A Study to Evaluate the Symptomatic Efficacy and Safety of LafaxidTM (Lafutidine 10mg) in Patients with Acid Peptic Disorders in India

Abstract

Aims: To evaluate the symptomatic efficacy and safety of Lafaxid™ (lafutidine 10 mg) in Indian patients with Acid Peptic disorder (APD). Study Design: An observational, prospective, uncontrolled, open-label multi-centric study. Place and Duration of Study: Patients were recruited from 12 cities across India by 61 investigators, between October 2010 and December 2011. Methodology: We included 1500 patients (973 men, 527 women; age range 15-85 years) with Acid Peptic disorder. Lafutidine (10 mg tablets) was prescribed by the physicians as once daily dose (OD) for 28 days. The efficacy was analysed based on the change in the symptom baseline score on the 100 point Visual Analogue Scale (VAS) for individual symptoms, and the safety was determined based on adverse events reported during the study with the prescribed usage of lafutidine on day 14 and day 28 after start of the treatment. Results: Lafutidine monotherapy was given to 1378 patients. A very high reduction in the mean VAS score was observed from baseline for individual symptoms, viz. nausea, vomiting, belching, heart burn, epigastric pain, acid regurgitation, abdominal bloating & loss of appetite at the end of the study. The global mean VAS score (a sum of individual symptom VAS score) of these patients decreased from 120.34 ± 67.58 to 14.18 ± 26.97 at the end of the study (P < .001). There were 124 APD patients, previously treated but uncontrolled, with acid inhibitors like PPIs, H2RAs etc., also showed a significant reduction (157.42 ± 83.88 to 26.47 ± 46.34) in the VAS score on day 28 (P<.001). During the entire study, adverse events of mild and moderate nature were observed in 0.4% (6 patients) of the total patient population. Conclusion: The present study demonstrates that therapy with Lafaxid™ is symptomatically effective and well tolerated in patients with APDs.