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Efficacy and safety of pregabalin in patients with spinal cord injury: a pooled analysis.
Curr Med Res Opin. 2013 Dec; 29(12):1675-83.CM

Abstract

OBJECTIVE

To summarize the efficacy and examine the safety and tolerability of pregabalin in patients with central neuropathic pain due to spinal cord injury (SCI).

RESEARCH DESIGN AND METHODS

Data were pooled from two 12 to 16 week, placebo-controlled trials of pregabalin in patients with neuropathic pain due to SCI. Pain diaries were used to rate pain from 0 = no pain to 10 = worst possible pain. Efficacy measures included: mean change in pain from baseline to endpoint; duration adjusted average change (DAAC) in pain; the percentage of patients with ≥30% or ≥50% reductions in pain score from baseline to endpoint; and Patient Global Impression of Change (PGIC) score at endpoint. Adverse events (AEs) were also compared between treatment groups.

RESULTS

In total 174 patients received placebo and 182 received pregabalin. Mean change in pain from baseline to endpoint was improved in the pregabalin group compared with placebo (placebo-adjusted difference = -0.79; 95% CI = -1.15, -0.43; p < 0.001; baseline-observation-carried-forward). DAAC in pain was improved in patients receiving pregabalin compared with placebo (p < 0.001). The percentage of patients achieving ≥30% and ≥50% reductions in pain from baseline to endpoint was greater in the pregabalin arm compared with placebo (placebo: 30% = 22.5%, 50% = 11.6: pregabalin 30% = 35.6%, 50% = 22.4%) (all p < 0.01). PGIC scores at endpoint were significantly better in the pregabalin arm compared with placebo (p < 0.05). Treatment-related AEs, most commonly somnolence, dizziness, dry mouth, fatigue, edema, blurred vision, and constipation occurred more frequently in patients treated with pregabalin than placebo. The majority of AEs were mild to moderate in severity.

CONCLUSIONS

Pregabalin reduced neuropathic pain due to SCI over a 12 to 16 week treatment period. Treatment-related AEs were mostly mild to moderate in severity and are consistent with the known safety profile of pregabalin. These findings should not be extrapolated to longer durations of treatment or other patient populations.

Authors+Show Affiliations

Pfizer Inc. , New York, NY , USA.No affiliation info availableNo 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

23998397

Citation

Parsons, Bruce, et al. "Efficacy and Safety of Pregabalin in Patients With Spinal Cord Injury: a Pooled Analysis." Current Medical Research and Opinion, vol. 29, no. 12, 2013, pp. 1675-83.
Parsons B, Sanin L, Yang R, et al. Efficacy and safety of pregabalin in patients with spinal cord injury: a pooled analysis. Curr Med Res Opin. 2013;29(12):1675-83.
Parsons, B., Sanin, L., Yang, R., Emir, B., & Juhn, M. (2013). Efficacy and safety of pregabalin in patients with spinal cord injury: a pooled analysis. Current Medical Research and Opinion, 29(12), 1675-83. https://doi.org/10.1185/03007995.2013.834815
Parsons B, et al. Efficacy and Safety of Pregabalin in Patients With Spinal Cord Injury: a Pooled Analysis. Curr Med Res Opin. 2013;29(12):1675-83. PubMed PMID: 23998397.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of pregabalin in patients with spinal cord injury: a pooled analysis. AU - Parsons,Bruce, AU - Sanin,Luis, AU - Yang,Ruoyong, AU - Emir,Birol, AU - Juhn,Mark, Y1 - 2013/09/23/ PY - 2013/9/4/entrez PY - 2013/9/4/pubmed PY - 2014/6/24/medline SP - 1675 EP - 83 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 29 IS - 12 N2 - OBJECTIVE: To summarize the efficacy and examine the safety and tolerability of pregabalin in patients with central neuropathic pain due to spinal cord injury (SCI). RESEARCH DESIGN AND METHODS: Data were pooled from two 12 to 16 week, placebo-controlled trials of pregabalin in patients with neuropathic pain due to SCI. Pain diaries were used to rate pain from 0 = no pain to 10 = worst possible pain. Efficacy measures included: mean change in pain from baseline to endpoint; duration adjusted average change (DAAC) in pain; the percentage of patients with ≥30% or ≥50% reductions in pain score from baseline to endpoint; and Patient Global Impression of Change (PGIC) score at endpoint. Adverse events (AEs) were also compared between treatment groups. RESULTS: In total 174 patients received placebo and 182 received pregabalin. Mean change in pain from baseline to endpoint was improved in the pregabalin group compared with placebo (placebo-adjusted difference = -0.79; 95% CI = -1.15, -0.43; p < 0.001; baseline-observation-carried-forward). DAAC in pain was improved in patients receiving pregabalin compared with placebo (p < 0.001). The percentage of patients achieving ≥30% and ≥50% reductions in pain from baseline to endpoint was greater in the pregabalin arm compared with placebo (placebo: 30% = 22.5%, 50% = 11.6: pregabalin 30% = 35.6%, 50% = 22.4%) (all p < 0.01). PGIC scores at endpoint were significantly better in the pregabalin arm compared with placebo (p < 0.05). Treatment-related AEs, most commonly somnolence, dizziness, dry mouth, fatigue, edema, blurred vision, and constipation occurred more frequently in patients treated with pregabalin than placebo. The majority of AEs were mild to moderate in severity. CONCLUSIONS: Pregabalin reduced neuropathic pain due to SCI over a 12 to 16 week treatment period. Treatment-related AEs were mostly mild to moderate in severity and are consistent with the known safety profile of pregabalin. These findings should not be extrapolated to longer durations of treatment or other patient populations. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/23998397/Efficacy_and_safety_of_pregabalin_in_patients_with_spinal_cord_injury:_a_pooled_analysis_ L2 - https://www.tandfonline.com/doi/full/10.1185/03007995.2013.834815 DB - PRIME DP - Unbound Medicine ER -