Luigino Calzetta1, Maria Gabriella Matera2, Fulvio Braido3, Marco Contoli4, Angelo Corsico5, Fabiano Di Marco6, Pierachille Santus7, Nicola Scichilone8, Mario Cazzola9, Paola Rogliani10. 1. Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy. Electronic address: luigino.calzetta@uniroma2.it. 2. Department of Experimental Medicine, University of Campania Luigi Vanvitelli, Naples, Italy. Electronic address: mariagabriella.matera@unina2.it. 3. Department of Internal Medicine, IRCCS San Martino di Genova University Hospital, Genoa, Italy. Electronic address: fulvio.braido@unige.it. 4. Department of Medical Sciences, University of Ferrara, Ferrara, Italy. Electronic address: marco.contoli@unife.it. 5. Department of Molecular Medicine, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. Electronic address: corsico@unipv.it. 6. Department of Health Sciences, University of Milan, San Paolo Hospital, Milan, Italy. Electronic address: fabiano.dimarco@unimi.it. 7. Department of Health Sciences, University of Milan, ASST Fatebenefratelli-Sacco, Milan, Italy. Electronic address: pierachille.santus@unimi.it. 8. Department of Internal Medicine, University of Palermo, Italy. Electronic address: nicola.scichilone@unipa.it. 9. Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy. Electronic address: mario.cazzola@uniroma2.it. 10. Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy. Electronic address: paola.rogliani@uniroma2.it.
Abstract
BACKGROUND: Conflicting findings exist on the benefit of withdrawal of inhaled corticosteroid (ICS) in chronic obstructive pulmonary disease (COPD). We performed a quantitative synthesis in order to assess real impact of ICS discontinuation in COPD patients. METHODS: We carried out a meta-analysis via random-effects model on the available clinical evidence to evaluate the effect of ICS discontinuation in COPD. Randomized clinical trials and observational real-life studies investigating the effects of ICS withdrawal on the risk of COPD exacerbation, lung function (forced expiratory volume in 1 s [FEV1]) and quality of life (St. George's Respiratory Questionnaire [SGRQ]) were identified by searching from published studies and repository databases. RESULTS: ICS withdrawal did not significantly (P > 0.05) increase the overall rate of COPD exacerbation, although a clinically important increased risk of severe exacerbation was detected (Relative Risk >1.2). ICS withdrawal significantly (P < 0.001) impaired both lung function (-30 ml FEV1) and quality of life (+1.24 SGRQ units), although in a non-clinically important manner. The time to the first exacerbation was significantly (P < 0.05) shorter in the patients who discontinued ICS. CONCLUSIONS: The discrepancy between statistical analysis and clinical interpretation of this meta-analytic evaluation demonstrates the strong clinical need in understanding what is the real impact of ICS withdrawal in COPD. ICS discontinuation is a complex procedure that requires a well planned and tailored strategy. Further well designed studies on withdrawal of ICS should be performed by clustering COPD patients with regard to the phenotype characteristics, rate of exacerbations/year, decline of lung function, and quality of life.
BACKGROUND: Conflicting findings exist on the benefit of withdrawal of inhaled corticosteroid (ICS) in chronic obstructive pulmonary disease (COPD). We performed a quantitative synthesis in order to assess real impact of ICS discontinuation in COPD patients. METHODS: We carried out a meta-analysis via random-effects model on the available clinical evidence to evaluate the effect of ICS discontinuation in COPD. Randomized clinical trials and observational real-life studies investigating the effects of ICS withdrawal on the risk of COPD exacerbation, lung function (forced expiratory volume in 1 s [FEV1]) and quality of life (St. George's Respiratory Questionnaire [SGRQ]) were identified by searching from published studies and repository databases. RESULTS: ICS withdrawal did not significantly (P > 0.05) increase the overall rate of COPD exacerbation, although a clinically important increased risk of severe exacerbation was detected (Relative Risk >1.2). ICS withdrawal significantly (P < 0.001) impaired both lung function (-30 ml FEV1) and quality of life (+1.24 SGRQ units), although in a non-clinically important manner. The time to the first exacerbation was significantly (P < 0.05) shorter in the patients who discontinued ICS. CONCLUSIONS: The discrepancy between statistical analysis and clinical interpretation of this meta-analytic evaluation demonstrates the strong clinical need in understanding what is the real impact of ICS withdrawal in COPD. ICS discontinuation is a complex procedure that requires a well planned and tailored strategy. Further well designed studies on withdrawal of ICS should be performed by clustering COPD patients with regard to the phenotype characteristics, rate of exacerbations/year, decline of lung function, and quality of life.
Authors: Marc Miravitlles; Borja G Cosío; Aurelio Arnedillo; Myriam Calle; Bernardino Alcázar-Navarrete; Cruz González; Cristóbal Esteban; Juan Antonio Trigueros; José Miguel Rodríguez González-Moro; José Antonio Quintano Jiménez; Adolfo Baloira Journal: Respir Res Date: 2017-11-28
Authors: Didier Cataldo; Eric Derom; Giuseppe Liistro; Eric Marchand; Vincent Ninane; Rudi Peché; Hans Slabbynck; Walter Vincken; Wim Janssens Journal: Int J Chron Obstruct Pulmon Dis Date: 2018-07-05