Roflumilast, a once-a-day oral tablet, would be the first in an entirely new class of treatment for COPD if it receives regulatory approval from the authorities in Europe (EMEA) and the US (FDA).
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At the time of the study there was even an FDA-advisory specifically urging caution regarding the off-label use of quetiapine in patients with dementia.
There was also a statistically significant difference with roflumilast in other prespecified endpoints, including median time to first exacerbation (moderate to severe in the salmeterol study, and mild, moderate and severe in the tiotropium study) and in
A significant worsening of symptoms called an exacerbation or lung attack can last several weeks.
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Breathing becomes severely compromised and patients may need to be admitted to hospital.
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* Beta-blockers (eg, propranolol) because the risk of low blood sugar may be increased. They may also hide certain signs of low blood sugar and make it more difficult to notice
Thirty of the adverse events occurred outside the United States.
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