people died of COPD in 2005, which corresponds to 5% of all deaths globally. The WHO predicts that total deaths from COPD could increase by more than 30% in the next 10 years unless urgent action is taken to reduce the underlying risk factors, especially smoking.
Think COPDifferently (Nycomed information site for european medical professionals only)
WHO Facts on COPD
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Daxas?
Manufacturer:
Forest Laboratories
Pharmacological Class:
Selective phosphodiesterase 4 (PDE4) inhibitor
Active Ingredient(s):
Roflumilast 500mcg; tabs.
Indication(s):
To reduce risk of COPD exacerbations in severe COPD patients with chronic bronchitis and a history of exacerbations. Not for the relief of acute bronchospasm.
Pharmacology:
Both roflumilast and its active metabolite (roflumilast N-oxide) selectively inhibit the activity of phosphodiesterase 4, an enzyme that mediates the breakdown of intracellular cyclic AMP. The resultant increased levels of intracellular cyclic AMP in lung cells may be related to the clinical effects of roflumilast, but the exact mechanism of action is not well defined.
Clinical Trials:
The safety and efficacy of roflumilast in the management of COPD was eva luated in several randomized double-blind, controlled, parallel group clinical trials involving a total of 9,394 adult patients with nonreversible obstructive lung disease. Four of these were placebo-controlled 1-year trials in patients with severe COPD that were designed to eva luate the efficacy of roflumilast on COPD exacerbations. In two of these trials, inhaled corticosteroids and short-acting beta agonists were allowed. Lung function (FEV1) and the rate of moderate or severe COPD exacerbations was a co-primary endpoint. Both trials failed to show a significant reduction in the rate of COPD exacerbations. Subsequent trials were designed based on an analysis of a subset of these patients who appeared to have a better response compared to the overall population. These two trials enrolled 3,096 patients with severe COPD associated with chronic bronchitis, at least one COPD exacerbation in the previous year, and at least a 20 pack-year smoking history. Long-acting beta agonists and short-acting anti-muscarinics were allowed, but not inhaled corticosteroids. In both of these trials, roflumilast 500mcg once daily showed a significant reduction in the rate of moderate or severe COPD exacerbations compared to placebo. Also, in these four trials, roflumilast 500mcg daily resulted in a significant improvement in lung function.
Two additional studies were 6-month efficacy trials in patients with moderate-to-severe COPD conducted to assess the effect on lung function of roflumilast as add-on therapy to a long-acting beta agonist or a long-acting anti-muscarinic. No trials have been conducted to assess the effects of roflumilast on COPD exacerbations when added to a fixed-dose combination product containing a long-acting beta agonist and inhaled corticosteroid.
Legal Classification:
Rx
Adults:
500mcg once daily.
Children:
Not recommended.
Contraindication(s):
Moderate-to-severe liver impairment (Child-Pugh Class B or C).
Warnings/Precautions:
Depression. Suicid |
