The study aimed to compare the Pregabalin safety and efficacy in concern to painful diabetic peripheral neuropathy (pDPN) management among people with type 1/type 2 diabetes mellitus (T2DM).
Diabetic peripheral
neuropathy is a devastating issue that involves nerve damage due to high blood
glucose levels. Pregabalin is an FDA approved drug to counter DPN associated
pain. The study helps to elucidate the efficacy of Pregabalin among type one
and two diabetic patients.
The study aimed to compare the Pregabalin safety and efficacy in concern to painful diabetic peripheral neuropathy (pDPN) management among people with type 1/type 2 diabetes mellitus (T2DM).
Ten randomised clinical trials were analysed to collect the pooled data regarding change sleep disturbance and pain scores from baseline to 12 weeks and last observation carried forward (LOCF) using mixed model repeated measures (MMRM). The Adverse events (AEs) were also noticed.
Baseline demographic features were comparable in the placebo (T1DM/T2DM; 92/868) and pregabalin-treated (T1DM/T2DM; 1632/156) group. T1DM group patients were ∼10 years younger than T2DM patients. The mean ± SD baseline sleep and pain scores for Pregabalin and placebo noticed were (T1DM: 5.2 ± 2.4 and 5.2 ± 2.7; T2DM: 5.3 ± 2.5 and 5.1 ± 2.5) and (T1DM: 6.2 ± 1.4 and 6.5 ± 1.6; T2DM: 6.5 ± 1.5 and 6.4 ± 1.5). Mean CFB treatment differences (pregabalin minus placebo) measured by MMRM were considerably diverse for sleep and pain with each diabetes type (all weeks p < .05). With LOCF, Pregablin’s odds ratios (ORs) of achieving 30% pain reduction of Pregabalin’s were comparable with T1DM (2.01) and T2DM (1.91). ORs of 30% improvement in sleep quality of Pregabalin were 1.81 with T1DM and 2.01 with T2DM. The reported adverse events matched up with the known safety profile of Pregabalin.
Pregabalin improved pain
and sleep quality remarkably, without a clinically meaningful variation between
diabetes types.
Curr Med Res Opin
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.
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