Treatment of COPD Groups GOLD A and B with Inhaled Corticosteroids in the COSYCONET Cohort – Determinants and Consequences

Figures & data

Table 1 Characteristics of Patients in GOLD Groups A/B Stratified by Treatment with/without ICS

		ICS Never^#	ICS Always^#	p-value
		N = 297	N = 311
Age (y)		65.7 ± 8.4	67.3 ± 7.6	0.0130
Male		187 (63.0)	216 (69.5)	0.0906
BMI (kg/m^2)		26.7 ± 4.8	27.2 ± 5.1	0.1888
FFMI (kg/m^2) ^+		18.4 ± 2.3	18.4 ± 2.6	0.9204
Smoking status	Active	117 (39.4)	65 (20.9)	<0.0001
	Not active *	180 (60.6)	246 (79.1)	<0.0001
Education	Basic	157 (52.9)	177 (56.9)	0.5192
	Secondary	84 (28.3)	76 (24.4)
	Higher	56 (18.9)	58 (18.7)
Years since COPD diagnosis		5.7 ± 5.8	8.0 ± 6.1	<0.0001
GOLD groups (mMRC)	A	218 (73.4)	191 (61.4)	0.0016
	B	79 (26.6)	120 (38.6)
mMRC ^+		1.19 ± 0.72	1.42 ± 0.79	0.0001
Exacerbation history	None	197 (66.3)	158 (50.8)	0.0001
	Mild/Moderate	100 (33.7)	153 (49.2)
FEV1 (%predicted)		62.9 ± 17.3	54.2 ± 17.6	<0.0001
FVC (%predicted)		86.8 ± 16.8	80.1 ± 16.9	<0.0001
FEV1/FVC		72.2 ± 13.4	67.2 ± 13.5	<0.0001
ITGV (%predicted)		140.5 ± 29.2	144.0 ± 31.1	0.1551
RV (%predicted)		154.4 ± 39.4	166.1 ± 43.2	0.0007
RV/TLC		123.0 ± 22.0	132.2 ± 23.7	<0.0001
TLCO (%predicted) ^+		62.0 ± 19.1	59.5 ± 21.5	0.1351
KCO (%predicted) ^+		67.1 ± 24.1	68.2 ± 25.0	0.5718
OCS		12 (4.0)	24 (7.7)	0.0549
DemTect		15.4 ± 2.8	15.4 ± 2.7	0.8905
PHQ-9		4.8 ± 3.9	5.1 ± 4.0	0.2480
6-MWD (m) ^+		466.6 ± 85.7	433.1 ± 99.6	<0.0001
IPAQ ^+		4808.8 ± 3777.8	4386.4 ± 3632.8	0.1632
BODE ^+		1.31 ± 1.40	2.14 ± 1.77	<0.0001
SGRQ symptoms		43.3 ± 19.6	48.3 ± 19.6	0.0021
SGRQ activity ^+		44.1 ± 23.5	51.3 ± 23.4	0.0002
SGRQ impacts ^+		19.2 ± 15.2	22.6 ± 17.4	0.0114
EQ-VAS ^+		65.2 ± 16.4	62.6 ± 16.3	0.0603
CAT total score		14.2 ± 6.1	15.9 ± 6.5	0.0007

Notes: ^#ICS always was coded as yes, if a patient reported the intake of ICS at both visits. ICS never was defined as no ICS prescription at both visits. ⁺Used as outcome; other variables were use as predictors of treatment with ICS. *Ex- or never-smoker. Mean values and standard deviations, as well as absolute numbers are given. Comparisons between groups were performed by chi-square tests, ANOVA and Kruskal–Wallis tests, as appropriate.

Figure 1 Consort diagram of the study population.

Table 2 Prevalence of Comorbidities

	ICS Never	ICS Always	p-value
	N = 297	N = 311
Diabetes	32 (10.8)	39 (12.5)	0.4980
Gastrointestinal disorders *	112 (37.7)	117 (37.6)	0.9818
Hyperuricemia	39 (13.1)	58 (18.7)	0.0633
Hyperlipoproteinemia	126 (42.4)	133 (42.8)	0.9323
Osteoporosis *	30 (10.1)	35 (11.3)	0.6456
Hypertension *	154 (51.9)	186 (59.8)	0.0483
Cardiac disease ^#	65 (21.9)	58 (18.7)	0.3208

Notes: *Self-reported information was combined with disease-specific medication. ^#At least one out of: Coronary artery disease, heart failure, myocardial infarction. Absolute numbers and percentages are given. p-values refer to the comparison between patients without and with ICS and were derived from Chi-square statistics.

Table 3 Treatment with Respiratory Medication

	ICS Never	ICS Always
	N = 297	N = 311
No respiratory medication	83 (27.9)
Only LAMA	62 (20.9)
Only LABA	46 (15.5)
LAMA + LABA	106 (35.7)
Only ICS		4 (1.3)
LAMA + ICS		9 (2.9)
LABA + ICS		74 (23.8)
LAMA + LABA + ICS		224 (72.0)

Notes: Absolute numbers and row percentages are given. All numbers are based on information assessed at visit 1.

Table 4 Mean Annual Direct Healthcare Costs in €

	ICS Never	ICS Always	p-value
	N = 297	N = 311
Total direct costs	4206 ± 4854	4547 ± 3822	<0.0001
Medication costs*	1490 ± 1286	2191 ± 1004	<0.0001
Respiratory medication	750 ± 488	1528 ± 495	<0.0001
Other medication	740 ± 1143	663 ± 826	0.4162
Inpatient costs	1336 ± 2437	1224 ± 2312	0.9826
Outpatient costs	616 ± 459	660 ± 458	0.1844
Rehabilitation costs	194 ± 445	201 ± 485	0.9733
Physiotherapy costs	76 ± 139	79 ± 143	0.9131

Notes: *Medication costs was restricted to prescription-only pharmaceuticals and based on information about name, national drug code, defined daily doses, and pharmacy retails prices. Mean values and standard deviations are given. p values were based on Kruskal–Wallis tests. All costs refer to the price year 2012.

Figure 2 Determinants of ICS therapy before and after weighting. Standardized mean differences of variables were calculated based on propensity scores leading to inverse probability of treatment weights (IPW).

Table 5 Association Between ICS and Outcome Measures (Always vs Never)

Outcomes	Estimate		95% CI	p-value
Health-related quality of life
EQ-VAS	2.39	(↑)	0.44 to 4.34	0.0163
SGRQ symptoms	−0.55		−2.50 to 1.41	0.5839
SGRQ activity	−1.56		−3.45 to 0.33	0.1064
SGRQ impacts	−1.04		−2.55 to 0.48	0.1805
Diffusion capacity
TLCO (%predicted)	3.65	(↑)	1.24 to 6.05	0.0030
KCO (%predicted)	3.16		−0.48 to 6.8	0.0885
Fat free mass index	−0.20		−0.41 to 0.00	0.0502
Physical activity
6-MWD	−2.42		−13.79 to 8.96	0.6768
IPAQ	23.43		−544.22 to 591.0	0.9355

Notes: Estimates with 95% CI for the variable ICS=always are shown. Each row represents a separate linear regression model, adjusted for covariates and including the IPW (based on propensity scores). The symbol next to the estimate indicates the direction of change for estimates with p<0.05: ↑ improvement of outcome, ↓ deterioration of outcome.

Figure 3 Effect of ICS therapy on direct healthcare costs. Factors with 95% CI for the variable ICS=always are shown. Each factor was calculated by a separate gamma regression model, adjusted for covariates and including the IPW (based on propensity scores).