Transdermal buprenorphine may be an effective therapy for diabetic peripheral neuropathic pain (DPNP), however the treatment was associated with a high rate of adverse events, mostly nausea and/or vomiting.
The findings come from a newly published multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. Ninety-three patients with type 1 or 2 diabetes were enrolled and received either buprenorphine (5μg/h) or placebo patches. All of the patients had been experiencing moderate to severe DPNP for a minimum of 6 months on maximal tolerated conventional therapy. The dose was titrated to effect to a maximum of 40μg/h.
Results showed that of those who completed the study, the buprenorphine group had 86.3% who experienced a 30% reduction in average versus baseline pain at week 12, compared with the 56.6% in the placebo group who experienced the same reduction (P<0.001).
The intention-to-treat analysis, with the same end point, showed a nonsignificant trend favoring the buprenorphine group (51.7% vs. 41.3%, P=0.175).
However, many patients did not complete the study; 37 patients in the buprenorphine group and 24 in the placebo group. Those in the buprenorphine group mostly reported nausea and/or vomiting as their reason for halting treatment.
The authors concluded, that when tolerated, transdermal buprenorphine is an effective therapy for DPNP adding that, “Nausea and constipation need to be managed proactively to optimize treatment outcomes.”
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