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Adding theophylline to ICS does not reduce exacerbations in COPD

Adding theophylline to ICS does not reduce exacerbations in COPD

Adults with COPD at high risk of exacerbation treated with inhaled corticosteroids, the addition of low-dose theophylline did not reduce the number COPD exacerbations over a 1-year period compared with placebo, according to a study published in the journal JAMA Network.

Oral theophylline has been used as a bronchodilator to treat COPD for decades; however, to achieve modest bronchodilatation through phosphodiesterase inhibition, blood concentrations (10-20 mg/L) are required that are associated with adverse effects. Recently there has been interest in using theophylline at a low dose in COPD to achieve plasma levels of 1 to 5 mg/L.

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Graham Devereux et al conducted a pragmatic randomized clinical trial to investigate the effectiveness of adding low-dose theophylline to inhaled corticosteroids in COPD.

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The study included 1578 participants with COPD with a follow up of 3 years. Participants had a ratio of forced expiratory volume in the first second to forced vital capacity (FEV1/FVC) of less than 0.7 with at least 2 exacerbations (treated with antibiotics, oral corticosteroids, or both) in the previous year and were using an inhaled corticosteroid.

The study participants were randomized to receive low-dose theophylline (200 mg once or twice per day) to provide plasma concentrations of 1 to 5 mg/L (determined by ideal body weight and smoking status) (n = 791) or placebo (n = 787).

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The primary outcome was moderate or severe exacerbations treated with antibiotics, oral corticosteroids, or both over the 1-year treatment period.

The key study findings included are:

  • In total, there were 3430 exacerbations: 1727 in the theophylline group vs 1703 in the placebo group.
  • Serious adverse events in the theophylline and placebo groups included cardiac, 2.4% vs 3.4%; gastrointestinal, 2.7% vs 1.3%; and adverse reactions such as nausea (10.9% vs 7.9%) and headaches (9.0% vs 7.9%).

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“The current study attempted to replicate the use of low-dose theophylline in routine clinical practice with 121 geographically dispersed study centers, minimal inclusion criteria, infrequent study assessments, no changes to routine care, usual care settings, and use of participant-reported exacerbations,” write the authors.

The study concluded that the findings do not support the use of low-dose theophylline as adjunctive therapy to inhaled corticosteroids for the prevention of COPD exacerbations.

For reference log on to 10.1001/jama.2018.14432

Source: With inputs from JAMA Network

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