The Comparison of the efficacy of
Sildenafil alone versus Sildenafil plus
Bosentan in newborns with persistent
pulmonary hypertension
DR.NAZIA FATIMA
The Children’s Hospital and The Institute of Child Health,
Multan

Nazia Fatima1, Sohail Arshad2, Ahmad Iqbal
Quddusi3,Abdur Rehman4 ,Ashee Nadeem5,
Imran Iqbal6
1. Dr. Nazia Fatima, FCPS.
2. Dr. SohailArshad, FCPS.
3. Dr. Ahmad IqbalQuddusi, FCPS.
4. Dr. AbdurRehman, FCPS.
5. Dr. Imran Iqbal, FCPS.
6. Dr. AsheeNadeem
1-6: Department of Paediatric Medicine,
Children Hospital and Institute of Child Health
Multan, Pakistan.
Grant Support & Financial Disclosures
None
Correspondence
Dr. Nazia Fatima, FCPS.
NICU
Children Hospital and Institute of Child Health
Multan.
Email: nazia_khurram@yahoo.com
Cell: 03334179233

Introduction
 Persistent pulmonary hypertension is a serious disease
among newborns .
 Inhaled nitric oxide is first line of therapy along with
extracorporeal membrane oxygenation.
 Pulmonary vasodilators such as sildenafil ,bosentan and
milrinone are also used to treat persistent pulmonary
hypertension especially in resource limited centers where
inhaled nitric oxide is not available .
 The objective of this study was to compare the effect of
sildenafil alone and sildenafil with bosentan on severity of
tricuspid regurgitation and duration of hospitalization in
newborns with persistent pulmonary hypertension.

Methods
• It was single blinded clinical trial conducted at
The Children’s Hospital & the Institute of Child
Health, Multan, Pakistan, from July 2016 to
December 2016.
• Newborns with pulmonary hypertension were
admitted and divided into two groups.
• Group A was treated with sildenafil (2mg per kg
per dose three times a day) and group B with
both sildenafil (2mg per kg per dose three times a
day) and bosentan (1mg per kg per dose twice a
day).

Results
• There were 50 newborns in each group.
• The mean age, sex distribution and baseline
TR measurement (mmHg) at the time of
admission was similar in both the groups .
• Measurement of TR (mmHg) after 72 hours
admission was significantly less in Group B as
compared to group A(11
±4.62versus23±4.78),p value<0.0001.

• The mean duration of hospital stay (days) was
10.12± 5.20 in group A and 7.56±3.77 in group
B (p- value <0.0001) .
• There was no mortality in any group and no
case of hypotension in both groups.

Group A
n= 50
Group B
n=50
p- value
53.30 ± 9.35 41.66 ± 9.47 <0.0001
TR (mmHg) reduction 72
hours after
admission
(Mean ± SD)
Outcome Variable
23.66±4.78 <0.0001
Duration of hospital stay
(days)
(Mean ± SD)
TR (mmHg) 72 hours after
admission
( Mean ± SD)
7.56 ± 3.77 <0.0001
Table-II: Comparison of outcome Variables in the study group

• There were no studies done to see the combined effect of
sildenafil and bosentan in resource limited centers so our
study is the first to see their combined effect.
• However, endothelin receptor antagonists in our study
showed improvement in outcome when given along with
sildenafil.
• Our results support earlier case reports that showed
improvement in hypoxemia of newborns with persistent
pulmonary hypertension when treated with bosentan.
• Our results also supports the results of randomized control
trial done by Mohamed et al that showed the improvement
in oxygenation by using bosentan as compared to placebo.

CONCLUSION
• Persistent pulmonary hypertension is a
significant cause of neonatal morbidity and
mortality.
• Combined use of pulmonary vasodilators,
sildenafil and bosentan, is more effective in
centers where inhaled NO is not available.
• Further research needed to improve the
outcome of neonates with persistent
pulmonary hypertension.