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Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Thorax 2014 ; 69 (7): 616-22 Nephropedia Template TP
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Benefits and harms of roflumilast in moderate to severe COPD #MMPMID24347460
Yu T; Fain KM; Boyd CM; Singh S; Weiss CO; Li T; Varadhan R; Puhan MA
Thorax 2014[Jul]; 69 (7): 616-22 PMID24347460show ga
Background: Roflumilast, a phosphodiesterase 4 inhibitor, was approved for the prevention of COPD exacerbations. It is unclear in which patients roflumilast will have a favorable benefit-harm balance. Our aim was to quantitatively assess the benefits and harms of roflumilast (500 mcg per day) compared to placebo. Methods and Findings: We used trial data released by the US Food and Drug Administration to estimate the treatment effects of roflumilast. We used data from observational studies when available to estimate the baseline risks for COPD exacerbations and gastrointestinal, neurological and psychiatric harms associated with roflumilast. Using simulation, we calculated the probability that roflumilast provides net benefit. We examined the impacts of different baseline risks for exacerbations and the severity of exacerbations. We varied weights (i.e., relative importance) for outcomes and treated death as a competing risk in the analyses. The probability that roflumilast provides net benefit approximates 0% across different age categories of men and women with varying baseline risks for exacerbations. Using different weights for outcomes did not change the probability that roflumilast provides net benefit. Only in the sensitivity analysis restricted to the prevention of severe exacerbations there was a probability of >50% that roflumilast provides net benefit if the baseline risk of having at least one severe exacerbation per year exceeds 22%. Conclusions: Our results suggest roflumilast only provides net benefit to patients at a high risk of severe exacerbations. Guideline developers should consider different recommendations for COPD patients at different baseline risks for exacerbations.