A US database study characterizing patients initiating a budesonide–formoterol combination versus tiotropium bromide as initial maintenance therapy for chronic obstructive pulmonary disease

Figures & data

Table 1 Baseline demographic characteristics and prescribing physician type

	Group 1: BFC without previous tiotropium or ICS–LABA		Group 2: tiotropium without previous tiotropium or ICS–LABA		Group 1 versus group 2
					Odds ratio/mean difference*	95% CI*		P-value*
	n/mean	%/SD	n/mean	%/SD		Lower	Upper
All patients	6,940		10,831
Prescriber specialty
Allergist/immunologist	170	2.5%	106	1.0%	2.54	1.99	3.24	<0.0001
Pulmonologist	1,604	23.1%	2,882	26.6%	0.83	0.77	0.89	<0.0001
Cardiologist	127	1.8%	239	2.2%	0.83	0.67	1.03	0.0846
Internal medicine	1,802	26.0%	2,939	27.1%	0.94	0.88	1.01	0.0854
Family/general practitioner	1,867	26.9%	2,916	26.9%	1.00	0.93	1.07	0.9758
Nonphysician	295	4.3%	461	4.3%	1.00	0.86	1.16	0.9857
Other specialty	131	1.9%	191	1.8%	1.07	0.86	1.34	0.5449
Unknown	944	13.6%	1,097	10.1%	1.40	1.27	1.53	<0.0001
Index year (n, %)
2009	2,216	31.9%	3,649	33.7%	0.92	0.87	0.99	0.0150
2010	2,579	37.2%	3,764	34.8%	1.11	1.04	1.18	0.0011
2011	1,971	28.4%	3,225	29.8%	0.94	0.88	1.00	0.0493
2012	174	2.5%	193	1.8%	1.42	1.15	1.74	0.0009
Age (n, %)
40–49 years	820	11.8%	761	7.0%	1.77	1.60	1.97	<0.0001
50–59 years	1,828	26.3%	2,436	22.5%	1.23	1.15	1.32	<0.0001
60–64 years	1,078	15.5%	1,681	15.5%	1.00	0.92	1.09	0.9816
65+ years	3,214	46.3%	5,953	55.0%	0.71	0.67	0.75	<0.0001
Mean ± SD	64.3	12.1	66.9	11.8	−2.67	−3.03	−2.30	<0.0001
Sex (n, %)
Male	3,178	45.8%	5,349	49.4%	1.16	1.09	1.23	<0.0001
Female	3,762	54.2%	5,482	50.6%	0.87	0.82	0.92	<0.0001
Health plan type (n, %)
HMO	1,321	19.0%	2,416	22.3%	0.82	0.76	0.88	<0.0001
PPO	4,128	59.5%	6,577	60.7%	0.95	0.89	1.01	0.0987
CDHP	198	2.9%	246	2.3%	1.26	1.05	1.53	0.0153
Other commercial	1,293	18.6%	1,592	14.7%	1.33	1.23	1.44	<0.0001
Geographic region (n, %)
Northeast	1,227	17.7%	2,360	21.8%	0.77	0.71	0.83	<0.0001
Midwest	2,766	39.9%	4,051	37.4%	1.11	1.04	1.18	0.0010
South	1,979	28.5%	2,895	26.7%	1.09	1.02	1.17	0.0092
West	968	13.9%	1,525	14.1%	0.99	0.91	1.08	0.8050

Notes:

* Chi-square test odds ratio was used for categorical variables, and Student’s t-test difference in means used for continuous variables. Statistical comparisons compared group 1 to group 2 (reference group), ie, mean difference = mean (group 1) – mean (group 2), and odds ratio = odds (group 1)/odds (group 2).

Abbreviations: BFC, budesonide–formoterol; ICS, inhaled corticosteroid; LABA, long-acting β₂-adrenergic agonist; SD, standard deviation; CI confidence interval; HMO, health maintenance organization; PPO, preferred provider organization; CDHP, consumer-driven health plan.

Table 2 Comorbid conditions during the 12-month preindex period

	Group 1: BFC without previous tiotropium or ICS–LABA		Group 2: tiotropium without previous tiotropium or ICS–LABA		Group 1 versus group 2
					Odds ratio*	95% CI*		P-value*
	n	%	n	%		Lower	Upper
Number of patients	6,940		10,831
Comorbid conditions (n, % for each comorbidity)
Hypertension	4,092	59.0%	6,552	60.5%	0.94	0.88	1.00	0.0423
Dyslipidemia	3,049	43.9%	4,801	44.3%	0.98	0.93	1.05	0.6070
Asthma	1,716	24.7%	1,377	12.7%	2.26	2.09	2.44	<0.0001
Diabetes mellitus	1,630	23.5%	2,404	22.2%	1.08	1.00	1.16	0.0449
Other coronary artery disease	1,557	22.4%	3,038	28.1%	0.74	0.69	0.80	<0.0001
Other lung diseases	1,187	17.1%	2,086	19.3%	0.87	0.80	0.94	0.0003
Congestive heart failure	917	13.2%	1,755	16.2%	0.79	0.72	0.86	<0.0001
GERD	888	12.8%	1,220	11.3%	1.16	1.05	1.27	0.0021
Sleep apnea	781	11.3%	1,087	10.0%	1.14	1.03	1.25	0.0098
Sinusitis	720	10.4%	711	6.6%	1.65	1.48	1.84	<0.0001
Allergic rhinitis	558	8.0%	446	4.1%	2.04	1.79	2.32	<0.0001
Anxiety	536	7.7%	716	6.6%	1.18	1.05	1.33	0.0047
Peripheral vascular disease/atherosclerosis	518	7.5%	1,056	9.8%	0.75	0.67	0.83	<0.0001
Stroke, TIA, or cerebrovascular disease	477	6.9%	971	9.0%	0.75	0.67	0.84	<0.0001
Morbid obesity†	439	6.3%	498	4.6%	1.40	1.23	1.60	<0.0001
Osteoporosis	322	4.6%	614	5.7%	0.81	0.71	0.93	0.0027
Myocardial infarction	299	4.3%	645	6.0%	0.71	0.62	0.82	<0.0001

