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Two New LDL Cholesterol Drugs May Have Big Impact on Heart Disease

Twitter Summary: Two new LDL cholesterol drugs may have big impact on #heartdisease, both FDA-submitted – future data to solidify heart-healthy effects

A new class of cholesterol medication has made waves this past week after highly anticipated clinical studies showed a dramatic reduction in the risk of heart attacks and strokes. These medications, called PCSK9 inhibitors, work to increase the body’s ability to remove LDL cholesterol (the “bad” kind) from the blood. Previous studies had already shown that these drugs can reduce LDL cholesterol to levels as low as those achieved by statins (such as simvastatin, Lipitor, or Crestor). However, it was not previously clear whether these reductions in LDL cholesterol would lead to reduced heart attacks and strokes. Several other classes of cholesterol drugs have been developed that improve cholesterol numbers but don’t actually prevent heart problems. Therefore, the medical community has been holding its breath, waiting to see if the PCSK9 inhibitors will pan out. The initial verdict from these early clinical trials appears to be: yes.

Sanofi and Amgen both have PCSK9 inhibitor drugs already submitted to the FDA for approval – Sanofi’s Praluent and Amgen’s Repatha. New clinical data was released for both of these drugs on the same day this past week, providing brand new insight into the future of heart disease prevention. At the recent American College of Cardiology Scientific Sessions, there were new results from extensions of a drug called Repatha’s (Amgen) phase 2 and 3 clinical trials. The studies randomized 4,465 participants with high heart disease risk to either receive Repatha or a placebo drug (essentially a sugar pill with no active medication) in addition to standard treatment with statins and/or other lipid lowering drugs. The addition of Repatha to standard treatment led to a 61% greater reduction in LDL cholesterol after 12 weeks compared to standard treatment alone. A one-year follow up analysis also showed that Repatha led to a 53% reduced risk of heart problems such as heart attack, stroke, etc. compared to those not on Repatha. This is still early data, and a much larger study focused specifically on Repatha’s impact on heart disease (expected to be completed by early 2017) will provide more concrete evidence of its heart-protective qualities (or lack thereof), but the data does look quite promising for such an early stage.

On the same day as the Repatha presentation, there were also results on another similar PSCSK9 inhibitor drug called Praluent, which is made by Sanofi and Regeneron. The companies announced the results of an 18-month study, which like with Repatha, were pretty breathtaking. Specifically, they showed an additional 62% reduction in LDL cholesterol at 24 weeks in those taking Praluent with standard care compared to those on standard treatment alone. A 78-week follow-up analysis found that the addition of Praluent decreased the risk of heart problems by 48% compared to standard treatment. These are very preliminary results and again, an ongoing trial (expected to be completed in 2017) will provide a more concrete indication of Praluent’s potential heart benefits.

Bottom line, both of these PCSK9 inhibitors demonstrate impressive LDL cholesterol lowering effects, and also appear to reduce heart problems. Even larger studies designed to definitively show that PCSK9 inhibitors prevent heart problems are underway and expected to be completed by 2017. Until those studies are out, though, there is a lot of reason for optimism about this new drug class.

It’s likely that statins will remain the first line choice for reducing LDL cholesterol for most patients, because they are safe, taken orally, well studied, inexpensive (Lipitor recently went generic), and reduce LDL cholesterol, heart attacks, and stroke. However, some people may not get to low enough LDL cholesterol levels with statins alone, and other people may experience side effects using statins. For these groups of people, PCSK9 inhibitors may be a big step forward in heart health.  Indeed, one in four deaths in the US is attributed to heart disease, and it remains the leading cause of death. Diabetes is also a major risk factor for heart disease, with over seven million people with diabetes above the age of 35 having self-reported heart disease or stroke. As people with diabetes live longer, protecting the heart and preventing other complications will be the key to a better quality of life, and we’re not surprised to see that the focus on heart health and diabetes is only growing. –AJW/ER