Effectiveness and safety of levosulpiride in the treatment of dysmotility-like functional dyspepsia.

The objective of this study was to assess the effectiveness and safety of levosulpiride in patients with dysmotility-like functional dyspepsia including nonerosive reflux esophagitis in conditions of daily practice. The study was conducted as a prospective, open-label, multicenter design in 342 patients with dysmotility-like functional dyspepsia (n=279) and nonerosive reflux disease (n=63), who received levosulpiride 25 mg 3 times daily orally for 4 weeks. Individual symptoms (pain/discomfort, fullness, bloating, early satiety, pyrosis, regurgitation, and nausea/vomiting) and a global symptom score were assessed at 15, 30, and 60 days after starting treatment. Adverse events also were recorded. There were 151 men and 191 women (mean age 38.8 years) who referred dyspeptic symptoms for a mean of 10.2 (10.7) months. A total of 66.4% patients were treated with 75 mg/day levosulpiride and 33.6% with 50 mg/day. At the 15-day visit, a decrease greater than 50% in the global symptom score was observed. The frequency and intensity of individual symptoms showed a statistically significant decrease (p<0.001) at all visits compared with baseline. At the 30-day visit, all symptoms had almost disappeared, a trend that was maintained until the last visit. Treatment with levosulpiride was well tolerated and only 40 adverse events were recorded (galactorrhea 26.7%, somnolence 17.8%, fatigue 11.1%, headache 11.5%) and no patient had to abandon the study due to side effects. In conclusion, levosulpiride is an effective and safe drug in the treatment of dysmotility-like functional dyspepsia and non-erosive reflux disease.