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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04774406

Enrollment

2336

Registered

2021-03-01

Start date

2021-02-24

Completion date

2022-09-01

Last updated

2023-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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.

Interventions

DRUGolaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparib

All patients treated at least with 1 PARPi (alone or in combination)

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026