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New Study Demonstrates Ramelteon Does Not Exacerbate Respiratory Depressant Effects in Patients With Moderate-to-Severe COPD
Date:12/3/2007

ORLANDO, Fla., Dec. 3 /PRNewswire/ -- A new study presented today showed that ramelteon did not exacerbate respiratory depressant effects in patients (40 years and older) with moderate to severe chronic obstructive pulmonary disease (COPD), as measured by oxygenation or abnormal breathing events relative to placebo. Results of this double-blind, placebo-controlled trial were presented at the 53rd International Respiratory Congress of the American Association for Respiratory Care.

"Getting adequate sleep is essential to maintaining health in people who live with COPD. These results suggest that ramelteon is a sleep medication that can be used safely in adults suffering from moderate to severe COPD who are concerned with breathing impairment during sleep," said Thomas Roth, PhD, director, Henry Ford Sleep Research and Disorders Center. "While traditional sleep aids can negatively affect respiration during sleep in patients with COPD, this study demonstrated that ramelteon does not produce such respiratory depressant effects."

According to the National Institutes of Health, more than 12 million Americans are currently diagnosed with COPD. It is the fourth leading cause of death in the United States and causes serious, long-term disability.

"Patients with COPD -- usually characterized by a combination of chronic bronchitis and emphysema -- must take extreme care in ensuring they receive enough oxygen at all times, particularly when sleeping. Other medications used for insomnia may reduce upper airway muscle tone, which can lead to increased hypoxemia," said Dr. Roth. "This study shows that there was no difference in blood oxygen saturation all night between placebo and ramelteon."

Study Design

A total of 25 adults age 40 or older with moderate to severe COPD were randomized to receive ramelteon 8 mg or placebo 30 minutes before overnight monitoring of oxygen saturation (SaO2) by pulse oximetry and sleep by polysomnography. After
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SOURCE Takeda Pharmaceuticals North America, Inc.
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