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Med J Islam Repub Iran. 2016 Feb 20;30:332. eCollection 2016.

The safety and effectiveness of the current treatment regimen with or without roflumilast in advanced COPD patients: A systematic review and meta-analysis of randomized controlled trials.

Author information

MSc Student, HTA, Tehran University of Medical Sciences, Tehran, Iran.
Assistant Professor, National Institute of Health Research, Tehran University of Medical Sciences, Tehran, Iran.
PhD, Office for Clinical Trials, Food and Drug Organization, Tehran, Iran.
Associate Professor, Department of Health Management and Economics, and Knowledge Utilization Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Associate Professor, Department of Pulmonary Medicine, Tehran University of Medical Sciences, Tehran, Iran.
PhD Student in Health Economics, Department of Health Economics, School of Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran.
Young Researchers and Elites Club, Science and Research Branch, Islamic Azad University, Tehran, Iran.



Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease, which reduces the lung function and causes respiratory symptoms over time, and it is primarily associated with shortness of breath, cough and sputum production. Roflumilast, which is a long-acting selective inhibitor, reduces the anti-inflammatory effect of the main symptoms of COPD. The aim of this study was to compare the clinical effectiveness of adding roflumilast to the current treatment regimen of patients with severe COPD.


To retrieve the marker studies, medical databases were searched up to February 2014. We included studies, which compared the clinical effectiveness and safety of roflumilast as concomitant to Long-acting ß2-agonist/Long-acting muscarinic antagonist (LABA/LAMA) regimen, in adult patients with severe COPD. The number of exacerbations, changes in the lung function FEV1, FEV1/FVC and quality of life were the major predefined outcomes. Meta-analysis of outcomes was performed by the RevMan software, with I(2)> 50%, representing considerable heterogeneity.


Seven randomized controlled trials and two systematic reviews were included. In terms of safety, participants were likely to experience more side effects from roflumilast compared to placebo, particularly gastrointestinal effects (diarrhea, nausea, vomiting), headache and weight loss. There was no significant difference in the risk of cardiac complications or flu-like symptoms or upper respiratory tract infection in the two groups. In terms of effectiveness, only a small improvement was observed in SGRQ (St George's Respiratory Questionnaire) index. Roflumilast reduced moderate to severe attacks, and caused significant improvements in the lung function regardless of the severity of the disease and the concurrent use of other standard COPD therapies.


Roflumilast anti-inflammatory therapy reduces the chronic bronchitis symptoms in patients with moderate to severe COPD, and it can be safely used with other drugs simultaneously.


COPD; Effectiveness; Roflumilast; Safety


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