Background & Aims

With increasing pain severity, patients with painful diabetic peripheral neuropathy (pDPN) experience more impairment in daily functioning, sleep and health related Quality of Life (QoL) and negative effect on mood.1,2 Early diagnosis and effective treatment are important and promoted in treatment guidelines.3 First line treatments include antidepressants, anticonvulsants and topical treatment with high concentration capsaicin 179 mg patch (HCCP). The effect of HCCP on QoL has been assessed in pDPN patients with the Norfolk QoL scale. A significant improvement was noted with HCCP.4 The same study also demonstrated improvement of mood with HCCP. 4 The German Pain e-Registry (web-based) collects data from chronic pain patients in a standardized way and offers options to explore treatment effects beyond pain (validated QoL and mood questionnaires are routinely completed by the participating patients). This study assesses the effect of HCCP on pain, QoL and mood in pDNP patients.

Methods

This is a cohort analysis of a non-interventional, retrospective 12 months study using anonymized routine care data from the German Pain eRegistry. The analysis is part of a larger study with the goal to correlate responder rates to baseline characteristics in patients with peripheral neuropathic pain treated with HCCP. Patients with a diagnosis of pDPN, exposed to at least one HCCP treatment and followed up for 12 months, were selected. The current analysis focuses on the assessment of QoL as measured by the Veterans RAND-12: a brief, generic, multi-use, self-administered health survey comprised of 12 items that measures physical [physical component score (PCS)] and mental health [mental component score (MCS)] status. Mood was assessed by the Depression, Anxiety and Stress Scale (DASS-21). Each item on the DASS-21 is scored on a scale of 0 – 3 (0= did apply to me all; 3 = applied to me very much or most of the time). Assessments happened at baseline and after each HCCP treatment.

Results

826 pDPN patients were included and received 1 HCCP treatment; 653, 464, and 279 had 2, 3 and 4 treatments respectively. The mean (SD) age was 66.8 (13.1) years and pain duration was 5 (3.6) years. The baseline mean (SD) 24 hour average pain score was 57.5 (18.2). From baseline to 12 months follow-up, the mean (SD) PCS and MCS significantly increased from 27.6 (7.7) and 40.4 (12.2) at baseline to 35.3 (10.0) and 51.1 (16.0), respectively (p<0.001) and the DASS-21 sum scores for depression, anxiety and stress significantly decreased from mean (SD) of 8.6 (5.6), 6.6 (4.8) and 11.7 (6.0) to 4.0 (3.0), 3.1 (2.5) and 5.4 (3.6) respectively (p<0.001). The percentage of patients without depression/anxiety/stress symptoms significantly increased from 27.7, 32.2, 30.3 at baseline to 63.8, 64.5, 79.2 at 12 months follow-up respectively (p<0.001). At baseline all patients used concomitant analgesic medication, of those who received 4 HCCP treatments, 28.7% were without such medication at Month 12

Conclusions

In line with the literature, the pDPN patients included in this cohort study had high pain scores at baseline even though all received concomitant pain medication. Their QoL as measured by the PCS and MCS was well below the general population average score of 50. Only approximately 30 % of the patients did not report any symptoms of depression, anxiety and stress. After treatment with HCCP not only pain scores improved (reported elsewhere) but we also observed improvement on assessments of QoL and mood. Best results were observed in those who continued treatment with HCCP (maximum number of treatments evaluated was 4 over the 12 month follow up period). These data support the position of HCCP as a first line treatment in pDPN and support that treatment outcomes continue to improve with repeated regular use of HCCP.

References

1.Alleman CJ, Westerhout KY, Hensen M, Chambers C, Stoker M, Long S, van Nooten FE. Humanistic and economic burden of painful diabetic peripheral neuropathy in Europe: A review of the literature. Diabetes Res Clin Pract. 2015 Aug;109(2):215-25.
2.Kec D, Rajdova A, Raputova J, Adamova B, Srotova I, Nekvapilova EK, Michalcakova RN, Horakova M, Belobradkova J, Olsovsky J, Weber P, Hajas G, Kaiserova M, Mazanec R, Potockova V, Ehler E, Forgac M, Birklein F, Üçeyler N, Sommer C, Bednarik J, Vlckova E. Risk factors for depression and anxiety in painful and painless diabetic polyneuropathy: A multicentre observational cross-sectional study. Eur J Pain. 2022 Feb;26(2):370-389.
3.Blonde L, Umpierrez GE, Reddy SS, McGill JB, Berga SL, Bush M, Chandrasekaran S, DeFronzo RA, Einhorn D, Galindo RJ, Gardner TW, Garg R, Garvey WT, Hirsch IB, Hurley DL, Izuora K, Kosiborod M, Olson D, Patel SB, Pop-Busui R, Sadhu AR, Samson SL, Stec C, Tamborlane WV Jr, Tuttle KR, Twining C, Vella A, Vellanki P, Weber SL. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. Endocr Pract. 2022 Oct;28(10):923-1049
4.Vinik AI, Perrot S, Vinik EJ, et al. Capsaicin 8% patch repeat treatment plus standard of care (SOC) versus SOC alone in painful diabetic peripheral neuropathy: A randomised, 52-week, open-label, safety study. BMC Neurol 2016;16(1):251.

Presenting Author

Tamara Quandel

Poster Authors

Mariëlle Eerdekens

MD

Grünenthal

Lead Author

E-mail

Michael A Überall (MD)

Institute of Neurological Sciences, Nürnberg, Germany.

Lead Author

E-mail

Tamara Quandel

Grünenthal GmbH Stolberg Germany

Lead Author

E-mail

Sylvia Engelen

Grünenthal GmbH Aachen Germany

Lead Author

E-mail

Rita Freitas

Grünenthal S.A., Lisbon Portugal

Lead Author

E-mail

Lucia Garcia-Guerra

Grünenthal Pharma SA Madrid Spain

Lead Author

E-mail

Yana Mas

Laboratoires Grünenthal SAS Paris France

Lead Author

E-mail

Samuel Allen

Averitas Pharma Inc Morristown NY USA

Lead Author

E-mail

Topics

  • Evidence, Clinical Trials, Systematic Review, Guidelines, and Implementation Science