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Antihypertensive drugs and erectile dysfunction as seen in spontaneous reports, with focus on angiotensin II type 1 receptor blockers
2010 (English)In: Drug, Healthcare and Patient Safety, ISSN 1179-1365, E-ISSN 1179-1365, Vol. 2, 21-25 p.Article in journal (Refereed) Published
Abstract [en]

AIM: To describe spontaneously reported cases of erectile dysfunction (ED) in association with angiotensin II type I blockers (ARB) and other antihypertensive drugs.

SUBJECTS AND METHODS: All spontaneously reported cases of ED submitted to the Swedish Medical Products Agency (MPA) between 1990 and 2006, where at least one antihypertensive drug was the suspected agent, were scrutinized. Patient demographics, drug treatment and adverse reactions were recorded. Using the Bayesian Confidence Propagation Neural Network (BCPNN) method, the information component (IC) was calculated.

RESULTS: Among a total of 225 reports of ED, 59 involved antihypertensive drugs including ARB (9 cases) as suspected agents. A positive IC value was found indicating that ED was reported more often in association with antihypertensive drugs classes, except for angiotensin-converting enzyme inhibitors, compared with all other drugs in the database. Positive dechallenge was reported in 43 cases (72%).

DISCUSSION: All classes of major antihypertensive drugs including ARB were implicated as suspected agents in cases of ED. Few risk factors were identified. The relatively high reporting of ED in association with ARB is in contrast with previous studies, suggesting that ARB have neither a positive nor any effect on ED. This discrepancy suggests that further studies are warrnted on this potential adverse reaction to ARB.

Place, publisher, year, edition, pages
Dove Medical Press Ltd , 2010. Vol. 2, 21-25 p.
Keyword [en]
erectile dysfunction, adverse drug reaction, spontaneous reporting, antihypertensive drugs, angiotensin II type 1 receptor blockers
National Category
Medical and Health Sciences
Research subject
Natural Science, Biomedical Sciences
Identifiers
URN: urn:nbn:se:lnu:diva-26677OAI: oai:DiVA.org:lnu-26677DiVA: diva2:629618
Available from: 2013-06-17 Created: 2013-06-17 Last updated: 2017-12-06Bibliographically approved
In thesis
1. Pharmacovigilance: spontaneous reporting in health care
Open this publication in new window or tab >>Pharmacovigilance: spontaneous reporting in health care
2013 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Pharmacovigilance in healthcare is essential for safe drug treatment. Spontaneous reporting is the most common source of information in the context of implementing label changes and taking a drug off the market. However, underreporting is found to be very prevalent. One way to decrease underreporting is to include different categories of healthcare professionals in such reporting and to investigate attitudes towards and incentives for reporting adverse drug reaction (ADR)s.

As nurses form the largest group of health professionals, a sample of nurses were allowed and encouraged to report ADR during a 12 month period after they had received training in pharmacovigilance. A questionnaire posted to physicians and nurses investigated their knowledge and attitudes towards reporting. Spontaneous reports of torsade de pointes (TdP) and erectile dysfunction (ED) were scrutinized with respect to the reported drugs, risk factors and if the reaction was listed in the summary of product characteristics (SPC).

After training, the nurses produced relevant reports and three years after the introduction of nurses in the reporting scheme, more than half of the responding nurses were aware of their role as reporters. Both nurses and physicians stated that the most important factor for reporting a suspected ADR was the severity of the ADR and an ADR arising in response to a newly approved drug. A web-based reporting system was deemed to facilitate the reporting. In spontaneous reports of TdP, citalopram was reported as a suspected drug. However, neither QT prolongations, nor TdP, were labelled in the SPC. ED was reported for all antihypertensive drugs including angiotensin II type I blockers. A positive information component (IC), assessing the disproportionality between the observed and the expected number of reports, was found indicating that ED was reported more often in association with antihypertensive drug classes, except for angiotensinconverting enzyme inhibitors.

This thesis demonstrates the importance of pharmacoviglilance in healthcare in terms of capturing new signals. By including nurses as reporters, the overall safety of drugs might improve. Information and education are needed to secure safe treatment when applying drugs.

Place, publisher, year, edition, pages
Linnaeus University Press, 2013. 56 p.
Series
Linnaeus University Dissertations, 132/2013
Keyword
Pharmacovigilance, adverse drug reaction, spontaneous reporting, nurses, physicians, attitudes, torsades de pointes, erectile dysfunction
National Category
Medical and Health Sciences
Research subject
Natural Science, Biomedical Sciences
Identifiers
urn:nbn:se:lnu:diva-26820 (URN)978-91-87427-24-4 (ISBN)
Public defence
2013-05-08, N2007, Smålandsgatan 26a, Kalmar, 13:00 (Swedish)
Opponent
Supervisors
Available from: 2013-06-19 Created: 2013-06-19 Last updated: 2017-05-30Bibliographically approved

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