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June 29, 2022Open Access

Evaluation of cardiac toxicity with ponatinib using a spontaneous reporting database

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Why the study?

Does ponatinib increase the risk of cardiac toxicity compared to other drugs in a spontaneous reporting database?

Population

1,772,494 adverse event reports in the Japanese Adverse Drug Event Report database, including 1,152 reports…

Comparison

Ponatinib vs All other drugs in the database

Design

Other

Follow-up

Up to 2 years (730 days) for time to onset analysis

Key result

Ponatinib exposure was significantly associated with increased reporting odds of 13 cardiac toxicities, most frequently hypertension (ROR 16.18) and coronary artery stenosis (ROR 82.50).

Authors

YKYuko KanbayashiMUMayako UchidaKNKana Nakano

Discussion

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Overview

Signals warrant closer cardiac monitoring during ponatinib use; hypothesis-generating and require prospective confirmation.

Study Design

Type

Observational (n=1,772,494)

Structured PICO

Does ponatinib increase the risk of cardiac toxicity compared to other drugs in a spontaneous reporting database?

P
Population
1,772,494 adverse event reports from a Japanese pharmacovigilance database, including 1,152 reports of adverse events caused by ponatinib, of which 163 were cardiac toxicities.
E
Exposure
Ponatinib (identified as the suspected drug in adverse event reports)
C
Comparator
All other drugs in the database (used as the reference to calculate the reporting odds ratio)
O
Outcome
Risk of ponatinib-induced cardiac toxicity (measured by reporting odds ratio), time to onset, and post hoc outcomessafety

Main Result

Odds Ratio: 16.18 (95% CI 11.99–21.83)

p-value: p=<0.001

Ponatinib is associated with a significantly increased risk of multiple cardiac toxicities, including hypertension and severe vascular occlusive events, which can occur early or more than a year after treatment initiation.

Limitations

  • The JADER database is based on self-reports, which introduces various reporting biases, including both over- and underreporting.
  • Lack of comprehensive medical records and medication histories limits the scope of analysis, as dosages and durations of ponatinib use were unavailable.
  • The possibility of AEs being caused by concomitantly used anticancer drugs cannot be ruled out.
  • Potential confounding, selection, and information biases cannot be fully excluded.
  • JADER database is based on self-reports, which introduces reporting biases including over- and underreporting
  • Lack of comprehensive medical records and medication histories limits analysis (dosages and durations unavailable)
  • Possibility of adverse events being caused by concomitantly used anticancer drugs cannot be ruled out
  • Potential confounding, selection, and information biases cannot be fully excluded

Cite This Study

Kanbayashi et al. (2022) conducted an observational in Cardiac toxicity (n=1,772,494). Ponatinib vs. All other drugs in the database was evaluated on Reporting odds ratio (ROR) for hypertension (ROR 16.18, 95% CI 11.99-21.83, p=<0.001). Ponatinib exposure was significantly associated with increased reporting odds of 13 cardiac toxicities, most frequently hypertension (ROR 16.18) and coronary artery stenosis (ROR 82.50).

synapsesocial.com/papers/6a9a20ab79baac75cffb4691https://doi.org/10.21203/rs.3.rs-1789857/v1
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