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WHITEHOUSE STATION, N.J. — Merck & Co., Inc. today announced changes to the product label for SINGULAIR(R) (montelukast sodium), which includes new information from a 56-week clinical study that demonstrated that children with asthma (6-8 years of age) taking SINGULAIR 5 mg tablets once daily had similar growth rates as children taking placebo. In the same study, children taking the inhaled steroid beclomethasone dipropionate 168 mcg twice daily had slower growth rates than children on either SINGULAIR or placebo.
“The new label language provides physicians and patients with important new information on SINGULAIR that should prove helpful in furthering their understanding of the medicines used in the treatment of asthma,” said Theodore F. Reiss, M.D., vice president, Clinical Research, Merck Research Laboratories.

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Study results
Results from the 56 week, multi center, double-blind, randomized active and placebo controlled parallel group study of 360 patients with mild asthma showed that the differences in growth rates, expressed as least-squares (LS) mean (95% confidence interval (CI)) in centimeters (cm)/year, for SINGULAIR minus placebo, beclomethasone minus placebo, and SINGULAIR minus beclomethasone treatment groups were 0.03 (CI, -0.26, 0.31), -0.78 (CI, -1.06, -0.49); and 0.81 (CI, 0.53, 1.09), respectively. The primary comparison was the difference in growth rates between SINGULAIR and placebo groups.
Growth rates, expressed as LS mean (95% CI) in cm/year, for the SINGULAIR, placebo, and beclomethasone treatment groups were 5.67 (CI, 5.46, 5.88), 5.64 (CI, 5.42, 5.86), and 4.86 (CI, 4.64, 5.08), respectively. Treatment groups included SINGULAIR 5 mg once daily, placebo, and beclomethasone dipropionate administered as 168 mcg twice daily with a spacer device.
Important information about SINGULAIR for treatment of asthma
The use of SINGULAIR for asthma may not eliminate the need for inhaled or oral corticosteroids. Patients should be advised to take SINGULAIR daily as prescribed even when they have no symptoms, as well as during periods of worsening asthma, and to contact their physician if their asthma is not well controlled. SINGULAIR should not be used for the fast relief of acute asthma attacks or used alone to treat and manage asthma made worse by exercise. Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking SINGULAIR.
In clinical studies for asthma, side effects in adults and children taking SINGULAIR were usually mild and generally did not cause patients to discontinue therapy. The most commonly reported side effects varied by age and included headache, ear infection, sore throat and upper respiratory infection.
SINGULAIR is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines in over 20 therapeutic categories. The company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
Forward-looking statement
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck’s business, particularly those mentioned in the cautionary statements in Item 1 of Merck’s Form 10-K for the year ended Dec. 31, 2004, and in its periodic reports on Form 10-Q and Form 8-K, which the company incorporates by reference.
Prescribing information and patient product information for SINGULAIR are attached.
SINGULAIR(R) (montelukast sodium) is a registered trademark of Merck & Co., Inc.