Investigation of the Effect of the Atherogenic Index on the Therapeutic Response to Tadalafil in Patients With Vascular Erectile Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- Association Between Baseline Atherogenic Index of Plasma and Tadalafil Nonresponse at Week 12
研究概览
简要总结
This prospective single-center observational cohort study examined whether baseline atherogenic index of plasma (AIP), calculated from routine triglyceride and high-density lipoprotein cholesterol measurements, was associated with response to once-daily tadalafil in men aged 40 years or older with erectile dysfunction. Tadalafil 5 mg once daily was prescribed as part of routine clinical care, independently of study participation, and participants were prospectively followed for 12 weeks. Erectile function was assessed using the six-item International Index of Erectile Function-Erectile Function domain (IIEF-EF) at baseline and Week 12. Treatment response was defined as an increase of at least 4 points in the IIEF-EF score from baseline. All participants received tadalafil, and there was no untreated or placebo comparator; therefore, the study evaluated the association between baseline AIP and observed outcome during tadalafil treatment.
详细描述
The atherogenic index of plasma (AIP) is a laboratory-based marker of atherogenic dyslipidemia and subclinical atherosclerosis. AIP was calculated as log10(triglycerides/high-density lipoprotein cholesterol) after conversion of both lipid values to mmol/L. Because vascular and metabolic abnormalities contribute to erectile dysfunction and may influence response to phosphodiesterase type 5 inhibitors, baseline AIP may be associated with treatment outcomes during tadalafil therapy.
This was a prospective, single-center observational cohort study of men aged 40 years or older with predominantly vasculogenic erectile dysfunction based on clinical assessment and predefined eligibility criteria. Participants were consecutively enrolled from an outpatient urology clinic. Baseline demographic, clinical, and laboratory data were recorded. Tadalafil 5 mg once daily was prescribed as part of routine clinical care, independently of study participation, and enrolled participants were prospectively followed for 12 weeks.
Erectile function was assessed using the six-item International Index of Erectile Function-Erectile Function domain (IIEF-EF) at baseline and Week 12. The primary objective was to evaluate the association between baseline AIP and tadalafil treatment response. Treatment response was defined as an increase of at least 4 points in the IIEF-EF score from baseline to Week 12; an increase of less than 4 points was classified as nonresponse.
Because all participants received tadalafil and the study did not include an untreated or placebo comparator, the association between AIP and outcome was interpreted as prognostic during tadalafil treatment rather than as evidence of causality or differential treatment benefit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged 40 years or older Erectile dysfunction symptoms for at least 3 months International Index of Erectile Function-Erectile Function domain (IIEF-EF) score below 26 Predominantly vasculogenic erectile dysfunction based on medical history, focused physical examination, and baseline clinical assessment Suitable for tadalafil treatment Phosphodiesterase type 5 inhibitor-naive or no phosphodiesterase type 5 inhibitor use for at least 1 month before enrollment Provided written informed consent
排除标准
- •Contraindication to tadalafil, including nitrate use Major cardiovascular disease within the previous 6 months or other clinically unstable cardiovascular conditions Diagnosed hypogonadism or hormone replacement therapy Severe hepatic or renal insufficiency Predominantly psychogenic erectile dysfunction Erectile dysfunction primarily attributable to neurological, hormonal, or medication-related causes Previous radical pelvic surgery or major pelvic trauma Penile anatomical abnormalities, including Peyronie's disease Alcohol or substance dependence Poorly controlled diabetes mellitus, defined as glycated hemoglobin (HbA1c) of 8.0% or higher Use of medications affecting lipid metabolism, such as corticosteroids Initiation or dose modification of lipid-lowering therapy within the previous 3 months Uncontrolled thyroid dysfunction Active infection or inflammatory disease Active malignancy treatment
研究组 & 干预措施
Men With Predominantly Vasculogenic Erectile Dysfunction
Men aged 40 years or older with predominantly vasculogenic erectile dysfunction who were prescribed tadalafil 5 mg orally once daily as part of routine clinical care, independently of study participation, and were prospectively followed for 12 weeks.
干预措施: tadalafil (Drug)
结局指标
主要结局
Association Between Baseline Atherogenic Index of Plasma and Tadalafil Nonresponse at Week 12
时间窗: Baseline and Week 12
Baseline atherogenic index of plasma (AIP) was calculated as log10(triglycerides/high-density lipoprotein cholesterol) after conversion of both values to mmol/L. Erectile function was assessed using the six-item International Index of Erectile Function-Erectile Function domain (IIEF-EF) at baseline and Week 12. Treatment response was defined as an increase of at least 4 points in the IIEF-EF score from baseline to Week 12, and nonresponse was defined as an increase of less than 4 points. The association between baseline AIP and tadalafil nonresponse at Week 12 was evaluated.
Association Between Atherogenic Index of Plasma and Response to Tadalafil Treatment
时间窗: 1 Month
Assessment of the relationship between the baseline Atherogenic Index of Plasma (AIP) and the therapeutic response to daily tadalafil 5 mg treatment in patients with vascular erectile dysfunction. Treatment response will be evaluated by the change in erectile function scores measured using the International Index of Erectile Function (IIEF-5) before and after one month of therapy.
次要结局
未报告次要终点
研究者
M. B. Can Balci
Professor of Urology
Taksim Egitim ve Arastirma Hastanesi
