Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced that the Trial Evaluating Cardiovascular
Outcomes with Sitagliptin (TECOS) of Merck’s DPP-4 inhibitor,
JANUVIA® (sitagliptin), achieved its primary endpoint of
non-inferiority for the composite cardiovascular (CV) endpoint.
Among secondary endpoints, there was no increase in hospitalization
for heart failure in the sitagliptin group versus placebo. The
complete results of TECOS will be presented on June 8, 2015 at the
75th Scientific Sessions of the American Diabetes Association.
The TECOS CV safety trial was led by an independent academic
research collaboration between the University of Oxford Diabetes
Trials Unit (DTU) and the Duke University Clinical Research
Institute (DCRI).
Indications and Limitations of Use for JANUVIA®
(sitagliptin)
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
JANUVIA is contraindicated in patients with a history of a
serious hypersensitivity reaction to sitagliptin, such as
anaphylaxis or angioedema. There have been postmarketing reports of
acute pancreatitis, including fatal and nonfatal hemorrhagic or
necrotizing pancreatitis, in patients taking JANUVIA. After
initiating JANUVIA, observe patients carefully for signs and
symptoms of pancreatitis. If pancreatitis is suspected, promptly
discontinue JANUVIA and initiate appropriate management.
About the TECOS CV Safety Trial
TECOS was an event-driven trial conducted in adults with type 2
diabetes and a history of cardiovascular disease. The study was
designed to assess the CV safety of long-term treatment with
JANUVIA as part of usual diabetes care compared with usual care
without JANUVIA. The primary endpoint was the composite of time to
the first of any of the following confirmed events:
cardiovascular-related death, nonfatal myocardial infarction,
nonfatal stroke, or unstable angina requiring hospitalization.
TECOS enrolled 14,724 participants from 38 countries between
December 2008 and July 2012. The median patient follow-up was
approximately three years.
Selected important risk information about JANUVIA®
(sitagliptin) 25 mg, 50 mg and 100 mg tablets
(continued)
Assessment of renal function is recommended prior to initiating
JANUVIA and periodically thereafter. A dosage adjustment is
recommended in patients with moderate or severe renal insufficiency
and in patients with end-stage renal disease requiring hemodialysis
or peritoneal dialysis. Caution should be used to ensure that the
correct dose of JANUVIA is prescribed.
There have been postmarketing reports of worsening renal
function, including acute renal failure, sometimes requiring
dialysis. A subset of these reports involved patients with renal
insufficiency, some of whom were prescribed inappropriate doses of
sitagliptin.
When JANUVIA was used in combination with a sulfonylurea or
insulin, medications known to cause hypoglycemia, the incidence of
hypoglycemia was increased over that of placebo. Therefore, a lower
dose of sulfonylurea or insulin may be required to reduce the risk
of hypoglycemia.
The incidence (and rate) of hypoglycemia based on all reports of
symptomatic hypoglycemia were: 12.2 percent (0.59 episodes per
patient-year) for JANUVIA 100 mg in combination with glimepiride
(with or without metformin), 1.8 percent (0.24 episodes per
patient-year) for placebo in combination with glimepiride (with or
without metformin), 15.5 percent (1.06 episodes per patient-year)
for JANUVIA (sitagliptin) 100 mg in combination with insulin (with
or without metformin), and 7.8 percent (0.51 episodes per
patient-year) for placebo in combination with insulin (with or
without metformin).
There have been postmarketing reports of serious
hypersensitivity reactions in patients treated with JANUVIA®
(sitagliptin), such as anaphylaxis, angioedema and exfoliative skin
conditions including Stevens-Johnson syndrome. Onset of these
reactions occurred within the first 3 months after initiation of
treatment with JANUVIA, with some reports occurring after the first
dose. If a hypersensitivity reaction is suspected, discontinue
JANUVIA, assess for other potential causes for the event, and
institute alternative treatment for diabetes.
Angioedema has also been reported with other dipeptidyl
peptidase-4 (DPP-4) inhibitors. Use caution in a patient with a
history of angioedema with another DPP-4 inhibitor because it is
unknown whether such patients will be predisposed to angioedema
with JANUVIA.
There have been no clinical studies establishing conclusive
evidence of macrovascular risk reduction with JANUVIA or with any
other antidiabetic drug.
In clinical studies, the adverse reactions reported, regardless
of investigator assessment of causality, in greater than or equal
to 5 percent of patients treated with JANUVIA as monotherapy and in
combination therapy, and more commonly than in patients treated
with placebo, were upper respiratory tract infection,
nasopharyngitis and headache.
About Merck
Today’s Merck is a global health care 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 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 health care 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 U.S. 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’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 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 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 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).
Please see Prescribing Information for JANUVIA®
(sitagliptin) at
http://www.merck.com/product/usa/pi_circulars/j/januvia/januvia_pi.pdf
and Medication Guide for JANUVIA at
http://www.merck.com/product/usa/pi_circulars/j/januvia/januvia_mg.pdf.
MerckMedia:Pam Eisele, 267-305-3558Kim Hamilton,
908-740-1863orInvestor:Joe Romanelli, 908-740-1986Justin Holko,
908-740-1879
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