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

Abstract

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.

• Authors: M Xochilcal-Morales, E M Castro, J Guajardo-Rosas, T N Obregón, J C Acevedo, J M G Chucan, R Plancarte-Sanchez, G Davila, D Wajsbrot, M Guerrero, R Vinueza
• Journal: International journal of clinical practice (Int J Clin Pract) Vol. 64 Issue 9 Pg. 1301-9 (Aug 2010) ISSN: 1742-1241 [Electronic] India
• PMID: 20487048 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics
• Pregabalin
• gamma-Aminobutyric Acid

Topics

• Adult
• Aged
• Aged, 80 and over
• Analgesics (administration & dosage, adverse effects)
• Colombia
• Dose-Response Relationship, Drug
• Ecuador
• Female
• Humans
• Male
• Mexico
• Middle Aged
• Neuralgia (drug therapy)
• Pain Measurement
• Peru
• Pregabalin
• Prospective Studies
• Treatment Outcome
• Venezuela
• Young Adult
• gamma-Aminobutyric Acid (administration & dosage, adverse effects, analogs & derivatives)