Cargando…

Effect of a Dose-Escalation Regimen for Improving Adherence to Roflumilast in Patients with Chronic Obstructive Pulmonary Disease

BACKGROUND: The adverse effects of the phosphodiesterase-4 inhibitor roflumilast, appear to be more frequent in clinical practice than what was observed in chronic obstructive pulmonary disease (COPD) clinical trials. Thus, we designed this study to determine whether adverse effects could be reduced...

Descripción completa

Detalles Bibliográficos
Autores principales: Hwang, Hyunjung, Shin, Ji Young, Park, Kyu Ree, Shin, Jae Ouk, Song, Kyoung-hwan, Park, Joonhyung, Park, Jeong Woong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Korean Academy of Tuberculosis and Respiratory Diseases 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4620324/
https://www.ncbi.nlm.nih.gov/pubmed/26508918
http://dx.doi.org/10.4046/trd.2015.78.4.321
_version_ 1782397272530616320
author Hwang, Hyunjung
Shin, Ji Young
Park, Kyu Ree
Shin, Jae Ouk
Song, Kyoung-hwan
Park, Joonhyung
Park, Jeong Woong
author_facet Hwang, Hyunjung
Shin, Ji Young
Park, Kyu Ree
Shin, Jae Ouk
Song, Kyoung-hwan
Park, Joonhyung
Park, Jeong Woong
author_sort Hwang, Hyunjung
collection PubMed
description BACKGROUND: The adverse effects of the phosphodiesterase-4 inhibitor roflumilast, appear to be more frequent in clinical practice than what was observed in chronic obstructive pulmonary disease (COPD) clinical trials. Thus, we designed this study to determine whether adverse effects could be reduced by starting roflumilast at half the dose, and then increasing a few weeks later to 500 µg daily. METHODS: We retrospectively investigated 85 patients with COPD who had taken either 500 µg roflumilast, or a starting dose of 250 µg and then increased to 500 µg. We analyzed all adverse events and assessed differences between patients who continued taking the drug after dose escalation and those who had stopped. RESULTS: Adverse events were reported by 22 of the 85 patients (25.9%). The most common adverse event was diarrhea (10.6%). Of the 52 patients who had increased from a starting dose of 250 µg roflumilast to 500 µg, 43 (82.7%) successfully maintained the 500 µg roflumilast dose. No difference in factors likely to affect the risk of adverse effects, was detected between the dose-escalated and the discontinued groups. Of the 26 patients who started with the 500 µg roflumilast regimen, seven (26.9%) discontinued because of adverse effects. There was no statistically significant difference in discontinuation rate between the dose-escalated and the control groups (p=0.22). CONCLUSION: Escalating the roflumilast dose may reduce treatment-related adverse effects and improve tolerance to the full dose. This study suggests that the dose-escalated regimen reduced the rate of discontinuation. However, longer-term and larger-scale studies are needed to support the full benefit of a dose escalation strategy.
format Online
Article
Text
id pubmed-4620324
institution National Center for Biotechnology Information
language English
publishDate 2015
publisher The Korean Academy of Tuberculosis and Respiratory Diseases
record_format MEDLINE/PubMed
spelling pubmed-46203242015-10-27 Effect of a Dose-Escalation Regimen for Improving Adherence to Roflumilast in Patients with Chronic Obstructive Pulmonary Disease Hwang, Hyunjung Shin, Ji Young Park, Kyu Ree Shin, Jae Ouk Song, Kyoung-hwan Park, Joonhyung Park, Jeong Woong Tuberc Respir Dis (Seoul) Original Article BACKGROUND: The adverse effects of the phosphodiesterase-4 inhibitor roflumilast, appear to be more frequent in clinical practice than what was observed in chronic obstructive pulmonary disease (COPD) clinical trials. Thus, we designed this study to determine whether adverse effects could be reduced by starting roflumilast at half the dose, and then increasing a few weeks later to 500 µg daily. METHODS: We