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Pregabalin Beneficial Effects on Sleep Quality or Health-Related Quality of Life Are Poorly Correlated With Reduction on Pain Intensity After an 8-Week Treatment Course

Perez-Lloret, Santiago MD, PhD*; Rojas, Gloria Meza MD; Menoni, Maria Celia MD; Ruiz, Gabriela MD§; Velásquez, Carolina MD; Rodriguez, Hernán MD§; Rey, María Verónica PharmD*; Cardinali, Daniel P. MD, PhDfor the PGB Study Team

doi: 10.1097/WNF.0b013e31823df2dc
Original Articles

Background Pregabalin (PGB) has been shown to improve sleep quality and health-related quality of life (HRQoL) as well as pain intensity in patients with neuropathic pain.

Objective The objective of the study was to explore the magnitude of the correlations between changes in pain intensity, sleep quality, and HRQoL after PGB treatment.

Methods One hundred thirty-eight patients with neuropathic pain of any origin and without an adequate response to analgesics received an 8-week treatment course of PGB in an open-label fashion. Pain intensity, sleep quality, and HRQoL outcomes were evaluated at baseline and at week 8 by means of an 11-point (0-10) numerical rating scale (NRS), the Pittsburgh Sleep Quality Index (PSQI), and the EuroQol health-state visuoanalogic scale (EQ-5D VAS) score, respectively.

Results At week 8, mean PGB dose was 166.7 ± 7.8 mg/d. Pain intensity NRS score, PSQI total score, and EQ-5D VAS score were improved by 66.5% ± 1.9%, 40.0% ± 3.6%, and 26.4% ± 4.7% (all P < 0.01), respectively. Correlations between percent change from baseline in pain NRS score and PSQI total score or EQ-5D VAS scores were r = 0.36 (P < 0.01, R2 = 0.11) and r = −0.20 (P < 0.02, R2 = 0.05), respectively. A multivariate logistic regression analysis disclosed that PSQI score change below the median (ie, a better outcome) was related to higher EQ-5D VAS score change (odds ratio, 2.15; 95% confidence interval, 1.09–4.25), whereas pain intensity NRS score change below the median was not (odds ratio, 1.58; 95% confidence interval,0.78–3.23).

Conclusions In our study, PGB-related improvements in sleep quality and HRQoL were marginally related to reductions in pain intensity in patients with neuropathic pain. Improvement in sleep quality was a significant predictor of better HRQoL, whereas pain intensity reduction was not.

*Pharmacology Department, Paul Sabatier University, Toulouse, France; †Instituto Mutual de la Salud, ‡Servicio de Endocrinología y Metabolismo del Hospital Central, and §Centro Médico Santa Clara, Asunción, Paraguay; and ∥Departamento de Docencia e Investigación, Facultad de Ciencias Médicas, Pontificia Universidad Católica Argentina, Buenos Aires, Argentina.

Conflicts of Interest and Source of Funding: This study was funded with an educational grant by Recalcine Laboratories. Recalcine was not involved in the design, conduction, or analysis of the study. The authors have no conflicts of interest to declare.

The study team was composed of Dr Daisy Arguello, Dr Aida Caballero Cantero, Dr Graciela Elizeche, Dr Edith Falcon de Legal, Dr Celia Menoni, Dr Gloria Meza Rojas, Dr Aurora Olmedo Bareiro, Dr Tanya Paiva Rochol, Dr Santiago Perez Lloret, Dr Jose Luis Ippolito, Dr Gabriela Ruiz, Dr Hernán Rodríguez, Dr José Sánchez Talavera, Dr Carolina Velázquez, and Dr Elizabeth Valinotti.

Address correspondence and reprint requests to Santiago Perez Lloret, MD, PhD, Department of Clinical Pharmacology, Faculty of Medicine, 37 Allées Jules Guesde, 31000, Toulouse, France; E-mail:

© 2012 Lippincott Williams & Wilkins, Inc.