Clinical course of COPD patients with exercise-induced elevation of pulmonary artery pressure or less severe pulmonary hypertension presenting with respiratory symptoms and the impact of bosentan intervention—prospective, single-center, randomized, parallel-group study

Table 2 Adverse events observed in untreated and drug-treated patients with eePAP or less severe PH

	All	Untreated group	Drug-treated group
Exacerbation of dyspnea	20	14	6
Time to exacerbation of dyspnea (mean ± SD) (days)	200.35 ± 176.24	128.07 ± 108.96	369.00 ± 195.97
Increase of the O₂ dose	11	8	3
Time to O₂ dose increase (mean ± SE) (days)	168.00 ± 125.23	181.88 ± 152.84	304.00 ± 246.31
All-cause hospitalization (hospitalization-free survival days)^a	8 (364.63 ± 238.24)	6 (339.50 ± 208.53)	2 (440.00 ± 405.88)
Hospitalization (hospital-free survival days) from respiratory-related causes	3 (230.67 ± 230.53)	2 (269.5 ± 311.83)	1 (153)
All-cause death (survival days)	7 (403.00 ± 239.83)	6 (349.00 ± 211.02	1 (727)
Death from possible respiratory-related causes (survival days)	3 (454.00 ± 325.34)	2 (317.50 ± 316.08)	1 (727)
Other adverse events	19	15^b	4

Acute exacerbation of COPD (n = 2), aplastic anemia (n = 1), lumbar spondylolisthesis (n = 1)
^aOne suicide patient in the untreated group was not counted in hospitalization (hospital-free survival days) because of being treated as discontinued case
^bPneumoniae (n = 2), myocardial infarction (n = 2), aortic aneurysm (n = 2), pulmonary thrombosis-emboli (n = 1), sepsis due to urinary tract infection (n = 1), cancer (n = 2), cerebral infarction (n = 1), acute exacerbation of COPD (n = 1), pneumothorax with rib fracture (n = 1), hemosputum (n = 1), suicide (n = 1)^*

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