A, Patients treated with 2 categories of medications at the same time contribute to both regimens. The denominator was all patients (N = 3495), including those who did not start any treatment. B, Temporal trends in prescriptions for opioids (alone or in combination with other medications) compared with other medications only (recommended, acceptable, or both) among patients who received treatment.
eTable 1. Classification of included pain medications
eTable 2. Comorbidity code sets
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Fan J, Jeffery MM, Hooten WM, Shah ND, McCoy RG. Trends in Pain Medication Initiation Among Patients With Newly Diagnosed Diabetic Peripheral Neuropathy, 2014-2018. JAMA Netw Open. 2021;4(1):e2035632. doi:10.1001/jamanetworkopen.2020.35632
Diabetic peripheral neuropathy (DPN) affects approximately half of people living with diabetes.1 Approximately half of patients with DPN have pain2 resulting in debility, disability, and impaired quality of life.3 Clinical guidelines recommend use of anticonvulsants, antidepressants (serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants), or topical analgesics for painful DPN owing to their demonstrated efficacy and safety in this context.2,4 To promote safe and evidence-based pain management, we examined initiation of pain medication among adults with newly diagnosed DPN.
This retrospective cohort study used electronic health record data from the Mayo Clinics in Rochester, Minnesota; Phoenix, Arizona; and Jacksonville, Florida, health systems. We examined first-line analgesic medications prescribed to adults with a new diagnosis of DPN between January 1, 2014, and December 31, 2018. This study was approved by the Mayo Clinic institutional review board. Informed consent was waived owing to the use of preexisting population-level electronic health record data. The study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline.
Included medications were prescribed during the first year after diagnosis and had not been prescribed in the preceding 12 months (nonopioids) or 3 months (opioids). Medications were regarded as concurrent if they were prescribed within 2 weeks of each other and were categorized as (1) guideline recommended (pregabalin, gabapentin, and serotonin-norepinephrine reuptake inhibitors); (2) opioids, which are not recommended; and (3) acceptable (topical analgesics, tricyclic antidepressants, and other anticonvulsants) (eTable 1 in the Supplement).2,4
New diagnosis of DPN was established using International Classification of Diseases, Ninth Revision and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision codes preceded by a 2-year period without these diagnoses. Logistic regression models examined demographic and clinical (eTable 2 in the Supplement) factors associated with prescriptions for any treatment among all patients and for opioids or guideline-recommended medications specifically among patients who received treatment. To ensure that patients were active in our health systems, we required that any prescription be issued during the 18 months before DPN diagnosis and between 1 month and 1 year after diagnosis. Analyses were performed using R, version 3.6.1 (R Project for Statistical Computing).
We identified 3495 adults with newly diagnosed DPN, of whom 1406 (40.2%) started a new pain medication after diagnosis (Table). Between 2014 and 2018, the adjusted odds of starting a new pain medication decreased by 35%, from 45.6% (287 of 630) of the cohort in 2014 to 35.2% (243 of 691) in 2018. The odds of treatment initiation were greatest among patients with depression (odds ratio [OR], 1.61; 95% CI, 1.35-1.93), arthritis (OR, 1.21; 95% CI, 1.02-1.43), and back pain (OR, 1.34; 95% CI, 1.16-1.55) and decreased significantly over time among all patients. Among 1406 patients who received treatment, opioids were prescribed to 616 (43.8%), recommended medications to 603 (42.9%), and acceptable medications to 289 (20.6%). Male sex was associated with greater odds of opioid use compared with use of other medications, and presence of fibromyalgia was associated with lower odds of opioid use. Comorbid arthritis was associated with decreased odds of recommended medication use. Crude rates of opioid use decreased over time, whereas rates of recommended medication increased (Figure). However, trends were not significant after adjustment for demographic and clinical factors (Table).
Between 2014 and 2018, initiation of pain medication among patients with newly diagnosed DPN decreased by 35%. Overall, 43.8% patients initiating therapy were prescribed opioids compared with 42.9% who were prescribed guideline-recommended medications. Such high rates of opioid use by patients with DPN, a lifelong pain syndrome, are concerning because safer effective treatment options are available.
Rates of opioid use exceeded those reported previously5 likely because we did not exclude patients with preexisting pain or mood disorders, which are common in this population, making our study findings more generalizable. Our analyses are limited by the inability to examine the clinical context of pain management, including pain severity and other potential indications for opioid therapy, or contraindications to guideline-recommended treatments. Our sample size may be underpowered to ascertain factors associated with the choice of specific treatment regimens. Our data could not capture the duration of opioid therapy; thus, some prescriptions may have been for short-term rather than long-term use. In addition, the patients included in the study received care in 3 institutions and, as such, may not be representative of all patients with DPN. Further research is needed to examine DPN management trends nationally, identify factors associated with opioid use and barriers to evidence-based alternatives, and develop interventions to improve DPN management in clinical practice.
Accepted for Publication: December 9, 2020.
Published: January 28, 2021. doi:10.1001/jamanetworkopen.2020.35632
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Fan J et al. JAMA Network Open.
Corresponding Author: Rozalina G. McCoy, MD, MS, Division of Community Internal Medicine, Department of Medicine, Mayo Clinic, 200 First St, SW Rochester, MN 55905 (firstname.lastname@example.org).
Author Contributions: Drs McCoy and Fan had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Hooten, McCoy.
Acquisition, analysis, or interpretation of data: Fan, Jeffery, Shah.
Drafting of the manuscript: Fan, McCoy.
Critical revision of the manuscript for important intellectual content: Fan, Jeffery, Hooten, Shah.
Statistical analysis: Fan, Jeffery.
Administrative, technical, or material support: Hooten, Shah.
Conflict of Interest Disclosures: Dr Jeffery reported receiving research support through grants to the Mayo Clinic from the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH) and receiving grants from the Agency for Healthcare Research and Quality (AHRQ), the Food and Drug Administration (FDA)–funded Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI), the American Cancer Society, the National Center for Advancing Translational Sciences, and the National Institute on Drug Abuse. Dr Shah reported receiving research support through grants to the Mayo Clinic from the NHLBI, NIH and grants from AHRQ, the FDA-funded Yale-Mayo Clinic CERSI, the Centers for Medicare & Medicaid Innovation under the Transforming Clinical Practice Initiative, the National Science Foundation, and the Patient-Centered Outcomes Research Institute. Dr McCoy reported receiving grants from the AARP Quality Measure Innovation program through a collaboration with OptumLabs and the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. No other disclosures were reported.
Funding/Support: This study was funded by grant K23DK114497 from the the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH (Dr McCoy).
Role of the Funder/Sponsor: The NIDDK, NIH had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: The study contents are the sole responsibility of the authors and do not necessarily represent the official views of NIH.
Meeting Presentation: This paper was presented at the virtual 80th Scientific Sessions of the American Diabetes Association; June 13, 2020.
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