Tesis

Perbandingan efektivitas vonoprazan dengan esomeprazole dalam memperbaiki gejala awal pasien esofagitis erosif : sebuah uji acak tersamar ganda = Comparison of the effectiveness of vonoprazan and esomeprazole in initial symptomatic relief in patients with erosive esophagitis: a double-blind randomized controlled trial.

Latar Belakang: Esofagitis Erosif (EE) merupakan inflamasi pada mukosa esofagus yang umumnya diakibatkan oleh refluks asam dari gaster dan duodenum. Supresi asam lambung merupakan terapi utama dalam penatalaksanaan EE. Proton Pump Inhibitor (PPI), salah satunya Esomeprazole, merupakan obat yang terbukti paling baik dalam beberapa dekade terakhir. Potassium Competitive Acid Blocker (PCAB), salah satunya Vonoprazan, menjadi obat alternatif dalam beberapa tahun terakhir karena dapat mencapai efek teraupetik lebih cepat. Belum ada penelitian yang membandingkan secara langsung Esomeprazole 40 mg dengan Vonoprazan 20 mg dalam memperbaiki gejala awal pasien EE. Tujuan: Diketahui perbandingan efektivitas Vonoprazan dan Esomeprazole dalam memperbaiki gejala pasien EE dalam satu minggu dan dua minggu. Metode: Penelitian ini merupakan uji acak tersamar ganda pada pasien dengan GerdQ > 8 dan ditemukan EE pada pemeriksaan esofagogastroduodenoskopi (EGD). Pasien diberikan Vonoprazan 20 mg atau Esomeprazole 40 mg dengan dosis sekali sehari selama 2 minggu. kemudian dinilai kembali GerdQ setelah satu dan dua minggu pasca pemberian obat. Perbaikan gejala pasien dinilai dengan proporsi pasien yang mencapai Complete Resolution (CR). Hasil: Sebanyak 216 subjek penelitian masuk ke dalam studi, dengan 111 kelompok Vonoprazan dan 105 kelompok Esomeprazole. Pasca pemberian terapi satu minggu, dengan analisis Intention-To-Treat (ITT), didapatkan proporsi CR kelompok Vonoprazan sebesar 39,6% dan kelompok Esomeprazole sebesar 42,9% (p=0,63), sedangkan analisis Per-Protocol didapatkan proporsi sebesar 43,1% dan 45,9% (p=0,69). Pasca pemberian terapi dua minggu, dengan analisis ITT didapatkan proporsi CR sebesar 60,4% pada kelompok Vonoprazan dan 61% pada kelompok Esomeprazole (p=0,93), sedangkan analisis PP menunjukkan proporsi sebesar 66,3% dan 64% (p=0,96). Simpulan: Tidak terdapat perbedaan bermakna antara efektivitas Vonoprazan dengan Esomeprazole dalam memperbaiki gejala pasien esofagitis erosif dalam satu dan dua minggu.
Kata kunci: Esofagitis Erosif, Vonoprazan, Esomeprazole, GerdQ


Erosive Esophagitis (EE) is an inflammation of the esophageal mucosa, commonly caused by acid reflux from the gastic and duodenum. Gastric acid suppression is the cornerstone of EE therapy. Proton Pump Inhibitors (PPIs), such as Esomeprazole, have been proven to be the most effective treatment over the past decades. Potassium-Competitive Acid Blockers (PCABs), such as Vonoprazan, have emerged in recent years as alternative treatments due to their faster onset of therapeutic effect. As yet, no head-to-head studies have directly compared Esomeprazole 40 mg and Vonoprazan 20 mg in improving the initial symptomatic relief. Objective: To compare the effectiveness of Vonoprazan and Esomeprazole in improving symptoms of erosive esophagitis after one and two weeks of treatment. Methods: This study is a double-blind randomized controlled trial involving patients with a GerdQ score ≥ 8 and confirmed EE on esophagogastroduodenoscopy (EGD). Patients were assigned to receive either Vonoprazan 20 mg or Esomeprazole 40 mg once daily for two weeks. Symptom improvement was assessed using GerdQ at the end of the first and second weeks after starting the medication. Initial symptomatic relief was defined as the proportion of patients achieving complete resolution (CR). Results: A total of 216 subjects were included in the study, with 111 receiving Vonoprazan and 105 receiving Esomeprazole. After one week of therapy, with Intention-To-Treat (ITT) analysis, CR in the Vonoprazan group was 39.6% and in the Esomeprazole group was 42.9% (p = 0.63). The Per-Protocol (PP) analysis showed 43.1% and 45.9%, respectively (p = 0.69). After two weeks of treatment, the ITT analysis showed CR in 60,4% of the Vonoprazan group and 61% of the Esomeprazole group (p=0,93), while the PP analysis showed showed 66.3% and 64% (p = 0.96). Conclusion: There was no significant difference in the effectiveness of Vonoprazan compared to Esomeprazole in achieving initial symptomatic relief of erosive esophagitis after one and two weeks of treatment.
Keywords: Erosive Esophagitis, Vonoprazan, Esomeprazole, GerdQ