Udenafil Improves Exercise Capacity in Patients with Chronic Obstructive Pulmonary Disease: A Prospective Study

Figures & data

Figure 1.  Study flow diagram.

Table 1.  Baseline characteristics of the study patients

Variables	N = 23
Age	70 (43–80)
Sex, male	22 (96)
Body mass index (kg/m2)	19.3 (14.2–25.6)
History of smoking	22 (96)
Current smoker	3 (13)
Ever-smoker	19 (83)
Never-smoker	1 (4)
Number of pack-years	53 (0–120)
Spirometry
FEV1, L	0.98 (0.60–1.70)
FEV1,% pred	35 (22–50)
FVC, L	2.84 (1.59–4.13)
FVC,% pred	73 (46–109)
FEV1/FVC,%	32 (19–66)
Respiratory medication,%
Inhaled anticholinergics	18 (78)
Inhaled or systemic β2 agonist	23 (100)
Inhaled or systemic corticosteroid	20 (87)
Theophylline compound	21 (91)
SGRQ Total score, units	54.8 (19.3–86.2)
6-Minute walk distance, m	343 (120–510)
PASP, mmHg	36 (25–94)
NT-proBNP, pmol/L	66.1 (12–1948)
Baseline oxygen saturation,%	95 (84–98)
Baseline Borg dyspnea score	2.0 (0–5.0)
Use of home oxygen	4 (17%)

Data were presented by numbers (%) or median (range). PASP = pulmonary artery systolic pressure.

Table 2.  Change of parameters after 8 weeks of udenafil treatment*

	Baseline	After udenafil	P-value
6-Minute walk distance, m†	314.5 ± 106.5	348.3 ± 103.8	0.02
SGRQ Total score, units
Total score	54.8 (19.3–86.2)	52.7 (24.0–82.2)	0.39
Symptoms score	67.8 (18.9–97.7)	64.9 (11.6–92.9)	0.61
Activity score	80.3 (35.8–100)	79.7 (23.7–100)	0.39
Impacts score	37.2 (7.2–83.1)	38.2 (3.6–77.2)	0.59
Pulmonary function
FEV1, L	0.98 (0.60–1.70)	1.00 (0.58–1.62)	0.43
FEV1,% pred	35 (22–50)	39 (22–54)	0.46
PASP, mmHg	36.1 (25.0–94.0)	30.2 (5.0–102.6)	0.02
NT-proBNP, pmol/L	66.1 (12–1948)	79.6 (18–1499)	0.90
Oxygen saturation,%
Before 6MWT	95 (84–98)	95 (86–99)	0.17
After 6MWT	90 (64–98)	89 (67–98)	0.17
Borg dyspnea score
Before 6MWT	2.0 (0–5.0)	2.0 (0–7.0)	0.92
After 6MWT	4.0 (0–5.0)	3.0 (0–8.0)	0.58

*Data were presented by median (range) and analyzed by Wilcoxon signed rank test.

†Data were presented by mean ± SD.

Table 3.  Differences in baseline parameters between improvers (increased 6MWD) and nonimprovers (decreased 6MWD) after 8 weeks of udenafil treatment

	Decreased 6MWD (N = 9)	Increased 6MWD (N = 14)	P–value
Age	70 (57–80)	70 (43–74)	0.82
Pack-years, yr	60 (15–120)	52.8 (0–97)	0.41
Body mass index (Kg/m2)	18.8 (15.1–19.7)	21.0 (14.2–25.6)	0.06
FEV1, L	0.82 (0.60–1.16)	1.00 (0.61–1.70)	0.26
FEV1,% pred	32 (22–49)	38 (27–50)	0.31
SGRQ, units	54.3 (19.3–83.4)	56.9 (31.4–86.2)	0.60
6-Minute walk distance, m	385 (150–510)	341.5 (180–425)	0.91
PASP, mmHg	36.4 (25–43)	35.8 (25–75)	0.83
NT-proBNP, pmol/L	92.9 (41–367)	46.8 (12–1948)	0.10
Baseline oxygen saturation	95 (84–98)	96 (86–97)	0.97
Baseline Borg dyspnea score	0.5 (0–3)	2.0 (0–5)	0.36

Data were presented by median (range) and analyzed by Mann-Whitney U-test.

Table 4.  Adverse events in dropout patients

Patient No.	Adverse event	Duration of medication (days)
1	Nausea	20
2	Flushing, Palpitation	1
3	Abdominal pain	3
4	Insomnia, Palpitation	1
5	Dizziness, Thirsty	3
6	Flushing, Dizziness	7
7	Aggravation of dyspnea	5
8	Aggravation of dyspnea	15
9	Aggravation of dyspnea	32

Table 5.  Comparisons between patients with or without adverse events

	Had adverse events (N = 9)	No adverse events (N = 23)	P-value
Age	74 (58–78)	67 (43–80)	0.09
Pack-years, yr	35 (8–75)	53 (0–120)	0.40
Body mass index (Kg/m2)	20.7 (17.9–24.9)	19.3 (14.2–25.6)	0.19
FEV1, L	0.94 (0.61–1.53)	0.98 (0.60–1.70)	0.74
FEV1,% pred	40 (28–72)	35 (22–50)	0.35
Baseline SGRQ, units	62.6 (39.5–87.3)	54.8 (19.3 –86.2)	0.56
Initial 6-Minute walk distance, m	300 (232–370)	343 (120–510)	0.50
Initial PASP, mmHg	22.5 (5–95)	36.1 (25–94)	0.01
Initial NT-proBNP, pmol/L	111.9 (20–1550)	66.1 (12–1948)	0.59
Baseline oxygen saturation	96 (90–96)	95 (84–98)	0.80
Baseline Borg dyspnea score	0.5 (0–7)	2 (0–5)	0.91

Data were presented by median (range) and analyzed by Mann-Whitney U-test.