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FDA approves Liptruzet for LDL cholesterol
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The FDA approved Liptruzet tablets for treating elevated LDL cholesterol in patients with primary or mixed hyperlipidemia when diet alone is not enough.
Liptruzet (Merck) is an adjunctive therapy for reducing total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides and non-HDL cholesterol and to increase HDL in patients with primary hyperlipidemia or mixed hyperlipidemia.
In a multicenter, double blind, placebo-controlled clinical study, 628 patients with hyperlipidemia were treated with Liptruzet (with ezetimibe and atorvastatin) for up to 12 weeks. Trials results indicated LDL cholesterol was reduced by 53% at the lowest dose 10/10 mg (mean baseline LDL 177 mg/dL), 54% at the 10/20 mg dose (mean baseline LDL 184 mg/dL) and 61% at the maximum dose 10/80 mg (mean baseline LDL 183 mg/dL).
Pooled across doses, Liptruzet reduced LDL cholesterol by a mean 56% compared with 44% for all atorvastatin doses pooled. Atorvastatin reduced LDL cholesterol by 37% at 10 mg, 42% at 20 mg, 45% at 40 mg and 54% at 80 mg.
“A significant percentage of patients are unable to lower their LDL cholesterol to recommended levels despite treatment,” Peter H. Jones, MD, associate professor of medicine, Baylor College of Medicine, Houston, Texas, said in a press release. “Along with a healthy diet, Liptruzet is an effective new lipid-lowering treatment option that may help address this unmet need as the complementary actions of its components can provide significant additional LDL lowering beyond atorvastatin therapy alone.”
The most common adverse effects of Liptruzet included increased alanine transaminase, increased aspartate transaminase and musculoskeletal pain.