Hypertensive events after the initiation of contemporary cancer therapies for breast cancer control.
FDA adverse event reporting system
cardio-oncology
hypertension
national inpatient sample
Journal
Cancer medicine
ISSN: 2045-7634
Titre abrégé: Cancer Med
Pays: United States
ID NLM: 101595310
Informations de publication
Date de publication:
01 2023
01 2023
Historique:
revised:
03
05
2022
received:
05
10
2021
accepted:
11
05
2022
pubmed:
29
5
2022
medline:
20
1
2023
entrez:
28
5
2022
Statut:
ppublish
Résumé
Contemporary therapies improve breast cancer (BC) outcomes. Yet, many of these therapies have been increasingly linked with serious cardiotoxicity, including reports of profound hypertension. Yet, the incidence, predictors, and impacts of these events are largely unknown. Leveraging two large U.S.-based registries, the National Inpatient Sample (NIS) and the Food and Drug Administration Adverse Event Reporting System (FAERS) databases, we assessed the incidence, factors, and outcomes of hypertensive events among BC patients from 2007 to 2015. Differences in baseline characteristics, hypertension-related discharges, and complications were examined over time. Further, we performed a disproportionality analysis using reporting-odds-ratios (ROR) to determine the association between individual BC drugs and hypertensive events. Utilizing an ROR cutoff of >1.0, we quantified associations by drug-class, and individual drugs with the likelihood of excess hypertension. Overall, there were 5,464,401 BC-admissions, of which 46,989 (0.8%) presented with hypertension. Hypertensive BC patients were older, and saw initially increased in-hospital mortality, which equilibrated over time. The mean incidence of hypertension-related admissions was 732 per 100,000 among BC patients, versus 96 per 100,000 among non-cancer patients (RR 7.71, p < 0.001). Moreover, in FAERS, those with hypertension versus other BC-treatment side-effects were more frequently hospitalized (40.1% vs. 36.7%, p < 0.001), and were most commonly associated with chemotherapy (45.9%). Outside of Eribulin (ROR 3.36; 95% CI 1.37-8.22), no specific drug was associated with a higher reporting of hypertension; however, collectively BC drugs were associated with a higher odds of hypertension (ROR 1.66; 95% CI 1.09-2.53). BC therapies are associated with a substantial increase in limiting hypertension.
Sections du résumé
BACKGROUND
Contemporary therapies improve breast cancer (BC) outcomes. Yet, many of these therapies have been increasingly linked with serious cardiotoxicity, including reports of profound hypertension. Yet, the incidence, predictors, and impacts of these events are largely unknown.
METHODS
Leveraging two large U.S.-based registries, the National Inpatient Sample (NIS) and the Food and Drug Administration Adverse Event Reporting System (FAERS) databases, we assessed the incidence, factors, and outcomes of hypertensive events among BC patients from 2007 to 2015. Differences in baseline characteristics, hypertension-related discharges, and complications were examined over time. Further, we performed a disproportionality analysis using reporting-odds-ratios (ROR) to determine the association between individual BC drugs and hypertensive events. Utilizing an ROR cutoff of >1.0, we quantified associations by drug-class, and individual drugs with the likelihood of excess hypertension.
RESULTS
Overall, there were 5,464,401 BC-admissions, of which 46,989 (0.8%) presented with hypertension. Hypertensive BC patients were older, and saw initially increased in-hospital mortality, which equilibrated over time. The mean incidence of hypertension-related admissions was 732 per 100,000 among BC patients, versus 96 per 100,000 among non-cancer patients (RR 7.71, p < 0.001). Moreover, in FAERS, those with hypertension versus other BC-treatment side-effects were more frequently hospitalized (40.1% vs. 36.7%, p < 0.001), and were most commonly associated with chemotherapy (45.9%). Outside of Eribulin (ROR 3.36; 95% CI 1.37-8.22), no specific drug was associated with a higher reporting of hypertension; however, collectively BC drugs were associated with a higher odds of hypertension (ROR 1.66; 95% CI 1.09-2.53).
