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An observational cohort study investigating the cardiovascular safety of tadalafil when prescribed in primary care in England: mortality due to ischaemic heart disease

An observational cohort study investigating the cardiovascular safety of tadalafil when prescribed in primary care in England: mortality due to ischaemic heart disease
An observational cohort study investigating the cardiovascular safety of tadalafil when prescribed in primary care in England: mortality due to ischaemic heart disease
OBJECTIVE To examine the cardiovascular safety of tadalafil, a phosphodiesterase type-5 inhibitor used for treating erectile dysfunction in patients prescribed this drug by general practitioners (GPs) in England in 2003, focusing on mortality due to ischaemic heart disease (IHD).
PATIENTS AND METHODS Patients in this observational cohort study were identified from dispensed prescriptions for tadalafil issued by GPs from February to November 2003. Demographic and outcome data were requested from patients' GPs using a postal questionnaire. A standardized mortality ratio (SMR) was calculated using indirect standardization for all deaths from IHD or myocardial infarction (MI) in male patients who were prescribed tadalafil, regardless of whether they were taking tadalafil at the time, compared to those in the English male population (2002).
RESULTS Clinical information was obtained for 6266 patients; patient sex could not be confirmed for 37 but in the remaining 6229 the median age was 61 years (interquartile range 53–68). The age was not specified for 2361 (37.7%) of the patients. Excluding patients not taking tadalafil at the time of the event, cardiovascular events included chest pain in 20, angina in 18, MI in 15 (including six fatal) and IHD in 11 (including five fatal). There were also six deaths where the cause was not ascertained; five of these patients were known to be male. Comparison of mortality due to IHD or MI for men with those in the English male population (2002) provided an SMR of 0.91 (95% confidence interval 0.50–1.48).
CONCLUSIONS The results from this study suggest a similar incidence of death due to IHD or MI in men prescribed tadalafil to that in the male English population. However, due to possible under-reporting and the limitations of using an external comparator, these results should be interpreted in context with other studies on the cardiovascular effects and safety of tadalafil.
england, myocardial ischemia, humans, middle aged, questionnaires, disease, pain, patients, epidemiology, cohort studies, male, erectile dysfunction, family practice, research support
1464-4096
387-393
Hazell, Lorna
3bd28ce4-b95c-4126-9468-9de4148382b4
Boshier, Andrew
330539eb-7784-4d6c-8a8b-4ad034e9e880
Harris, Scott
19ea097b-df15-4f0f-be19-8ac42c190028
Wilton, Lynda V.
256cf2df-2315-4a38-b928-d67e5517f7cf
Shakir, Saad A.W.
648f9207-b801-4dc9-9f7f-b694bb4dc518
Hazell, Lorna
3bd28ce4-b95c-4126-9468-9de4148382b4
Boshier, Andrew
330539eb-7784-4d6c-8a8b-4ad034e9e880
Harris, Scott
19ea097b-df15-4f0f-be19-8ac42c190028
Wilton, Lynda V.
256cf2df-2315-4a38-b928-d67e5517f7cf
Shakir, Saad A.W.
648f9207-b801-4dc9-9f7f-b694bb4dc518

Hazell, Lorna, Boshier, Andrew, Harris, Scott, Wilton, Lynda V. and Shakir, Saad A.W. (2007) An observational cohort study investigating the cardiovascular safety of tadalafil when prescribed in primary care in England: mortality due to ischaemic heart disease. BJU International, 99 (2), 387-393. (doi:10.1111/j.1464-410X.2007.06581.x).

Record type: Article

Abstract

OBJECTIVE To examine the cardiovascular safety of tadalafil, a phosphodiesterase type-5 inhibitor used for treating erectile dysfunction in patients prescribed this drug by general practitioners (GPs) in England in 2003, focusing on mortality due to ischaemic heart disease (IHD).
PATIENTS AND METHODS Patients in this observational cohort study were identified from dispensed prescriptions for tadalafil issued by GPs from February to November 2003. Demographic and outcome data were requested from patients' GPs using a postal questionnaire. A standardized mortality ratio (SMR) was calculated using indirect standardization for all deaths from IHD or myocardial infarction (MI) in male patients who were prescribed tadalafil, regardless of whether they were taking tadalafil at the time, compared to those in the English male population (2002).
RESULTS Clinical information was obtained for 6266 patients; patient sex could not be confirmed for 37 but in the remaining 6229 the median age was 61 years (interquartile range 53–68). The age was not specified for 2361 (37.7%) of the patients. Excluding patients not taking tadalafil at the time of the event, cardiovascular events included chest pain in 20, angina in 18, MI in 15 (including six fatal) and IHD in 11 (including five fatal). There were also six deaths where the cause was not ascertained; five of these patients were known to be male. Comparison of mortality due to IHD or MI for men with those in the English male population (2002) provided an SMR of 0.91 (95% confidence interval 0.50–1.48).
CONCLUSIONS The results from this study suggest a similar incidence of death due to IHD or MI in men prescribed tadalafil to that in the male English population. However, due to possible under-reporting and the limitations of using an external comparator, these results should be interpreted in context with other studies on the cardiovascular effects and safety of tadalafil.

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More information

Published date: 19 January 2007
Keywords: england, myocardial ischemia, humans, middle aged, questionnaires, disease, pain, patients, epidemiology, cohort studies, male, erectile dysfunction, family practice, research support

Identifiers

Local EPrints ID: 61813
URI: http://eprints.soton.ac.uk/id/eprint/61813
ISSN: 1464-4096
PURE UUID: 6814f894-fb8d-4123-a4db-bd815c8380be

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Date deposited: 10 Sep 2008
Last modified: 08 Jan 2022 01:14

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Contributors

Author: Lorna Hazell
Author: Andrew Boshier
Author: Scott Harris
Author: Lynda V. Wilton
Author: Saad A.W. Shakir

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