Study identification

EU PAS number

EUPAS7588

Study ID

20325

Official title and acronym

An Observational Study of Upper Gastrointestinal Tract (UGIT) Bleeding Events in Patients Taking Duloxetine and NSAIDs (F1J-MC-B040)

DARWIN EU® study

No

Study countries

United States

Study description

This study was a retrospective case-control analysis. The interaction between duloxetine and prescribed NSAIDs is described as the odds ratio (OR) for risk of UGI bleed where there is exposure to both duloxetine and prescription nonselective NSAIDs, COX-2 selectiveNSAIDs or prescription aspirin. Multivariable analysis using logistic regression provided adjusted OR and 95% confidence intervals (CIs). The primary endpoint of whether concomitant use of duloxetine and Rx NSAIDs is associated with a synergistic effect on the risk of UGIbleed was conducted with a relative excess risk due to interaction (RERI) calculation. The risk of UGI bleeding associated with duloxetine exposure was assessed via multivariable analysis, and the severity ofUGI bleeding cases across all study populations was described. The interaction between duloxetine and prescription NSAIDs (nonselective NSAIDs, COX-2 selective NSAIDs, and prescription aspirin combined)as well as over the counter (OTC) NSAIDs was conducted as sensitivity analyses.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Hu Li

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)