PMID- 12796155
OWN - NLM
STAT- MEDLINE
DCOM- 20030708
LR  - 20220316
IS  - 0012-3692 (Print)
IS  - 0012-3692 (Linking)
VI  - 123
IP  - 6
DP  - 2003 Jun
TI  - Cardiovascular safety of salmeterol in COPD.
PG  - 1817-24
AB  - BACKGROUND: Patients with COPD have an increased risk of cardiovascular disease. 
      Despite the clinical benefits of long-acting beta-agonist agents in the treatment 
      of COPD, patients may be at an increased risk of cardiovascular toxicity, 
      including tachyarrhythmia due to beta-adrenergic stimulation. OBJECTIVE: To 
      evaluate the cardiovascular safety of salmeterol in COPD patients by conducting a 
      pooled analysis of cardiovascular safety data. DESIGN: Randomized, double-blind, 
      parallel group, multiple-dose studies, which included salmeterol, 50 micro g bid, 
      and placebo arms. STUDY SELECTION: Seven of a total of 17 studies met the 
      predefined inclusion requirements and were pooled. A total of 1,443 patients 
      received placebo, while 1,410 patients received salmeterol, 50 micro g bid. The 
      median duration of treatment was 24 weeks (range, 12 to 52 weeks). RESULTS: 
      Treatment with salmeterol, 50 micro g bid, showed no increased risk of 
      cardiovascular adverse events (AEs) compared with placebo (relative risk, 1.03; 
      95% confidence interval, 0.8 to 1.3; p = 0.838). Both groups had a similar 
      incidence of cardiovascular events (8%), including cardiovascular deaths. The 
      incidence of cardiovascular AEs increased with age, concurrent cardiovascular 
      conditions, and treatment with antiarrhythmic/bradycardic agents, although 
      increases were comparable in both treatment groups. There were no episodes of 
      sustained ventricular tachycardia, and no clinically significant differences were 
      observed in 24-h heart rate, ventricular and supraventricular ectopic events, 
      qualitative ECGs, QT intervals, or vital signs between the salmeterol, 50 micro g 
      bid, group and the placebo group. Similar findings were observed when patients 
      were stratified for age of > 65 years or the known presence of cardiovascular 
      disease. CONCLUSIONS: Treatment with salmeterol, 50 micro g bid, does not 
      increase the risk of cardiovascular AEs in this population of COPD patients 
      compared with placebo.
FAU - Ferguson, Gary T
AU  - Ferguson GT
AD  - Pulmonary Research Institute of SouthEast Michigan, Livonia, MI 48152, USA.
FAU - Funck-Brentano, Christian
AU  - Funck-Brentano C
FAU - Fischer, Tracy
AU  - Fischer T
FAU - Darken, Patrick
AU  - Darken P
FAU - Reisner, Colin
AU  - Reisner C
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Chest
JT  - Chest
JID - 0231335
RN  - 0 (Adrenergic beta-Agonists)
RN  - 0 (Bronchodilator Agents)
RN  - 6EW8Q962A5 (Salmeterol Xinafoate)
RN  - QF8SVZ843E (Albuterol)
SB  - IM
MH  - Adrenergic beta-Agonists/administration & dosage/*adverse effects
MH  - Aged
MH  - Albuterol/administration & dosage/*adverse effects/*analogs & derivatives
MH  - Bronchodilator Agents/administration & dosage/*adverse effects
MH  - Cardiovascular Diseases/chemically induced
MH  - Cardiovascular System/*drug effects
MH  - Double-Blind Method
MH  - Electrocardiography
MH  - Electrocardiography, Ambulatory
MH  - Female
MH  - Humans
MH  - Male
MH  - Pulmonary Disease, Chronic Obstructive/*drug therapy/physiopathology
MH  - Salmeterol Xinafoate
MH  - Tachycardia/chemically induced
EDAT- 2003/06/11 05:00
MHDA- 2003/07/09 05:00
CRDT- 2003/06/11 05:00
PHST- 2003/06/11 05:00 [pubmed]
PHST- 2003/07/09 05:00 [medline]
PHST- 2003/06/11 05:00 [entrez]
AID - S0012-3692(16)34798-5 [pii]
AID - 10.1378/chest.123.6.1817 [doi]
PST - ppublish
SO  - Chest. 2003 Jun;123(6):1817-24. doi: 10.1378/chest.123.6.1817.