PMID- 19124357
OWN - NLM
STAT- MEDLINE
DCOM- 20090210
LR  - 20220409
IS  - 1753-4658 (Print)
IS  - 1753-4658 (Linking)
VI  - 2
IP  - 2
DP  - 2008 Apr
TI  - Arformoterol and salmeterol in the treatment of chronic obstructive pulmonary 
      disease: a one year evaluation of safety and tolerance.
PG  - 37-48
LID - 10.1177/1753465808089455 [doi]
AB  - INTRODUCTION: Concerns have been raised regarding the safety of extended use of 
      long-acting beta2-agonists (LABAs). The safety of arformoterol (50 microg QD), 
      and salmeterol (42 microg BID), was assessed over 12 months in subjects with 
      COPD. The study also examined the occurrence of tolerance with these agents, i.e. 
      whether improvement in airway function diminished or frequency of exacerbations 
      increased with 12-months of use. METHODS: Subjects with COPD (mean FEV1 1.2 L, 
      ~41% predicted) were enrolled in the study and randomized to receive nebulized 
      arformoterol 50 microg QD (n = 528) or salmeterol 42 microg BID (MDI; n = 265) in 
      a prospective, multicenter, open-label, 12-month trial. The frequency of adverse 
      events, COPD exacerbations, and use of short-acting bronchodilator agents were 
      assessed throughout the study period. Pulmonary function was also examined. 
      RESULTS: Among treated subjects, the frequency of adverse events was similar for 
      those taking arformoterol (90.5%) and salmeterol (88.3%). Tremor was more 
      frequent among subjects treated with arformoterol (13.4%) than those treated with 
      salmeterol (1.1%). The frequency of COPD exacerbations did not increase over 12 
      months for arformoterol and salmeterol (weeks 0-13: 15.7% and 11.7%, 
      respectively; weeks 39-52: 10.0% and 9.4%, respectively). Supplemental 
      ipratropium bromide and rescue racemic albuterol use decreased for both groups by 
      0.8 to 1.5 actuations/day, decreases that remained stable throughout the 52-week 
      study. Mean predose (trough) FEV1 improved for arformoterol and salmeterol at 
      week 13 (7.1% +/- 17.0 and 7.6% +/- 17.8, respectively) and the improvement 
      continued at week 52 (5.9% and 6.2%, respectively). Mean peak percent predicted 
      postdose FEV1 over the course of the 52-week study declined by about 2% for both 
      treatments, but throughout was higher for arformoterol than for salmeterol. 
      CONCLUSION: In this trial, both arformoterol 50 microg QD and salmeterol 42 
      microg BID were well tolerated in patients with COPD. Both LABAs produced 
      effective bronchodilation and their use was not associated with the development 
      of clinically meaningful tolerance over a 1-year treatment period.
FAU - Donohue, J F
AU  - Donohue JF
AD  - University of North Carolina School of Medicine, Chapel Hill, NC, USA.
FAU - Hanania, N A
AU  - Hanania NA
FAU - Sciarappa, K A
AU  - Sciarappa KA
FAU - Goodwin, E
AU  - Goodwin E
FAU - Grogan, D R
AU  - Grogan DR
FAU - Baumgartner, R A
AU  - Baumgartner RA
FAU - Hanrahan, J P
AU  - Hanrahan JP
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - England
TA  - Ther Adv Respir Dis
JT  - Therapeutic advances in respiratory disease
JID - 101316317
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Ethanolamines)
RN  - 6EW8Q962A5 (Salmeterol Xinafoate)
RN  - GR88G0I6UL (Ipratropium)
RN  - QF8SVZ843E (Albuterol)
RN  - W34SHF8J2K (Formoterol Fumarate)
SB  - IM
MH  - Albuterol/*analogs & derivatives/therapeutic use
MH  - Arrhythmias, Cardiac/epidemiology
MH  - Bronchitis/epidemiology
MH  - Bronchodilator Agents/*therapeutic use
MH  - Ethanolamines/*therapeutic use
MH  - Female
MH  - Forced Expiratory Volume
MH  - Formoterol Fumarate
MH  - Humans
MH  - Ipratropium/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Myocardial Ischemia/epidemiology
MH  - Nebulizers and Vaporizers
MH  - Prospective Studies
MH  - Pulmonary Disease, Chronic Obstructive/*drug therapy
MH  - Respiratory Tract Infections/epidemiology
MH  - Salmeterol Xinafoate
MH  - Tremor/epidemiology
EDAT- 2009/01/07 09:00
MHDA- 2009/02/12 09:00
CRDT- 2009/01/07 09:00
PHST- 2009/01/07 09:00 [entrez]
PHST- 2009/01/07 09:00 [pubmed]
PHST- 2009/02/12 09:00 [medline]
AID - 2/2/37 [pii]
AID - 10.1177/1753465808089455 [doi]
PST - ppublish
SO  - Ther Adv Respir Dis. 2008 Apr;2(2):37-48. doi: 10.1177/1753465808089455.