Introduction:
Roflumilast
is the only phosphodiesterase 4 inhibitor approved for the treatment of
COPD patients with chronic cough and sputum, and a history of
exacerbations, but the compliance to treatment is reduced by poorly
tolerated adverse events (AEs).
Areas covered:
The
synthesis of clinical evidences indicates that roflumilast 500μg
once-daily increased the risk of AEs, with no impact on the risk of
serious AEs (SAEs), compared with placebo. Gastrointestinal AEs were
common in patients treated with roflumilast, that may also induce
headache, backpain and insomnia. Roflumilast protects against COPD
related AEs. The frequency of very SAEs was rare but greater in patients
treated with roflumilast than placebo, although factors other than the
study drug were related with these SAEs.
Expert opinion:
The
safety profile of roflumilast administered in combination with further
drugs for the treatment of COPD should be investigated through
specifically designed RCTs, and the post-marketing surveillance might
help to characterize the real risk of very SAEs. Roflumilast may provide
more benefit than harm in patients at high risk of severe
exacerbations, and the therapy discontinuation may be reduced by a
correct education of patients on the generally transient and
mild-to-moderate nature of gastrointestinal AEs induced by this drug.
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