Merck, a global healthcare leader, announced 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, to be held from August 29 to September 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.
“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 US 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 US and EU 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.
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.
The cross-sectional, observational study DYSIS examined lipid goal attainment among statin-treated patients including patients suffering from coronary heart disease (CHD), diabetes, chronic kidney disease or peripheral atherosclerotic disease. DYSIS enrolled approximately 60,000 patients from 30 countries from regular clinical practice such as physicians’ offices and hospital outpatient wards between 2008 and 2012. DYSIS II, a continuation of DYSIS study evaluating lipid goal attainment, enrolled approximately 4,000 ACS patients and 7,000 CHD patients globally between 2012 and 2014.
Vytorin contains ezetimibe and simvastatin. Vytorin is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides, and non–HDL cholesterol, and to increase HDL cholesterol in patients with primary (heterozygous familial and nonfamilial) hyperlipidemia or mixed hyperlipidemia when diet alone is not enough.
No incremental benefit of Vytorin on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established. Vytorin is not indicated to reduce cardiovascular events in patients who have presented with acute coronary syndromes.
In clinical trials, the most commonly reported side effects, regardless of cause, included headache (5.8 per cent), increased ALT (3.7 per cent), myalgia (3.6 per cent), upper respiratory tract infection (3.6 per cent), and diarrhea (2.8 per cent).
Zetia, administered alone or in combination with a statin, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol, LDL cholesterol, apolipoprotein B, and non-HDL cholesterol in patients with primary (heterozygous familial and non-familial) hyperlipidemia when diet alone is not enough.
The effect of Zetia on cardiovascular morbidity and mortality has not been determined. Zetia is not indicated for use with a statin to further reduce cardiovascular events in patients who have presented with acute coronary syndromes.