The primary endpoint was mean SaO2 for the entire night. The findings
revealed that there was no statistically significant difference in SaO2 for
the entire night observed among the patients treated with ramelteon
compared to placebo (92.2 vs. 92.4%, P=0.576). Additional results showed:
-- Compared with placebo, there was no statistically significant
difference in the number of minutes in the night that SaO2 was <80% and
<90% (P=0.927 and P=0.653, respectively).
-- The mean apnea-hypopnea index was similar between ramelteon and placebo
-- A significant increase in total sleep time (389.0 vs 348.4 min,
P=0.019) and sleep efficiency (81.0 vs 72.6%, P=0.019) was observed
with ramelteon vs placebo.
-- Latency to persistent sleep was shorter with ramelteon vs placebo (23.1
vs 56.9 min) (P=0.051).
-- Adverse events were reported in four patients with ramelteon and four
patients with placebo treatment; none was noted as serious or led to
People with COPD have few options for treating insomnia because the traditional sleep medications cause a sedative effect that can further depress respiration. "This study is important in helping us understand the effects of ramelteon in patients with moderate to severe COPD," said Louis J. Mini, MD, medical director, Neuroscience, Takeda Pharmaceuticals North America, Inc. "COPD is a common disorder seen in clinical practice, and studies of this type provide useful information for physicians treating this population."
Ramelteon 8 mg is currently marketed as ROZEREM(TM). ROZEREM is
indicated for the treatment of insomnia characterized by difficulty with
sleep onset. ROZEREM can be prescribed for long-term use. ROZEREM is the
first and only prescription
|SOURCE Takeda Pharmaceuticals North America, Inc.|
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