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Evaluation of syncope association with α1-adrenoceptor blockers in males using the FAERS database: impact of concomitant hypertension.
Pharmazie. 2019 12 01; 74(12):755-759.P

Abstract

Previous studies have revealed an association between the administration of α1-adrenoceptor blockers (α1Bs) and episodes of syncope in patients with benign prostatic hyperplasia (BPH). The objective of the present study was to evaluate the association between α1Bs and syncope in BPH patients with hypertension using two different pharmacoepidemiological indices. Using the US Food and Drug Administration Adverse Event Reporting System, we analyzed the whole dataset and subsets for specific indications, including hypertension, diabetes, and dyslipidemia, for males older than 40 years. The drugs of interest were alfuzosin, doxazosin, and terazosin as non-selective α1Bs and silodosin and tamsulosin as selective α1Bs. The reporting odds ratio (ROR) and information component (IC) were used for signal detection. The association between the non-selective α1Bs and syncope was observed for all the items examined. The results obtained using the whole dataset, as well as the diabetes and dyslipidemia subsets, were same for the selective and non-selective α1Bs in terms of the association with syncope, while no association with syncope was observed for both silodosin [ROR: 1.09, 95% confidence interval (CI): 0.61-1.93; IC: 0.10, 95% CI: -0.72-0.92] and tamsulosin (ROR: 1.08, 95% CI: 0.90-1.30; IC: 0.10, 95% CI: -0.17-0.37) in patients with hypertension. The data suggested that α1Bs, even those with receptor subtype selectivity, were associated with syncope. Thus, careful attention should be paid when prescribing α1Bs, especially to patients who do not take medications for hypertension.

Authors

No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31907118

Citation

Ohyama, K, et al. "Evaluation of Syncope Association With Α1-adrenoceptor Blockers in Males Using the FAERS Database: Impact of Concomitant Hypertension." Die Pharmazie, vol. 74, no. 12, 2019, pp. 755-759.
Ohyama K, Hori Y, Sugiura M. Evaluation of syncope association with α1-adrenoceptor blockers in males using the FAERS database: impact of concomitant hypertension. Pharmazie. 2019;74(12):755-759.
Ohyama, K., Hori, Y., & Sugiura, M. (2019). Evaluation of syncope association with α1-adrenoceptor blockers in males using the FAERS database: impact of concomitant hypertension. Die Pharmazie, 74(12), 755-759. https://doi.org/10.1691/ph.2019.9706
Ohyama K, Hori Y, Sugiura M. Evaluation of Syncope Association With Α1-adrenoceptor Blockers in Males Using the FAERS Database: Impact of Concomitant Hypertension. Pharmazie. 2019 12 1;74(12):755-759. PubMed PMID: 31907118.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of syncope association with α1-adrenoceptor blockers in males using the FAERS database: impact of concomitant hypertension. AU - Ohyama,K, AU - Hori,Y, AU - Sugiura,M, PY - 2020/1/8/entrez PY - 2020/1/8/pubmed PY - 2020/1/8/medline SP - 755 EP - 759 JF - Die Pharmazie JO - Pharmazie VL - 74 IS - 12 N2 - Previous studies have revealed an association between the administration of α1-adrenoceptor blockers (α1Bs) and episodes of syncope in patients with benign prostatic hyperplasia (BPH). The objective of the present study was to evaluate the association between α1Bs and syncope in BPH patients with hypertension using two different pharmacoepidemiological indices. Using the US Food and Drug Administration Adverse Event Reporting System, we analyzed the whole dataset and subsets for specific indications, including hypertension, diabetes, and dyslipidemia, for males older than 40 years. The drugs of interest were alfuzosin, doxazosin, and terazosin as non-selective α1Bs and silodosin and tamsulosin as selective α1Bs. The reporting odds ratio (ROR) and information component (IC) were used for signal detection. The association between the non-selective α1Bs and syncope was observed for all the items examined. The results obtained using the whole dataset, as well as the diabetes and dyslipidemia subsets, were same for the selective and non-selective α1Bs in terms of the association with syncope, while no association with syncope was observed for both silodosin [ROR: 1.09, 95% confidence interval (CI): 0.61-1.93; IC: 0.10, 95% CI: -0.72-0.92] and tamsulosin (ROR: 1.08, 95% CI: 0.90-1.30; IC: 0.10, 95% CI: -0.17-0.37) in patients with hypertension. The data suggested that α1Bs, even those with receptor subtype selectivity, were associated with syncope. Thus, careful attention should be paid when prescribing α1Bs, especially to patients who do not take medications for hypertension. SN - 0031-7144 UR - https://www.unboundmedicine.com/medline/citation/31907118/Evaluation_of_syncope_association_with_α1-adrenoceptor_blockers_in_males_using_the_FAERS_database:_impact_of_concomitant_hypertension L2 - https://www.ingentaconnect.com/openurl?genre=article&issn=0031-7144&volume=74&issue=12&spage=755&aulast=Ohyama DB - PRIME DP - Unbound Medicine ER -
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