication, but to encourage lifestyle changes instead. Plus, subgroups may experience more benefits from adding a second agent because they have diabetes or metabolic syndrome.

The problem is that healthcare providers want proven therapies, however, they need the right data. PCSK9 is not a proven therapy, so he says that the new guidelines will have to address that. Also, trials looking at the baseline risk need to confirm treatment strategies. Robinson explained that focusing on end goals could lead treatment in the wrong direction. If there is a ‘right’ number goal, even physicians don’t really know what that is. “We’re not there yet,” Robinson said. Blumenthal agreed with this point which is why he pushes improvements in lifestyle.

Overall there was more agreement than disagreement. Key points that both parties acknowledged was the need to assess risk, optimize lifestyle and adherence to therapy, and follow up and measure lipids. The final point indicated that therapy intensity and add-ons should be looked at with on a patient-specific level while focusing on LDL cholesterol.

Luckily, Ballantyne didn’t have to use his referee whistle.