Eficacia y tolerancia de la pregabalina en el tratamiento del dolor neuropático: Estudio multicéntrico

• Autores: V. De Sanctis Briggs, J. Guitart Vela, M. Vargas, F. Rodelas, J. Fuentes, M. D. Pérez, Jesús Cuenca Peña, M. Casals , A. Tomás, Víctor Mayoral Rojals
• Localización: Revista de la Sociedad Española del Dolor (SED), ISSN 1134-8046, Vol. 18, Nº. 5, 2011, págs. 267-275
• Idioma: español
• Títulos paralelos:
  • Efficacy and safety of pregabalin in neuropathic pain: Multicenter study
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• Resumen
  • español

    Introducción: Se pretendió evaluar la eficacia y tolerabilidad de la pregabalina, para el tratamiento del dolor neuropático en las Unidades de Dolor hospitalarias. Material y método: Estudio prospectivo, multicéntrico, abierto, que se llevó a cabo en 10 unidades del dolor de hospitales de Cataluña. Se prescribió pregabalina, a criterio del facultativo, de manera consecutiva. Criterios de inclusión: consentimiento, dolor neuropático, mayor de edad y paciente externo. Criterios de exclusión: alteraciones cognitivas, embarazo. Se estipularon 5 visitas: basal, 15 días, 1 mes, 2 y 3 meses de tratamiento. La titulación de las dosis de pregabalina estaba preespecificada. Se registró edad, sexo, tipo de dolor neuropático, EVA (basal, 15 días, 1 mes, 2 meses, 3 meses), escala MOS de sueño (basal y tercer mes), tratamiento farmacológico concomitante y episodios de efectos adversos. Se crearon 3 grupos de estudio: pregabalina + antiinflamatorios no esteroideos (AINE) + antidepresivos tricíclicos (AINE + ATC), pregabalina + AINE + ansiolíticos (AINE + ANS), pregabalina + AINE + opioides (AINE + OPI). Se efectuó prueba paramétrica t de Student y test no paramétrico de Wilcoxon para datos apareados de variables cuantitativas. Resultados: Se reclutaron 578 pacientes de los que 472 (81,66%) completaron el estudio. El 98,8% recibieron politerapia. El alivio del dolor registró una media de -3,6 (± 1,9) (p < 0,0001) puntos. Por tipo de dolor: mixto -3,7 (±1,7) (p < 0,0001); puro -3,4 (± 2,2) (p < 0,0001). Por medicación coadyuvante: grupo AINE + ATC -3,1 (± 1,9) (p = 0,0002); AINE + ANS -3,4 (± 2,0) (p < 0,0001); AINE + OPI -3,7 (± 1,9) (p < 0,0001). Mejora del sueño: media de -1,9 (± 6,4) (p < 0,0001) puntos. Por tipología: mixto -3,1 (± 7,0) (p < 0,0001); puro -1,1 (± 4,2) (p < 0,0001). Por medicación coadyuvante: grupo AINE + OPI -2,1 (± 6,0) (p < 0,0001); AINE + ATC y AINE + ANS ambos -1,0 no estadísticamente significativo, (p = 0,1250 y p = 0,4063 respectivamente). 90 pacientes (15,6%) discontinuaron el estudio debido a efectos adversos. Conclusiones: La pregabalina produjo una reducción rápida y significativa del dolor neuropático, una relevante mejoría del sueño, demostrando un perfil bajo de interacción y buena tolerancia.

  • English

    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.

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