retrospectively investigated 85 patients with COPD who had taken either 500 µg roflumilast, or a starting dose of 250 µg and then increased to 500 µg. We analyzed all adverse events and assessed differences between patients who continued taking the drug after dose escalation and those who had stopped. RESULTS: Adverse events were reported by 22 of the 85 patients (25.9%). The most common adverse event was diarrhea (10.6%). Of the 52 patients who had increased from a starting dose of 250 µg roflumilast to 500 µg, 43 (82.7%) successfully maintained the 500 µg roflumilast dose. No difference in factors likely to affect the risk of adverse effects, was detected between the dose-escalated and the discontinued groups. Of the 26 patients who started with the 500 µg roflumilast regimen, seven (26.9%) discontinued because of adverse effects. There was no statistically significant difference in discontinuation rate between the dose-escalated and the control groups (p=0.22). CONCLUSION: Escalating the roflumilast dose may reduce treatment-related adverse effects and improve tolerance to the full dose. This study suggests that the dose-escalated regimen reduced the rate of discontinuation. However, longer-term and larger-scale studies are needed to support the full benefit of a dose escalation strategy. The Korean Academy of Tuberculosis and Respiratory Diseases 2015-10 2015-10-01 /pmc/articles/PMC4620324/ /pubmed/26508918 http://dx.doi.org/10.4046/trd.2015.78.4.321 Text en Copyright©2015. The Korean Academy of Tuberculosis and Respiratory Diseases. All rights reserved. http://creativecommons.org/licenses/by-nc/4.0/ It is identical to the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/)
spellingShingle Original Article
Hwang, Hyunjung
Shin, Ji Young
Park, Kyu Ree
Shin, Jae Ouk
Song, Kyoung-hwan
Park, Joonhyung
Park, Jeong Woong
Effect of a Dose-Escalation Regimen for Improving Adherence to Roflumilast in Patients with Chronic Obstructive Pulmonary Disease
title Effect of a Dose-Escalation Regimen for Improving Adherence to Roflumilast in Patients with Chronic Obstructive Pulmonary Disease
title_full Effect of a Dose-Escalation Regimen for Improving Adherence to Roflumilast in Patients with Chronic Obstructive Pulmonary Disease
title_fullStr Effect of a Dose-Escalation Regimen for Improving Adherence to Roflumilast in Patients with Chronic Obstructive Pulmonary Disease
title_full_unstemmed Effect of a Dose-Escalation Regimen for Improving Adherence to Roflumilast in Patients with Chronic Obstructive Pulmonary Disease
title_short Effect of a Dose-Escalation Regimen for Improving Adherence to Roflumilast in Patients with Chronic Obstructive Pulmonary Disease
title_sort effect of a dose-escalation regimen for improving adherence to roflumilast in patients with chronic obstructive pulmonary disease
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4620324/
https://www.ncbi.nlm.nih.gov/pubmed/26508918
http://dx.doi.org/10.4046/trd.2015.78.4.321
work_keys_str_mv AT hwanghyunjung effectofadoseescalationregimenforimprovingadherencetoroflumilastinpatientswithchronicobstructivepulmonarydisease
AT shinjiyoung effectofadoseescalationregimenforimprovingadherencetoroflumilastinpatientswithchronicobstructivepulmonarydisease
AT parkkyuree effectofadoseescalationregimenforimprovingadherencetoroflumilastinpatientswithchronicobstructivepulmonarydisease
AT shinjaeouk effectofadoseescalationregimenforimprovingadherencetoroflumilastinpatientswithchronicobstructivepulmonarydisease
AT songkyounghwan effectofadoseescalationregimenforimprovingadherencetoroflumilastinpatientswithchronicobstructivepulmonarydisease
AT parkjoonhyung effectofadoseescalationregimenforimprovingadherencetoroflumilastinpatientswithchronicobstructivepulmonarydisease
AT parkjeongwoong effectofadoseescalationregimenforimprovingadherencetoroflumilastinpatientswithchronicobstructivepulmonarydisease