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Novel therapy non-inferior to Nexium in erosive esophagitis
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Tegoprazan, a novel potassium-competitive acid blocker, was non-inferior to Nexium for the treatment of erosive esophagitis, according to results of a parallel-group comparison study.
Poong-Lyul Rhee, MD, PhD, of the department of medicine at Samsung Medical Center in Seoul, South Korea, and colleagues wrote that treatment with proton pump inhibitors, like Nexium (esomeprazole, Pfizer), often results in high healing rates, but some patients still have endoscopic evidence of esophagitis or reflux symptoms. They wanted to test esomeprazole against tegoprazan, which is fast acting and can control gastric pH for a prolonged period.
“The therapeutic potential of tegoprazan may be derived from its ability to accumulate at high concentrations in the canaliculi of gastric parietal cells,” they wrote. “Consequently, it is slowly cleared from the gastric glands and exerts its effects independent of acid levels, leading to a strong and sustained effect.”
Researchers conducted a multicenter, randomized, double-blind, parallel-group comparison study comprising 302 patients with endoscopically confirmed erosive esophagitis. They randomly assigned patients to receive either 50 mg or 100 mg of tegoprazan or 40 mg of esomeprazole for 4 to 8 weeks. The cumulative proportion of patients with health erosive esophagitis confirmed by endoscopy up to 8 weeks from initiation of treatment served as the primary endpoint.
Investigators found that cumulative healing rates at week 8 were 98.9% for tegoprazan 50 mg (91/92), 98.8% for tegoprazan 100 mg (90/91) and 98.9% for esomeprazole (87/88).
The incidence of adverse events was comparable across all groups, and researchers did not identify any new safety signals.
Rhee and colleagues wrote that their findings show that tegoprazan showed non-inferior efficacy to esomeprazole for the treatment of erosive esophagitis.
“Both doses of tegoprazan were highly effective in healing [erosive esophagitis],” they wrote. “Tegoprazan 100 mg did not provide additional clinical benefit over tegoprazan 50 mg. However, we did not observe any superior results of tegoprazan over esomeprazole since the healing rates in all treatment groups were too high to detect any significant differences.” – by Alex Young
Disclosures: Rhee report no relevant financial disclosures. Please see the full study for all other authors’ relevant financial disclosures.
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