Why Dr. Nissen Disagrees with ACC/AHA Statin Guidelines
CurrentMD faculty member and world-renowned cardiologist, Dr. Steven Nissen, has strong opinions on how best to manage dyslipidemia with non-statin therapy – some of which are at odds with the guidelines. Here are some excerpts from the expert perspective he gave to Knowledge to Practice on the topic.
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Why non-statin therapy should be the second line of defense:
“My view of the situation is that non-statin therapies are always to be considered the second line. If you think about LDL, we have drugs like ezetimibe and the PCSK9 inhibitors, and we now have some outcome data for both drugs. There’s a little bit of data for ezetimibe in an outcome trial, but it showed a very small effect. Only a 6.4% reduction in morbidity and mortality. We have much more data on statin therapies. Statins are inexpensive, they’re widely available, they’re well-tolerated, and they have extremely robust evidence for a reduction in morbid mortal events. So, the most important message is, ‘Statins first.’”
Why he takes issue with cost-effectiveness studies:
“I am not a big fan of these types of studies. These studies that do a lot of modeling, they’re really trying to guess at the impact. I don’t think medicine is best practiced by dumbing it down so that you look at every patient in the same way. What makes medicine great is the ability to customize therapy for individual patients. The way I try to approach this is not to do some pharmacoeconomic analysis but to look at the patient. If you see somebody that’s had multiple myocardial infarctions and bypass surgery or multiple stents, has a high LDL, or perhaps doesn’t tolerate statin therapies, well then, yes, it may be expensive, but that expensive therapy for that patient can be lifesaving. Let the health economists worry about all of this – I think we have to treat patients one by one as individuals.”
Why he disagrees with the ACC/AHA Prevention Guidelines:
“I do not subscribe to the ACC/AHA prevention guidelines which basically say, ‘give a high-intensity statin.’ The so-called ‘fire-and-forget’ strategy. I believe that these guidelines were written in error and that we really should target getting a low LDL level. If I have somebody that’s a very high risk, have had multiple events, have many risk factors, and their LDL is still in the range that I’m uncomfortable with, let’s say over a 100, then for some of them, I will consider adding an agent like ezetimibe. For others, I will consider a PCSK9 inhibitor and I’ll fight the war with the pharmacy benefit managers to try to get them covered for that therapy.”
Why he thinks we should give up on HDL cholesterol:
“There is one area, however, that I’ve been very discouraged about and that is HDL raising therapies. We simply have not seen an effective HDL raising therapy that lowers cardiovascular risk. And I’ve worked on this now for several decades and I’m ready to throw in the towel. I just don’t think that HDL is a target, and I think as we go forward we’re going to have to concentrate on these other targets, not on HDL cholesterol.”
Why he’s excited about the future:
“We’re entering a new era here. With the genomic studies that are coming along, we’re able to now validate other targets and there are a number of them that are currently being investigated. Not all of them are easily targeted, but some of them are. Let me give you an example of one that I think is very exciting, and that’s Lipoprotein(a). We’ve known for decades that that is an important risk factor, but we had no effective way to reduce Lipoprotein(a).
There are now short interfering RNA therapies in development by at least two companies that can knock down Lipoprotein(a) by 90% or more. Those agents are going to need to get into clinical trials, and there is a lot of optimism in the scientific community that the strategy will work. And there are even some yet to be discovered. Now that we’re entering the era of genomic medicine, I think there will be new targets emerging with the ability to build antibodies against almost anything. This era of targeted therapy is very exciting, and it is very likely to result in important new discoveries.”