Pregabalin is a commonly used
therapy currently recommended as first-line treatment for a number of
neuropathic pain (NeP) conditions. Since licensure, a number of clinical trials of
pregabalin in different NeP conditions have been completed from which additional data on safety and tolerability can be drawn. In this analysis, patient-level data from 31 randomized clinical trials of
pregabalin in peripheral NeP sponsored by Pfizer were pooled and assessed for incidence of adverse events (AEs). Incidence by age, disease condition, and race, together with risk differences and time to onset and resolution of AEs, was assessed. In total, 7,510 patients were included: 4,884 on
pregabalin (representing 805 patient-years treatment) and 2,626 on placebo.
Pregabalin vs. placebo risk analysis identified 9 AEs with a risk difference, for which the lower limit of the 95% confidence interval (CI) was > 1%:
dizziness (risk difference [95% CI]: (17.0 [15.4 to 18.6]),
somnolence (10.8 [9.5 to 12.1]), peripheral
edema (5.4 [4.3 to 6.4]), weight increase (4.7 [3.9 to 5.5]), dry mouth (2.9 [2.1 to 3.8]),
constipation (2.3 [1.5 to 3.2]), blurred vision (2.2 [1.6 to 2.9]), balance disorder (2.0 [1.5 to 2.5]), and euphoric mood (1.6 [1.2 to 2.0]). The most common AEs,
dizziness and
somnolence, typically emerged within the first 1 to 2 weeks of treatment and resolved 1 to 2 weeks later, without resulting in
cessation of treatment. The data from this review provide information, indicating which AEs may be expected in patients treated with
pregabalin, and suggest that careful dose titration to the highest tolerable dose is the most appropriate approach in clinical practice.