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Merck & Co., Inc. (MRK) Release: New Analysis Shows That Patients With Type 2 Diabetes and Mild Renal Impairment Had Similar Improvement in Blood Sugar Control and Experienced Less Hypoglycemia With JANUVIA® (sitagliptin) Compared to Sulfonylurea


6/24/2013 9:03:09 AM

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WHITEHOUSE STATION, N.J., June 22, 2013 –Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from a post-hoc pooled analysis showing patients with type 2 diabetes and mild renal impairment treated with JANUVIA® (sitagliptin) 100 mg once-daily achieved similar blood sugar reductions as those treated with the sulfonylureas glipizide or glimepiride, with significantly fewer events of hypoglycemia (low blood sugar), and with weight loss instead of weight gain. Results were presented at the American Diabetes Association 73rd Scientific Sessions. “Chronic renal disease is, unfortunately, an increasingly common problem in patients with type 2 diabetes—and one which can complicate physicians’ management of their patients’ blood sugar control,” said Peter Stein, vice president of Clinical Research for diabetes and endocrinology, Merck Research Laboratories. “Treatments which can help patients with diabetes and renal insufficiency get to improved glycemic control, without increasing the risk of hypoglycemia, may be very useful.”

Patients taking JANUVIA 100 mg once-daily achieved similar blood sugar reductions (-0.62 LS mean A1C[1] reduction from a baseline of 7.6%) as patients taking a sulfonylurea (-0.68 LS mean A1C reduction from a baseline of 7.6%). Of the patients taking JANUVIA® (sitagliptin), 6.8 percent experienced one or more episodes of symptomatic hypoglycemia, compared to 26.2 percent of patients taking a sulfonylurea(p<0.001). Patients taking JANUVIA also experienced weight loss (-0.9 kg or approximately 2 lbs.) compared to weight gain (+1.4 kg or approximately 3 lbs.) with a sulfonylurea (p<0.001).

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. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with JANUVIA or with any other antidiabetic drug.

Design of Post-hoc Analysis

This post-hoc analysis pooled data from three randomized, double-blind studies conducted over 25-30 weeks that included 1,180 patients with type 2 diabetes and mild renal insufficiency[2]. The analysis compared the effects of JANUVIA 100 mg (n=584) once daily to a sulfonylurea, either glipizide or glimepiride (n=596) in titrated doses, on change from baseline in A1C, fasting plasma glucose, body weight, and the incidence of symptomatic hypoglycemia.

Selected Important Risk Information About JANUVIA® (sitagliptin) 50 mg, 100 mg tablets 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® (sitagliptin), observe patients carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, promptly discontinue JANUVIA and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking JANUVIA.

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 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, 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®(sitagliptin).

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 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’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’s 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).

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