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Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomised, placebo-controlled clinical trial.
Pain. 2004 May; 109(1-2):26-35.PAIN

Abstract

This study was designed to assess the efficacy and safety of pregabalin-a novel alpha(2)-delta ligand with analgesic, anxiolytic, and anticonvulsant activity-for treating neuropathic pain in patients with post-herpetic neuralgia (PHN). Two hundred and thirty-eight patients were randomised into this multicentre, doubleblind, placebo-controlled trial to receive 150 (n=81), 300 mg/day (n=76) pregabalin, or placebo (n=81) for 8 weeks. Among the exclusion criteria was failure to respond to previous treatment for PHN with gabapentin at doses > or =1200 mg/day. Endpoint mean pain scores were significantly reduced in patients receiving 150 or 300 mg/day pregabalin compared with placebo. Efficacy was observed as early as week 1 and was maintained throughout the study. Significantly more patients in both pregabalin groups (150 mg, 26%; 300 mg, 28%) were responders (> or =50% decrease in mean pain score from baseline to endpoint) than in the placebo group (10%). Additionally, by week 1 and for the study's duration, 150 and 300 mg/day pregabalin significantly reduced weekly mean sleep interference scores. More pregabalin-treated patients than placebo-treated patients reported that they were 'much improved' or 'very much improved'. Health-related quality-of-life (HRQoL) measurements using the SF-36 Health Survey demonstrated improvement in the mental health domain for both pregabalin dosages, and bodily pain and vitality domains were improved in the 300 mg/day group. The most frequent adverse events were dizziness, somnolence, peripheral oedema, headache, and dry mouth. Pregabalin efficaciously treated the neuropathic pain of PHN. Additionally, pregabalin was associated with decreased sleep interference and significant improvements in HRQoL measures.

Authors+Show Affiliations

Department of Anaesthesiology, University of Cologne, Cologne, Germany. rainer.sabatowski@uni-koeln.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15082123

Citation

Sabatowski, Rainer, et al. "Pregabalin Reduces Pain and Improves Sleep and Mood Disturbances in Patients With Post-herpetic Neuralgia: Results of a Randomised, Placebo-controlled Clinical Trial." Pain, vol. 109, no. 1-2, 2004, pp. 26-35.
Sabatowski R, Gálvez R, Cherry DA, et al. Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomised, placebo-controlled clinical trial. Pain. 2004;109(1-2):26-35.
Sabatowski, R., Gálvez, R., Cherry, D. A., Jacquot, F., Vincent, E., Maisonobe, P., & Versavel, M. (2004). Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomised, placebo-controlled clinical trial. Pain, 109(1-2), 26-35.
Sabatowski R, et al. Pregabalin Reduces Pain and Improves Sleep and Mood Disturbances in Patients With Post-herpetic Neuralgia: Results of a Randomised, Placebo-controlled Clinical Trial. Pain. 2004;109(1-2):26-35. PubMed PMID: 15082123.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomised, placebo-controlled clinical trial. AU - Sabatowski,Rainer, AU - Gálvez,Rafael, AU - Cherry,David A, AU - Jacquot,Florence, AU - Vincent,Emmanuelle, AU - Maisonobe,Pascal, AU - Versavel,Mark, AU - ,, PY - 2003/07/10/received PY - 2003/12/18/revised PY - 2004/01/05/accepted PY - 2004/4/15/pubmed PY - 2004/7/13/medline PY - 2004/4/15/entrez SP - 26 EP - 35 JF - Pain JO - Pain VL - 109 IS - 1-2 N2 - This study was designed to assess the efficacy and safety of pregabalin-a novel alpha(2)-delta ligand with analgesic, anxiolytic, and anticonvulsant activity-for treating neuropathic pain in patients with post-herpetic neuralgia (PHN). Two hundred and thirty-eight patients were randomised into this multicentre, doubleblind, placebo-controlled trial to receive 150 (n=81), 300 mg/day (n=76) pregabalin, or placebo (n=81) for 8 weeks. Among the exclusion criteria was failure to respond to previous treatment for PHN with gabapentin at doses > or =1200 mg/day. Endpoint mean pain scores were significantly reduced in patients receiving 150 or 300 mg/day pregabalin compared with placebo. Efficacy was observed as early as week 1 and was maintained throughout the study. Significantly more patients in both pregabalin groups (150 mg, 26%; 300 mg, 28%) were responders (> or =50% decrease in mean pain score from baseline to endpoint) than in the placebo group (10%). Additionally, by week 1 and for the study's duration, 150 and 300 mg/day pregabalin significantly reduced weekly mean sleep interference scores. More pregabalin-treated patients than placebo-treated patients reported that they were 'much improved' or 'very much improved'. Health-related quality-of-life (HRQoL) measurements using the SF-36 Health Survey demonstrated improvement in the mental health domain for both pregabalin dosages, and bodily pain and vitality domains were improved in the 300 mg/day group. The most frequent adverse events were dizziness, somnolence, peripheral oedema, headache, and dry mouth. Pregabalin efficaciously treated the neuropathic pain of PHN. Additionally, pregabalin was associated with decreased sleep interference and significant improvements in HRQoL measures. SN - 0304-3959 UR - https://www.unboundmedicine.com/medline/citation/15082123/Pregabalin_reduces_pain_and_improves_sleep_and_mood_disturbances_in_patients_with_post_herpetic_neuralgia:_results_of_a_randomised_placebo_controlled_clinical_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0304395904000156 DB - PRIME DP - Unbound Medicine ER -