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A survey of the FAERS database concerning the adverse event profiles of α1-adrenoreceptor blockers for lower urinary tract symptoms.
Int J Med Sci. 2013; 10(7):864-9.IJ

Abstract

PURPOSE

Current guidelines recommend α1-adrenoreceptor blockers (A1Bs) for treating lower urinary tract symptoms suggestive of benign prostatic hyperplasia, but their adverse effects can be problematic. In this study, reports submitted to the US Food and Drug Administration Adverse Event Reporting System (FAERS) between 1997 and 2011 were reviewed to assess the safety profiles of A1Bs.

METHODS

After deleting duplicated submissions and revising arbitrary drug names, reports involving A1Bs for male patients were analyzed. Data mining algorisms were used for the quantitative detection of signals, where a signal represents an association between a drug and an adverse event or a drug-associated adverse event, including the proportional reporting ratio, reporting odds ratio, information component given by a Bayesian confidence propagation neural network, and empirical Bayes geometric mean.

RESULTS

The total number of reports used was 1,260,182. Signal scores suggested the associations of alfuzosin, doxazosin, tamsulosin, and terazosin with dizziness/vertigo, orthostatic hypotension, erectile dysfunction, ejaculation dysfunction (EjD), thirst/dry mouth, and constipation; however, reports on naftopidil, silodosin, and urapidil were not enough to compare with the other 4 A1Bs. Signal scores for EjD were higher for tamsulosin, and those for dizziness/vertigo were lower for doxazosin than for the other 3 drugs.

CONCLUSIONS

Tamsulosin-associated EjD, which was found in clinical studies, was reproduced in this analysis with markedly higher signal scores, and these results strongly suggest the necessity of well-organized clinical studies on A1B-associated adverse events.

Authors+Show Affiliations

Department of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23781132

Citation

Yoshimura, Koji, et al. "A Survey of the FAERS Database Concerning the Adverse Event Profiles of Α1-adrenoreceptor Blockers for Lower Urinary Tract Symptoms." International Journal of Medical Sciences, vol. 10, no. 7, 2013, pp. 864-9.
Yoshimura K, Kadoyama K, Sakaeda T, et al. A survey of the FAERS database concerning the adverse event profiles of α1-adrenoreceptor blockers for lower urinary tract symptoms. Int J Med Sci. 2013;10(7):864-9.
Yoshimura, K., Kadoyama, K., Sakaeda, T., Sugino, Y., Ogawa, O., & Okuno, Y. (2013). A survey of the FAERS database concerning the adverse event profiles of α1-adrenoreceptor blockers for lower urinary tract symptoms. International Journal of Medical Sciences, 10(7), 864-9. https://doi.org/10.7150/ijms.5892
Yoshimura K, et al. A Survey of the FAERS Database Concerning the Adverse Event Profiles of Α1-adrenoreceptor Blockers for Lower Urinary Tract Symptoms. Int J Med Sci. 2013;10(7):864-9. PubMed PMID: 23781132.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A survey of the FAERS database concerning the adverse event profiles of α1-adrenoreceptor blockers for lower urinary tract symptoms. AU - Yoshimura,Koji, AU - Kadoyama,Kaori, AU - Sakaeda,Toshiyuki, AU - Sugino,Yoshio, AU - Ogawa,Osamu, AU - Okuno,Yasushi, Y1 - 2013/05/15/ PY - 2013/01/17/received PY - 2013/05/05/accepted PY - 2013/6/20/entrez PY - 2013/6/20/pubmed PY - 2014/1/16/medline KW - FAERS KW - adverse events KW - pharmacoepidemiology. KW - α1 blockers SP - 864 EP - 9 JF - International journal of medical sciences JO - Int J Med Sci VL - 10 IS - 7 N2 - PURPOSE: Current guidelines recommend α1-adrenoreceptor blockers (A1Bs) for treating lower urinary tract symptoms suggestive of benign prostatic hyperplasia, but their adverse effects can be problematic. In this study, reports submitted to the US Food and Drug Administration Adverse Event Reporting System (FAERS) between 1997 and 2011 were reviewed to assess the safety profiles of A1Bs. METHODS: After deleting duplicated submissions and revising arbitrary drug names, reports involving A1Bs for male patients were analyzed. Data mining algorisms were used for the quantitative detection of signals, where a signal represents an association between a drug and an adverse event or a drug-associated adverse event, including the proportional reporting ratio, reporting odds ratio, information component given by a Bayesian confidence propagation neural network, and empirical Bayes geometric mean. RESULTS: The total number of reports used was 1,260,182. Signal scores suggested the associations of alfuzosin, doxazosin, tamsulosin, and terazosin with dizziness/vertigo, orthostatic hypotension, erectile dysfunction, ejaculation dysfunction (EjD), thirst/dry mouth, and constipation; however, reports on naftopidil, silodosin, and urapidil were not enough to compare with the other 4 A1Bs. Signal scores for EjD were higher for tamsulosin, and those for dizziness/vertigo were lower for doxazosin than for the other 3 drugs. CONCLUSIONS: Tamsulosin-associated EjD, which was found in clinical studies, was reproduced in this analysis with markedly higher signal scores, and these results strongly suggest the necessity of well-organized clinical studies on A1B-associated adverse events. SN - 1449-1907 UR - https://www.unboundmedicine.com/medline/citation/23781132/A_survey_of_the_FAERS_database_concerning_the_adverse_event_profiles_of_α1_adrenoreceptor_blockers_for_lower_urinary_tract_symptoms_ L2 - http://www.medsci.org/v10p0864.htm DB - PRIME DP - Unbound Medicine ER -