Efficacy and safety of pregabalin 600 mg/d for treating painful diabetic peripheral neuropathy: A double-blind placebo-controlled trial
2008

Pregabalin for Painful Diabetic Neuropathy

Sample size: 167 publication 10 minutes Evidence: high

Author Information

Author(s): Joseph C Arezzo, Julio Rosenstock, Linda LaMoreaux, Lynne Pauer

Primary Institution: Albert Einstein College of Medicine

Hypothesis

Does pregabalin 600 mg/d effectively relieve pain in patients with diabetic peripheral neuropathy compared to placebo?

Conclusion

Pregabalin 600 mg/d effectively reduced pain, was well tolerated, and had no significant effect on nerve conduction in patients with painful diabetic neuropathy.

Supporting Evidence

  • Pregabalin-treated patients had lower mean pain scores than controls.
  • 49% of pregabalin patients were responders compared to 23% of placebo patients.
  • No significant changes in nerve conduction were observed with pregabalin treatment.

Takeaway

This study found that a medication called pregabalin helps reduce pain for people with diabetes-related nerve pain, and it doesn't hurt their nerves.

Methodology

A randomized, double-blind, placebo-controlled trial over 13 weeks with 167 patients across 23 centers.

Potential Biases

Potential ascertainment bias in reporting peripheral edema due to frequent assessments.

Limitations

The study may have biases due to the assessment of adverse events and the exclusion of patients with certain conditions.

Participant Demographics

Patients were men and women aged ≥18 years with type 1 or type 2 diabetes and painful diabetic neuropathy.

Statistical Information

P-Value

p<0.001

Confidence Interval

95% CI, -1.96 to -0.60

Statistical Significance

p<0.001

Digital Object Identifier (DOI)

10.1186/1471-2377-8-33

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