Aside from Zetia there haven’t been any good non-statin options for lowering LDL Cholesterol. Statin drugs like Lipitor (atorvastatin), Zocor (simvastatin) and Crestor work well to lower the “bad” cholesterol, the LDL, and have remained first line therapy for many years. Finally, there may be something new to get excited about. But, it does have some “issues.”
Juxtapid is a new medication approved for lowering cholesterol. For now it is approved for use only in patients with familial hypercholesterolemia already on statin mediations. Those are patients with extreme elevations in LDL cholesterol and high risk of early heart disease. It is unknown whether Juxtapid will eventually receive approval for the treatment of high cholesterol in all adults.
Juxtapid is not a statin, and is the first in a new class of medications called microsomal triglyceride transfer protein (MTP) inhibitors. Expect more from that class.
How do we know it works? When added to statin therapy in patients with familial hypercholesterolemia, Juxtapid significantly reduced LDL by 40 – 50%, which is huge.
Juxtapid has issues, however, that will prevent it from being a game changer for cholesterol. Its side effect profile stinks. Twenty eight percent of patients studied had diarrhea, nausea, vomiting or abdominal pain. Ugh. Juxtapid also caused a bump in liver function blood tests in 34% of treated folks. Based on these results, liver tests have to be obtained before and during treatment. This is the same hassle faced with the statin drugs (Lipitor, Zocor, Crestor, etc.). It works well, but at a cost.
Juxtapid received FDA approval in December 2012, and will be available early in 2013. If covered by insurance, it is likely to be a Tier 2 or 3 medication, meaning a high copay; Juxtapid will cost more than $20,000 for a 30-day supply, or more than $250,000 per year. There is no patient assistance program available yet.
Due to the required liver tests before and during treatment, prescribers, pharmacies, and patients must enroll in the Juxtapid REMS (Risk Evaluation and Mitigation Strategy) Program, which means that not all doctors and pharmacies will be able to prescribe and dispense Juxtapid.
Excited or not?
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