PENGARUH TERAPI SILDENAFIL TERHADAP HEALTH-RELATED QUALITY OF LIFE PASIEN HIPERTENSI ARTERI PULMONAL AKIBAT DEFEK SEPTUM ATRIUM SEKUNDUM DEWASA YANG BELUM DIKOREKSI

FERA HIDAYATI, Dr. dr. Lucia Kris Dinarti, SpPD, SpJP (K).; Dr.Med.dr.Putrika Prastuti Ratna Gharini, SpJP(K),

2018 | Tesis-Spesialis | SP KARDIOLOGI DAN KEDOKTERAN VASKULAR

Latar belakang: Health related quality of life (HRQoL) merupakan parameter patient reported outcome untuk menilai efektifitas terapi yang penting dalam uji klinis. Hipertensi arteri pulmonal (HAP) merupakan komplikasi defek septum atrium (DSA) yang sering terjadi. Penelitian ini bertujuan untuk mengetahui perbedaan HRQoL pasien HAP dengan DSA antara sebelum dan setelah terapi sildenafil. Metode penelitian: Penelitian ini merupakan studi kuasi eksperimental dengan desain one group pre and post test di RSUP Dr Sardjito Yogyakarta yang dilakukan sejak April 2016 hingga Agustus 2017. Pasien HAP akibat DSA sekundum dewasa yang belum dikoreksi, telah terdaftar dalam registri STUDI pulmonary arterial hypertension (PAH) - atrial septal defect (ASD), memenuhi kriteria inklusi dan eksklusi dimasukkan sebagai subyek. HRQoL dinilai dengan kuesioner EuroQol-5 Dimensions 3 Levels (EQ-5D-3L) saat awal penelitian dan 12 minggu setelah terapi sildenafil oral 3 x 20 mg. Analisis statistik dilakukan untuk mengetahui perbedaan skor utilitas EQ-5D dan EQ-VAS sebelum dan setelah terapi. Hasil: Sejumlah 18 subyek mengikuti penelitian selama 12 minggu dengan rerata usia 38.72 ± 10.81 tahun yang terdiri dari wanita 83.33% (15) dan laki-laki 16.67% (3). Dimensi yang paling sering mengalami masalah sebelum terapi adalah rasa kesakitan/tidak nyaman (83%) dan rasa cemas/depresi (78%). Rerata skor utilitas EQ-5D dan EQ-VAS meningkat dari 0.558 menjadi 0.664 (p 0.014, IK95% 0.024-0.187) dan 65 menjadi 71,67 (p 0.005, IK95% 2.3211.02) setelah terapi. Angka drop out yang tinggi (18,2%) dinilai dapat mempengaruhi validitas hasil penelitian ini. Efek samping ringan dilaporkan oleh 11,11% subyek yang membaik dengan penurunan dosis. Kesimpulan: Pemberian terapi sildenafil oral selama 12 minggu pada pasien HAP akibat DSA sekundum dewasa yang belum dikoreksi dapat meningkatkan HRQoL yang bermakna secara statistik.

Background: Assessment of health-related quality of life (HRQoL) are often measured as an important patient-reported outcome 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 with one group pre and post test design at Sardjito Hospital Yogyakarta since April 2016 to August 2017. Adults with PAH related uncorrected secundum ASD, listed at PAH-ASD registry, and met the inclusion and exclusion criteria were recruited as subject. Interview was done at pre and 12 weeks post therapy sildenafil oral 3 x 20 mg using the EQ-5D-3L questionnaire. Serious adverse effects (SAE) and adverse reactions was observed then sildenafil dose was adjusted. Statistical analysis was done to determine the differences of EQ-5D utility and EQ-VAS score at pre and post therapy. Results: We enrolled 18 adult patients with PAH related uncorrected secundum ASD, of which 83.33% (15) were female and 16.67% (3) were male with mean age is 38.72±10.81 years old. Side effect is reported by 11.11% (2) subjects which resolved by lowering the dose. The most frequent reported problems pre therapy were pain/discomfort (83%) and anxiety/depression (78%). Paired T-test results showed the mean value of EQ-5D utility score was 0,558 while 0,664 post therapy (p:0.014; 95% CI 0.024-0.187). Whereas, the mean of EQ-VAS pre and post therapy was 65 and 71.67, respectively (p:0.005; 95% CI 2.3211.02). High drop out rates (18,2%) need to be considered. Mild side effects were experienced by 11,11% (2) subjects. Conclusion: The administration of oral sildenafil therapy during 12 weeks in adult patients with PAH related uncorrected secundum ASD, gives better HRQoL.

Kata Kunci : health related quality of life, hipertensi arteri pulmonal, defek septum atrium, sildenafil, health related quality of life, pulmonary arterial hypertension, atrial septal defect