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Pregabalin for peripheral neuropathic pain: a multicenter, enriched enrollment randomized withdrawal placebo-controlled trial.
Clin J Pain 2011 Mar-Apr; 27(3):185-93CJ

Abstract

OBJECTIVES

To date, published neuropathic pain randomized controlled trials of pregabalin have involved primarily diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN). This multicenter trial evaluated pregabalin in a broader range of neuropathic pain etiologies.

METHODS

In this enriched enrollment randomized withdrawal trial, 256 patients received single blind, flexible dose pregabalin for 4 weeks; stable concomitant analgesics were allowed. One hundred sixty-five (65%) had a ≥30% pain improvement and 157 were randomized and treated, double blind, to either continue pregabalin (n=80) or to receive placebo (n=77) for 5 weeks.

RESULTS

Of the single blind responders randomized, 81% on placebo and 86% on pregabalin completed the double-blind phase. At the double-blind endpoint, mean (SD) pain scores were 2.9 (1.9) in the pregabalin group and 3.5 (1.7) in the placebo group (P=0.002). These modest yet significant pregabalin-placebo differences were observed within each of the subgroups of patients with a diagnosis of either DPN or PHN (P=0.03), and with other diagnoses (P=0.02). Significant differences were also observed in sleep interference, Hospital Anxiety and Depression Scale Anxiety and Depression subscales, and other secondary measures. In total, 28 out of 80 (35.0%) in the pregabalin group and 28 out of 77 (36.4%) in the placebo group had either a meaningful increase in pain or discontinued the double-blind phase. Adverse events were consistent with the known tolerability profile of pregabalin and led to discontinuation of 9 during the single-blind phase, and 5 and 2 patients from the placebo and pregabalin groups, respectively.

DISCUSSION

These results support previous evidence of pregabalin efficacy but further demonstrate efficacy and tolerability in a broader range of peripheral neuropathic pain conditions beyond just DPN and PHN.

Authors+Show Affiliations

Department of Anesthesiology, Queen's University, Kingston, Ontario, Canada. gilroni@post.queensu.caNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

21178603

Citation

Gilron, Ian, et al. "Pregabalin for Peripheral Neuropathic Pain: a Multicenter, Enriched Enrollment Randomized Withdrawal Placebo-controlled Trial." The Clinical Journal of Pain, vol. 27, no. 3, 2011, pp. 185-93.
Gilron I, Wajsbrot D, Therrien F, et al. Pregabalin for peripheral neuropathic pain: a multicenter, enriched enrollment randomized withdrawal placebo-controlled trial. Clin J Pain. 2011;27(3):185-93.
Gilron, I., Wajsbrot, D., Therrien, F., & Lemay, J. (2011). Pregabalin for peripheral neuropathic pain: a multicenter, enriched enrollment randomized withdrawal placebo-controlled trial. The Clinical Journal of Pain, 27(3), pp. 185-93. doi:10.1097/AJP.0b013e3181fe13f6.
Gilron I, et al. Pregabalin for Peripheral Neuropathic Pain: a Multicenter, Enriched Enrollment Randomized Withdrawal Placebo-controlled Trial. Clin J Pain. 2011;27(3):185-93. PubMed PMID: 21178603.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pregabalin for peripheral neuropathic pain: a multicenter, enriched enrollment randomized withdrawal placebo-controlled trial. AU - Gilron,Ian, AU - Wajsbrot,Dalia, AU - Therrien,François, AU - Lemay,Jacinthe, PY - 2010/12/24/entrez PY - 2010/12/24/pubmed PY - 2011/6/3/medline SP - 185 EP - 93 JF - The Clinical journal of pain JO - Clin J Pain VL - 27 IS - 3 N2 - OBJECTIVES: To date, published neuropathic pain randomized controlled trials of pregabalin have involved primarily diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN). This multicenter trial evaluated pregabalin in a broader range of neuropathic pain etiologies. METHODS: In this enriched enrollment randomized withdrawal trial, 256 patients received single blind, flexible dose pregabalin for 4 weeks; stable concomitant analgesics were allowed. One hundred sixty-five (65%) had a ≥30% pain improvement and 157 were randomized and treated, double blind, to either continue pregabalin (n=80) or to receive placebo (n=77) for 5 weeks. RESULTS: Of the single blind responders randomized, 81% on placebo and 86% on pregabalin completed the double-blind phase. At the double-blind endpoint, mean (SD) pain scores were 2.9 (1.9) in the pregabalin group and 3.5 (1.7) in the placebo group (P=0.002). These modest yet significant pregabalin-placebo differences were observed within each of the subgroups of patients with a diagnosis of either DPN or PHN (P=0.03), and with other diagnoses (P=0.02). Significant differences were also observed in sleep interference, Hospital Anxiety and Depression Scale Anxiety and Depression subscales, and other secondary measures. In total, 28 out of 80 (35.0%) in the pregabalin group and 28 out of 77 (36.4%) in the placebo group had either a meaningful increase in pain or discontinued the double-blind phase. Adverse events were consistent with the known tolerability profile of pregabalin and led to discontinuation of 9 during the single-blind phase, and 5 and 2 patients from the placebo and pregabalin groups, respectively. DISCUSSION: These results support previous evidence of pregabalin efficacy but further demonstrate efficacy and tolerability in a broader range of peripheral neuropathic pain conditions beyond just DPN and PHN. SN - 1536-5409 UR - https://www.unboundmedicine.com/medline/citation/21178603/Pregabalin_for_peripheral_neuropathic_pain:_a_multicenter_enriched_enrollment_randomized_withdrawal_placebo_controlled_trial_ L2 - http://Insights.ovid.com/pubmed?pmid=21178603 DB - PRIME DP - Unbound Medicine ER -