Narayan Kissoon, MD
Neurologist
Mayo Clinic
Rochester, Minnesota
Ashley Guesnier, PharmD
Senior Manager, Global Health Economics & Outcomes Research – Pain
Vertex Pharmaceuticals Incorporated
Boston, Massachusetts
Meaghan O’Connor, MPH
Scientist
IQVIA
Johnston, Rhode Island
Elizabeth Brennan, PhD
Outcomes Research Associate
IQVIA
Johnston, Rhode Island
Ann M. Menzie, MS
Senior Director, Health Economics and Outcomes Research
Vertex Pharmaceuticals Incorporated
Boston, Massachusetts
Pain associated with diabetic peripheral neuropathy (DPN) is a common complication of diabetes, affecting an estimated 10-30% of patients with diabetes in the United States (US). As a chronic neuropathic condition that primarily involves the lower extremities, painful DPN can significantly impair quality of life by limiting mobility, disrupting sleep, and contributing to emotional distress. Managing painful DPN is challenging due to the need to balance medication side effects with patient-specific factors such as comorbidities and polypharmacy. Five products have been approved by the US Food and Drug Administration (FDA) for the management of pain associated with DPN: duloxetine, pregabalin, tapentadol, capsaicin 8% patch, and spinal cord stimulation devices. Other medications used in clinical practice include gabapentin, tricyclic antidepressants (TCAs), and sodium channel blockers. Despite currently available therapies, healthcare professionals (HCPs) continue to face challenges in managing pain related to diabetic polyneuropathy. While prior research has described the symptoms and clinical burden of this condition, few studies have explored the challenges associated with and typical practices used in managing painful DPN from the HCP perspective.
Purpose/Objectives:
The objectives of this research were to better understand: 1) the challenges HCPs face when managing pain associated with DPN in adult patients; and 2) HCPs' prescribing habits and factors that influence those habits in order to identify unmet needs associated with the management of painful DPN.
Methods:
This study used a cross-sectional design and qualitative research methods to collect and analyze data from HCPs treating adult patients with painful DPN. Using purposive sampling, the study team recruited US-based physicians who specialized in neurology, family or internal medicine (i.e., general practitioners), or pain medicine; had ≥3 years of experience managing ≥2 patients with chronic DPN per week; and spend 50% of their time in the clinical setting. Although the study was granted exemption by an independent institutional review board, participants confirmed consent verbally at the start of the interview.
One-on-one, 60-minute interviews were conducted using a study-specific interview guide. The interviews were semi-structured, which allowed for probing and exploration to clarify responses or explore new themes if needed. Transcripts were coded and analyzed in NVivo qualitative data analysis software using thematic analysis to identify key themes related to physicians’ experiences with managing painful DPN.
Results:
Twenty HCPs participated in the study, with an equal distribution between generalists (family medicine or internal medicine; n=10) and specialists (neurology, n=5; pain medicine, n=5). The sample was mostly male (n=13, 65%) and White (n=11, 55%). On average, participants had 24.3 years of experience managing painful DPN and reported treating between 2-50 patients with pain associated with DPN per week.
The majority of participants (n=14) relied more on their personal clinical experience over published guidelines when developing patient-care plans, emphasizing the need for individualized approaches to managing painful DPN. Improving or maintaining patients’ daily functioning was most participants' primary treatment goal (n=14), followed by achieving adequate pain relief to support sleep (n=7), and encouraging patients to more actively and effectively manage their diabetes (n=5) as it is the root cause of painful DPN.
Participants characterized prescribing decisions for painful DPN as complex, as they must consider factors such as individual patient characteristics (e.g., age, sex, comorbidities; n=15), potential drug-drug interactions/allergies (n=14), medication side effects (n=12), and the likelihood of patient compliance (n=9) when prescribing. Almost all participants (n=19) explicitly mentioned the importance of considering the risk of dizziness and drowsiness/sedation when making prescribing decisions, particularly in older patients at increased risk of falls.
All participants prescribed antiseizure medications, such as gabapentinoids (n=20), and most prescribed TCAs (n=18), serotonin-norepinephrine reuptake inhibitors (SNRIs; n=18), opioids (n=18), and/or topical creams (n=18). Choice of therapy depended on patient-specific factors such as comorbidities, past treatment experience, and severity of DPN pain. The most frequently prescribed first-line therapies included gabapentin (n=16), pregabalin (n=7), topical creams (n=7), and duloxetine (n=6).
While nearly half of participants (n=9) preferred starting patients on monotherapy to attribute effectiveness and/or side effects to a specific agent, all participants (n=20) described using combination therapy for multiple reasons, including simultaneously addressing comorbidities (e.g., depression; n=7), avoiding maximum doses (n=5), improving pain relief (n=4), targeting different aspects of pain (n=2), and balancing tolerability with side effects (n=2). When asked about reasons for changing therapies for painful DPN, participants most commonly cited lack of effectiveness (n=16), followed by side effects (n=10) and issues with tolerability (n=8).
Conclusions/Implications for future research and/or clinical care:
This qualitative study investigated physicians’ perspectives managing patients with pain associated with DPN in real-world settings, highlighting variability in prescribing practices and the emphasis on individualized patient-care plans. These insights reflect the complexity of managing painful DPN and highlight the limitations of currently available neuropathic pain medications, often prompting physicians to initiate combination therapy or change treatment altogether. The results of this study help identify and underscore the unmet needs associated with the current neuropathic pain medications used to treat painful DPN and may help inform future efforts to support more patient-centered care.