Following the FDA approval of vonoprazan in the treatment of erosive esophagitis, Dr Colin Howden discussed important information about the new therapy.
In the wake of the recent FDA approval of vonoprazan (Voquenza) in the treatment of erosive esophagitis, Colin Howden, MD, of the University of Tennessee, shared insights into the underlying mechanisms of this novel medication, who may benefit the most, as well as detailed helpful information for patients to be aware of when starting this therapy. Vonoprazan is a potassium-competing acid blocker and, at present, has been approved in the form of 10 mg and 20 mg tablets in the treatment of all grades of erosive esophagitis.
Transcript
This transcript has been lightly edited.
Are there specific patient populations that benefit more from vonoprazan compared to other acid blockers?
Vonoprazan has a role in the treatment of erosive esophagitis and was recently approved by the FDA for that indication. Because it suppresses gastric acid secretion to a greater degree than proton pump inhibitors, it is more likely to heal erosive esophagitis and perhaps, more importantly, it's more likely to keep erosive esophagitis healed during maintenance treatment in the large US and European randomized control trial that was responsible for the FDA approval of vonoprazan. It was compared with the proton pump inhibitor lansoprazole. The primary endpoint was the healing of erosive esophagitis after 8 weeks of double-blinded treatment. And that was a non-inferiority endpoint. So vonoprazan 20 mg was non-inferior to lansoprazole 30 mg, each given once daily in healing erosive esophagitis after 8 weeks.
Once that non-inferiority endpoint was met, there was a superiority analysis performed that was a predetermined exploratory analysis and vonoprazan 20 mg was superior to lansoprazole 30 mg once daily in healing all grades of erosive esophagitis. Other predetermined secondary endpoints include the healing of severe erosive esophagitis, which we define as Los Angeles grade C and D. And that was superior—I should say vonoprazan 20 mg was superior to lansoprazole 30 mg in healing severe erosive esophagitis, that is, erosive esophagitis with Los Angeles grade C or D.
In the maintenance phase of the study, patients with healed erosive esophagitis were re-randomized to maintenance treatment with vonoprazan in 10 mg, or lansoprazole 15 mg, which is the FDA approved dose of lansoprazole for maintenance treatment. And again, maintenance of remission of erosive esophagitis was superior after 24 weeks with vonoprazan 10 mg vs lansoprazole 15 mg. So there are advantages of a vonoprazan over lansoprazole in healing erosive esophagitis—all grades of erosive esophagitis—but particularly severe grades. And importantly, vonoprazan was also superior to lansoprazole in maintaining patients that are in healed condition.
Are there any specific dietary or lifestyle recommendations that patients should follow, or potential drug interactions they should be aware of while taking vonoprazan?
Well, patients with gastroesophageal reflux disease, including those who have erosive esophagitis, should be advised not to eat 2 to 3 hours before bedtime. And those patients who are overweight or obese or whose weight has recently increased should be given advice about sensible weight loss. Other lifestyle interventions in reflux disease include advice about smoking, excess alcohol consumption, and avoidance of certain dietary triggers. These make good medical sense. They are good medicine. It's good medicine to advise patients to stop smoking and to avoid excessive alcohol use but they make very little impact on the treatment of the reflux disease, but its sound medical practice. As far as drug interactions, there are a few potential interactions with vonoprazan. These are listed in the prescribing information. The important one is the antiviral drug rilpivirine, that is a contra-indication to the use of vonoprazan. So vonoprazan should not be used in patients who are receiving rilpivirine.
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