Analyses of pooled clinical trial data have reported the good response of international populations to Pregabalin by baseline neuropathic pain (NeP) severity. However, studies on patients from Japan are lacking. A post hoc pooled analysis evaluated the efficacy of Pregabalin in Japanese subjects for treating moderate or severe baseline NeP.

The study evaluated the efficacy of Pregabalin by baseline pain severity (moderate or severe NeP). It pooled the data from three placebo-controlled trials enrolling Japanese subjects with postherpetic neuralgia (PHN), diabetic peripheral neuropathy (DPN), and spinal cord injury (SCI). The trials on PHN and DPN contained a 1-week titration of Pregabalin from 150 mg/day to 300 or 600 mg/day; the SCI trial contained a 4-week dose optimization phase (150 mg/day, titrated up to 600 mg/day). The duration of treatment was 13–16 weeks (excluding 1-week taper periods), with Pregabalin administered in two divided doses/day.

The treatment cohorts showed comparable Mean baseline pain scores and demographic characteristics. Pregabalin treatment significantly reduced pain scores from baseline to endpoint compared to placebo in subjects with moderate and severe baseline pain. Pregabalin caused significant improvements in mean sleep scores from baseline to endpoint compared with placebo in subjects with both moderate and severe baseline pain. Pregabalin caused a ≥30% reduction in pain from baseline in a greater proportion of subjects in both pain cohorts compared to the placebo. Higher proportions of pregabalin-treated vs. placebo-treated subjects moved to a less severe pain category at the endpoint. Similar to the known safety profile of Pregabalin, common adverse events were dizziness, somnolence, weight gain, and peripheral edema.

Thus, Pregabalin is efficient for pain relief and sleep improvement with a consistent safety profile in Japanese subjects with either moderate or severe baseline pain severity.

J Pain Res. 2019 Mar 22;12:1061-1068. Doi: 10.2147/JPR.S181729. PMID: 30962707; PMCID: PMC6434920.