Exacerbation Burden in COPD and Occurrence of Mortality in a Cohort of Italian Patients: Results of the Gulp Study

Figures & data

Table 1 Patients’ Characteristics at Enrollment

Variables
Male, n (%)		810/1111 (72.9)
Median (IQR) age, years		76 (70–82)
Age group, n (%)	<65 years	120/1111 (10.8)
	65–75 years	399/1111 (35.9)
	>75 year	592/1111 (53.3)
Median (IQR) BMI		26.5 (23.4–29.4)
Smoking, n (%)	Non-smoker	50/1101 (4.5)
	Active smoker	772/1101 (70.1)
	Former smoker	279/1101 (25.3)
Median (IQR) smoking history, PY		40 (30–60)
Family history of respiratory diseases, n (%)		74/959 (7.7)
Phenotype	Chronic bronchitis	141/949 (14.9)
	Emphysema	539/949 (56.8)
	Mixed	269/949 (28.4)

Abbreviations: IQR, interquartile range; BMI, Body Mass Index; PY, Pack Year = (Cigarettes per day/Pack size) x Years; Mixed, chronic bronchitis and emphysema.

Table 2 Exacerbations and Treatment Patterns During the Follow-Up

Variables
2015
Median (IQR) moderate exacerbation		0 (0–1)
Median (IQR) severe exacerbation		0 (0–0)
≥1 moderate exacerbation, n (%)		364/976 (37.3)
≥1 severe exacerbation, n (%)		173/972 (17.8)
COPD therapy, n (%)	No therapy	20/977 (2.1)
	LABA	35/977 (3.6)
	LAMA	171/977 (17.5)
	LABA/LAMA	205/977 (21.0)
	ICS/LABA	132/977 (13.5)
	ICS/LABA/LAMA	414/977 (42.4)
Pneumonia, n (%)		36/859 (4.2)
2016
Median (IQR) moderate exacerbation		0 (0–1)
Median (IQR) severe exacerbation		0 (0–0)
≥1 moderate exacerbation, n (%)		371/896 (41.4)
≥1 severe exacerbation, n (%)		169/896 (18.9)
COPD therapy, n (%)	No therapy	16/897 (1.8)
	LABA	23/897 (2.6)
	LAMA	126/897 (14.1)
	LABA/LAMA	232/897 (25.9)
	ICS/LABA	101/897 (11.3)
	ICS/LABA/LAMA	399/897 (44.5)
Pneumonia, n (%)		48/796 (6.0)
2017
Median (IQR) moderate exacerbation		0 (0–1)
Median (IQR) severe exacerbation		0 (0–0)
≥1 moderate exacerbation, n (%)		325/813 (40.0)
≥1 severe exacerbation, n (%)		124/813 (15.3)
COPD therapy, n (%)	No therapy	10/818 (1.2)
	LABA	16/818 (2.0)
	LAMA	107/818 (13.1)
	LABA/LAMA	235/818 (28.7)
	ICS/LABA	69/818 (8.4)
	ICS/LABA/LAMA	381/818 (46.6)
Pneumonia, n (%)		28/735 (3.8)
Death, n (%)		114/859 (13.3)
GOLD FEV1, n (%)	1	150/1 (14.9)
	2	452/1009 (44.8)
	3	283/1009 (28.1)
	4	124/1009 (12.3)
GOLD 2016, n (%)	A	164/941 (17.4)
	B	137/941 (14.6)
	C	203/941 (21.6)
	D	437/941 (46.4)
GOLD 2017, n (%)	A	212/933 (22.7)
	B	183/933 (19.6)
	C	152/933 (16.3)
	D	386/933 (41.4)

Abbreviations: IQR, interquartile range; FEV1, forced expiratory volume in first second.

Table 3 Exacerbations Over 3 Years in a, B, C and D Categories

2016 Plus 2017	A (n= 515)	B (n= 154)	C (n= 112)	D (n= 195)	p-value
Median (IQR) moderate exacerbation	0 (0–1)	1 (0–2)	1 (0–2)	4 (2–5)	0.0001*
Median (IQR) severe exacerbation	0 (0–0)	0 (0–0)	1 (0–1)	0 (0–2)	0.0001^†
≥1 exacerbation, n (%)	209 (45.5)	107 (79.3)	82 (83.7)	186 (97.4)	<0.0001^††
≥1 moderate exacerbation, n (%)	130/458 (28.4)	82/135 (60.7)	57/98 (58.2)	173/191 (90.6)	<0.0001^‡
≥1 severe exacerbation, n (%)	64/458 (14.0)	25/135 (18.5)	50/98 (51.0)	66/191 (34.6)	<0.0001^§

Notes: Grouped data from 2016 and 2017. Patients have been classified according to their baseline exacerbation history in A, B, C, and D category. Rate of exacerbation has been compared between categories. *Category A VS Category B p-value <0.0001; Category A VS Category B p-value <0.0001; Category A VS Category D p-value <0.0001; Category B VS Category D p-value <0.0001; Category C VS Category D p-value <0.0001. ^†Category A VS Category C p-value <0.0001; Category A VS Category D p-value <0.0001; Category B VS Category C p-value <0.0001; Category B VS Category D p-value= 0.0002; Category C VS Category D p-value= 0.03. ^††Category A VS Category B p-value <0.0001; Category A VS Category C p-value <0.0001; Category A VS Category D p-value <0.0001; Category B VS Category D p-value <0.0001; Category C VS Category D p-value <0.0001. ^‡Category A VS Category B p-value <0.0001; Category A VS Category C p-value <0.0001; Category A VS Category D p-value <0.0001; Category B VS Category D p-value <0.0001; Category C VS Category D p-value <0.0001. ^§Category A VS Category C p-value <0.0001; Category A VS Category D p-value.

Table 4 Pharmacological Therapy for COPD, 2015 Vs 2017

	2017						Therapeutic Switch
2015	No Therapy	LABA	LAMA	LABA/LAMA	ICS/LABA	ICS/LABA/LAMA
No therapy (n=10)	60.0	–	20.0	–	20.0	–	40.0
LABA (n= 31)	–	41.9	12.9	38.7	3.2	3.2	58.1
LAMA (n= 132)	–	–	65.2	22.0	3.8	9.1	34.8
LABA/LAMA (n= 176)	0.6	–	2.3	81.8	0.6	14.8	18.2
ICS/LABA (n= 110)	1.8	1.8	6.4	13.6	48.2	28.2	51.8
ICS/LABA/LAMA (n= 346)	–	–	0.9	8.7	1.5	89.0	11.0

Notes: Percentage of patients who moved from the therapy indicated in the corresponding raw (2015) to the therapy specified in the crossing column (2017). Grey boxes correspond to percentage of patients who maintained same therapy.

Figure 1 Association between baseline descriptors and mortality outcome during follow-up: multivariable logistic regression model. The forest plot illustrates the odds of mortality with 95% confidence intervals (CI). CI and p-values are reported on the left of y axis. Values higher than 1 favor risk of death.

Abbreviations: BMI, body mass index; IC, inspiratory capacity; IQR, inter quartile range; FEV1, forced expiratory volume in first second.