Patient-Reported Outcomes in Subjects with Painful Trigeminal Neuralgia Receiving Pregabalin: Evidence from Medical Practice in Primary Care Settings

Abstract

Effects of pregabalin (PGB) on patient-reported health outcomes were assessed in 65 PGB-naive subjects with trigeminal neuralgia refractory to previous analgesic therapy in a prospective, multicentre observational study carried out in primary care. Twelve weeks' monotherapy with PGB ( n = 36) or add-on ( n = 29), reduced baseline intensity of pain by a mean ± S.D. of −40.0 ± 22.1 mm [−55.4%, effect size (ES) 2.32; P < 0.0001] with 59.4% of responders (pain reduction ≥ 50%), and produced 34.6 ± 29.3 additional days with no/mild pain. Anxiety/depression symptoms decreased by −3.8 ± 3.5 and −4.5 ± 4.2 points (ES 0.95 and 1.02; P < 0.0001), respectively. PGB improved sleep by −17.9 ± 19.6 points (ES 1.18; P < 0.0001) and improved patient functioning (Sheehan Disability Index) by decreasing overall scoring by −8.6 ± 5.9 points (ES 1.59; P < 0.0001). Health state (EQ-5D) increased by 31.6 ± 22.2 mm (ES 1.67; P < 0.0001), with 0.0388 ± 0.0374 gained quality-adjusted life-years. In spite of the small sample size, results support the effectiveness of PGB for the improvement in pain and related health symptoms.