Medical Journal of the Islamic Republic Of Iran
مجله پزشکی جمهوری اسلامی ایران
Med J Islam Repub Iran
Medical Sciences
http://mjiri.iums.ac.ir
2
journal2
1016-1430
2251-6840
8
10.18869/mjiri
14
8888
13
en
jalali
1394
10
1
gregorian
2016
1
1
30
1
online
1
fulltext
en
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
Health Technology Assessment
Health Technology Assessment
Original Research
Original Research
<p dir="ltr"> </p>
<p dir="ltr"><strong>Background: </strong>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.</p>
<p dir="ltr"><strong> Methods</strong>: 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<sup>2</sup>> 50%, representing considerable heterogeneity.</p>
<p dir="ltr"><strong> Results</strong>: 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.</p>
<p dir="ltr"><strong> Conclusion</strong>: 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.</p>
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Roflumilast, COPD, Safety, Effectiveness.
183
198
http://mjiri.iums.ac.ir/browse.php?a_code=A-10-1-964&slc_lang=en&sid=1
Saeideh
Jafari Andarian
ja.saeideh@gmail.com
200319475328460021507
200319475328460021507
No
Tehran University of Medical Sciences, Tehran, Iran.
Alireza
Olyaeemanesh
arolyaee@yahoo.com
200319475328460021508
200319475328460021508
Yes
National Institute of Health Research, Tehran University of Medical Sciences, Tehran, Iran.
Seyed Alireza
Hosseini
hosseini.reza7@gmail.com
200319475328460021509
200319475328460021509
No
Office for Clinical Trials, Food and Drug Organization, Tehran, Iran.
Ali
Akbari Sari
akbarisari@tums.ac.ir
200319475328460021510
200319475328460021510
No
Department of Health Management and Economics, and Knowledge Utilization Research Center, Tehran University of Medical Sci-ences, Tehran, Iran.
Shahram
Firoozbakhsh
200319475328460021511
200319475328460021511
No
Department of Pulmonary Medicine, Tehran University of Medical Sciences, Tehran, Iran.
Mojtaba
Nouhi Jadesi
mojtabanouhi@gmail.com
200319475328460021512
200319475328460021512
No
Department of Health Economics, School of Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran.
Mohammadreza
Mobinizadeh
mobinreza@yahoo.com
200319475328460021513
200319475328460021513
No
Young Researchers and Elites Club, Science and Research Branch, Islamic Azad University, Tehran, Iran.