Roflumilast for the Treatment of COPD in an Asian Population

Zheng, Jinping; Yang, Jinghua; Zhou, Xiangdong; Zhao, Li; Hui, Fuxin; Wang, Haoyan; Bai, Chunxue; Chen, Ping; Li, Huiping; Kang, Jian; Brose, Manja; Richard, Frank; Goehring, Udo-Michael; Zhong, Nanshan

doi:10.1378/chest.13-1252

Cited by 36 publications

(38 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In fact, although we can generally confirm previous results from meta-analysis published in 2011 25 , 2013 24 and 2014 23 , our meta-analytic approach has identified a different overall risk of AEs, provided specific data on the risk of SAEs, and reported a more selective characterization of AEs induced by roflumilast. The differences between our results and those of previous meta-analyses may be related with the current availability of results from recently published RCTs [40][41][42] , that together enrolled more that 2,500 COPD patients, and with the fact that our meta-analysis has been specifically designed for assessing the safety profile of roflumilast in COPD. However, we cannot exclude that a different meta-analytic approach may have lead to at least partially different effects estimates.…”

Section: Results Evaluationcontrasting

confidence: 74%

“…Evidence of asymmetry from Egger's test was considered to be significant for P<0.1, and the graphical representation of 90% confidence bands have been presented 29 . Results obtained from 11,537 COPD patients (roflumilast n=5,893, placebo n=5,644) were selected from 9 published papers including 11 RCTs [40][41][42][43][44][45][46][47][48] . All studies were randomized and double-blind, and have been published between 2005 and 2015.…”

Section: Data Synthesis and Analysismentioning

confidence: 99%

“…Downloaded by [Nanyang Technological University] at 19:23 10 June 2016 assess effects of roflumilast during exercise, and those of Zheng et al42 and Lee et al45 were carried out in Asian populations.However, the effects estimates generated by a meta-analysis may not always fit with real life. In effect, the discrepancy between the safety profile reported by the RCTs selected for meta-analysis and the real-world clinical practice may be related with the evidence that roflumilast is usually administered in patients suffering from frequent COPD exacerbations that may have several cardiovascular comorbidities 84 , whereas the majority of patients with cardiopulmonary comorbidities are usually excluded from RCTs.…”

mentioning

confidence: 99%

See 2 more Smart Citations

Drug safety evaluation of roflumilast for the treatment of COPD: a meta-analysis

Rogliani

Calzetta

Cazzola

et al. 2016

Expert Opinion on Drug Safety

View full text Add to dashboard Cite

The safety profile of roflumilast administered in combination with further drugs for the treatment of COPD should be investigated through specifically designed RCTs, and the post-marketing surveillance might help to characterize the real risk of very SAEs. Roflumilast may provide more benefit than harm in patients at high risk of severe exacerbations, and the therapy discontinuation may be reduced by a correct education of patients on the generally transient and mild-to-moderate nature of gastrointestinal AEs induced by this drug.

show abstract

Section: Results Evaluationcontrasting

confidence: 74%

Section: Data Synthesis and Analysismentioning

confidence: 99%

mentioning

confidence: 99%

See 1 more Smart Citation

Drug safety evaluation of roflumilast for the treatment of COPD: a meta-analysis

Rogliani

Calzetta

Cazzola

et al. 2016

Expert Opinion on Drug Safety

View full text Add to dashboard Cite

show abstract

“…Further, the adverse effects were similar to those found in the Caucasian population. In another recent study, the efficacy and safety of roflumilast was determined in predominantly ethnic Chinese patients 32. Three hundred and thirteen patients were randomized in a double-blind fashion to either roflumilast 500 μg or placebo.…”

Section: Clinical Efficacymentioning

confidence: 99%

Vulnerable COPD patients with comorbidities: the role of roflumilast

Lipari¹,

Kale-Pradhan²

2014

TCRM

View full text Add to dashboard Cite

Roflumilast is a selective phosphodiesterase-4 (PDE-4) inhibitor that was approved by the US Food and Drug Administration in February 2011 for the management of chronic obstructive pulmonary disease (COPD). Literature was retrieved through PubMed using the terms “roflumilast” and “COPD”. Reference citations from publications identified were also reviewed. All articles published in English using the terms “roflumilast” and “COPD” were retrieved. For evaluation of clinical efficacy, published Phase III studies and pooled analyses of Phase III trials were included. In seven published Phase III trials, roflumilast at 500 μg daily showed improvements in lung function as measured by pre- and post-bronchodilator forced expiratory volume in 1 second. Roflumilast appears to be useful in vulnerable patients who are at high risk for exacerbations. Roflumilast was found to be effective when administered alone and with concomitant long-acting bronchodilator therapy in the Caucasian and Asian population. Patients with severe-to-very severe COPD, chronic bronchitis, and frequent history of exacerbations derived the greatest benefit with roflumilast. Compared to the standard of care therapies, roflumilast is more cost-prohibitive. Roflumilast was well tolerated, with the most common adverse events observed in clinical trials being diarrhea, nausea, and headache. Weight loss and increased risk of psychiatric events have also been observed with roflumilast in clinical trials. Roflumilast is a safe and effective option for the treatment of COPD.

show abstract

“…A multicenter clinical trial demonstrated that roflumilast can improve lung function significantly in Chinese population [11]. However, to the best of our knowledge, there is no literature reporting the pharmacokinetics of roflumilast and roflumilast N-oxide in healthy Chinese subjects.…”

Section: Introductionmentioning

confidence: 98%