Prevalence and Incidence of Underlying Disease Diagnosed in Men With Erectile Dysfunction When Prescribed a PDE5i for the First Time
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98,832
- 主要终点
- Percentage of Participants With Underlying Condition Until Day -1 of the Index PDE5i Prescription
研究概览
简要总结
Erectile dysfunction (ED) has been identified as an independent risk factor for existing cardiovascular disease, preceding a major cardiovascular event by an average of about 5 years. Are men prescribed a PDE5 inhibitor for ED more likely to have a new diagnosis of underlying medical conditions compared to men of a similar age not receiving PDE5 inhibitor treatment?
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Records of men aged >18 years with an index PDE5 inhibitor (sildenafil, tadalafil or vardenafil) prescription between January 1st, 1999, and June 30th, 2008
- •no prior PDE5 inhibitor prescription before the index prescription
- •continuous enrolment with medical history for ≥60 months prior to the index prescription date
排除标准
- •Records of female subjects and any male subjects not meeting the inclusion criteria will be excluded
- •A subject can only be selected once independent of the assignment to the target or the control populations.
结局指标
主要结局
Percentage of Participants With Underlying Condition Until Day -1 of the Index PDE5i Prescription
时间窗: Day -92 up to Day -1 of index prescription
Underlying conditions were defined as any diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.
Cumulative Percentage of Participants With New Diagnosis of Underlying Condition Between Index PDE5i Prescription (Day 0) and Day 91
时间窗: Day 0 to Day 91 post index prescription
New diagnosis of underlying condition at prescription was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.
Percentage of Participants With New Diagnosis of Underlying Condition Between Day 366 and Day 457 Post the Index PDE5i Prescription
时间窗: Day 366 up to Day 457 post index prescription
New diagnosis of underlying condition was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.
Percentage of Participants With New Diagnosis of Underlying Condition Between Day -92 and Day -1 Prior to the Index PDE5i Prescription
时间窗: Day -92 up to Day -1 of index prescription
New diagnosis of underlying condition was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.
Percentage of Participants With Underlying Condition at PDE5i Market Introduction During the Early Study Period
时间窗: Up to 3 years (Early study period - January 1999 to December 2001)
Underlying condition at PDE5i market introduction was defined as any diagnosis of interest until day -1 in participants who received the index prescription between January 1, 1999 and December 31, 2001 for the three years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.
次要结局
- Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Establishment During the End of Study Period(Up to 2 years (End of study period - July 2006 to June 2008))
- Percentage of Participants With Underlying Condition at PDE5i Establishment During the End of Study Period(Up to 2 years (End of study period - July 2006 to June 2008))
- Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Market Introduction During the Early Study Period(Up to 3 years (Early study period - January 1999 to December 2001))