PMID- 23197074
OWN - NLM
STAT- MEDLINE
DCOM- 20130807
LR  - 20181202
IS  - 1753-4666 (Electronic)
IS  - 1753-4658 (Linking)
VI  - 7
IP  - 1
DP  - 2013 Feb
TI  - Efficacy and safety of roflumilast in patients with chronic obstructive pulmonary 
      disease: a systematic review and meta-analysis.
PG  - 13-24
LID - 10.1177/1753465812466167 [doi]
AB  - 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 
      long-term safety of roflumilast before its wider use.
FAU - Oba, Yuji
AU  - Oba Y
AD  - Division of Pulmonary, Critical Care and Environmental Medicine, University of 
      Missouri, School of Medicine, One Hospital Drive, CE 412 Columbia, MO 65212, USA. 
      obay@health.missouri.edu
FAU - Lone, Nazir A
AU  - Lone NA
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
PT  - Systematic Review
DEP - 20121129
PL  - England
TA  - Ther Adv Respir Dis
JT  - Therapeutic advances in respiratory disease
JID - 101316317
RN  - 0 (Aminopyridines)
RN  - 0 (Benzamides)
RN  - 0 (Cyclopropanes)
RN  - 0 (Phosphodiesterase 4 Inhibitors)
RN  - 0P6C6ZOP5U (Roflumilast)
SB  - IM
CIN - Ther Adv Respir Dis. 2013 Aug;7(4):247-9. PMID: 23823487
MH  - Aged
MH  - Aminopyridines/adverse effects/*therapeutic use
MH  - Benzamides/adverse effects/*therapeutic use
MH  - Cyclopropanes/adverse effects/therapeutic use
MH  - Disease Progression
MH  - Female
MH  - Humans
MH  - Lung/*drug effects/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Multivariate Analysis
MH  - Odds Ratio
MH  - Phosphodiesterase 4 Inhibitors/adverse effects/*therapeutic use
MH  - Pulmonary Disease, Chronic Obstructive/diagnosis/*drug therapy/physiopathology
MH  - Risk Assessment
MH  - Treatment Outcome
EDAT- 2012/12/01 06:00
MHDA- 2013/08/08 06:00
CRDT- 2012/12/01 06:00
PHST- 2012/12/01 06:00 [entrez]
PHST- 2012/12/01 06:00 [pubmed]
PHST- 2013/08/08 06:00 [medline]
AID - 1753465812466167 [pii]
AID - 10.1177/1753465812466167 [doi]
PST - ppublish
SO  - Ther Adv Respir Dis. 2013 Feb;7(1):13-24. doi: 10.1177/1753465812466167. Epub 
      2012 Nov 29.