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J Clin Oncol. 2015 Dec 7. pii: JCO.2015.63.8221. [Epub ahead of print]

Randomized Double-Blind Trial of Pregabalin Versus Placebo in Conjunction With Palliative Radiotherapy for Cancer-Induced Bone Pain.

Fallon M, Hoskin PJ, Colvin LA, et al

In a multicenter, double-blind randomized trial in adults with moderate to severely painful radiologically-proven bone metastases, due to receive radiotherapy, pregabalin (titrated over 4 weeks) was compared to placebo. From nearly 2000 patients screened, 233 were randomly assigned (the target was 260): 117 to placebo and 116 to pregabalin; all were included in the analysis. Patients had a variety of cancers, with prostate, breast and lung being the most common. In the pregabalin arm, 45 patients (39%) had a reduction of ≥ 2 points in worst pain by week 4 (the primary end point), compared with 47 (40%) in the placebo arm. The secondary end points of average pain, pain interference, or quality of life were also the same between arms. There were significant improvements in mood and a decrease in breakthrough pain episodes with pregabalin. There were no differences in adverse events. This study does not support the routine use of pregabalin in patients with cancer-induced bone pain receiving radiotherapy however future research is needed to evaluate the effect of pregabalin in patients with a neuropathic component to their cancer-induced bone pain.

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