Arterial Hypertension Related to PARP Inhibitors (ArteRIB)

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: May 9, 2021

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

  • Drug: olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparib
    • All patients treated at least with 1 PARPi (alone or in combination)

Arms, Groups and Cohorts

  • parp inhibitors
    • All patients treated at least with 1 PARPi

Clinical Trial Outcome Measures

Primary Measures

  • hypertension reports related to PARPi.
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • University Hospital, Caen
  • Provider of Information About this Clinical Study
    • Sponsor

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