Long-term Opioid Therapy, Misuse and Mortality in Patients With Chronic Non-cancer Pain in Germany

NCT03778450 | Completed

• 1 other identifier: VF_1014_1040_Study Protocol
• Study Type: observational
• Target: 3,232
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Mortality

  Primary endpoint is death by any course in the study follow-up. Death will be assessed during the follow-up period by number of patients who deceased during follow-up period (2013 - 2017) via the date of death in German claims data base.

  2013 - 2017

Secondary Outcomes (8)

• Hospitalization due to any course

  2013 - 2017

• Number of ICU-stays

  2013 - 2017

• Hospitalization with to misuse or addiction

  2013 - 2017

• Number of coding of procedures in hospitals

  2013 - 2017

• Number of patients with a ca misuse or addiction diagnosis in the outpatient sector

  2013 - 2017

Study Arms (2)

Analgesics, Opioid

Patients are only included if they have been diagnosed in at least three quarters in the study period with one of the following diagnoses: R51, R52\*, M00\*-M99\*, G43\*-G44\*, G50.0 or G50.1, F45.4\*, G62\*, or E10.4\*-E14.4 plus G63.3. At least one diagnoses must be between 1 January 2012 and index treatment and main and secondary hospital diagnoses (i.e. Haupt- und Nebendiagnosen) will be used to include the patients.

Drug: Analgesics, Opioid

Non-Opioid Analgesic

Patients are only included if they have been diagnosed in at least three quarters in 2012 with one of the following diagnoses: R51, R52\*, M00\*-M99\*, G43\*-G44\*, G50.0 or G50.1, F45.4\*, G62\*, or E10.4\*-E14.4 plus G63.3.At least one diagnoses must be between 1 January 2012 and index treatment and main and secondary hospital diagnoses (i.e. Haupt- und Nebendiagnosen) will be used to include the patients.

Drug: Non-Opioid Analgesic

Interventions

Analgesics, Opioid DRUG

Patients are included in the long-term opioid group if they started an opioid-therapy between 2013 and 2017 and received consecutive prescriptions for opioid medications over a minimum of 3 quarters, over a 60-month period between January 1, 2013, and December 31, 2017. The treatment will be assessed using the ATC codes of opioid treatment N02AA01, N02AA05, N02AB03, N02AE01, N02AX02, N02AX01, N02AX06) reported in reimbursed medicines to patients.

Also known as: Opioid Group

Analgesics, Opioid

Non-Opioid Analgesic DRUG

Patients with non-opioid pain medication are included, if they received a medication therapy with anticonvulsants (gabapentin, pregabalin, carbamazepine), antidepressants or non-opioid analgesics (NSAIDs, Metamizole) over a minimum of 3 quarters, over a 60-month period between January 1, 2013, and December 31, 2017. The non-opioid treatment will be assessed using the ATC codes (N03AX12, N03AX16, N03AF01) of treatment reported in reimbursed medicines to patients.

Also known as: Non-Opioid Group

Non-Opioid Analgesic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The database contains data on around 4 million insured people from 69 German statutory health insurances (SHI). German SHI system comprises of approximately 120 independent health insurance companies. Funds paid by these SHI to any provider of health care (e.g. hospitals, physicians, pharmacies, psychotherapists and physiotherapists) represent almost the complete picture of the total health care costs of individual patients. All health insurance data can be linked to patients' demographics including age and gender. T

You may qualify if:

• \- Patients are only included if they have been diagnosed in at least three quarters in the study period with one of the following diagnoses: R51, R52\*, M00\*-M99\*, G43\*-G44\*, G50.0 or G50.1, F45.4\*, G62\*, or E10.4\*-E14.4 plus G63.3. At least one diagnoses must be between 1 January 2012 and index treatment and main and secondary hospital diagnoses (i.e. Haupt- und Nebendiagnosen) will be used to include the patients.

You may not qualify if:

• Patients with present opioid and non-opioid pain medication prescriptions in 2012 are excluded from analysis (therapy-naïve patients only).
• Palliative care, coded by ICD-10 code Z51.5 or OPS code 8-982\*, 8-98e\*, 8-98h\* before index date is excluded
• Opioid substitution treatment with ICD-10 code Z51.83 in the study period is excluded.

Sponsors & Collaborators

• LinkCare GmbH: lead
• Grünenthal GmbH: collaborator
• Klinikum Saarbrücken: collaborator
• Ruhr University of Bochum: collaborator
• Technical University of Munich: collaborator

Study Sites (1)

LinkCare GmbH

Stuttgart, 70469, Germany

Location

Related Publications (1)

• Hauser W, Schubert T, Vogelmann T, Maier C, Fitzcharles MA, Tolle T. All-cause mortality in patients with long-term opioid therapy compared with non-opioid analgesics for chronic non-cancer pain: a database study. BMC Med. 2020 Jul 15;18(1):162. doi: 10.1186/s12916-020-01644-4.

  PMID: 32664901 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Analgesics, Opioid; Analgesics, Non-Narcotic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Tino Schubert

  LinkCare GmbH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Managing Partner

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 19, 2018
• Study Start: December 5, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)