Notes:

* Odds ratio from Pearson’s χ² test, odds ratio = odds (group 1)/odds (group 2);

† defined using ICD-9-CM diagnosis (BMI ≥30).

Abbreviations: BFC, budesonide–formoterol; BMI, body mass index; ICS, inhaled corticosteroid; LABA, long-acting β₂-adrenergic agonist; CI confidence interval; GERD, gastroesophageal reflux disease; TIA, transient ischemic attack; ICD-9-CM, International Classification of Diseases, ninth revision, clinical modification.

Table 3 Prior medication use during the 12-month preindex period

	Group 1: BFC without previous tiotropium or ICS–LABA		Group 2: tiotropium without previous tiotropium or ICS–LABA		Group 1 versus group 2
					Odds ratio*	95% CI*		P-value*
	n	%	n	%		Lower	Upper
Number of patients	6,940		10,831
Respiratory medications
Nebulizer treatment	1,140	16.4%	1,189	11.0%	1.59	1.46	1.74	<0.0001
ICS monotherapy use	771	11.1%	957	8.8%	1.29	1.17	1.43	<0.0001
LABA monotherapy use	187	2.7%	244	2.3%	1.20	0.99	1.46	0.0618
LTRA monotherapy use	802	11.6%	648	6.0%	2.05	1.84	2.29	<0.0001
Theophylline use	145	2.1%	181	1.7%	1.26	1.01	1.57	0.0427
SABA	3,044	43.9%	3,764	34.8%	1.47	1.38	1.56	<0.0001
SAMA	282	4.1%	407	3.8%	1.09	0.93	1.27	0.3031
SABA–SAMA combination use	1,147	16.5%	1,367	12.6%	1.37	1.26	1.49	<0.0001
OCS monotherapy use	3,178	45.8%	3,744	34.6%	1.60	1.50	1.70	<0.0001

Notes:

* Odds ratio from Pearson’s χ² test, odds ratio = odds (group 1)/odds (group 2).

Abbreviations: BFC, budesonide–formoterol; CI, confidence interval; ICS, inhaled corticosteroid; LABA, long-acting β-agonist; LTRA, leukotriene receptor antagonist; SABA, short-acting β₂-agonist; SAMA, short-acting muscarinic antagonist; OCS, oral corticosteroid.

Figure 1 COPD-related resource utilization by service type during 12-month preindex period.

Abbreviations: COPD, chronic obstructive pulmonary disease; BFC, budesonide–formoterol combination; hosp, hospitalization; ER, emergency room; OCS, oral corticosteroid.

Figure 2 COPD-related resource utilization by procedure during 12-month preindex period.

Abbreviations: COPD, chronic obstructive pulmonary disease; BFC, budesonide–formoterol combination; CT, computed tomography; func, function; rehab, rehabilitation.

Table 4 COPD exacerbation rates during 12-month preindex period by age-group

	BFC						Tiotropium
	All patients		<65 years		≥65+ years		All patients		<65 years		≥65+ years
	n	%	n	%	n	%	n	%	n	%	n	%
Total number of patients	6,940		3,726		3,214		10,831		4,878		5,953
With prior COPD exacerbation	3,483	50.2%	1,996	53.6%	1,487	46.3%	4,375	40.4%	2,088	42.8%	2,287	38.4%
COPD inpatient hospitalization	491	7.1%	220	5.9%	271	8.4%	763	7.0%	299	6.1%	464	7.8%
COPD ER visit	535	7.7%	307	8.2%	228	7.1%	929	8.6%	423	8.7%	506	8.5%
OCS use	3,178	45.8%	1,855	49.8%	1,323	41.2%	3,744	34.6%	1,827	37.5%	1,917	32.2%

Notes: COPD exacerbation defined as inpatient hospitalization with primary diagnosis for COPD, ER visit with any diagnosis for COPD, or prescription fill for OCS.

Abbreviations: COPD, chronic obstructive pulmonary disease; BFC, budesonide–formoterol; ER, emergency room; OCS, oral corticosteroid.

Figure 3 All-cause health care costs during 12-month preindex period.

Abbreviations: BFC, budesonide–formoterol combination; ER, emergency room; USD, United States dollar.

Figure 4 COPD-related health care costs during 12-month preindex period.

Abbreviations: COPD, chronic obstructive pulmonary disease; BFC, budesonide–formoterol combination; ER, emergency room; USD, United States dollar.