Pregabalin in neuropathic pain syndromes: A post-marketing surveillance study on efficacy,safety and tolerability

ABSTRACT

CONTEXT Pregabalin has shown efficacy in the treatment of multiple chronic pain syndromes. OBJECTIVES: The objective was to evaluate the overall safety and tolerability of pregabalin in the treatment of a several neuropathic pain syndromes in a naturalistic setting using a flexible dosage regimen.METHODS: Patients aged >- 18 years with neuropathic pain of various etiologies participated in an open-label, non-comparative study at 95 sites in the Philippines. Treatment included pregabalin for 4 weeks, with upward dosage titration to 600 mg/day at investigator discretion. Efficacy was rated with an 11-point pain visual analog scale (VAS). Physicians and patients rated pregabalin on treatment satisfaction, efficacy and safety using a Clinical Global Impression (CGI) rating scale. Descriptive statistics were used for quantitative variables and categorical frequency counts for qualitative variables. RESULTS: The efficacy analysis (intent-to-treat) included 1603 patients. Mean VAS pain score improved from baseline (7.2 +- 1.6) to 3.8 +- 1.8 at second visit and 2.3 +- 1.4 at last visit. Physicians' and patients' impression of pregabalin regarding treatment satisfaction, efficacy and safety using a CGI rating scale showed> 75% who gave a rating of excellent at second visit gave the same rating at final visit. Adverse events (AEs) were generally mild to moderate, with dizziness and somnolence most frequently reported. DISCUSSION: Improvement in mean VAS pain scores as well as physicians' and patients' overall satisfaction with tolerability and efficacy support the usefulness of pregabalin in the treatment of various neuropathic pain syndromes in Asian patients. WHAT'S KNOWN? Pregabalin is effective for the treatment of chronic pain syndromes, including painful diabetic peripheral neuropathy, postherpetic neuralgia, spinal cord injury and fibromyalgia. WHAT'S NEW? This open-label, non-comparative study demonstrates safety, tolerability and efficacy for neuropathic pain syndromes in Asian patients.