Pregabalin is currently recommended as a first-line treatment for many neuropathic pain (NeP) conditions and is indicated for the management of NeP associated with diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), and spinal cord injury, for the treatment of fibromyalgia, and for adjunctive therapy for partial seizures. Studies on adverse events (AEs) associated with pregabalin have been primarily limited to population-level data, but a new analysis pooled patient-level data from 31 randomized, placebo-controlled studies of pregabalin in peripheral NeP.

The studies ranged from two to 18 weeks and dosing included fixed doses of 75, 150, 300, 450, and 600mg/day and flexible dose of either 100–600mg/day or 150– 600mg/day; safety data was available on 7,509 patients. AEs occurred in >2% of patients treated with pregabalin (all doses combined), with incidence of AEs increasing with higher fixed doses and lowest in the ≤150mg/day group and the flexible-dosing group.

Most AEs were more common with increased age except weight increase and euphoric mood (which were more common in younger patients). Reports of constipation with pregabalin was higher in older patients but there was also a higher incidence with placebo, resulting in a lower risk difference than in younger patients. In the studies, 4% of patients withdrew from their trial due to dizziness and 1.9% due to somnolence; each typically emerged within the first one to two weeks of treatment, with a median time to onset of nine and 10 days, respectively.

The incidences of most common AEs in the pooled data was lower than those reported in the current prescribing/product information for pregabalin, which may be due to the greater number of flexible-dose studies that have been recently conducted. This information can help clinicians in informing patients about potential AEs associated with pregabalin, as well as the importance of careful dose titration and AE monitoring in the first weeks of treatment.

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