Liptruzet, a New Combination Therapy for Hyperlipidemia, Approved

Merck announced that the FDA has approved Liptruzet (ezetimibe and atorvastatin) tablets for the treatment of elevated low-density lipoprotein (LDL) cholesterol in patient with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough. Liptruzet is also approved for the reduction of elevated total cholesterol and LDL cholesterol in patients with homozygous familial hypercholesterolemia (HoFH) as an adjunct to other lipid-lowering treatments or if no treatments are available. Liptruzet is a once daily combination drug containing ezetimibe, a cholesterol absorption inhibitor and atorvastatin, a HMG-CoA reductase inhibitor.

In a multicenter, double-blind, placebo-controlled study in which 628 patients with hyperlipidemia were treated for up to 12 weeks, Liptruzet reduced LDL cholesterol by a mean 56% across all doses (eztimibe/atorvastatin 10mg/10mg, 10mg/20mg, 10mg/40mg) compared to 44% for all atorvastatin doses pooled; P<0.01.

A six-week study, with 556 high risk patients taking atorvastatin 40mg but not at LDL cholesterol <70mg/dL were randomized to either Liptruzet 10mg/40mg coadministered as ezetimibe and atorvastatin (n=277) or atorvastatin 80mg (n=279). Results demonstrated that Liptruzet 10mg/40mg further lowered LDL cholesterol by an average of 27% vs 11% when titrating atorvastatin 80mg (P<-0.05). This additional reduction resulted in 74% of patient achieving LDL cholesterol <70mg/dL compared to 32% of patient taking atorvastin 80mg.

In a separate six-week study, 184 moderately high-risk patients taking atorvastatin 20mg but not at LDL cholesterol <100mg/dL were randomized to either ezetimibe 10mg plus atorvastatin 20mg (N=92) or atorvastatin 40mg (N=92). Results demonstrated that Liptruzet 10mg/20mg further lowered LDL cholesterol by an average of 31% compared to 11% when titrating to atorvastatin 40mg (P<0.05). This additional reduction resulted in 84% of patients treated with Luptruzet 10mg/20mg achieving LDL cholesterol <100mg/dL compared to 49% of patients taking atorvastatin 40mg.

Liptruzet is available as a once-daily tablet containing ezetimibe/atorvastatin in fixed 10mg/10mg, 10mg/20mg, 10mg/40mg, or 10mg/80mg dosage strengths. It will be available the week of May 6.

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