This study aimed to compare the efficacy and safety of pregabalin for painful diabetic peripheral neuropathy (pDPN) in type 1 (T1DM) or 2 diabetes mellitus (T2DM) subjects.
Pregabalin belongs to the class of anticonvulsants, which
works by reducing the number of pain signals sent out by impaired nerves in the
body. All the analyses of pain and sleep scores (MMRM and LOCF) in this study
were significant at all time points for subjects with type 2 diabetes
mellitus.
This
study aimed to compare the efficacy and safety of pregabalin for painful
diabetic peripheral neuropathy (pDPN) in type 1 (T1DM) or 2 diabetes mellitus
(T2DM) subjects.
The pooled data from 10 RCTs (pregabalin-treated T1DM and
T2DM subjects with pDPN) were examined for change from baseline (CFB) scores
(pain and sleep disturbance) via the mixed model repeated measures (MMRM)
through Week 12 and the last observation carried forward (LOCF). Adverse events
(AEs) were recorded.
Pregabalin-treated
(T1DM 156 [8.7%]; T2DM 1632 [91.3%]) and placebo subjects (T1DM 92 [9.6%]; T2DM
868 [90.4%]) had comparable baseline demographic characteristics between
treatment groups within the same diabetes type. T2DM (vs T1DM) subjects were ∼10 years older. With
pregabalin and placebo, respectively, mean ± SD baseline pain (T1DM: 6.2 ± 1.4
and 6.5 ± 1.6; T2DM: 6.5 ± 1.5 and 6.4 ± 1.5) and sleep scores (T1DM: 5.2 ± 2.4
and 5.2 ± 2.7; T2DM: 5.3 ± 2.5 and 5.1 ± 2.5) were comparable. Using MMRM, mean
CFB treatment differences (pregabalin minus placebo) were significantly
different for pain and sleep with either diabetes types (all
weeks p < .05). With LOCF, pregabalin’s odds ratios (ORs) of achieving
30% pain reduction were similar with T2DM (OR, 1.91, 95% CI [1.61, 2.27]) and
T1DM (2.01 [1.18, 3.44]) (both p ≤ .01). Pregabalin’s ORs of 30%
improvement in sleep quality was 1.81 (95% CI, 1.06, 3.09) with T1DM and 2.01
(1.69, 2.39) with T2DM (both p < .05). AEs were consistent with the
known safety profile of pregabalin.
Pregabalin
significantly improved pain and sleep quality, without a clinically meaningful
difference between diabetes types.
Current Medical Research and Opinion
The efficacy of pregabalin for treating pain associated with diabetic peripheral neuropathy in subjects with type 1 or type 2 diabetes mellitus
B Parsons et al.
Comments (0)