The holidays are always a time when everyone needs to be especially careful about the amount of cholesterol in their diets. This is especially true for the approximately 1 million Americans with a rare inherited condition known as homozygous familial hypercholesterolemia (HoFH). that makes it impossible for the body to remove LDL (bad) cholesterol from the blood. As a result, those with HoFH often experience heart attacks and death before age 30.
To combat this, U.S. Food and Drug Administration has just approved Juxtapid (lomitapide) to reduce low-density lipoprotein (LDL) cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein (non-HDL) cholesterol in patients with HoFH. Juxtapid is intended for use in combination with a low fat diet and other lipid-lowering treatments.
“Juxtapid, in addition to diet changes and other cholesterol-lowering treatments, is a new option for those suffering with HoFH and the serious health consequences resulting from this condition,” said Eric Colman, M.D., deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center.for Drug Evaluation and Research.
Juxtapid is a capsule taken once a day, without food, and at least two hours after the evening meal. Patients should take supplements that contain fat-soluble vitamins and essential fatty acids daily while taking Juxtapid.
The safety and effectiveness of Juxtapid were evaluated in a clinical trial of 29 patients with HoFH. On average, levels of LDL cholesterol fell by approximately one-half during the first 26 weeks among those who tolerated the drug. Juxtapid carries a Boxed Warning regarding a serious risk of liver toxicity because it is associated with liver enzyme abnormalities and accumulation of fat in the liver, which could potentially lead to progressive liver disease with chronic use. Juxtapid also reduces the absorption of fat-soluble nutrients and interacts with several other medications.
The most common adverse reactions in the clinical trial included diarrhea, nausea, vomiting, indigestion, and abdominal pain.
Note: According to national standards here in the United States, normal cholesterol levels for adults combining both high density lipotproteins (HDL) “good” cholesterol manufactured naturally by our bodies and low density lipoproteins (LDL) “bad”cholesterol obtained by eating food animal products such as meat milk, cheese and eggs, etc., should total 200 mg/dl ( 45-50 HDL and 150 LDL for adult men and 50-60 HDL plus around 140 LDL for women) or lower. Readings of 200-239mg/dl is considered borderline safe, and total levels over 240 is considered high risk for heart disease.