Severe COPD with chronic bronchitis and frequent exacerbations — SCE Respiratory MCQ
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Correct answer: D — Initiate 250 micrograms once daily for 28 days, then 500 micrograms once daily, with weight and mood monitoring
She meets the NICE criteria for specialist-initiated roflumilast: severe COPD with chronic bronchitis, post-bronchodilator FEV1 below 50% predicted, and at least two exacerbations in 12 months despite LAMA/LABA/ICS therapy. The recommended initiation regimen is 250 micrograms once daily for 28 days, followed by the therapeutic maintenance dose of 500 micrograms once daily. The introductory dose reduces early adverse effects and treatment discontinuation but is subtherapeutic and should not be continued as maintenance. Her severe renal impairment does not require dose adjustment and is not a contraindication. Low body weight is also not an absolute contraindication, although weight should be checked at each visit in an underweight patient; treatment should be stopped if unexplained clinically concerning weight loss develops. Patients below 60 kg also have an increased risk of sleep disturbance. A remote depressive episode without suicidal ideation or behaviour does not automatically preclude treatment. It requires an individualised benefit–risk assessment and counselling to report mood or behavioural changes. Roflumilast is not recommended when depression has been associated with suicidal ideation or behaviour, and it should be discontinued if new or worsening psychiatric symptoms or suicidality emerge. Starting 500 micrograms immediately omits the recommended tolerability lead-in, whereas indefinite 250-microgram treatment is unlikely to provide adequate PDE4 inhibition.
Reference: Roflumilast for treating chronic obstructive pulmonary disease: Recommendations (26 July 2017) — https://www.nice.org.uk/guidance/ta461/chapter/1-Recommendations Roflumilast 500 micrograms Tablets: Summary of Product Characteristics (29 June 2026) — https://www.medicines.org.uk/emc/product/13453/smpc Roflumilast 500 micrograms Tablets: Summary of Product Characteristics (29 June 2026) — https://www.medicines.org.uk/emc/product/13453/smpc