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Revista de la Sociedad Española del Dolor

versión impresa ISSN 1134-8046


SANCTIS-BRIGGS, V. De et al. Efficacy and safety of pregabalin in neuropathic pain: Multicenter study. Rev. Soc. Esp. Dolor [online]. 2011, vol.18, n.5, pp.267-275. ISSN 1134-8046.

Aim and objective: This study was intended to avaluate the efficacy and tolerability of pregabalin in patients with neuropathic pain and concomitant medication. Material and methods: Investigator-initiated, prospective multicenter study, open-label, uncontrolled conducted in 10 pain units from Catalonia hospitals. Pregabalin was consecutively prescribed at the physicians' discretion to avoid selective bias. Inclusion criteria were: outpatient, age >18 years, admission diagnosis as "neuropathic pain" and informed consent. Exclusion criteria were pregnancy or cognitive disorders. Protocol scheduled five study visits: at baseline, 15 days, 1 month, 2 months, and 3 months of treatment. Titration of pregabalin doses was pre-specified. We recorded: age, sex, type of neuropathic pain (pure or mixed), VAS (baseline, 15 days, 1 month, 2 and 3 months), MOS sleep scale (baseline and third month), concomitant drug treatment and adverse effects episodes. Patients were divided into three groups: pregabalin + NSAID + tricyclic antidepressants (NSAID+TCA), pregabalin + NSAID + anxiolytics (NSAID+ANX), pregabalin + NSAID + opioids (NSAID+OPI). A parametric Student's t test and non-parametric Wilcoxon test for paired data of quantitative variables were performed. Results: 578 patients were recruited and 472 (81.66%) completed the study. 98.8% of patients were treated with politherapy. Pain relief: mean reduction by -3.6 (± 1.9) (p < 0.0001) points. By type of pain: mixed pain -3.7 (± 1.7) (p < 0.0001); pure neuropathic pain -3.4 (± 2.2) (p < 0.0001). By adjuvant medication, the NSAID + TCA group -3.1 (± 1.9) (p = 0.0002); NSAID + ANX -3.4 (± 2.0) (p < 0.0001); NSAID + OPI -3.7 (± 1.9) (p < 0.0001). Sleep improvement: mean reduction by -1.9 (± 6.4) (p < 0.0001) points. By type of pain: mixed pain -3.1 (± 7.0) (p < 0.0001); pure neuropathic pain -1.1 (± 4.2) (p < 0.0001). By adjuvant medication, NSAID+OPI -2.1 (± 6.0) (p < 0.0001); NSAID + TCA and NSAID + ANX groups both -1.0 not statistically significant (p = 0.1250 and p = 0.4063 respectively). 90 patients (15.6%) discontinued the study due to adverse effects. Conclusions: Treatment with pregabalin induces a fast and significant relief of neuropathic pain, improves sleep and shows a low drug interaction profile.

Palabras clave : Neuropathic pain; Pregabalin; Analgesics; Drug therapy.

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