Vardenafil efficacy for the treatment of persistent pulmonary hypertension of the newborn

Table 1 Baseline characteristics of enrolled participants, n (%)/mean ± SD

Characteristic	Vardenafil group (n = 37)	Sildenafil group (n = 18)
Gestational age (week)	37.07 ± 1.95	37.74 ± 1.54
Full term/preterm	26 (70.3)/11 (29.7)	14 (77.8)/4 (22.1)
Maternal age (year)	25.90 ± 6.89	29.62 ± 6.83
Antenatal history
Steroids	1 (2.7)	2 (11.1)
Gestational diabetes	4 (10.81)	0
Gestational hypertension	4 (10.81)	1 (5.5)
Delivery cesarian/vaginal	27 (73)/10 (27)	12 (65)/6 (35)
Birth weight (kg)	2.86 ± 0.54	2.65 ± 0.57
Gender (female:male)	21 (56.8):16 (43.2)	11 (61):7 (39)
Deformities	3 (8.1) trisomy 21; 1 (2.7) omphalocele	2 (11.1) piere robin; 2 (11.1) meningocele
Age at diagnosis (day)	2.38 ± 0.83	2.22 ± 0.55
PDA shunt R-L or bidirectional	8 (21.62)	3 (16.67)
PFO shunt R-L or bidirectional	7 (18.9)	6 (33.33)
Tricuspid regurgitation	37 (100)	18 (100)
Pulmonary mid systolic notch	37 (100)	18 (100)
Secondary PPHN causes	21 (56.7) sepsis	10 (55.5) sepsis
	2 (5.4) erythrocytosis	2 (11.1) MAS
	1 (2.7) asphyxia	1 (5.5) asphyxia
	1 (2.7) CDH	1 (5.5) RDS

PDA: Persistent ductus arteriosus; R-L: Right to left shunt; PFO: Persistent foramen oval; sPAP: Pulmonary artery systolic pressure; MAS: Meconium aspiration syndrome; CDH: Congenital diaphragmatic hernia; RDS: Respiratory distress syndrome; PPHN: Persistent pulmonary hypertension of the newborn.

Table 2 Comparison of intervention outcomes between treatment groups, n (%)/mean ± SD

Parameter	Vardenafil (n = 37)	Sildenafil (n = 18)
Pulmonary hypertension severity
Baseline
Severe	23 (62.2)	13 (72.2)
Moderate	14 (37.8)	5 (27.8)
After 1 day
Severe	0 (0)	4 (22.2)
Moderate	12 (32.4)	9 (50)
Mild	2 (5.4)	0 (0)
Normal	23 (62.2)	5 (28)
After 2 days
Severe	0/141	1/131
Moderate	1/141	4/131
Mild	2/141	1/131
Normal	10/141	6/131
Dead	1/141	1/131
After 3 days
Mild	0/31	1/61,2
Normal	3/31	4/61
Dead	0/01	1/61
Pulmonary vascular resistance
Baseline
High	37 (100)	18 (100)
After 1 day
High	1 (2.7)	2 (11.1)
Border line	6 (16.2)	10 (55.5)
Normal	30 (81.1)	6 (33.3)
After 2 days
High	0/61	1/111
Borderline	0/61	1/111
Normal	6/61	9/111
Pulmonary artery flow velocity (m/second)
Baseline	0.891 ± 0.125	0.893 ± 0.159
After 1 day	1.11 ± 0.18	1.017 ± 0.20
After 2 days	1.20 ± 0.19	1.037 ± 0.24
After 3 days	1.23 ± 0.18	1.1 ± 0.20
Heart rate (bpm)
Baseline	133.3 ± 9.13	138.8 ± 13.75
After 1 day	128.0 ± 11.4	132.1 ± 10.3
After 2 days	120.98 ± 9.3	116.8 ± 9.3
Blood pressure (mm Hg)
Systolic
Baseline	65.8 ± 3.54	67.0 ± 6.75
After 1 day	67.8 ± 3.92	70.9 ± 4.91
After 2 days	75.0 ± 5.97	76.1 ± 8.94
Diastolic
Baseline	35.0 ± 2.43	36.0 ± 3.9
After 1 day	36.9 ± 4.25	38.2 ± 5.14
After 2 days	41.9 ± 3.72	40.6 ± 5.83

¹The number of cases in each category out of the total sample (i.e., cases that have not been normalized yet).

²Normalized on the following day.