Examining the Effectiveness of Monotherapy versus Combination Therapy for Pulmonary Hypertension in Patients with Congenital Heart Disease: A Short-Term Outcome Comparison Study

Abstract

Introduction: Pulmonary arterial hypertension (PAH) is a serious condition characterized by a gradual increase in pulmonary vascular resistance, which can lead to right heart failure and death. Although the underlying cause of PAH is complex, there are three main pathways involved in the disease: endothelin, nitric oxide, and prostacyclin. Medications that target these pathways have been effective in extending the lives of PAH patients, but the disease remains fatal. Combining different medications is an attractive option for treating PAH, and this study aimed to compare the outcomes of using a single medication versus combining multiple medications over a short period of time.

Aim of the study: The study aimed to compare the short-term outcome of monotherapy and combination therapy in the treatment of Pulmonary hypertension

Methods: This randomized control trial study was conducted at the Department of Cardiology, Ranpur Medical College, Rangpur, Bangladesh. The study duration was 2 years, from January 2019 to January 2021. During this period, a total of 140 participants were selected for the study following the inclusion, and exclusion criteria from those diagnosed case of pulmonary hypertension with congenital heart disease admitted to the Pediatric Cardiology Department, Bangabandhu Sheikh Mujib Medical University, NICVD, NHF. The selected participants were then divided into two groups of 70 each through random selection.

Result: The majority of the participants in this study were between 12 to 15 years of age, with 54.3% in Group A (treated with Sildenafil) and 60.0% in Group B (treated with a combination of medications). Group A consisted of 70 patients, of whom 28 (40.0%) were male and 42 (60.0%) were female. In Group B, 24 (34.4%) patients were male and 46 (65.7%) were female. There were no significant differences between the two groups in terms of mean age or sex. The most common congenital heart defect among the participants was ventricular septal defects (VSD), followed by atrioventricular septal defects (AVSD), and atrial septal defects (ASD). After 3 and 6 months of follow-up, the study found statistically significant differences between the two groups in terms of SpO2 per exercise, 6-minute walk distance, SpO2 after exercise, and alanine aminotransferase. However, there were no significant differences in adverse effects between the two groups. Pulmonary artery systolic pressure (PASP) was significantly reduced in the combination therapy group compared to the monotherapy group.

Conclusion: The study found that combining Bosentan with oral Sildenafil medication is a safe and effective treatment for patients with PAH associated with CHD. The combination therapy resulted in significant improvements in clinical status, effort SpO2, exercise tolerance, hemodynamics, and PASP after 3- and 6-month follow-ups. Therefore, the study concludes that combination therapy is more successful than monotherapy for treating PAH associated with CHD.