Status: Planned First registered on: 08/08/2020
Last updated on: 08/08/2020
1. Study identification
EU PAS Register NumberEUPAS36689
Official titleComparative safety study of tramadol and codeine users: a population-based cohort study
Study title acronym
Study typeObservational study
Brief description of the studyDespite 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIDIAPJGol
Department/Research groupInstitut Universitari d'Investigació en Atenció Primària Jordi Gol
Organisation/affiliationIDIAPJGol
Website/Homepagewww.idiapjgol.org
Details of (Primary) lead investigator
Title Dr
Last name Carlen
First name Reyes
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed28/06/2018
Start date of data collection01/09/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report30/09/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherIDIAP Jordi Gol100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Carlen
First name Reyes
Address line 1Gran Via Corts Catalanes, 587
Address line 2àtic 
Address line 3 
CityBarcelona 
Postcode08007 
CountrySpain
Phone number (incl. country code)0034934824110 
Alternative phone number 
Fax number (incl. country code) 
Email address creyes@idiapjgol.info
Public Enquiries
Title Dr 
Last name Carlen 
First name Reyes 
Address line 1Gran Via Corts Catalanes, 587 
Address line 2àtic 
Address line 3 
CityBarcelona 
Postcode08007 
CountrySpain 
Phone number (incl. country code)0034934824110 
Alternative phone number 
Fax number (incl. country code) 
Email address creyes@idiapjgol.info 
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