Randomised 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. J Clin Oncol 2015. Published Online First.

In a multicenter, double-blind randomised 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 …