EZETIMIBE: ALERTA [MedWatch]

Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor): Early Communication about an Ongoing Data Review

Audience: Cardiovascular healthcare professionals and patients
[UPDATE 01/08/2009] The FDA has completed its review of the final clinical study report of ENHANCE and issued an update.

[Posted 01/25/2008] FDA provided healthcare professionals with an early communication about an ongoing data review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor). This early communication is in keeping with FDA’s commitment to inform the public about ongoing postmarketing drug issues.

Merck/Schering Plough Pharmaceuticals reported preliminary results from the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial. This trial was designed to evaluate the amount of atherosclerotic plaque in blood vessels located in the neck based on images obtained through ultrasound in patients treated with Vytorin (ezetimibe plus simvastatin) or simvastatin alone. Merck/Schering Plough stated that there was no significant difference between Vytorin and simvastatin in the amount of atherosclerotic plaque in the inner walls of the carotid (neck) arteries despite greater lowering of LDL-cholesterol (bad cholesterol) with Vytorin compared to simvastatin. Once Merck/Schering Plough completes the analysis of the unblinded data from ENHANCE, it will submit a final study report to FDA. Once FDA receives the final study report, FDA estimates it will take approximately 6 months to fully evaluate the data. After reviewing the data from the ENHANCE study, and considering all other available information about the link between LDL lowering and reduction of cardiovascular events, FDA will determine whether any further regulatory action is warranted with regard to Zetia and Vytorin and also whether any changes to FDA’s current approach to drugs that lower LDL cholesterol are warranted.

Patients should talk to their doctors if they have any questions about the information from the ENHANCE trial.

[January 08, 2009 - Update of Safety Review - FDA]
[July 18, 2008 - Making Sense of Vytorin Concerns - Consumer Q & A - FDA]
[January 25, 2008 - Early Communication about an Ongoing Data Review - FDA]

The FDA has completed its review of the final clinical study report of ENHANCE and issued an update. Read the MedWatch safety summary, including links to the January 2008 FDA Early Communication and the January 2009 Update, at

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Ezetimibe

NOTA DEL BLOG: LOS ALERTAS DE LA FDA SE EXPRESAN TAL CUAL HAN SIDO INFORMADOS Y EDITADOS, EN IDIOMA INGLÉS DE MODO DE NO TERGIVERSAR EL SENTIDO ORIGINAL QUE SE PRETENDE TRANSMITIR. NO OBSTANTE ELLO, EL PROFESIONAL DEL EQUIPO DE SALUD QUE SOLICITE UNA TRADUCCIÓN DE ESTE MATERIAL, PREVIA ACREDITACIÓN DE SU CONDICIÓN, LA RECIBIRÁ DE MANERA GRATUITA ENVIÁNDOSE LUEGO COPIA DE LA TRADUCCIÓN A LA PROPIA FDA DE MODO QUE LA MISMA SE INCORPORE A LA BASE DE DATOS EN IDIOMA ESPAÑOL, EN LOS ESTADOS UNIDOS DE NORTEAMÉRICA.