Real-World Treatment Patterns and Gaps in Clinical Management of Lumbar Disc Herniation in the United States
INTRODUCTION
-Lumbar disc herniation (LDH) is a common chronic condition frequently affecting lower back and legs and causing debilitating pain
-LDH affects approximately 1-3% of the population annually, primarily affecting individuals between 30 and 50 years of age1
-Conservative treatments are the first line treatments for most newly diagnosed LDH patients
-While conservative treatments are usually effective for initial symptomatic relief, many patients will require epidural steroid injection (ESI) and some may require surgeries2
-ESI has no confirmed long-term benefits and carries the risk of neurological complications;3,4 surgery carries the risk of complications, risk relating to general anesthesia, along with a chance of re-herniation5
OBJECTIVE
-This study seeks to describe current treatment patterns and inform gaps in clinical management of patients with newly diagnosed LDH
METHODS
Study Design and Sample Selection
-A retrospective study using IQVIA PharMetrics® Plus database (01/01/2018 to 03/31/2023)
-The selection of LDH sample was described in Table 1
Statistical Analysis
-Demographic and clinical characteristics during the 6-month baseline period were summarized and compared across subgroups defined based on treatments received. Continuous variables were compared using Wilcoxon Rank Sum Test and categorical variables were compared using Chi-squared Test
-Treatment patterns (including conservative treatments, ESI, and LDH surgery) were described over a three-year follow-up period. Conservative treatments included nonopioid analgesics (including NSAID, acetaminophen, etc.), opioids, systemic glucocorticoids, benzodiazepines and antispasmodic agents, physical/massage therapy, spinal manipulation, and acupuncture
-Time from first ESI to second ESI were described during the follow-up period among ESI- treated patients, using Kaplan-Meier (KM) analysis
RESULTS
Treatment Patterns and Sequences
-Almost all patients (98.4%) were treated with conservative treatment during the follow-up period and 23.0% of patients required ESI and/or surgery to manage their LDH
-The group of patients who received ESI and/or surgery were on average 1-2 years older and had a slightly lower percentage of female patients compared to patients who received conservative treatments only (Table 2)
Utilization of ESI
-Overall, 19.8% of LDH patients received at least one ESI with or without surgery; more than half of ESI-treated patients (52.4%) received multiple ESIs (Figure 1)
-Among ESI-treated patients, the average duration from LDH diagnosis to first ESI was 6.2 months, with 53.4% and 82.3% received first ESI within 3 months and one year, respectively
-50.0% of the patients who received first ESI also received second ESI within 1 year (Figure 3)
Utilization of surgery
-Overall, 7.2% of LDH patients underwent LDH surgeries with or without ESI; one in ten surgery-treated patients (9.6%) received multiple surgeries
-Among surgery-treated patients, the average duration from LDH diagnosis to first surgery was 8.4 months, with 53.5% and 74.7% received first surgery within 6 months and one year, respectively
KEY TAKEAWAYS
-Around one quarter of newly diagnosed LDH patients received ESIs and/or surgeries after conservative treatment
-Half of the patients who received ESI needed additional ESIs within one year, indicating potential lack of effectiveness
-Close to one-fifth of ESI-treated patients underwent surgery including repeated surgeries
-Among surgery- treated patients, close to half directly received surgery without ESI
-Unmet needs exist in the current treatment options for LDH patients, highlighting the need for new effective treatment options to reduce the need for surgeries and ESIs
