SynthesisInternational journal of chronic obstructive pulmonary disease2016
Potential treatment benefits and safety of roflumilast in COPD: a systematic review and meta-analysis.
Synthesis in International journal of chronic obstructive pulmonary disease, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.
- Phosphodiesterase-4 inhibitors for chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2020Pooled it
- Pharmacokinetics, Safety and Tolerability of HPP737, a Novel PDE4 Inhibitor, in Healthy Chinese Participants: Phase I Study.Drug design, development and therapy · 2026Trial
- Mechanisms of Action of Herbal Preparations for the Rehabilitation of Dust-Related Diseases of the Bronchopulmonary System.Biomedicines · 2026Review
- A New Adjuvant Treatment for Glioblastoma Using Aprepitant, Vortioxetine, Roflumilast and Olanzapine: The AVRO Regimen.International journal of molecular sciences · 2025Review
- High Throughput Pharmacovigilance Screening for Roflumilast Adverse Effects in Real-World Settings: A Sequence Symmetry Analysis.Basic & clinical pharmacology & toxicology · 2025Article
- Phosphodiesterase Inhibition as a Therapeutic Strategy for Chronic Obstructive Pulmonary Disease: Where We Have Been and What Lies Ahead.Chronic obstructive pulmonary diseases (Miami, Fla.) · 2025Article
- Differential response to roflumilast in patients with chronic obstructive pulmonary disease: real-world evidence.Journal of thoracic disease · 2024Article
- Difamilast for the treatment of atopic dermatitis.The Journal of international medical research · 2023Review
- Mucus Hypersecretion in Chronic Obstructive Pulmonary Disease and Its Treatment.Mediators of inflammation · 2023Review
- Article
- 5-Hydroxymethylcytosine Signatures in Circulating Cell-Free DNA as Early Warning Biomarkers for COVID-19 Progression and Myocardial Injury.Frontiers in cell and developmental biology · 2021Article
- Roflumilast (Daliresp®) to reduce acute pulmonary events in fibrotic sarcoidosis: a multi-center, double blind, placebo controlled, randomized clinical trial.Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG · 2021Article
- Roflumilast in Severely Ill Patients with Chronic Obstructive Pulmonary Disease with Frequent Exacerbations: Risk of Pneumonia Hospitalization and Severe Exacerbations.Journal of clinical medicine · 2020Article
- Management of the COPD Patient with Comorbidities: An Experts Recommendation Document.International journal of chronic obstructive pulmonary disease · 2020Article
- Inhibition of phosphodiesterase 4 by FCPR16 protects SH-SY5Y cells against MPPRedox biology · 2018Article
- Phosphodiesterase type 4 inhibition enhances nitric oxide- and hydrogen sulfide-mediated bladder neck inhibitory neurotransmission.Scientific reports · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCurrent evidence suggests that roflumilast is efficacious in treating COPD, especially in preventing the acute exacerbation of COPD.
objectivesThis study was designed to evaluate the clinical effects and safety of roflumilast in the treatment of stable COPD using randomized clinical trial (RCT) data.
methodsA MEDLINE, EMBASE, and Cochrane Controlled Trials Register search was carried out. RCTs reporting the treatment effects of roflumilast in COPD were identified. Relevant data were extracted and a meta-analysis was performed.
resultsA total of nine articles and 13 RCT studies were identified. Overall, 29.1% of the subjects in the roflumilast group showed evidence of exacerbation. The corresponding figure was 32.2% in the placebo group. According to pooled analysis, the use of roflumilast reduced COPD exacerbations in comparison to placebo (odds ratio [OR] =0.82, 95% confidence interval [CI] =0.75-0.9). The quality of life and spirometry were improved. For patients receiving baseline pre-bronchodilators, their average forced expiratory volume in the first second showed evidence of change when they took roflumilast (64.88 mL; 95% CI =54.09-75.66). Those who took placebo showed no evidence of change. Similar result was observed in patients receiving baseline (54.49 mL; 95% CI =44.04-64.94). As for the safety of roflumilast treatment, the overall cumulative incidence of adverse drug reaction was 54.2% in the roflumilast group and 48.2% in the placebo group (OR =1.36, 95% CI =1.13-1.65). The adverse effects included diarrhea, headache, nausea, weight loss, and insomnia.
conclusionThe efficacy of roflumilast in the prevention of acute exacerbation of COPD is obvious. Roflumilast is proved to be able to improve spirometry of COPD patients. The adverse drug reaction did not increase significantly in the roflumilast group compared with the control group. COPD patients can benefit from roflumilast therapy. However, our results are limited by the cohort design of the selected studies and the degree of heterogeneity among them; hence, more randomized trials are needed to further support this conclusion.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.