DTB: Vol 21, No 4. August - October 2013

Roflumilast for stable COPD, another example of hasty positioning in (some) Clinical Practice Guidelines

In the management of stable COPD, roflumilast has only shown an improvement in lung function and a modest reduction in exacerbations when compared to placebo. However, there are no data on roflumilast efficacy incorporated into therapeutic regimens commonly employed in clinical practice. There is concern regarding the safety profile of the drug and it is under an extensive risk management plan. The positioning of roflumilast is different in the three aforementioned guidelines: 1) as an alternative to inhaled cortisteroids in patients with severe or very severe COPD and with high risk of exacerbations in cases of chronic bronchitis (Gold guidelines, 2013); 2) only in the context of clinical research (Guia Salud), and 3) at the same level as inhaled corticosteroids and employed in multiple combinations in patients with a mixed phenotype COPD-asthma and patients characterised by acute exacerbations of chronic bronchitis (GesEPOC guidelines).




Entrevista a Cecilia Calvo, farmacéutica de AP del Servicio Madrileño de Salud, sobre su artículo titulado “Roflumilast en el tratamiento de estable. Otro ejemplo de posicionamiento precipitado en (algunas) guías de práctica clínica”.

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