In patients with sciatica pain, treatment with pregabalin did not significantly reduce pain intensity compared with placebo, according to results published in The New England Journal of Medicine.1
Pregabalin has been shown to be effective for the treatment of other types of neuropathic pain, including postherpetic neuralgia and diabetic neuropathy; however, previous trials in patients with sciatica pain have been plagued by limitations.2 In addition, questions have been raised regarding the risk-benefit of pregabalin in this population given its association with suicidality3,4 and potential for misuse.
In the current study, Stephanie Mathieson, MChiro, of the University of Sydney, Australia, and colleagues conducted a randomized double-blind placebo-controlled trial (Pregabalin in Addition to Usual Care for Sciatica [PRECISE]) to evaluate the efficacy, safety, and cost-effectiveness of pregabalin in patients with sciatica-related pain. The researchers recruited patients with moderate to severe sciatica who were experiencing a current episode. The starting dose was 150 mg/d (75 mg twice a day) of pregabalin or matched placebo. The maximum dose of pregabalin was 600 mg/d. The dose was increased over a 4-week period, followed by a 4-week maintenance phase. Pain intensity score (0-10) was assessed at 8 and 52 weeks.
The researchers enrolled a total of 207 patients, with 106 patients randomly assigned to receive pregabalin and 101 to receive placebo. Mean leg pain intensity score at baseline was 6.3±1/8 in the pregabalin group and 6.1±1.9 in the placebo group. In all, 94% of patients enrolled in the pregabalin group and 92% of patients enrolled in the placebo group completed the 8-week trial, and 86% of patients overall completed the 52-week follow-up.
At week 8, the mean difference in leg pain intensity score between the groups was not significant (unadjusted score, 3.7 in the pregabalin group and 3.1 in the placebo group; adjusted mean difference, 0.5; 95% CI, −0.2 to 1.2; P =.19); similar results were observed at week 52 (unadjusted score, 3.4 in the pregabalin group and 3.0 in the placebo group; adjusted mean difference, 0.3; 95% CI, −0.5 to 1.0; P =.46).
As for secondary outcomes, pregabalin appeared to have no positive effect on 8- or 52-week disability, back pain intensity, global perceived effect, quality of life physical component, or quality of life mental component. There was also no observed between-group difference for hours a patient was absent from work, patients who used additional medications, or patients who used other health services. Due to futility, no cost-effectiveness analysis was performed. Notably, the number of adverse events in the pregabalin group was significantly higher than that in the placebo group (124 events vs 43 events; P =.002).
Despite being adequately powered to detect between-group differences, pregabalin was found to have no significant effect on pain reduction and other variables compared with placebo, confirming the results of previous trials. The results suggest “differences in pathophysiological features between other types of neuropathic pain and sciatica and suggests that the recommendations from guidelines regarding neuropathic pain may not extend to sciatica,” the researchers concluded.
Disclosures: Dr Maher reports receiving lecture fees from Pfizer, Dr McLachlan reports receiving grant support from GlaxoSmithKline Australia, and Dr Day reports receiving consulting fees, paid to his institution, from GlaxoSmithKline Australia, and fees for meeting participation from Reckitt Benckiser.
- Mathieson S, Maher CG, McLachlan AJ, et al. Trial of pregabalin for acute and chronic sciatica. N Engl J Med. 2017;376:1111-20. doi:10.1056/NEJMoa1614292
- Baron R, Freynhagen R, Tölle TR, et al. The efficacy and safety of pregabalin in the treatment of neuropathic pain associated with chronic lumbosacral radiculopathy. Pain. 2010;150:420-427.
- Arana A, Wentworth CE, Ayuso-Mateos JL, Arellano FM. Suicide-related events in patients treated with antiepileptic drugs. N Engl J Med. 2010;363:542-551.
- US Food and Drug Administration. Statistical review and evaluation: antiepileptic drugs and suicidality. Rockville, MD: Department of Health and Human Services, 2008. Accessed March 27, 2017.