EN | UA
EN | UA

Help Support

Back

The study of efficacy and safety of pregabalin for painful diabetic peripheral neuropathy in Chinese patients

The study of efficacy and safety of pregabalin for painful diabetic peripheral neuropathy in Chinese patients The study of efficacy and safety of pregabalin for painful diabetic peripheral neuropathy in Chinese patients
The study of efficacy and safety of pregabalin for painful diabetic peripheral neuropathy in Chinese patients The study of efficacy and safety of pregabalin for painful diabetic peripheral neuropathy in Chinese patients

In Chinese patients with painful diabetic peripheral neuropathy (pDPN) very limited information existed regarding the efficacy of pregabalin.

See All

Key take away

Pregabalin is a gabapentinoid that was used mainly for the management of neuropathic pain. It specifically binds to alpha-2-delta subunit to produce antiepileptic and analgesic actions. In this study, the efficacy of pregabalin for diabetic neuropathy has been evaluated, and it has been determined that pregabalin can significantly reduce pain in a population of Chinese patients. 

Background

In Chinese patients with painful diabetic peripheral neuropathy (pDPN) very limited information existed regarding the efficacy of pregabalin.

Method

An 11-week double-blind placebo-controlled trial was conducted in Chinese pDPN patients randomized (1 : 1) to 300 mg/day pregabalin or placebo. The primary outcome was set as the change from baseline to endpoint in mean pain score (MPS; 0, no pain; 10, worst possible pain; using the mean of the last seven daily pain scores). Secondary outcomes included weekly MPS and responder status (MPS reduced by ≥30% or ≥50% vs. baseline). Subgroup analysis assessed patients with severe (≥7) baseline MPS. Adverse events (AEs) were reported. 

Result

In all, 620 patients were randomized (pregabalin, n = 313; placebo, n = 307). Improvement in MPS with pregabalin versus placebo was not significant (P = 0.0559). Post hoc sensitivity analyses, excluding one patient/site due to Good Clinical Practice (GCP) non-compliance, showed pregabalin significantly improved MPS when excluding the patient (P = 0.0448) or site (P = 0.0142). Pregabalin significantly improved weekly MPS (P = 0.0164) and ≥50% responders at endpoint (P = 0.0384). Improvement in the proportion of ≥30% responders, the impression of change, pain intensity, and sleep did not differ significantly between the treatment groups. In the severe pDPN subpopulation, pregabalin significantly improved MPS versus placebo (P = 0.0040). The most commonly reported AE was dizziness (9.6% vs. 3.9% with placebo).

Conclusion

Pregabalin did not significantly improve the primary measure of pain in the trial. Significant reductions in MPS were observed when excluding the GCP non-compliant patient/site and in the severe pDPN subpopulation. Pregabalin was well tolerated in Chinese pDPN patients.

Source:

J Diabetes. 2017 Jul 20

Article:

Efficacy and safety of pregabalin for painful diabetic peripheral neuropathy in a population of Chinese patients: a randomized, placebo-controlled trial.

Authors:

Mu Y et al.

Comments (0)

You want to delete this comment? Please mention comment Invalid Text Content Text Content cannot me more than 1000 Something Went Wrong Cancel Confirm Confirm Delete Hide Replies View Replies View Replies en
Try: