The FINANCIAL — Merck, known as MSD outside the United States and Canada, announced on August 20 that new analyses from the investigational IMPROVE-IT (IMProved Reduction of Outcomes: VYTORIN Efficacy International Trial) study of VYTORIN (ezetimibe and simvastatin), the TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) cardiovascular safety trial of JANUVIA (sitagliptin), and real-world data from the Dyslipidemia International Study (DYSIS I and DYSIS II) will be presented at the upcoming European Society of Cardiology (ESC) Congress 2015, held Aug. 29 to Sept. 2, 2015.
IMPROVE-IT was designed to evaluate the cardiovascular benefit of the combination of ezetimibe and simvastatin compared to simvastatin alone. The TECOS cardiovascular safety trial was designed to assess the cardiovascular safety of Merck’s DPP-4 inhibitor, JANUVIA. In all, Merck has 13 data presentations at this year’s ESC, according to Merck.
“At this year’s European Society of Cardiology Congress, we are pleased to share new data from two important studies – IMPROVE-IT and the TECOS cardiovascular safety trial – which have already added substantially to our knowledge of cardiovascular disease and the cardiovascular safety profile of sitagliptin, respectively,” said Dr. Roy Baynes, senior vice president, global clinical development, Merck Research Laboratories.
The primary results from IMPROVE-IT, which enrolled 18,144 high-risk patients presenting with acute coronary syndromes (ACS), were presented in November 2014 at the American Heart Association Scientific Sessions and published in The New England Journal of Medicine in June 2015. VYTORIN and ZETIA (ezetimibe) are indicated for use along with a healthy diet to reduce elevated LDL cholesterol in patients with hyperlipidemia. The current U.S. Prescribing Information for VYTORIN and ZETIA states that the effect of ezetimibe on cardiovascular morbidity and mortality, alone or incremental to statin therapy, has not been determined. Merck has submitted the data from IMPROVE-IT to regulatory authorities in the U.S. and European Union to support a new indication for reduction of major cardiovascular events for VYTORIN and ZETIA.
TECOS was an event-driven study of more than 14,000 patients that evaluated the long-term cardiovascular safety of the addition of JANUVIA to usual care, compared to usual care without JANUVIA, in patients with type 2 diabetes and established cardiovascular disease. The primary results of the TECOS cardiovascular safety trial were presented at the 75th Scientific Sessions of the American Diabetes Association and published simultaneously in the New England Journal of Medicine in June 2015.
Indications and Limitations of Use for JANUVIA (sitagliptin) 25 mg, 50 mg and 100 mg tablets
JANUVIA is indicated, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus. JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JANUVIA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking JANUVIA.
Selected Important Risk Information about JANUVIA
JANUVIA is contraindicated in patients with a history of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema.
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with JANUVIA or with any other antidiabetic drug.