If you have very high cholesterol levels and can’t take statins, two new drugs are available if you have a genetic condition that causes alarmingly high levels of LDL, and another drug is awaiting approval from the FDA.
For most people with high cholesterol, cholesterol-lowering drugs known as statins work just fine. But there’s been a need to find something else to help patients who can’t tolerate statins’ side effects or for whom the drugs simply don’t work.
Approximately 5 percent of patients experience side effects, mostly muscle pain, when they take statins and that causes them to stop the drug. Others have alarmingly high levels of bad cholesterol (LDL) despite taking drugs to lower it. For these patients, here are some new developments.
Two new drugs for a genetic condition
Two new, non-statin drugs are available for patients with a genetic condition that causes them to receive two copies of a defective gene that normally contains the blueprints for the liver receptor to clear away LDL cholesterol. Some patients inherit one defective gene.
Now these patients have help in the drugs lomitapide, brand name Juxtapid, and mipomersen, brand name Kynamro. Only physicians who have completed specialized training can prescribe these new drugs because of the potential for side effects involving the liver.
Lomitapide also causes gastrointestinal problems in more than 90 percent of patients, and patients must follow a very low fat diet, while mipomersen, which is injected, can cause a reaction at the injection site and flu-like symptoms.
Both drugs cause an increase in liver fat, however. We don’t know if that leads to an increased risk of liver trouble over time because there’s no long-term outcome data. We also don’t know if their use will lead to fewer heart attacks and strokes—or a longer life.
What we do know is that patients with two defective gene copies have a shortened life span and a high likelihood of strokes and heart attacks that can begin in childhood. This group is often willing to accept a high rate of side effects in an effort to help with their dramatically high cholesterol levels.
Waiting in the wings
Alirocumab, another new drug, is in the final phase of study before the Food and Drug Administration decides on its release for public use. LDL decreases of 40 percent to 72 percent have been reported in clinical trials.
This drug is injected every two weeks. Its main side effects include cold-like symptoms. The Preventive Cardiology and Apheresis Clinic at The Heart Group of Lancaster General Health are active participants in the latest trial of this novel drug.
An old standby
It should be noted that one of the most effective treatments for those who, despite medications or who are intolerant of medications still have very high cholesterol levels, is lipid apheresis. In this procedure, which dates to the 1960s, cholesterol is removed from the bloodstream every two weeks. The Preventive Cardiology Clinic has an active program of lipid apheresis, as well as physicians trained in complex cholesterol management.
For more detailed information on the management of complex cholesterol problems, contact The Heart Group of Lancaster General Health at 717-544-8300.
Scott J. Deron, D.O., has been a prominent member of the Lancaster County medical community for nearly 20 years, serving in leadership positions and earning recognition for his commitment to patient care. He is an investigator in clinical research at The Lancaster Heart & Stroke Foundation and a past recipient of the Lancaster County Medical Society's Benjamin Rush Award for Outstanding Health Service Volunteer and the Nursing Practice Council Physician Award. He is board-certified in internal medicine, cardiology, interventional cardiology, and clinical lipidogy.