AIMS: The objective of this study was to evaluate the safety and efficacy of pregabalin at flexible doses of 150-600 mg/day in Latin American patients with neuropathic pain. METHODS: A prospective, multicentre, open-label, non-comparative study included patients age >or= 18 years diagnosed with neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, chemotherapy-induced peripheral neuropathic pain (PNP), or human immunodeficiency virus-related PNP. Eligible patients (N = 121) had a score of >or= 40 mm on the visual analogue scale and a daily pain rating scale (DPRS) score of >or= 4 throughout screening. Patients received flexible-dose pregabalin (150-600 mg/day) for 12 weeks, which included a 4-week dose-adjustment phase. The primary efficacy measure was change from baseline to end of treatment/last observation carried forward (EOT/LOCF) in weekly mean pain score on the DPRS. Secondary efficacy measures included pain, anxiety, sleep interference, treatment satisfaction and Patient and Clinician Global Impression of Change. RESULTS: Pregabalin significantly reduced the weekly mean pain score on DPRS from baseline to EOT/LOCF [-3.8 (95% CI: -4.2 to -3.3); p < 0.0001]. Reductions from baseline to EOT/LOCF were observed for all secondary efficacy outcomes (p < 0.0001). Pain and sleep interference were significantly improved compared with baseline across all weeks of the study, as early as 1 week after initiation of pregabalin (p < 0.0001). The most common adverse events (AEs) were somnolence, dizziness, weight gain and peripheral oedema. Nine (7.4%) patients discontinued the study because of AEs and 25 (20.7%) temporarily stopped or reduced their pregabalin dose because of AEs. CONCLUSIONS: Flexible-dose pregabalin (150-600 mg/day) significantly reduced pain and anxiety and improved sleep and was generally well tolerated in Latin American patients with neuropathic pain.