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New Data from IMPROVE-IT Study of VYTORIN® (ezetimibe-simvastatin) and TRA 2ºP TIMI 50 Study of ZONTIVITY® (vorapaxar) to be Presented at American College of Cardiology Scientific Sessions

Investigational data from IMPROVE-IT to be announced in Featured Clinical Research Session II

KENILWORTH, N.J.--Merck, known as MSD outside the United States and Canada, announced today that new data from two trials of the company’s cardiovascular medicines will be presented at the 2015 American College of Cardiology Annual Scientific Sessions (ACC.15), March 14-16 in San Diego. In all, eleven data presentations from company-sponsored studies will be presented at ACC.15, including new data from the investigational IMPROVE-IT (IMProved Reduction of Outcomes: VYTORIN Efficacy International Trial) study of VYTORIN (ezetimibe/simvastatin) and exploratory sub-analyses of the TRA 2°P TIMI 50 (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events) trial of ZONTIVITY (vorapaxar).

“The American College of Cardiology’s 64th Annual Scientific Sessions provide an opportunity for Merck to share new data from two of the largest cardiovascular outcomes trials of recent years,” said Dr. Daniel Bloomfield, vice president, Cardiovascular Diseases, Merck Research Laboratories. “We are pleased to share new data from these important studies with the scientific community.”

The primary results from the IMPROVE-IT trial of VYTORIN, which combines simvastatin with the non-statin ZETIA® (ezetimibe), were presented in November 2014. VYTORIN and ZETIA 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.

The TRA 2°P TIMI 50 study of ZONTIVITY (vorapaxar) supported the May 2014 approval of that medicine for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or in patients with peripheral arterial disease (PAD). In TRA 2°P TIMI 50, ZONTIVITY was shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke and urgent coronary revascularization. The U.S. Prescribing Information for ZONTIVITY includes a boxed warning regarding bleeding risk, which states that ZONTIVITY is not for use in patients with a history of stroke, transient ischemic attack (TIA) or intracranial hemorrhage (ICH), or active pathological bleeding. Antiplatelet agents, including ZONTIVITY, increase the risk of bleeding, including ICH and fatal bleeding.

The following data will be presented at ACC.15:

IMPROVE-IT Data in Featured Clinical Research Session II

  • (Abstract #414-03) Reduction in Total (First and Recurrent) Cardiovascular Events with Ezetimibe/Simvastatin compared with Simvastatin Alone post-Acute Coronary Syndromes in the IMPROVE-IT Trial. S. Murphy
    • Monday, March 16 12:30 PM-12:45 PM PT. Location: Room 6E.

TRA 2°P TIMI 50 Trial

  • (Abstract #1131M-11) Vorapaxar and Acute Limb Ischemia: Insights from the Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events-TIMI 50 Trial. A. Gutierrez
    • Saturday, March 14; 11:00 AM-11:10 AM PT. Location: Vascular Medicine Moderated Poster Theater, Poster Hall B1.
  • (Abstract #905-04) The role of Vorapaxar in Patients with Coronary Artery Bypass Grafting: Findings from the TRA 2P-TIMI 50 Trial. E. Kosova
    • Sunday, March 15; 10:57 AM-11:08 AM PT. Location: Room 7B.
  • (Abstract #1131M-05) Vorapaxar and Peripheral Revascularization: Insights from the TRA2P-TIMI 50 Trial. I. Gilchrist
    • Saturday, March 14; 10:15 AM-10:25 AM PT. Location: Vascular Medicine Moderated Poster Theater, Poster Hall B1.
  • (Abstract #1131M-03) Statin Intensity and Outcome in Patients with Peripheral Artery Disease: Insights from the TRA2P-TIMI 50 Trial. I. Gilchrist
    • Saturday, March 14; 10:00 AM-10:10 AM PT. Location: Vascular Medicine Moderated Poster Theater, Poster Hall B1.

Additional Merck-sponsored Data

  • (Abstract #1125M-09) Baseline LDL-C and Clinical Outcomes with Addition of Ezetimibe to Statin in 18,144 Patients Post ACS. R. Giugliano
    • Saturday, March 14; 10:45 AM-10:55 AM PT. Location: Acute Coronary Syndromes Moderated Poster Theater, Poster Hall B1.
  • (Abstract #1125M-07) Risk Stratification for Cardiovascular Events in the IMPROVE-IT Trial. E. Bohula
    • Saturday, March 14; 10:30 AM-10:40 AM PT. Location: Acute Coronary Syndromes Moderated Poster Theater, Poster Hall B1.
  • (Abstract #1133M-05) Cholesterol in Remnant-Lipoproteins as Measured by Different Methods. P. Toth
    • Saturday, March 14; 10:15 AM-10:25 AM PT. Location: Stable Ischemic Heart Disease Moderated Poster Theater, Poster Hall B1.
  • (Abstract #1194-364) Ezetimibe Does Not Increase Fasting Glucose Levels More than Statins Alone in Non-Diabetic, Hypercholesterolemic Patients. P. Toth
    • Sunday, March 15; 9:45 AM-10:30 AM PT. Location: Poster Hall B1.
  • (Abstract #1211-119) Low LDL-Cholesterol Target Achievement in Statin-Treated Patients in Clinical Practice in China and Europe: Results of the Dyslipidemia International Study (DYSIS) A. Gitt
    • Sunday, March 15; 3:45 PM-4:30 PM PT. Location: Poster Hall B1.
  • (Abstract # 1261-347) Effect of Beta-Blockade on Cardiovascular Event Rates in Patients with Asymptomatic Aortic Stenosis C. Bang
    • Monday, March 16; 9:45 AM-10:30 AM PT. Location: Poster Hall B1.
http://www.mercknewsroom.com/news-release/prescription-medicine-news/new-data-improve-it-study-vytorin-ezetimibesimvastatin-and-t 

Source: Merck 

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