The Effect of Oral Sildenafil Therapy on Health-Related Quality of Life in Adults with Pulmonary Arterial Hypertension related to Uncorrected Secundum Atrial Septal Defect: A Quasi Experimental Study

Abstract

Background: Assessment of health-related quality of life (HRQoL) are often measured as an important patient-reported outcome (PRO) in clinical studies. Pulmonary arterial hypertension (PAH) is a common complication of atrial septal defect (ASD). This study aimed to compare the HRQoL of PAH related uncorrected secundum ASD at pre and post therapy with oral sildenafil therapy. Methods: We conducted quasi experimental study at Sardjito General Hospital Yogyakarta since April 2016 to August 2017. Adults with PAH related uncorrected secundum ASD, listed on Congenital Heart Disease and Pulmonary Hypertension (COHARD-PH) registry, and met the inclusion and exclusion criteria were recruited as subject. Interview was done at pre and 12 weeks post oral sildenafil therapy 3 x 20 mg using the EQ-5D-3L questionnaire. Statistical analysis was done using paired T-test to determine the differences of EQ5D utility and EQVAS score at pre and post therapy. Results: A total of 18 adult patients with PAH related to uncorrected secundum ASD were enrolled in this study (83.33% female; mean age 38.72 ± 10.81 years old). The most frequent reported problems pre therapy were pain/discomfort (83%) and anxiety/depression (78%). Paired T-test results showed the mean value of EQ5D utility score pre and post therapy were 0.558 and 0.664 post therapy (p:0.014; 95% CI 0.024-0.187). Meanwhile, the mean of EQ-VAS pre and post therapy were 65 and 71.67, respectively (p:0.005; 95% CI 2.32-11.02). Conclusion: The administration of oral sildenafil therapy 3 x 20 mg during 12 weeks in adult patients with PAH related uncorrected secundum ASD gives better HRQoL.

Sildenafil for adult Asian patients with pulmonary arterial hypertension: a systematic review and meta-analysis

“…After screening the titles and abstracts, we selected 136 studies for full-text review. Finally, a total of 10 studies (five RCTs and five NRSIs) involving 480 patients were included (see Figure 1) (22,(32)(33)(34)(35)(36)(37)(38)(39)(40).…”

“…In the domain of other potential sources of bias, four studies (32,33,36,39) received funding from Pfizer and one contained error in data (37), so we rated all of them at high risk. For the five NRSIs, four (22,34,38,40) were assessed as moderate risk and one (35) was serious risk. Details are shown in Tables S1,S2.…”

“…Three studies (33,38,40) evaluated quality of life. There was a statistically significant improvement in the Short Form (SF)-36 domains of physical functioning, general health, and vitality for sildenafil-treated participants when compared to the placebo.…”