A Retrospective, Observational, Case cohort, Multicenter Study to Assess the Safety, Effectiveness & Utilization Pattern of Pregabalin-Duloxetine FDC in Neuropathic pain (ROME Study)

Neuropathic pain (NeP) is a severe form of chronic pain resulting from lesions or diseases affecting the somatosensory nervous system. It affects 3-17% of the population and is characterized by both positive symptoms (e.g., pain, paresthesia, numbness) and negative symptoms (e.g., sensory, motor, and cognitive deficits). NeP can result from various causes, including endocrine dysfunctions, viral infections, trauma, and treatment-related effects. Despite pharmacological treatments, only 30-40% of patients experience adequate relief, and the effectiveness of these drugs may decrease over time. As a result, combination therapies, such as duloxetine and pregabalin, have been explored for better management. Studies, including large-scale trials, suggest that the combination of moderate doses of duloxetine and pregabalin may offer comparable efficacy to high-dose monotherapy. Both drugs are recommended by key medical organizations and have FDA approval for managing diabetic peripheral neuropathy (DPN). This study aims to assess the safety, effectiveness, and utilization patterns of a Pregabalin-Duloxetine fixed-dose combination (FDC) in Indian patients with neuropathic pain, collecting data from approximately 10,000 patients across the country.