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2015 ; 10
(ä): 1015-26
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LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination
in patients with COPD
#MMPMID26082625
Zhong N
; Wang C
; Zhou X
; Zhang N
; Humphries M
; Wang L
; Thach C
; Patalano F
; Banerji D
Int J Chron Obstruct Pulmon Dis
2015[]; 10
(ä): 1015-26
PMID26082625
show ga
BACKGROUND: The current Global initiative for chronic Obstructive Lung Disease
(GOLD) treatment strategy recommends the use of one or more bronchodilators
according to the patient's airflow limitation, their history of exacerbations,
and symptoms. The LANTERN study evaluated the effect of the long-acting
?2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) dual bronchodilator,
QVA149 (indacaterol/glycopyrronium), as compared with the LABA/inhaled
corticosteroid, salmeterol/fluticasone (SFC), in patients with moderate-to-severe
COPD with a history of ?1 exacerbation in the previous year. METHODS: In this
double-blind, double-dummy, parallel-group study, 744 patients with
moderate-to-severe COPD with a history of ?1 exacerbations in the previous year
were randomized (1:1) to QVA149 110/50 ?g once daily or SFC 50/500 ?g twice daily
for 26 weeks. The primary endpoint was noninferiority of QVA149 versus SFC for
trough forced expiratory volume in 1 second (FEV1) at week 26. RESULTS: Overall,
676 patients completed the study. The primary objective of noninferiority between
QVA149 and SFC in trough FEV1 at week 26 was met. QVA149 demonstrated
statistically significant superiority to SFC for trough FEV1 (treatment
difference [?]=75 mL; P<0.001). QVA149 demonstrated a statistically significant
improvement in standardized area under the curve (AUC) from 0 hours to 4 hours
for FEV1 (FEV1 AUC0-4h) at week 26 versus SFC (?=122 mL; P<0.001). QVA149 and SFC
had similar improvements in transition dyspnea index focal score, St George
Respiratory Questionnaire total score, and rescue medication use. However, QVA149
significantly reduced the rate of moderate or severe exacerbations by 31%
(P=0.048) over SFC. Overall, the incidence of adverse events was comparable
between QVA149 (40.1%) and SFC (47.4%). The incidence of pneumonia was threefold
lower with QVA149 (0.8%) versus SFC (2.7%). CONCLUSION: These findings support
the use of the LABA/LAMA, QVA149 as an alternative treatment, over LABA/inhaled
corticosteroid, in the management of moderate-to-severe COPD patients (GOLD B and
GOLD D) with a history of ?1 exacerbation in the previous year.
|Administration, Inhalation
[MESH]
|Adrenergic beta-2 Receptor Agonists/administration & dosage/adverse
effects/*therapeutic use
[MESH]
|Adult
[MESH]
|Aged
[MESH]
|Bronchodilator Agents/administration & dosage/adverse effects/*therapeutic use
[MESH]
|Double-Blind Method
[MESH]
|Drug Combinations
[MESH]
|Female
[MESH]
|Fluticasone-Salmeterol Drug Combination/administration & dosage/adverse
effects/*therapeutic use
[MESH]
|Forced Expiratory Volume
[MESH]
|Glucocorticoids/administration & dosage/adverse effects/*therapeutic use
[MESH]
|Glycopyrrolate/administration & dosage/adverse effects/*analogs &
derivatives/therapeutic use
[MESH]
|Humans
[MESH]
|Indans/administration & dosage/adverse effects/*therapeutic use
[MESH]
|Lung/*drug effects/physiopathology
[MESH]
|Male
[MESH]
|Middle Aged
[MESH]
|Muscarinic Antagonists/administration & dosage/adverse effects/*therapeutic use
[MESH]
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