Publication:

Real-world evidence study evaluating the effectiveness, tolerability and utilization patterns of Vonoprazan in routine clinical practice across out-patient clinical setting in India

Background Gastroesophageal reflux disease (GERD) and peptic ulcer disease (PUD) are two of the most common acid-related gastrointestinal conditions in India. They are associated with significant morbidity and impaired quality of life. Vonoprazan has demonstrated clinical efficacy in clinical trials and offers rapid and sustained acid suppression. However, there is still a dearth of empirical data on its therapeutic application and efficacy in Indian patients.

Methods This multicentre, retrospective, observational real-world evidence study examined medical records from 8,325 patients prescribed Vonoprazan in outpatient settings across India during a 6-month period. Demographic details, indications, dose patterns, symptom improvement, treatment satisfaction, and safety outcomes were assessed using descriptive and comparative statistical methods.

Results GERD (55.98%) and acid peptic disorders (APD; 33.07%) as diagnosed by the treating physicians were the most common indicators for Vonoprazan treatment. The majority of patients (93.14%) received 20 mg of Vonoprazan once daily. Symptoms improved significantly, with heartburn relief reported in 97.53% of patients and acid regurgitation improvement in 91.80%. Severe heartburn dropped from 44.06% at baseline to 1.93% after treatment (p<0.05), while acid regurgitation decreased from 31.95% to 6.56% (p<0.05). Overall treatment satisfaction was high, with 73.44% of patients reporting being extremely satisfied.

Conclusions Vonoprazan demonstrated clinically meaningful real-world effectiveness, improvement in symptom control, favourable tolerability, and high patient satisfaction in Indian patients with GERD and other acid-related disorders, supporting its role as an effective therapeutic option in routine clinical practice.