CONCLUSIONS
BC therapies are associated with a substantial increase in limiting hypertension.
Identifiants
pubmed: 35633055
doi: 10.1002/cam4.4862
pmc: PMC9844596
doi:
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
297-305Subventions
Organisme : NHLBI NIH HHS
ID : K23 HL155890
Pays : United States
Organisme : NHLBI NIH HHS
ID : R01 HL170038
Pays : United States
Informations de copyright
© 2022 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
Références
J Am Coll Cardiol. 2007 Oct 9;50(15):1435-41
pubmed: 17919562
Curr Oncol. 2019 Jun;26(3):e322-e327
pubmed: 31285675
N Engl J Med. 2016 Nov 3;375(18):1738-1748
pubmed: 27717303
JAMA Oncol. 2018 Mar 08;4(3):e174519
pubmed: 29285538
Breast J. 2017 Mar;23(2):206-209
pubmed: 27779346
Int J Med Sci. 2013 Apr 25;10(7):796-803
pubmed: 23794943
N Engl J Med. 2019 Feb 14;380(7):617-628
pubmed: 30516102
J Am Coll Cardiol. 2020 Feb 18;75(6):620-628
pubmed: 32057377
J Biomed Inform. 2018 Jul;83:73-86
pubmed: 29860093
J Clin Oncol. 2007 Sep 1;25(25):3808-15
pubmed: 17664460
Heart Fail Clin. 2019 Oct;15(4):487-495
pubmed: 31472884
Drug Saf. 2014 Nov;37(11):971-80
pubmed: 25255848
J Clin Oncol. 2011 Feb 20;29(6):632-8
pubmed: 21205755
Ther Clin Risk Manag. 2017 Sep 11;13:1195-1203
pubmed: 28979130
Circulation. 2019 May 28;139(22):2594-2596
pubmed: 30882246
Pharmacoepidemiol Drug Saf. 2003 Oct-Nov;12(7):559-74
pubmed: 14558179
Hypertension. 2016 Feb;67(2):263-5
pubmed: 26553234
Blood. 2019 Nov 28;134(22):1919-1928
pubmed: 31582362
Cancer Med. 2023 Jan;12(1):297-305
pubmed: 35633055
J Natl Cancer Inst. 2010 May 5;102(9):596-604
pubmed: 20351338
J Cardiovasc Med (Hagerstown). 2010 Dec;11(12):861-8
pubmed: 20072001
Drug Saf. 2007;30(8):645-55
pubmed: 17696577
Blood. 2004 Sep 1;104(5):1534-41
pubmed: 15138160
Eur J Heart Fail. 2011 Jan;13(1):1-10
pubmed: 21169385
Stat Methods Med Res. 2017 Oct;26(5):2257-2269
pubmed: 26265769
Circulation. 2019 Mar 5;139(10):e56-e528
pubmed: 30700139
CA Cancer J Clin. 2021 Jan;71(1):7-33
pubmed: 33433946
Circulation. 2018 Feb 20;137(8):e30-e66
pubmed: 29437116
Resuscitation. 2019 Sep;142:30-37
pubmed: 31310845
Prog Cardiovasc Dis. 2019 Mar - Apr;62(2):116-126
pubmed: 30797800
CA Cancer J Clin. 2016 Jul;66(4):309-25
pubmed: 26919165
JACC CardioOncol. 2019 Dec;1(2):238-251
pubmed: 32206762
JAMA Intern Med. 2014 Dec;174(12):1934-5
pubmed: 25329621
Drug Saf. 2014 Oct;37(10):777-90
pubmed: 25151493
Clin Gastroenterol Hepatol. 2018 Mar;16(3):336-338
pubmed: 29155353
Biomed Inform Insights. 2017 Jun 08;9:1178222617713018
pubmed: 28634427
Drug Saf. 2014 Apr;37(4):283-94
pubmed: 24643967
Lancet. 2019 Sep 21;394(10203):1041-1054
pubmed: 31443926