Study identification

PURI

https://redirect.ema.europa.eu/resource/45210

EU PAS number

EUPAS36689

Study ID

45210

Official title and acronym

Comparative safety study of tramadol and codeine users: a population-based cohort study

DARWIN EU® study

No

Study countries

Spain

Study description

Despite the growing awareness of the harms produced by chronic opioid use, tramadol is still favourably recommended by remarkable clinical guidelines, therefore we aimed to assess the incidence of adverse events among incident users of tramadol compared to codeine users among subjects ≥ 18 years old in Catalonia, Spain. We conducted a population-based cohort study using the SIDIAP database (www.sidiap.org) which is a primary care database that covers over 5 million subjects in Catalonia (Spain). We included all incident users of study drugs (tramadol/codeine) (2007-2017) with no use in the previous year and ≥18 years old, ≥1 year of valid data. We excluded those with combined dispensation of tramadol and codeine in the same day as well as subjects with any of the outcome events of interest at the index date. Follow-up: (latest of) start of the study period or 1-year of valid data until (earliest of) end of enrolment, date of last capturing data, event of interest or end of follow-up. Our exposure were incident tramadol or codeine use (active comparator) and our outcomes, a composite cardiovascular event (cardiac arrythmia, heart failure, myocardial infarction, stroke), delirium, fractures, falls, sleep disorders, constipation, opioid dependence/abuse, all-cause mortality. Confounders: sociodemographic and socioeconomic characteristics, life style factors (alcohol and tobacco status), medical conditions and drugs, ATCs prescribed, GP visits, hospital admissions and traffic accidents. We calculated the Incidence rates, absolute rate difference, and adjusted hazard ratios with 95% confidence intervals using cause-specific Cox proportional hazards regression model accounting for competing risk of death. Propensity-score matching was used to minimize confounding.

Study status

Finalised
Research institution and networks

Institutions

Contact details

Carlen Reyes

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Other

More details on funding

IDIAP Jordi Gol
Study protocol
Initial protocol
English (344.25 KB - PDF)View document
Updated protocol
English (931.92 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable