Juan M. Hincapie-Castillo, PharmD, MS, PhD, an Assistant Professor of Epidemiology at the Gillings School of Global Public Health at the University of North Carolina Chapel Hill, received a 5-year career development (K01) award from the National Institute of Dental & Craniofacial Research (NIDCR) focused on trigeminal neuralgia (TN) in older adults.
This project, titled “Real-world Evidence Study with Patient Input to evaluate Treatment Effects in Trigeminal Neuralgia (RESPITE-TN),” is a mixed-methods research study that looks to generate evidence to guide patient-centered care in TN by contextualizing and assessing drug safety concerns relevant to older Americans. Current evidence, including findings from Dr. Hincapie-Castillo’s prior work, suggest an increasing reliance on gabapentin as the first line pharmacological treatment for newly diagnosed cases. Increasing use of gabapentin at higher doses carries significant risks for older adults who are more prone to adverse events than younger patients.
With support from the Facial Pain Association, the first phase of RESPITE-TN aims to document patient-reported experiences of initial TN diagnosis and treatment through qualitative interviews and a survey. Dr. Hincapie-Castillo will recruit people with lived experience (PWLE) of TN in the coming months to become paid study participants for data collection and volunteers for a PWLE advisory board. “I strongly believe that any clinical research must involve members of the community with lived experience,” said Dr. Hincapie-Castillo, who volunteers his time as the current President of the Board of Directors for the National Pain Advocacy Center (NPAC).
“I have witnessed firsthand how two close relatives diagnosed with TN were given high doses of gabapentin with severe adverse reactions and minimal pain relief,” said Dr. Hincapie-Castillo. “After a short phone call with each of them, I noticed that they were perfectly fine candidates for the first line treatment of oxcarbazepine and advised them to ask for a medication change from their prescribers. They both had pain relief with little adverse events soon after changing their medication. Not everyone has a pharmacist they can simply call when needed.”
Important patient input in RESPITE-TN will inform phase II of the study aiming to develop and validate a claims-based algorithm for incident diagnoses of TN in Medicare data. Phase III aims to evaluate the risk of injurious falls caused by antiepileptic medications among Medicare-insured patients using advanced analytics and machine learning.
