Is vonoprazan an alternative to pantoprazole in preventing post-EVL ulcers, bleeding?
Vonoprazan may be as effective as pantoprazole in reducing the risk of ulcers or bleeding following endoscopic variceal ligation (EVL) in patients with portal hypertension, according to a small study from Egypt presented at the United European Gastroenterology Week (UEG 2022).
The study population comprised 237 patients with portal hypertension secondary to liver cirrhosis (Child-Pugh class A–B/9) who were candidates for EVL (history of variceal bleeding, or without bleeding but contraindicated/intolerant to non-selective beta blockers). Following the procedure, the patients were randomized 1:1:1 to receive vonoprazan (20 mg QD), pantoprazole (40 mg QD), or placebo (no acid suppression therapy). Patients in each group had a median five bands placed during ligation.
At 14 days post-EVL, ulcers were detected in fewer patients who received vonoprazan than those who received pantoprazole or placebo (28.9, 32.9, and 78.7 percent, respectively; p<0.001). Patients in the vonoprazan group had a median two ulcers compared with three each in the pantoprazole and placebo groups, respectively (p<0.001). [UEG 2022, abstract LB01]
Ulcer size was also smaller in patients in the vonoprazan than pantoprazole or placebo groups (maximum length: 9.5, 10, and 14 mm, respectively; p<0.001; maximum width: 5, 5.50, and 9 mm, respectively; p<0.001).
Ulcer-related bleeding was significantly reduced among patients assigned to vonoprazan vs placebo (7.2 percent vs 18.7 percent; p=0.03) and those assigned to pantoprazole vs placebo (7.6 percent vs 18.7 percent; p=0.04), with no significant difference noted between vonoprazan and pantoprazole (p=0.92).
The incidence of post-EVL chest pain was also less likely in patients assigned to vonoprazan than placebo (25.3 percent vs 61.3 percent) and pantoprazole than placebo (30.4 percent vs 61.3 percent; p<0.001 for both), again with no significant difference between the vonoprazan and pantoprazole groups (p=0.48). Similarly, odynophagia was less frequent with vonoprazan compared with placebo (22.9 percent vs 45.3 percent; p=0.003) and pantoprazole vs placebo (26.6 percent vs 45.3 percent; p=0.015), with similar incidence between the vonoprazan and pantoprazole groups (p=0.72).
Regression analysis suggested that factors associated with the risk of post-EVL ulcer were variceal grade at baseline (odds ratio [OR] 2.76; p=0.006) and non-use of acid suppression (OR, 11.12; p<0.001). The same factors were associated with the risk of post-EVL bleeding (OR, 0.13; p=0.001 and OR, 3.75; p=0.005, respectively).
No treatment-related adverse events, biochemical deterioration, or life-threatening or severe adverse reactions or allergies were reported in this trial, and there were no drug-related treatment discontinuations.
“[The results of this trial showed that] a short course of vonoprazan [20 mg/day] is as effective and safe as pantoprazole 40 mg/day in the prevention of post-EVL ulcers and bleeding,” said study author Associate Professor Sameh Lashen from Alexandria University in Alexandria, Egypt.
Despite these positive findings, questions remain on drawing firm conclusions due to the small population and the exclusion of patients on beta-blockers. The latter was to reduce confounding, said Lashen, though according to a member of the audience, it highlights that standard of care post-EVL bleeding was not utilized in this patient population.