A prospective, open-label, multicentre study of pregabalin in the treatment of neuropathic pain in Latin America

• Published in: International journal of clinical practice (Esher) Vol. 64; no. 9; pp. 1301 - 1309
• Main Authors: Xochilcal-Morales, M., Castro, E. M., Guajardo-Rosas, J., Obregón, T. N., Acevedo, J. C., Chucan, J. M. G., Plancarte-Sanchez, R., Davila, G., Wajsbrot, D., Guerrero, M., Vinueza, R.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.08.2010; Wiley-Blackwell; Hindawi Limited
• Subjects: Adult; Age; Aged; Aged, 80 and over; Analgesics - administration & dosage; Analgesics - adverse effects; Anticonvulsants. Antiepileptics. Antiparkinson agents; Anxiety; Biological and medical sciences; body weight; Clinical outcomes; Clinical trials; Colombia; Cranial nerves. Spinal roots. Peripheral nerves. Autonomic nervous system. Gustation. Olfaction; Diabetes mellitus; Dose-Response Relationship, Drug; Drug dosages; Drug therapy; Ecuador; Edema; Female; gamma-Aminobutyric Acid - administration & dosage; gamma-Aminobutyric Acid - adverse effects; gamma-Aminobutyric Acid - analogs & derivatives; General aspects; Humans; Immunodeficiency; Male; Medical sciences; Mexico; Middle Aged; Nervous system (semeiology, syndromes); Neuralgia; Neuralgia - drug therapy; Neurology; Neuropathy; Neuropharmacology; obesity; Pain; Pain management; Pain Measurement; Peripheral neuropathy; Peru; Pharmacology. Drug treatments; Pregabalin; Prospective Studies; Side effects; Sleep; Treatment Outcome; Venezuela; Young Adult; America; Latin America; Colombia; Ecuador; Venezuela; Mexico; Peru; Drug; Nervous system diseases; Multicenter study; Anticonvulsant; Pregabalin; Medicine; Prospective; Analgesic; Pain; Treatment; Clinical trial; Neuralgia; Neurological disorder
• ISSN: 1368-5031; 1742-1241
• DOI: 10.1111/j.1742-1241.2010.02389.x

Summary 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 ≥ 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 ≥ 40 mm on the visual analogue scale and a daily pain rating scale (DPRS) score of ≥ 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.