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Pregabalin is safe and well tolerated treatment
option in patients with pDPN associated with different diabetes types that
donot share identical clinical profiles of pDPN.
A study in the 'Current Medical Research and Opinion' journal depicted that Pregabalin significantly improves pain and sleep quality, without a clinically meaningful difference between diabetes types.
Parsons B and his colleagues performed this study to compare pregabalin's efficacy and safety for painful diabetic peripheral neuropathy (pDPN) in people with type 1 (T1DM) or 2 diabetes mellitus (T2DM).
The pooled data from 10 randomized clinical trials (pregabalin-treated T1DM and T2DM subjects with pDPN). They were examined for change in baseline (CFB) scores (pain and sleep disturbance) applying the mixed model repeated measures (MMRM) through Week 12 and last observation carried forward (LOCF). The adverse events (AEs) were noted.
Total
1788 Pregabalin-treated (T1DM 156 [8.7%]; T2DM 1632 [91.3%]) and total 960 placebo subjects (T1DM 92 [9.6%]; T2DM
868 [90.4%]) had comparable baseline demographic characteristics between
treatment groups within the same diabetes type. The T2DM (vs T1DM) subjects
were 10 years older. The 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
in pregabalin and placebo. The mean CFB treatment differences (pregabalin minus
placebo) were significantly dissimilar for pain and sleep with either diabetes
types (all weeks p<0.05). Pregabalin's odds ratios (ORs) of achieving 30%
pain reduction were similar with T2DM and T1DM using LOCF. 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<0.05). The AEs were in accordance with the
known safety profile of pregabalin.
Curr Med Res Opin. 2018 Aug 7
The efficacy of pregabalin for treating pain associated with diabetic peripheral neuropathy in subjects with type 1 or type 2 diabetes mellitus
Parsons B et al.
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