MON-634 - Real-World Effectiveness of Capsaicin 8% Patch in Painful Diabetic Peripheral Neuropathy

Background:
The capsaicin 8% patch (Qutenza) is FDA-approved for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN). Capsaicin is a selective transient receptor potential vanilloid 1 (TRPV1) agonist that induces reversible defunctionalization of nociceptor terminals, resulting in reduced pain signaling with minimal systemic exposure. This study evaluated the real-world effectiveness of capsaicin 8% patch therapy over 12 months in patients with painful DPN.

Methods:
Twenty-six adults with painful DPN were included (53.8% female; 96.2% type 2 diabetes). Mean age was 61.7 ± 10.4 years, mean BMI was 33.3 ± 8.6, and mean DPN duration was 10.8 ± 4.1 years. At baseline, 73.1% were using at least one DPN medication. A capsaicin 8% patch was applied per standard clinical practice. Outcomes included Numeric Pain Rating Scale (NPRS), sleep quality (NRS-Sleep), and Patient Global Impression of Change (PGIC), assessed at baseline and follow-up visits. Mixed-effects models evaluated changes over time.

Results:
Baseline NPRS was 7.50 ± 2.43 (n=24). Mean NPRS progressively decreased to 6.50 ± 2.01 (Tx1, n=18), 6.23 ± 1.74 (Tx2, n=13), 4.71 ± 1.80 (Tx3, n=7), and 4.17 ± 2.79 (Tx4, n=6), representing a 44.4% reduction from baseline and exceeding the 30% threshold for clinically meaningful improvement. The effect of time on pain reduction was significant (F=4.74, p=0.0016), with the greatest reduction observed at Tx4 compared with baseline (Δ = −3.33; Bonferroni-adjusted p=0.0019). PGIC scores improved from baseline (3.15 ± 1.99) to Tx3 (5.33 ± 1.03) and Tx4 (5.40 ± 1.95), with a trend toward significance (p=0.0535). Sleep quality did not significantly change over time (p=0.574). Glycemic control remained stable throughout follow-up (baseline 7.58 ± 1.65% vs Tx4 7.04 ± 1.85%).

Conclusion:
In this real-world cohort, capsaicin 8% patch therapy produced sustained and clinically meaningful pain reduction in patients with painful DPN, with a magnitude exceeding reductions reported in pivotal trials. Although improvements in global impression and sleep did not reach statistical significance, likely due to small sample sizes at later timepoints, the robust pain reduction supports capsaicin 8% as an effective non-systemic treatment option for DPN.

*Unless otherwise noted, all abstracts presented at ENDO must not be released to the press or the public until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*