FDA approves Liptruzet
pharmafile | May 7, 2013 | News story | Sales and Marketing | FDA, Merck, liptruzet
Merck is celebrating after its once-daily anti-cholesterol pill Liptruzet was approved by US regulators, expanding its indications.
The drug – a combination of ezetimibe, which Merck markets on its own as Ezetrol, and the widely-prescribed atorvastatin, the active ingredient in Pfizer’s Lipitor – has been shown to lower LDL (or ‘bad’) cholesterol.
Liptruzet is not proven to be better than Lipitor when it comes to preventing cardiovascular morbidity and mortality – but the FDA is convinced of its worth, approving it for patients with primary or mixed hyperlipidemia, as an adjunct to diet when diet alone is not sufficient.
In this patient group it is indicated for the reduction of elevated total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides and non-high-density lipoprotein cholesterol and to increase HDL (‘good’) cholesterol.
Patients can struggle to lower their LDL cholesterol to recommended levels on atorvastatin alone, and it is thought that Liptruzet’s two components may be complementary to one another.
The pill has a dual action, inhibiting the absorption of cholesterol in the digestive tract through ezetimibe and putting a brake on the production of cholesterol in the liver via atorvastatin.
It is also indicated 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 such medicines are not available.
Available as a once-daily tablet containing 10 mg of ezetimibe combined with 10, 20, 40 or 80 mg of atorvastatin, it has a dosage range of 10/10 mg per day through to 10/80 mg daily.
It has performed well in various trials: in one multi-centre study of more than 600 patients with hyperlipidemia, Liptruzet provided LDL cholesterol reductions of 53% at the lowest dose (10/10 mg; mean baseline LDL-C 177 mg/dL), 54% at the 10/20 mg dose (mean baseline LDL-C 184 mg/dL), 56% at the 10/40 mg dose (mean baseline LDL-C 184 mg/dL) and 61% at the highest (10/80 mg; mean baseline LDL-C 183 mg/dL).
Overall it reduced LDL cholesterol by a mean 56% (mean baseline LDL-C 182 mg/dL) compared with 44% for all atorvastatin doses pooled (mean baseline LDL-C 181 mg/dL).
Atorvastatin’s LDL cholesterol reductions were 37% at 10 mg (mean baseline LDL-C 185 mg/dL), 42% at 20 mg (mean baseline LDL-C 177 mg/dL), 45% at 40 mg (mean baseline LDL-C 180 mg/dL) and 54% at 80 mg (mean baseline LDL-C 184 mg/dL).
Adam Hill
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