PHILADELPHIA—Patients with nonerosive reflux disease who manage their heartburn with daily vonoprazan also report durable and rapid-onset relief when transitioning to use the drug as an on-demand treatment, according to results presented at ACG 2024.
This new post hoc analysis of NERD-201 was designed “to evaluate the frequency of heartburn episodes when a patient switched to on-demand treatment after achieving symptom control with daily treatment for four weeks and to also evaluate how rapidly symptoms improved when treating new episodes during the on-demand treatment,” reported investigator Ronnie Fass, MD, the director of the Division of Gastroenterology and Hepatology at MetroHealth Medical Center, in Cleveland (oral paper presentation 4).
Related Content
NERD-201 consisted of a four-week run-in period during which patients received vonoprazan 20 mg daily, followed by a six-week on-demand period in patients who were 80% compliant with the drug and also reported no heartburn during the last seven days of the run-in period in electronic diary entries (n=207).
The patients eligible for the on-demand period were randomized to four arms: vonoprazan at 10 mg, 20 mg, and 40 mg or placebo, and followed for another week. Patients reported heartburn episodes as they occurred in an electronic diary, and symptoms were assessed at the time of treatment in 20-minute increments for up to three hours after patients took the drug.
Patients reported heartburn severity as none, mild, moderate, severe or very severe and “documented if they did not have heartburn episodes within 24 hours of drug consumption,” Dr. Fass said.
Improvement in severity was regarded as a minimum of one grade reduction from initial severity (e.g., from moderate to mild); on-demand dosing permitted only one dose of study drug every 24 hours.
During the screening period, patients only reported 16% of days as heartburn-free. During the run-in period of daily treatment, patients reported 83% heartburn-free days. This percentage fell to approximately 72% when patients switched to on-demand treatment, “but that was still significantly higher than during the screening period,” Dr. Fass said.
NERD-201 succeeded at its primary outcome of complete relief at three hours and sustained relief for 24 hours, but this didn’t capture how quickly symptoms started to improve, Dr. Fass said. “Therefore, we further examined the percentage of episodes that improved from the initial reported severity.”
The differences between vonoprazan and placebo were evident within as little as one hour, he noted. In addition, 90% of patients in the treatment arms had their symptoms improved in severity within two hours. This was seen at every dose of vonoprazan compared with placebo, regardless of the initial level of symptom severity, “although it appears severe episodes may have a higher improvement rate,” Dr. Fass said.
“Our findings support the use of vonoprazan as an on-demand option for patients with nonerosive reflux disease, although a confirmatory study in a larger patient population with a longer on-demand period is warranted.”
Dr. Fass reported financial relationships with Braintree/Sebela, Carnot, Daewoong, Dexcal, Eisai, GERDCare/Celexio, Intra-Sana, Medicamenta, Medtronic, Phathom, Restech, Syneos and Takeda. He is a member of the Gastroenterology & Endoscopy News editorial board.