May 3rd, 2013

FDA Approves Combination of Ezetimibe and Atorvastatin

The FDA has approved a new combination drug from Merck for lowering cholesterol. The drug, which will carry the brand name of Liptruzet, is a combination of two previously approved cholesterol-lowering drugs, ezetimibe and atorvastatin.

Merck said the new drug (pronounced “LIP-true-zett”) would be commercially available starting next week. Liptruzet will be available as a once-daily tablet combining 10 mg of ezetimibe with either 10, 20, 40, or 80 mg of atorvastatin. In clinical trials Liptruzet lowered LDL cholesterol by 53% to 61%, depending on dosage.

Merck said the drug had been approved  for the treatment of elevated LDL cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough. It is also indicated in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

Prior to going off patent in 2011, atorvastatin (Lipitor, Pfizer) had been the best-selling drug in the world for many years. Ezetimibe, marketed as Zetia, and, in combination with simvastatin, as Vytorin, was also a blockbuster, though in recent years its popularity has diminished as a result of controversy over the drug’s research program and the lack of evidence demonstrating clinical benefits beyond lowering the surrogate endpoint of LDL cholesterol. The Merck press release acknowledges this:

No incremental benefit of LIPTRUZET on cardiovascular morbidity and mortality over and above that demonstrated for atorvastatin has been established.”

Click here to read Merck’s press release.

Click here for a PDF of the Liptruzet label.

Click here for a PDF of the patient information sheet.



3 Responses to “FDA Approves Combination of Ezetimibe and Atorvastatin”

  1. David Kaufman, MD says:

    Now here is a perfect example of the outrageous practices of Big Pharma. Take two generic drugs, one with suspect data, and put them together so they can market them as “new, improved” and of course, branded, which equals expensive. No research, no innovation, no nothing….except more bucks for them and more damage to our healthcare system.

  2. Joseph Wildman, MD says:

    Agree 100% with Dr. Kaufman, but want to add: WHY has the FDA approved this combo when the EXISTING combo of Zetia and Zocor has NOT been proven to be of any CLINICAL benefit???? Undue influence is being wielded in some manner!!

  3. Joel Wolkowicz, MDCM says:

    Agree. Big Pharma and the FDA in collusion. Again