Pain Clinical Trial
Official title:
Long-term Opioid Therapy, Misuse and Mortality in Patients With Chronic Non-cancer Pain in Germany
Among patients receiving opioids for noncancer pain, recent research in North America showed a strong association between doses and opioid-related mortality, especially at dosages exceeding thresholds recommended in recent guidelines. However, the focus on over-dosage may underestimate overall opioid-related mortality and data on death associated with opioid use in a population-based cohort of chronic noncancer pain patients in Europe is scarce. Especially comparative studies studying the safety of long-term opioid therapy in a real-world setting relative to non-opioid medication for chronic noncancer pain are needed in a European context.
This is a cross-sectional observational cohort study between 2012 and 2017 of patients with
chronic noncancer pain. The primary objective is to investigate the association between
mortality among patients with chronic noncancer pain with long-term opioid-therapy compared
to non-opioid pain medication. The data will be retrieved from an anonymized German health
claims database including 4,00,000 persons insured by 69 German statutory health insurances.
The data set includes 5.0% of the population covered by statutory health insurances from
January 1, 2012, to December 31, 2017. Only anonymized and aggregated data (no directly or
indirectly identifying data) will be extracted.
Patients with headache, diseases of the musculoskeletal system and connective tissue,
migraine, trigeminal neuralgia, atypical facial pain, persistent somatoform pain disorder,
polyneuropathies, or diabetes mellitus with neurological complications in at least 3 quarters
between 01.01.2012 and their first pain medication claim are analyzed. Patients will be
stratified in an opioid and a non-opioid group and will be compared with a propensity score
matching approach.
Patients' follow-up period include 5 years after start treatment and chronic pain diagnosis
between 01.01.2013 and 31.12.2017. Each patient will be censored at death (death date),
switching of study group, 12 months without treatment or followed-up 5 years until last known
record for the, whichever happens first. The main analyses will be analyzed with a
multivariate Cox proportional hazards regression.
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