P1812 - Dual Release Gastro-Resistant Pantoprazole 80mg for Treatment of Partial or Non-Responders to Standard Dose of Proton Pump Inhibitor in Gastroesophageal Reflux Disease – A Prospective pH-Metry/Impedance-Controlled Study

Award: Presidential Poster Award

Yogesh Garje, MD¹, D. Nageshwar Reddy, MD, DM, DSc, FACG², Rakesh Kalapala, MD, DNB², Anudeep KV, MD, DNB², Neeraj Singhla, MD, DM², Shruti Dharmadhikari, MSc³, Chintan Khandhedia, MD³, Neeraj Markandeywar, MD³, Amey Mane, MD³, Suyog Mehta, MD³, Sadhna Joglekar, MD^1
1Sun Pharmaceutical Industries Limited, Mumbai, Maharashtra, India; ²Asian Institute of Gastroenterology, Hyderabad, Telangana, India; ³Sun Pharma Laboratories Limited, Mumbai, Maharashtra, India

Introduction: Limited evidence is available on effect of high dose proton pump inhibitor (PPI) formulation with Dual Release Gastro-Resistant (DRGR) technology on 24hr gastric pH. Pantoprazole 80mg DRGR uses high dose dual drug release technology allowing prolonged drug release. This first in world study assessed effect of pantoprazole 80mg DRGR tablets on 24hr gastric pH.

Methods: This was a prospective, open label, single arm study. Patients with refractory gastro esophageal reflux disease (GERD) aged between 18-65 years having moderate to severe heartburn for ≥1 day in past 7 days despite on PPI standard dose for 4-8 weeks prior to enrolment and having DeMeester score >14.7 as confirmed by endoscopy and combined 24hr pH metry were eligible. Pantoprazole DRGR 80mg was taken at ~30mins-1hr before first meal of the day for 4 weeks.

Results: After screening, 48 eligible patients were enrolled and all completed the study. After 4 weeks, 46% of patients had normal DeMeester score (< 14.7). Mean% of time with intragastric pH >4 during 24hr at baseline was 79.6% which increased to 89% at Week 4. At baseline 31% patients had their intragastric pH >4 for >90% of time in 24hr. This increased to 69% ( >2 times rise from baseline) at 4 weeks. Median pH during 24hrs, daytime and nighttime at Week 4 was 5.85, 6 and 5.69, respectively. At Week 4, significant improvement in individual components of DeMeester mean score was seen from baseline (DeMeester score -28.768±75.53; p=0.01, duration of longest reflux episode -28.02±76.38; p=0.01, recumbent time in reflux -63.86±186.60; p=0.02, number of reflux episodes lasting over 5 mins -4.4±9.91; p=0.003, time in reflux -124.40±329.22; p=0.01, upright time in reflux -60.63±177.32; p=0.02). Significant improvement in total frequency scale for symptoms of GERD(FSSG) score from baseline was observed at Week 4 (-11.8±9.57, p< 0.0001 v/s baseline). According to clinician, 58% patients showed very much to much improvement from baseline in their illness at Week 4. Mean change from baseline quality of life (GERD-HRQL) was -11.6 at Week 4 (p< 0.0001 v/s baseline). No safety concern was reported in the study.

Discussion: In this first in world study, pantoprazole DRGR 80mg was effective in lowering acid exposure during prolonged 24hr pH monitoring. Along with improvement in symptoms, patients’ QoL was also improved. Thus, pantoprazole DRGR 80 mg could be an effective and tolerable option for GERD patients not responding to standard doses of PPIs.


Disclosures:


Yogesh Garje, MD¹, D. Nageshwar Reddy, MD, DM, DSc, FACG², Rakesh Kalapala, MD, DNB², Anudeep KV, MD, DNB², Neeraj Singhla, MD, DM², Shruti Dharmadhikari, MSc³, Chintan Khandhedia, MD³, Neeraj Markandeywar, MD³, Amey Mane, MD³, Suyog Mehta, MD³, Sadhna Joglekar, MD¹. P1812 - Dual Release Gastro-Resistant Pantoprazole 80mg for Treatment of Partial or Non-Responders to Standard Dose of Proton Pump Inhibitor in Gastroesophageal Reflux Disease – A Prospective pH-Metry/Impedance-Controlled Study, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.