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Serious Side Effects Seen With Failed Merck & Co., Inc. (MRK) Niacin Drug


3/11/2013 7:43:54 AM

SAN FRANCISCO--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada, today announced that researchers from the Clinical Trial Service Unit at Oxford University presented results from the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study of TREDAPTIVE™(extended-release niacin/laropiprant) during a late-breaking clinical trials session at the American College of Cardiology 62nd Annual Scientific Sessions (abstract 300-14). HPS2-THRIVE was independently conducted by the Clinical Trial Service Unit at Oxford University, the regulatory sponsor of the trial, and funded by Merck.

Merck previously announced that the study did not meet its primary endpoint (December 20, 2012 news release). Adding TREDAPTIVE to statin therapy did not significantly further reduce the risk of major vascular events compared to statin therapy in patients at high risk of cardiovascular events. Additionally, there was a statistically significant increase in the incidence of some types of non-fatal serious adverse events in the group that received TREDAPTIVE. Merck announced in January that it was taking steps to suspend the availability of TREDAPTIVE in countries where the medicine has been approved (January 11, 2013 news release). TREDAPTIVE is not approved in the United States.

The results of HPS2-THRIVE in 25,673 patients were presented by Professor Jane Armitage, FFPH, FRCP, professor of clinical trials and epidemiology, Oxford University and the primary investigator for the HPS2-THRIVE study. In the trial, the composite primary endpoint of major vascular events (coronary death, non-fatal heart attack, stroke or any arterial revascularization) occurred in 13.2 percent of the patients taking TREDAPTIVE plus statin therapy (n=1,696) compared to 13.7 percent of the patients taking statin therapy alone (n=1,758) after a median 3.9 years of follow-up. This corresponded to a risk ratio of 0.96 (95 percent CI: 0.90-1.03; p=0.29).

As previously disclosed, there were statistically significant increases in non-fatal serious adverse events observed in patients taking TREDAPTIVE plus statin therapy compared to patients taking placebo plus statin therapy. These events included: diabetic complications, new onset diabetes, infection, gastrointestinal, musculoskeletal, bleeding (including gastrointestinal and intracranial) and skin. There was also a small excess in heart failure.

“Merck has a long and proud history of supporting major outcomes studies to investigate challenging scientific questions and advance our collective understanding of cardiovascular medicine,” said Michael Mendelsohn, M.D., senior vice president, cardiovascular medicine, Merck Research Laboratories. “The results of HPS2-THRIVE add substantially to the body of scientific knowledge in this important therapeutic area.”

About HPS2-THRIVE

As noted, HPS2-THRIVE (Clinicaltrials.gov identifier: NCT 00461630) was independently conducted by the Clinical Trial Service Unit at Oxford University and funded by Merck. The study enrolled 25,673 patients considered to be at high risk for cardiovascular events. Of those enrolled, 14,741 were from Europe (the United Kingdom and Scandinavia) and 10,932 were from China. HPS2-THRIVE compared extended-release niacin and laropiprant (a flushing pathway inhibitor) plus statin therapy versus statin therapy. It was not designed to assess directly the separate effects of either extended-release niacin or laropiprant.

About Merck

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2012 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Contact:

Merck

Media:

Pamela Eisele, 908-423-5042

Skip Irvine, 267-305-5397

or

Investors:

Carol Ferguson, 908-423-4465

Justin Holko, 908-423-5088


Read at BioSpace.com


   

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