New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Roflumilast - Daliresp by Forest Labs • Dose 500 mcg QD with or without food • Indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations • Neutrophils, eosinophils, and monocytes contain PDE4. Roflumilast is believed to exert an anti-inflammatory effect through inhibition of PDE4 in these cell types • Cost $211.50/30 tabs WAC Roflumilast - Daliresp • The pharmacologically active N-oxide metabolite is estimated to account for about 90% of roflumilast’s overall pharmacologic effects. The elimination halflife of the N-oxide metabolite is approximately 21 to 27 hours. Roflumilast N-oxide is predominantly metabolized via CYP3A4 • Drug Interactions: Use with strong cytochrome P450 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) is not recommended. • CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) may increase roflumilast systemic exposure and may result in increased adverse reactions. The risk of such concurrent use should be weighed carefully against benefit. Wayne Weart New Drug Update Part I
2 nd Annual Essentials in Primary Care Fall Conference Friday, November 11, 2011 Roflumilast - Daliresp • 3 placebo controlled trials in patients with COPD and at least 1 exacerbation requiring steroids in the last year randomized to either roflumilast 500 mcg or placebo QD for 52 weeks. – Change in postbrochodilator FEV ranged from 39-61 ml increase with roflumilast vs. placebo – Minimal reduction in moderate to severe exacerbations in 2 of the 3 trials- RR 0.85 and 0.82 (RRR 15 and 18%) (0.19 and 0.28 exacerbations per year) Roflumilast - Daliresp • Roflumilast 500 mcg plus salmeterol in patients with moderate to severe COPD vs. placebo plus salmeterol for 24 weeks. – Change in postbrochodilator FEV 1 60 ml increase with roflumilast vs. placebo – Non-significant reduction in mild, moderate or severe exacerbations with roflumilast vs. placebo RR 0.79 (P=0.1408) 2.4 VS. 1.9 exacerbations per year – Proportion of patients with a moderate or severe exacerbation RR 0.6 (P=0.0015) 18% vs. 11% – ARR 7%, NNT ~15 Wayne Weart New Drug Update Part I
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New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

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