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The Comparison of the efficacy of sildenafil alone.pptx

  1. 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
  2. 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: Cell: 03334179233
  3. 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.
  4. 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).
  5. 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.
  6. • 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.
  7. 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
  8. • 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.
  9. 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.