Roflumilast in Asian patients with COPD: A randomized placebo‐controlled trial

Lee, Sang Do; Hui, David S.; Mahayiddin, Aziah Ahmad; Roa, Camilo; Kwa, Kheng Hoe; Goehring, Udo Michael; Bredenbröker, Dirk; Kuo, Han Pin

doi:10.1111/j.1440-1843.2011.02038.x

Cited by 35 publications

(30 citation statements)

References 21 publications

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“…The incidence of serious AEs (SAEs) was reported in six trials comprising 7022 patients Lee et al 2011;Rabe et al 2005;Rennard et al 2011]. In our pooled analysis, SAEs occurred in 17.5% and 18.4% with roflumilast and placebo.…”

Section: Safetymentioning

confidence: 90%

“…The all-cause mortality rate was reported in four trials including 5014 patients ; Lee et al 2011]. None of the studies were sufficiently powered to detect a difference in mortality.…”

Section: Safetymentioning

confidence: 99%

“…Detailed information on AEs which were not included in the original studies was found on the internet (COPD Safety Pool) [Forest Research Institute, 2010]. These safety data included the total of 12,054 patients (6972 receiving roflumilast) enrolled in 14 controlled parallel group studies including all eight studies used in our meta-analysis except for the study by Lee and colleagues [Lee et al 2011]. This database was used in additional analyses for AEs and mortality.…”

Section: Study Selectionmentioning

confidence: 99%

“…All included studies reported AEs occurring in at least 2% of patients Fabbri et al 2009;Lee et al 2011;Rabe et al 2005;Rennard et al 2011]. A total of 8696 patients were included in the safety analysis.…”

Section: Safetymentioning

confidence: 99%

“…We found that two studies included two separate trials. We included six publications reporting the total of eight clinical trials (Figure 1) Fabbri et al 2009;Lee et al 2011;Rabe et al 2005;Rennard et al 2011]. Detailed information on AEs which were not included in the original studies was found on the internet (COPD Safety Pool) [Forest Research Institute, 2010].…”

Section: Study Selectionmentioning

confidence: 99%

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Efficacy and safety of roflumilast in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis

Oba

Lone

2012

Ther Adv Respir Dis

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Abstract:Background: Roflumilast, a phosphodiesterase 4 inhibitor, has been shown to improve lung function and reduce exacerbation rates, but is associated with adverse events (AEs). The purpose of this study was to systematically review the clinical effectiveness and safety of roflumilast. Methods: A systematic search was made of MEDLINE, Cochrane trials database, DARE and CINAHL. Randomized, controlled trials of more than 12 weeks' duration comparing roflumilast with placebo were reviewed. Studies were pooled to yield relative risk (RR), incident rate difference or weighted mean differences with 95% confidence intervals (CIs). Results: Eight trials (8698 patients) met the inclusion criteria. Roflumilast significantly reduced moderate to severe exacerbations (RR 0.85; 95% CI 0.80-0.91) compared with placebo, but not severe exacerbations (RR 0.83; 95% CI 0.68-1.01) or mortality (RR 0.90; 95% CI 0.63-1.28). Roflumilast significantly improved lung function relative to placebo, but not quality of life measures. AEs (RR 1.11; 95% CI 1.03-1.19) and discontinuations of treatment due to AEs (RR 1.63; 95% CI 1.45-1.84) were significantly more frequent with roflumilast than placebo. In the chronic obstructive pulmonary disease (COPD) Safety Pool (12,054 patients), the overall incidence of serious AEs did not differ between groups. However, atrial fibrillation (0.4% versus 0.2%; p = 0.02) and suicidality (0.08% versus 0%) were more frequent with roflumilast than placebo. Conclusions: The efficacy of roflumilast appears modest compared with other available therapies for COPD. Further studies are needed to investigate the risk-benefit ratio and longterm safety of roflumilast before its wider use.

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Section: Safetymentioning

confidence: 90%

“…The all-cause mortality rate was reported in four trials including 5014 patients ; Lee et al 2011]. None of the studies were sufficiently powered to detect a difference in mortality.…”

Section: Safetymentioning

confidence: 99%

Section: Study Selectionmentioning

confidence: 99%

Section: Safetymentioning

confidence: 99%

Section: Study Selectionmentioning

confidence: 99%

See 3 more Smart Citations

Efficacy and safety of roflumilast in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis

Oba

Lone

2012

Ther Adv Respir Dis

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Phosphodiesterase 4 inhibitors for chronic obstructive pulmonary disease

Chong

Leung

Poole

2013

Cochrane Database of Systematic Reviews

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BackgroundChronic obstructive pulmonary disease (COPD) is associated with cough, sputum production or dyspnoea, and a reduction in lung function, quality of life, and life expectancy. Apart from smoking cessation, no other treatments that slow lung function decline are available. Roflumilast and cilomilast are oral phosphodiesterase-4 (PDE ) inhibitors proposed to reduce the airway inflammation and bronchoconstriction seen in COPD. This Cochrane Review was first published in 2011, and was updated in 2017 and 2020. ObjectivesTo evaluate the e icacy and safety of oral PDE inhibitors for management of stable COPD. Search methodsWe identified randomised controlled trials (RCTs) from the Cochrane Airways Trials Register (date of last search 9 March 2020). We found other trials at web-based clinical trials registers. Selection criteriaWe included RCTs if they compared oral PDE inhibitors with placebo in people with COPD. We allowed co-administration of standard COPD therapy. Data collection and analysisWe used standard Cochrane methods. Two independent review authors selected trials for inclusion, extracted data, and assessed risk of bias. We resolved discrepancies by involving a third review author. We assessed our confidence in the evidence by using GRADE recommendations. Primary outcomes were change in lung function (minimally important di erence (MID) = 100 mL) and quality of life (scale 0 to 100; higher score indicates more limitations). Main resultsWe found 42 RCTs that met the inclusion criteria and were included in the analyses for roflumilast (28 trials with 18,046 participants) or cilomilast (14 trials with 6457 participants) or tetomilast (1 trial with 84 participants), with a duration between six weeks and one year or longer. These trials included people across international study centres with moderate to very severe COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) grades II to IV), with mean age of 64 years.We judged risks of selection bias, performance bias, and attrition bias as low overall amongst the 39 published and unpublished trials.

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