Seasonal variations in exacerbations and deaths in patients with COPD during the TIOSPIR^® trial

Figures & data

Table 1 Baseline demographic and clinical characteristics of patients from the northern and southern hemispheres

Variable	Northern hemispherea (n=15,968)	Southern hemisphereb (n=1,148)
Sex
Male	11,426 (71.6)	811 (70.6)
Female	4,542 (28.4)	337 (29.4)
Race
White	12,939 (81.0)	1,024 (89.2)
Black	178 (1.1)	78 (6.8)
Asian	2,383 (14.9)	45 (3.9)
Missing	468 (2.9)c	1 (0.1)d
Age, years	64.9±9.1	66.1±9.0
Age class, years
<60	4,476 (28.0)	287 (25.0)
60 to <70	6,259 (39.2)	443 (38.6)
≥70	5,233 (32.8)	418 (36.4)
Body mass index, kg/m^2	26.3±5.7	25.6±5.2
Body mass index class
Underweight (<18.5 kg/m^2)	1,013 (6.3)	85 (7.4)
Normal (18.5 to <25 kg/m^2)	6,210 (38.9)	476 (41.5)
Pre obese (25 to <30 kg/m^2)	5,140 (32.2)	369 (32.1)
Obese (≥30 kg/m^2)	3,605 (22.6)	218 (19.0)
COPD duration, years	7.4±6.2e	7.7±5.9
Smokers
Never smoked	3 (0.0)	0 (0.0)
Ex-smoker	9,745 (61.0)	849 (74.0)
Current smoker	6,220 (39.0)	299 (26.0)
Smoking history, pack-years	43.3±24.3	50.1±29.2
Pulmonary medication
ICS (but not LABA)	1,034 (6.5)	197 (17.2)
LABA (but not ICS)	1,628 (10.2)	78 (6.8)
Both ICS and LABA	8,239 (51.6)	633 (55.1)
Neither ICS nor LABA	5,067 (31.7)	240 (20.9)
Systolic blood pressure, mmHg	131.2±15.3f	127.9±15.4
Diastolic blood pressure, mmHg	78.1±9.6f	77.8±9.8
Pulse rate, bpm	76.8±11.7f	76.1±11.1
Region
Europe, Africa, Australia, New Zealand	9,197 (57.6)	442 (38.5)
Latin America	294 (1.8)	706 (61.5)
North America	4,121 (25.8)	0 (0.0)
Asia	2,356 (14.8)	0 (0.0)

Notes: Data are expressed as mean ± SD or as number (%) patients.

a Forty-three northern hemisphere countries: Austria, Belgium, Bulgaria, Canada, P.R. China, Croatia, Denmark, Finland, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Ireland, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, the Netherlands, Norway, Panamá, Philippines, Poland, Portugal, Republic of Korea, Romania, Russia, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan R.O.C., Thailand, Tunisia, Turkey, Ukraine, UK, and USA.

b Seven southern hemisphere countries: Argentina, Australia, Brazil, Colombia, New Zealand, Peru, and South Africa.

c This category includes 468 patients from France where race cannot be collected.

d One patient from Peru whose race was determined to be Mestizo.

e n=15,965 patients.

f n=15,959 patients.

Abbreviations: ICS, inhaled corticosteroids; LABA, long-acting beta-agonist.

Table 2 Number of exacerbations and deaths for patients from the northern and southern hemispheres

Variable	Northern hemisphere (n=15,968)	Southern hemisphere (n=1,148)
Total COPD exacerbations requiring treatment, n	17,742	1,752
Patients with ≥1 exacerbation, n (%)	7,660 (48.0)	682 (59.4)
Total moderate-to-severe COPD exacerbations, n	17,365	1,728
Patients with ≥1 moderate-to-severe exacerbation, n (%)	7,520 (47.1)	675 (58.8)
Total severe COPD exacerbations requiring hospitalization	3,563	253
Patients with ≥1 severe exacerbation requiring hospitalization, n (%)	2,336 (14.6)	170 (14.8)
Deaths, n (%)
All-cause	1,169 (7.3)	133 (11.6)
MACE	299	34
Neoplasms	284	21
Respiratory	393	53
Other	193	25

Abbreviation: MACE, major adverse cardiac event.

Figure 1 Numbers of exacerbations and incidence rates per 1,000 patient-months of exposure adjusted by hemisphere.

Note: (A) Number of all exacerbations, (B) occurrence of first exacerbation, (C) number of all severe exacerbations, (D) occurrence of first severe exacerbation, and (E) exacerbation incidence rates.
Abbreviations: NH, northern hemisphere; SH, southern hemisphere.

Figure 2 Mean frequency of all-cause deaths (per month as a percentage of the total deaths occurring over the study) and incidence rates of all-cause deaths per 1,000 patient-months of exposure.

Note: (A) Northern hemisphere: percentage of deaths, (B) northern hemisphere: incidence rate, (C) southern hemisphere: percentage of deaths, (D) southern hemisphere: incidence rate, (E) hemisphere adjusted percentage of deaths, and (F) hemisphere adjusted incidence rate.
Abbreviations: NH, northern hemisphere; SH, southern hemisphere.

Figure 3 Mean numbers and incidence rates per 1,000 patient-months of exposure for cause-specific deaths adjusted for hemisphere.

Note: (A) Number of MACE-related deaths, (B) incidence rate of MACE-related deaths, (C) number of respiratory-related deaths, (D) incidence rate of respiratory-related deaths, (E) number of neoplasm-related deaths, (F) incidence rate of neoplasm-related deaths, (G) number of other-related deaths, (H) incidence rate of other-related deaths.
Abbreviations: MACE, major adverse cardiac event; NH, northern hemisphere; SH, southern hemisphere.