Kevin Maki, PhD: The State of the Lipid Space and the Need for More In-Between Therapies

Kevin Maki, PhD, the chief scientist at the Midwest Biomedical Research Center for Metabolic and Cardiovascular Health, sat with MD Magazine to discuss the current state of the lipid space.

Maki, an expert in lipidology, expressed that statins, which are the current standard of care for lowering LDL cholesterol, work well and are affordable for one group of patients, but there remains a need to treat those who do not receive the expected effect from them. On the other hand, PCSK9 inhibitors, while effective, are costly, which creates a call for more options for statin-resistant patients.

Kevin Maki, PhD, the chief scientist at the Midwest Biomedical Research Center for Metabolic and Cardiovascular Health:

The lipid space has gone through its ups and downs. We had a long period between 2003 and fairly recently where we had no new class of lipid-altering medication approved, [but] we've had a couple of additional medications approved recently. All of the new medications have been relatively expensive, [though]. In some cases, they have a very limited indication and they are the group the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are a group of therapies that have a high expense, but they are very effective for lowering atherogenic cholesterol.

So in terms of alternatives, statins are very effective. Most of the statins are generic now, so they are relatively inexpensive. If a statin isn't enough—either the patient cannot tolerate it or on a maximal dose there simply is not a sufficient lowering of LDL and atherogenic cholesterol—then the options are limited, so we have ezetimibe, as an example, which provides a small additional reduction in LDL cholesterol. It's recently gone generic, so the cost is less of an issue now with ezetimibe than it was recently, but we don't have anything to add to that ezetimibe for a statin-treated patient right now other than a PCSK9 inhibitor.

So we have sort of the equivalent of something that gives us a small additional effect, I say a squirt gun or a bazooka, and we need some things that are in the middle. There are some new therapies in development, but it's going to be quite a while before they are available to patients. We are in a situation where we have very good treatment options and we need to figure out, ideally, additional treatment options that are less expensive than the PCSK9 inhibitors that can give an incremental reduction in atherogenic cholesterol, above and beyond what you see with a statin plus ezetimibe.

Some new things are in development. There are some other medications of like bile acid sequestrants and so forth, but nothing that sort of gives you a response that is in between that of ezetimibe and a PCSK9 inhibitor. There are some therapies that are in the pipeline, but none of them are very far advanced in their development. I say that new drugs are like guppies—many are birthed, but few make it to adulthood. So you know, I hate to speculate at this point because there are a lot of things that can prevent a drug from ultimately making it to market, but there are some reasonably promising therapies in development currently.