PMID- 27279341
OWN - NLM
STAT- MEDLINE
DCOM- 20170227
LR  - 20220408
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 15
IP  - 8
DP  - 2016 Aug
TI  - Drug safety evaluation of roflumilast for the treatment of COPD: a meta-analysis.
PG  - 1133-46
LID - 10.1080/14740338.2016.1199683 [doi]
AB  - INTRODUCTION: Roflumilast is the only phosphodiesterase 4 inhibitor approved for 
      the treatment of COPD patients with chronic cough and sputum, and a history of 
      exacerbations, but the compliance to treatment is reduced by poorly tolerated 
      adverse events (AEs). AREAS COVERED: The synthesis of clinical evidences 
      indicates that roflumilast 500mug once-daily increased the risk of AEs, with no 
      impact on the risk of serious AEs (SAEs), compared with placebo. Gastrointestinal 
      AEs were common in patients treated with roflumilast, that may also induce 
      headache, backpain and insomnia. Roflumilast protects against COPD related AEs. 
      The frequency of very SAEs was rare but greater in patients treated with 
      roflumilast than placebo, although factors other than the study drug were related 
      with these SAEs. EXPERT OPINION: 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.
FAU - Rogliani, Paola
AU  - Rogliani P
AD  - a Department of Systems Medicine , University of Rome Tor Vergata , Rome , Italy.
FAU - Calzetta, Luigino
AU  - Calzetta L
AD  - a Department of Systems Medicine , University of Rome Tor Vergata , Rome , Italy.
FAU - Cazzola, Mario
AU  - Cazzola M
AD  - a Department of Systems Medicine , University of Rome Tor Vergata , Rome , Italy.
FAU - Matera, Maria Gabriella
AU  - Matera MG
AD  - b Department of Experimental Medicine , Second University of Naples , Naples , 
      Italy.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
DEP - 20160620
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 0 (Aminopyridines)
RN  - 0 (Benzamides)
RN  - 0 (Cyclopropanes)
RN  - 0 (Phosphodiesterase 4 Inhibitors)
RN  - 0P6C6ZOP5U (Roflumilast)
SB  - IM
MH  - Aminopyridines/administration & dosage/adverse effects/*therapeutic use
MH  - Benzamides/administration & dosage/adverse effects/*therapeutic use
MH  - Cyclopropanes/administration & dosage/adverse effects/therapeutic use
MH  - Drug Therapy, Combination
MH  - Gastrointestinal Diseases/chemically induced/epidemiology
MH  - Humans
MH  - Medication Adherence
MH  - Phosphodiesterase 4 Inhibitors/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Pulmonary Disease, Chronic Obstructive/*drug therapy/physiopathology
MH  - Randomized Controlled Trials as Topic
MH  - Treatment Outcome
OTO - NOTNLM
OT  - PDE4 inhibitor
OT  - Rofllumilast
OT  - adverse events
OT  - meta-analysis
OT  - safety
EDAT- 2016/06/10 06:00
MHDA- 2017/02/28 06:00
CRDT- 2016/06/10 06:00
PHST- 2016/06/10 06:00 [entrez]
PHST- 2016/06/10 06:00 [pubmed]
PHST- 2017/02/28 06:00 [medline]
AID - 10.1080/14740338.2016.1199683 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2016 Aug;15(8):1133-46. doi: 10.1080/14740338.2016.1199683. 
      Epub 2016 Jun 20.