Abstract | BACKGROUND: METHODS: Patients with a pain score >or=4 (0-10 scale) were randomized and treated with either flexible-dose pregabalin 150-600 mg/day (n = 127) or placebo (n = 127) in an 8-week double-blind treatment period preceded by a 2-week placebo run-in. RESULTS:
Pregabalin was associated with a significantly greater improvement in the mean end-point pain score vs. placebo; mean treatment difference was -0.62 (95% CI -1.09 to -0.15) (P = 0.01). The average pregabalin dose at end-point was approximately 326 mg/day. Pregabalin was also associated with significant improvements from baseline in pain-related sleep interference, and the Medical Outcomes Study sleep scale sleep problems index and sleep disturbance subscale (all P < 0.001). In the all-patient group (ITT), pregabalin was associated with a statistically significant improvement in the Hospital Anxiety and Depression Scale anxiety subscale (P < 0.05). In total, 29% of patients had moderate/severe baseline anxiety; treatment with pregabalin in this subset did not significantly improve anxiety. More patients reported global improvement at end-point with pregabalin than with placebo (68% vs. 43%; overall P < 0.01). Adverse events led to discontinuation of 20% of patients from pregabalin and 7% from placebo. Mild or moderate dizziness and somnolence were the most common adverse events in the pregabalin group. CONCLUSION: Flexible-dose pregabalin 150-600 mg/day was effective in relieving neuropathic pain, improving disturbed sleep, improving overall patient status, and was generally well tolerated in patients with post-traumatic peripheral neuropathic pain.
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Authors | R van Seventer, F W Bach, C C Toth, M Serpell, J Temple, T K Murphy, M Nimour |
Journal | European journal of neurology
(Eur J Neurol)
Vol. 17
Issue 8
Pg. 1082-9
(Aug 2010)
ISSN: 1468-1331 [Electronic] England |
PMID | 20236172
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Analgesics
- Pregabalin
- gamma-Aminobutyric Acid
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Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Analgesics
(therapeutic use)
- Double-Blind Method
- Female
- Humans
- Intention to Treat Analysis
- Male
- Middle Aged
- Neuralgia
(drug therapy, etiology)
- Pain Measurement
(drug effects)
- Pain Threshold
(drug effects)
- Pregabalin
- Treatment Outcome
- gamma-Aminobutyric Acid
(analogs & derivatives, therapeutic use)
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