Posted by: APO | 30 June 2015

MSD’s Cardiovascular Safety Trial of JANUVIA (sitagliptin), Met Primary Endpoint in Patients with Type 2 Diabetes


MSD’s Cardiovascular Safety Trial of JANUVIA (sitagliptin), Met Primary Endpoint in Patients with Type 2 Diabetes

TECOS study showed that treatment with Sitagliptin does not increase the risks of Major cardiovascular events or hospitalization for heart failure

DUBAI, UAE, June 30, 2015/African Press Organization (APO)/ MSD, known as Merck (NYSE: MRK) (http://www.merck.com) in the United States and Canada, recently announced the primary results of the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), a placebo-controlled study of the cardiovascular (CV) safety of MSD’s DPP-4 inhibitor, JANUVIA® (sitagliptin).

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The TECOS cardiovascular safety trial was an event-driven study designed to assess the long-term CV safety of the addition of sitagliptin to usual care, compared to usual care without sitagliptin, in patients with type 2 diabetes and established CV disease.  The study enrolled more than 14,735 patients from 38 countries and was led by independent academic research collaboration between the University of Oxford Diabetes Trials Unit and the Duke University Clinical Research Institute, and was sponsored by MSD. Amongst the key findings, it was evident that there was no increase in CV-related deaths or hospitalization for heart failure in the Sitagliptin group versus placebo.

“Patients with type 2 diabetes need antihyperglycemic medicines to help control their blood sugar.  Because these patients are at increased risk for cardiovascular complications, understanding the cardiovascular safety of these medicines is important,” said study co-chair Rury Holman, Professor of Diabetic Medicine and Diabetes Trials Unit Director, University of Oxford.  “The results from TECOS showed that sitagliptin did not increase the risk of cardiovascular events in a diverse group of patients with type 2 diabetes at high cardiovascular risk.”

Overall, the primary endpoint occurred in 11.4 percent (n=839) of sitagliptin-treated patients compared with 11.6 percent (n=851) of placebo-treated patients in the Intention-to-Treat (ITT) analysis, and in 9.6 percent (n=695) of patients in both the sitagliptin and placebo groups in the Per Protocol (PP) analysis. In addition, there was no increase in hospitalization for heart failure, and rates of all-cause mortality were similar in both treatment groups, which were two key secondary endpoints.

“We believe the results of TECOS provide important clinical information about the cardiovascular safety profile of sitagliptin,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories.  “The TECOS CV safety trial reflects the best efforts of clinical scientists at the University of Oxford, the Duke Clinical Research Institute and MSD on behalf of patients around the world who suffer from type 2 diabetes.”

Distributed by APO (African Press Organization) on behalf of MSD (Merck Sharp & Dohme).

Media Contacts:

Shamim Kassibawi

shamim@efikra.com

+971 50 550 3230

About MSD

Today’s MSD (http://www.merck.com) is a global healthcare leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies, 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.

MSD 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 MSD’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; MSD’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of MSD/Merck patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

MSD/Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise except as required by applicable law. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in MSD’s/Merck’s 2014 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).

BACKGROUND INFORMATION: http://www.apo-mail.org/150630.pdf

SOURCE

MSD (Merck Sharp & Dohme)


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