Cardiovascular Outcomes Among Sildenafil Users
Cardiovascular Outcomes Among Sildenafil Users
Aim: To assess the incidence of serious cardiovascular disease (CVD) events (i.e. myocardial infarction (MI) and stroke) and all-cause mortality in men with erectile dysfunction (ED) who received prescriptions for sildenafil.
Methods: The International Men's Health Study (IMHS) was a prospective, observational cohort study of patients with ED and a new or existing prescription for sildenafil. Baseline and follow-up questionnaires provided information on demographics, CVD risk factors and ED. Postevent questionnaires were mailed to patients following possible nonfatal CVD events to collect information related to exposure to sildenafil/ED treatments before the event.
Results: Thirty-five CVD events were reported in 30 patients in the analysis set (n = 3813). The incidence of all-cause mortality, MI and stroke was 0.4, 0.6 and 0.1 per 100 patient-years of observation respectively. Among the six men who reported using sildenafil in the month before a nonfatal CVD event, two reported use in the 24 h before the event.
Conclusion: The results of the IMHS support previous reports that ED and CVD are often comorbid and share risk factors.
Sildenafil citrate (Viagra®) was the first orally active selective phosphodiesterase type-5 inhibitor (PDE-5i) for the treatment of erectile dysfunction (ED). In numerous clinical trials, sildenafil has proven to be an effective and well-tolerated treatment for ED of multiple aetiologies. Sildenafil has been approved by regulatory agencies in more than 115 countries, and more than 27 million men worldwide have been prescribed sildenafil for the treatment of ED.
During the 8 months following the 1998 marketing approval by the US Food and Drug Administration (FDA), a time during which more than 6 million prescriptions for sildenafil had been filled, voluntary spontaneous reports of cardiovascular disease (CVD) events and deaths in men taking sildenafil raised concerns about the cardiovascular safety of the drug. A report published by the FDA discussed 130 deaths, including 77 caused by CVD events, among men who had received prescriptions for sildenafil. However, the cause of death was missing or unknown in 48 patients, dosing information was unavailable for 68 patients, and the time from ingestion of sildenafil to cardiovascular event or death was unknown in 61 patients. Nevertheless, these reports raised questions of whether sildenafil treatment might trigger CVD events.
The International Men's Health Study (IMHS) was an international, prospective, observational cohort study that aimed to quantify rates of serious CVD events (i.e. myocardial infarction (MI) and stroke) and all-cause mortality in men with ED who received prescriptions for sildenafil. CVD risk factors and the time elapsed between sildenafil ingestion and the event(s) of interest were assessed to determine whether sildenafil use increased the risk of CVD events.
Summary and Introduction
Summary
Aim: To assess the incidence of serious cardiovascular disease (CVD) events (i.e. myocardial infarction (MI) and stroke) and all-cause mortality in men with erectile dysfunction (ED) who received prescriptions for sildenafil.
Methods: The International Men's Health Study (IMHS) was a prospective, observational cohort study of patients with ED and a new or existing prescription for sildenafil. Baseline and follow-up questionnaires provided information on demographics, CVD risk factors and ED. Postevent questionnaires were mailed to patients following possible nonfatal CVD events to collect information related to exposure to sildenafil/ED treatments before the event.
Results: Thirty-five CVD events were reported in 30 patients in the analysis set (n = 3813). The incidence of all-cause mortality, MI and stroke was 0.4, 0.6 and 0.1 per 100 patient-years of observation respectively. Among the six men who reported using sildenafil in the month before a nonfatal CVD event, two reported use in the 24 h before the event.
Conclusion: The results of the IMHS support previous reports that ED and CVD are often comorbid and share risk factors.
Introduction
Sildenafil citrate (Viagra®) was the first orally active selective phosphodiesterase type-5 inhibitor (PDE-5i) for the treatment of erectile dysfunction (ED). In numerous clinical trials, sildenafil has proven to be an effective and well-tolerated treatment for ED of multiple aetiologies. Sildenafil has been approved by regulatory agencies in more than 115 countries, and more than 27 million men worldwide have been prescribed sildenafil for the treatment of ED.
During the 8 months following the 1998 marketing approval by the US Food and Drug Administration (FDA), a time during which more than 6 million prescriptions for sildenafil had been filled, voluntary spontaneous reports of cardiovascular disease (CVD) events and deaths in men taking sildenafil raised concerns about the cardiovascular safety of the drug. A report published by the FDA discussed 130 deaths, including 77 caused by CVD events, among men who had received prescriptions for sildenafil. However, the cause of death was missing or unknown in 48 patients, dosing information was unavailable for 68 patients, and the time from ingestion of sildenafil to cardiovascular event or death was unknown in 61 patients. Nevertheless, these reports raised questions of whether sildenafil treatment might trigger CVD events.
The International Men's Health Study (IMHS) was an international, prospective, observational cohort study that aimed to quantify rates of serious CVD events (i.e. myocardial infarction (MI) and stroke) and all-cause mortality in men with ED who received prescriptions for sildenafil. CVD risk factors and the time elapsed between sildenafil ingestion and the event(s) of interest were assessed to determine whether sildenafil use increased the risk of CVD events.
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