Benefits and harms of roflumilast in moderate to severe COPD

Thorax
Tsung YuMilo A Puhan

Abstract

Roflumilast, a phosphodiesterase 4 inhibitor, has been approved for the prevention of chronic obstructive pulmonary disease (COPD) exacerbations. It is unclear which patients will have a favourable benefit-harm balance with roflumilast. Our aim was to quantitatively assess the benefits and harms of roflumilast (500 µg/day) compared with placebo. We used summary data released by the US Food and Drug Administration to estimate the treatment effects of roflumilast. Data from trials and observational studies were used 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, and varied weights (ie, 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 a net benefit. Only in...Continue Reading

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Citations

Jan 28, 2016·Current Opinion in Pulmonary Medicine·Hetal J Patel
Mar 5, 2016·Journal of Clinical Epidemiology·Kevin M FainMilo A Puhan
Sep 5, 2015·Drugs·Karly P Garnock-Jones
Mar 15, 2015·Thorax·Andy Bush, Ian Pavord
Dec 23, 2014·American Journal of Respiratory and Critical Care Medicine·Alvar AgustíJacob I Sznajder
Jun 10, 2016·Expert Opinion on Drug Safety·Paola RoglianiMaria Gabriella Matera
Jan 18, 2017·European Respiratory Review : an Official Journal of the European Respiratory Society·Beniamino GuerraMilo A Puhan
May 14, 2019·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Walter E RodriguezLeila Gobejishvili
Jan 15, 2020·Pharmaceutical Medicine·Raphaelle Beau-LejdstromMilo A Puhan
Aug 1, 2020·Neuroscience Letters·Lal Jabaris S SuginK Narayan Sunil
Sep 6, 2020·Multiple Sclerosis and Related Disorders·Alessandra SpanuMilo A Puhan
Feb 10, 2021·Expert Review of Clinical Pharmacology·Maria Gabriella MateraMario Cazzola
Mar 18, 2020·The Lancet. Respiratory Medicine·Amin AdibiMohsen Sadatsafavi
Mar 29, 2021·Journal of Clinical Epidemiology·Marc BuyseOriana Ciani

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