PMID- 20487048
OWN - NLM
STAT- MEDLINE
DCOM- 20110801
LR  - 20151119
IS  - 1742-1241 (Electronic)
IS  - 1368-5031 (Linking)
VI  - 64
IP  - 9
DP  - 2010 Aug
TI  - A prospective, open-label, multicentre study of pregabalin in the treatment of 
      neuropathic pain in Latin America.
PG  - 1301-9
LID - 10.1111/j.1742-1241.2010.02389.x [doi]
AB  - 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.
FAU - Xochilcal-Morales, M
AU  - Xochilcal-Morales M
AD  - Centro de Investigacion Clinica del Pacifico, Acapulco, Mexico.
FAU - Castro, E M
AU  - Castro EM
FAU - Guajardo-Rosas, J
AU  - Guajardo-Rosas J
FAU - Obregon, T N
AU  - Obregon TN
FAU - Acevedo, J C
AU  - Acevedo JC
FAU - Chucan, J M G
AU  - Chucan JM
FAU - Plancarte-Sanchez, R
AU  - Plancarte-Sanchez R
FAU - Davila, G
AU  - Davila G
FAU - Wajsbrot, D
AU  - Wajsbrot D
FAU - Guerrero, M
AU  - Guerrero M
FAU - Vinueza, R
AU  - Vinueza R
LA  - eng
SI  - ClinicalTrials.gov/NCT00407511
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20100510
PL  - India
TA  - Int J Clin Pract
JT  - International journal of clinical practice
JID - 9712381
RN  - 0 (Analgesics)
RN  - 55JG375S6M (Pregabalin)
RN  - 56-12-2 (gamma-Aminobutyric Acid)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Analgesics/*administration & dosage/adverse effects
MH  - Colombia
MH  - Dose-Response Relationship, Drug
MH  - Ecuador
MH  - Female
MH  - Humans
MH  - Male
MH  - Mexico
MH  - Middle Aged
MH  - Neuralgia/*drug therapy
MH  - Pain Measurement
MH  - Peru
MH  - Pregabalin
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - Venezuela
MH  - Young Adult
MH  - gamma-Aminobutyric Acid/administration & dosage/adverse effects/*analogs & 
      derivatives
EDAT- 2010/05/22 06:00
MHDA- 2011/08/02 06:00
CRDT- 2010/05/22 06:00
PHST- 2010/05/22 06:00 [entrez]
PHST- 2010/05/22 06:00 [pubmed]
PHST- 2011/08/02 06:00 [medline]
AID - IJCP2389 [pii]
AID - 10.1111/j.1742-1241.2010.02389.x [doi]
PST - ppublish
SO  - Int J Clin Pract. 2010 Aug;64(9):1301-9. doi: 10.1111/j.1742-1241.2010.02389.x. 
      Epub 2010 May 10.