The reasons for triple therapy in stable COPD patients in Japanese clinical practice

Figures & data

Table 1 Characteristics of the study populations

	Grade I	Grade II	Grade III	Grade IV	P-value
Number (%)	93 (21)	205 (46)	114 (26)	33 (7)
Female (%)	11 (12)	20 (10)	5 (4)	2 (6)
Age, years	71.6±8.1	72.8±8.4	72.8±7.7	72.3±7.9	ns
Smoking index, pack-years	53.0±31.5	53.7±27.6*	63.9±31.2	54.0±28.0	0.02
Current smokers (%)	9 (10)	30 (15)	15 (13)	4 (13)	ns
BMI, kg/m^2	22.9±2.9*,#	22.9±3.2*,#	21.7±3.5#	19.9±2.9	<0.0001
FEV1/FVC (%)	63.3±4.9	55.4±8.2	41.1±9.3	32.8±8.1	<0.0001
FEV1, mL	2,379±453	1,720±400	1,069±224	633±120	<0.0001
%FEV1	91.2±9.7	65.3±8	40.4±6	24.2±3.2	<0.0001

Notes: Data are presented as mean ± standard deviation.

* P<0.05 vs Grade III,

# P<0.05 vs Grade IV.

Abbreviations: BMI, body mass index; FEV₁, forced expiratory volume in 1 second; FVC, forced vital capacity; ns, not significant.

Table 2 Breakdown of drugs in single, double, or triple therapy

Number of drugs	Breakdown of drugs	Number of patients (%)
None		114 (26)
Single	ICS	5 (1)
	LABA	19 (4)
	LAMA	123 (28)
Double	ICS/LABA	46 (10)
	LABA/LAMA	39 (9)
	ICS/LAMA	4 (1)
Triple	ICS/LABA/LAMA	95 (21)

Abbreviations: ICS, inhaled corticosteroids; LABA, long-acting β₂ agonist; LAMA, long-acting muscarinic antagonist.

Table 3 Number of patients on none, single, double, or triple therapy in the groups based on GOLD spirometric grading

	Grade I	Grade II	Grade III	Grade IV
None (%)	38 (41)	51 (25)	10 (9)	4 (11)
Single (%)	36 (39)	77 (38)	33 (29)	1 (3)
Double (%)	7 (7)	46 (22)	33 (29)	14 (43)
Triple (%)	12 (13)	31 (15)	38 (33)	14 (43)

Abbreviation: GOLD, Global initiative for chronic Obstructive Lung Disease.

Figure 1 Reasons for triple therapy in GOLD Grade I, Grade II, Grade III, and Grade IV.

Notes: a) Added due to unsatisfactory improvement in shortness of breath with single or double therapy; b) added due to unsatisfactory improvement in cough/sputum with single or double therapy; c) addition of LAMA because of newly diagnosed COPD during the course of asthma treatment; d) addition of ICS/LABA due to likely comorbid asthma during the course of COPD treatment with LAMA; e) sustained use after starting with triple therapy because of severe symptoms and/or exacerbation on diagnosis; and f) others.
Abbreviations: GOLD, Global initiative for chronic Obstructive Lung Disease; LAMA, long-acting muscarinic antagonist; COPD, chronic obstructive pulmonary disease; ICS, inhaled corticosteroids; LABA, long-acting β₂ agonist.

Figure 2 Comparison of CAT scores in GOLD Grade II patients according to the number of inhaled medications.

Notes: Data are presented as mean ± standard deviation. The CAT score increases significantly as the number of drugs increases (P<0.05).
Abbreviations: CAT, COPD Assessment Test; GOLD, Global initiative for chronic Obstructive Lung Disease.

Figure 3 Comparison of the frequency of triple therapy using the GOLD 2011 classification.

Notes: The frequency is 9% in GOLD A (%FEV₁ ≥50% and CAT <10), 28% in GOLD B (%FEV₁ ≥50% and CAT ≥10), 21% in GOLD C (%FEV₁ <50% and CAT <10), and 37% in GOLD D (%FEV₁ <50% and CAT ≥10). The frequency is higher in GOLD D than in GOLD A (P<0.001).
Abbreviations: GOLD, Global initiative for chronic Obstructive Lung Disease; FEV₁, forced expiratory volume in 1 second; CAT, COPD Assessment Test.

Figure 4 Comparison of the frequency of triple therapy among the groups divided by LAA% on quantitative CT analysis.

Notes: No emphysema (LAA% <10, n=121), mild emphysema (10≤ LAA% <20, n=70), moderate emphysema (20≤ LAA% <30, n=52), and severe emphysema (LAA% ≥30, n=48). The frequency becomes significantly higher as the severity of emphysema increases (P<0.01).
Abbreviations: LAA, low-attenuation area; CT, computed tomography.