NCT04774406

Arterial Hypertension Related to PARP Inhibitors (ArteRIB)

Arterial Hypertension With PARP Inhibitors in Cancer Patients: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database (ArteRIB)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,336 (actual)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

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.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparib	All patients treated at least with 1 PARPi (alone or in combination)

Timeline

• Start date: 2021-02-24
• Primary completion: 2021-05-09
• Completion: 2022-09-01
• First posted: 2021-03-01
• Last updated: 2023-06-06

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study