Prognostic factors for clinical failure of exacerbations in elderly outpatients with moderate-to-severe COPD

Figures & data

Table 1 Baseline demographic and disease characteristics of randomized patients in the ITT (N=1,352) population

Characteristic	Moxifloxacin (N=677)	Amoxicillin/clavulanic acid (N=675)	Total (N=1,352)
Geographic region, n (%)
Asia Pacific	205 (30)	212 (31)	417 (31)
Europe	249 (37)	257 (38)	506 (37)
South Africa	27 (4)	15 (2)	42 (3)
Latin America	181 (27)	181 (27)	362 (27)
Canada	15 (2)	10 (1)	25 (2)
Male sex, n (%)	534 (79)	545 (81)	1,079 (80)
Race, n (%)
Caucasian	413 (61)	403 (60)	816 (60)
Asian	209 (31)	213 (32)	422 (31)
Other	55 (8)	59 (9)	114 (8)
Age (years), mean ± SD	69.6±6.8	69.6±6.6	69.6±6.7
Range	59–93	60–91	59–93
≥65 years, n (%)	486 (72)	492 (73)	978 (72)
BMI (kg/m^2), mean ± SD	25.0±5.4	24.7±5.2	24.8±5.3
Current smokers, n (%)	149 (22)	144 (21)	293 (22)
Coexisting illnesses, n (%)	533 (79)	545 (81)	1,078 (80)
Coronary artery disease	38 (6)	27 (4)	65 (5)
Congestive heart failure	34 (5)	42 (6)	76 (6)
Peripheral artery disease	15 (2)	5 (1)	20 (1)
Renal dysfunction	26 (4)	21 (3)	47 (3)
Liver dysfunction	13 (2)	14 (2)	27 (2)
Diabetes mellitus	67 (10)	77 (11)	144 (11)
Any respiratory comedication, n (%)	628 (93)	621 (92)	1,249 (92)
Short or long-acting β2-agonists	368 (54)	364 (54)	732 (54)
Inhaled steroidsa	389 (57)	371 (55)	760 (56)
Ipratropium or tiotropium	305 (45)	310 (46)	615 (45)
Xanthine derivatives	222 (33)	219 (32)	441 (33)
Previous antimicrobial use,b n (%)	235 (35)	227 (34)	462 (34)
Systemic steroid use, n (%)	236 (35)	239 (35)	475 (35)
Lung function at enrollment
FEV1 % predicted, mean ± SD	38.4±11.6	38.7±11.7	38.6±11.7
FEV1 (L), mean ± SD	0.982±0.370	0.978±0.360	0.980±0.365
FEV1 <30%, n (%)	174 (26)	165 (24)	339 (25)
Exacerbations in previous year
Mean ± SD	2.5±1.1	2.5±1.1	2.5±1.1
Range	1–15	1–10	1–15
Time since last exacerbation (days)
Mean ± SD	109.6±65.2	103.6±61.1	106.6±63.2

Notes:

a Includes combination therapy (steroid plus bronchodilators).

b Any antimicrobial given for any indication between 30 and 90 days prior to enrollment.

Abbreviations: BMI, body mass index; FEV₁, forced expiratory volume in 1 second; ITT, intent-to-treat; SD, standard deviation.

Figure 1 Prognostic factors associated with increased risk of clinical failure at EOT based on multivariate analysis.

Notes: Odds ratio is shown with horizontal line presentation of 95% CI. ^aContinuous variable.

Abbreviations: BT, body temperature; CI, confidence interval; EOT, end of therapy; LAMA, long-acting anticholinergic; N, number of patients in category; n, number of patients with clinical failures.

Figure 2 Prognostic factors associated with increased risk of clinical failure at 8 weeks posttherapy based on multivariate analysis.

Notes: Odds ratio is shown with horizontal line presentation of 95% CI. ^aContinuous variable.
Abbreviations: AP, Asia Pacific; BMI, body mass index; BT, body temperature; CAN, Canada; CI, confidence interval; EOT, end of therapy; EU, Europe; FEV₁, forced expiratory volume in 1 second; LA, Latin America; LABA, long-acting β₂-agonist; LAMA, long-acting anticholinergic; N, number of patients in category; n, number of patients with clinical failures; SA, South Africa.