Arterial Hypertension Related to PARP Inhibitors (ArteRIB)

Completed

• Conditions: Cancer
• Interventions: Drug: olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparib

• Registration Number: NCT04774406
• Lead Sponsor: University Hospital, Caen

Brief Summary

Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but serious (or not) adverse events such as hypertension whose data are scarce.

The objective was to investigate reports of hypertension related to PARPi, including olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, and fluzoparib using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.

Detailed Description

Here, investigators use the World Health Organization's (WHO) database of individual safety case reports, to identify cases of hypertension AE related to PARPi.

Study Timeline

• Study Start: 2021-02-24
• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-03-01
• Primary Completion: 2021-05-09
• Study Completion: 2022-09-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2336

Inclusion Criteria

• case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,
• patients treated with at least 1 PARPi (with ATC classification system): olaparib (ATC L01XX46), niraparib (ATC L01XX54), rucaparib (ATC L01XX55), talazoparib (ATC L01XX60), veliparib, pamiparib, fluzoparib (none).

Exclusion Criteria

-chronology not compatible between the PARPi and adverse event

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
parp inhibitors	olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparib	All patients treated at least with 1 PARPi

Primary Outcome Measures

Name	Time	Method
hypertension reports related to PARPi.	From inception to 16 Feb, 2023	Identification of the hypertension adverse event related to PARP inhibitors reported in the World Health Organization's (WHO) database of individual safety case reports.

Trial Locations

Locations (1)

Alexandre Joachim; 🇫🇷 Caen, Basse Normandie, France