Comparison of Risk of Pneumonia Caused by Fluticasone Propionate versus Budesonide in Chronic Obstructive Pulmonary Disease: A Nationwide Retrospective Cohort Study

Figures & data

Figure 1 Flowchart of patient selection.

Table 1 Baseline Characteristics of Study Subjects

	Fluticasone Propionate (n=14,518)		Budesonide (n= 14,518)		p value
	n	%	n	%
Age (years)
Mean (SD)	61.96 (11.53)		61.99 (11.35)		0.1341
40–49	2491	17.16	2342	16.13	0.2124
50–59	3735	25.73	3793	26.13
60–69	4286	29.52	4360	30.03
70–79	3084	21.24	3110	21.42
≥ 80	922	6.35	913	6.29
Sex
Male	8335	57.41	8294	57.13	0.6267
Female	6183	42.59	6224	42.87
Comorbidity
Diabetes	4414	30.40	4494	30.95	0.3087
Hypertension	4183	28.81	4200	28.93	0.8258
Heart failure	3660	25.21	3716	25.60	0.4503
Stroke	2955	20.35	3046	20.98	0.1872
Chronic kidney disease	715	4.92	720	4.96	0.8923
Chronic liver disease	5059	34.85	5057	34.83	0.6401
CCI
Mean (SD)	3.01 (2.08)		2.97 (2.06)
<2	4030	27.76	4112	28.32	0.2840
≥ 2	10,488	72.24	10,488	72.24
Bronchodilator
SABA	308	2.12	888	6.12	<0.0001
LAMA	1876	12.92	1905	13.12	0.6131
LABA	11,363	78.27	10,772	74.20	<0.0001
LABA/LAMA	971	6.69	953	6.56	0.6711
OCS prescription
Yes	12,256	84.42	12,341	85.00	0.1657
No	2262	15.58	2177	15.00
OCS prescription day
Mean (SD)	11.08 (17.45)		10.96 (17.57)		0.5365
Interval from COPD diagnosis to index date
Mean (SD)	441.4 (834.0)		466.2 (911.5)		0.0154

Abbreviations: SABA, short-acting β-agonist; LAMA, long-acting muscarinic antagonist; LABA, long-acting β₂ agonist; OCS, oral corticosteroid.

Table 2 Proportion of Subjects According to the Cumulative Doses of ICS

	Fluticasone Propionate (n=14,518)			Budesonide (n= 14,518)
	n		%	n	%
ICS cumulative dose (μg)
Mean (SD)	185,065 (524,205)			141,148 (318,030)
0–15,000	4801	33.07		4944	34.05
15,001–36,000	2354	16.21		2935	20.22
36,001–135,000	3625	24.97		3160	21.77
>135,000	3738	25.75		3479	23.96

Table 3 Crude Incidence Rate of Pneumonia According to the ICS Type and Dose

Variables	Fluticasone Propionate			Budesonide
	Person-Year	Pneumonia Cases	Incidence Rate (per 100,000)	Person-Year	Pneumonia Cases	Incidence Rate (per 100,000)
Total	70,811.79	2064	2,914.77	73,612.70	1548	2,102.90
ICS cumulative dose (μg)
0–15,000	21,606.49	462	2,138.25	22,421.82	439	1,957.91
15,001–36,000	10,996.52	301	2,737.23	14,340.45	275	1,917.65
36,001–135,000	17,359.32	545	3,139.52	15,287.24	309	2,021.29
>135,000	20,849.45	756	3,625.99	21,563.18	525	2,434.71

Figure 2 The probability free of pneumonia over time in patients treated with different types of ICSs.

Figure 3 Risk of pneumonia in fluticasone propionate users compared with budesonide users. Hazard ratios were calculated as the ratio of the risk of pneumonia in fluticasone propionate compared to budesonide (reference) within identical doses and presented with 95% CIs and p value.