Raffaele Antonelli Incalzi1, Francesco Blasi2,3, Giorgio Walter Canonica4, Maria Pia Foschino5, Renato Prediletto6, Lucia Simoni7, Alessandra Ori7, Clara Giovannetti8, Stefania Barsanti8, Nicola Scichilone9. 1. University Biomedical Campus of Rome, Via Alvaro del Portillo, 21, 00128, Rome, Italy. R.Antonelli@unicampus.it. 2. Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Adult Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Via Francesco Sforza, 35, 20122, Milan, Italy. 3. Department of Pathophysiology and Transplantation, University of Milan, Via Francesco Sforza, 35, 20122, Milan, Italy. 4. Personalized Medicine Asthma and Allergy Clinic, Humanitas University Humanitas Research Hospital Rozzano (Milan), Via Manzoni, 56, 20089, Rozzano (Milan), Italy. 5. MAR4 Univ., D'Avanzo Hospital, Viale degli Aviatori, 1, 71122, Foggia, Italy. 6. Pneumology, Institute of Clinical Physiology, National Research Council of Italy and Toscana G. Monasterio Foundation, Via Giuseppe Moruzzi, 1, 56124, Pisa, Italy. 7. Medineos Observational Research, Viale Virgilio 54/U, 41123, Modena, Italy. 8. Laboratori Guidotti, Via Livornese, 897, 56122, Pisa, Italy. 9. DIBIMIS, University of Palermo, Piazza delle Cliniche, 2, 90127, Palermo, Italy.
Abstract
INTRODUCTION: While selected clinical and laboratory findings are taken into account to find the best therapeutic strategies for chronic obstructive pulmonary disease (COPD), it is unknown whether the circadian rhythm of respiratory symptoms, a distinctive feature of COPD, affects the prescription pattern of pharmacological therapy. The main aim of this study was to verify whether the circadian rhythm of symptoms correlates with bronchodilating therapy prescribed to COPD patients as per clinical practice. A secondary objective was to assess the relationship between Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage and circadian rhythm of symptoms and health status. METHODS: Five hundred sixty-six COPD patients were enrolled in the Italian multicenter STORICO study. Patients underwent a multidimensional assessment, and correlates of prescribed therapy were assessed through a multivariate multilevel model. RESULTS: As expected, patients in GOLD D stage were more likely to receive triple inhaled therapy than GOLD A-C patients, but the circadian rhythm of symptoms, assessed by the nighttime, morning, and daytime symptoms of the COPD questionnaire, was unrelated to the prescription pattern. The multivariate model showed that emphysematous (EM) patients had a 50% increased risk compared with patients affected by chronic bronchitis (CB) of being prescribed long-acting β2-agonists (LABA)/long-acting muscarinic antagonist (LAMA) fixed-dose combination (FDC) instead of triple therapy [relative risk (RR) EM versus CB 1.50, 95% CI 1.11, 2.03]. Symptoms, mainly in the early morning and daytime, were highly prevalent, even in GOLD B stage (76%). CONCLUSION: Even if we cannot infer about causality of the symptoms-therapy relationship, based on the structured recording of circadian symptoms clearly shows that symptoms are poorly controlled as the circadian rhythm of symptoms does not correlate with the prescription pattern, and many patients are symptomatic both at daytime and by nighttime. Thus, therapy should be better tailored to the individual needs, with special attention to control nocturnal symptoms. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03105999.
INTRODUCTION: While selected clinical and laboratory findings are taken into account to find the best therapeutic strategies for chronic obstructive pulmonary disease (COPD), it is unknown whether the circadian rhythm of respiratory symptoms, a distinctive feature of COPD, affects the prescription pattern of pharmacological therapy. The main aim of this study was to verify whether the circadian rhythm of symptoms correlates with bronchodilating therapy prescribed to COPD patients as per clinical practice. A secondary objective was to assess the relationship between Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage and circadian rhythm of symptoms and health status. METHODS: Five hundred sixty-six COPD patients were enrolled in the Italian multicenter STORICO study. Patients underwent a multidimensional assessment, and correlates of prescribed therapy were assessed through a multivariate multilevel model. RESULTS: As expected, patients in GOLD D stage were more likely to receive triple inhaled therapy than GOLD A-C patients, but the circadian rhythm of symptoms, assessed by the nighttime, morning, and daytime symptoms of the COPD questionnaire, was unrelated to the prescription pattern. The multivariate model showed that emphysematous (EM) patients had a 50% increased risk compared with patients affected by chronic bronchitis (CB) of being prescribed long-acting β2-agonists (LABA)/long-acting muscarinic antagonist (LAMA) fixed-dose combination (FDC) instead of triple therapy [relative risk (RR) EM versus CB 1.50, 95% CI 1.11, 2.03]. Symptoms, mainly in the early morning and daytime, were highly prevalent, even in GOLD B stage (76%). CONCLUSION: Even if we cannot infer about causality of the symptoms-therapy relationship, based on the structured recording of circadian symptoms clearly shows that symptoms are poorly controlled as the circadian rhythm of symptoms does not correlate with the prescription pattern, and many patients are symptomatic both at daytime and by nighttime. Thus, therapy should be better tailored to the individual needs, with special attention to control nocturnal symptoms. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03105999.
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