Atherogenic Index of Plasma and Tadalafil Response in Erectile Dysfunction (AIVERT)

Investigation of the Effect of the Atherogenic Index on the Therapeutic Response to Tadalafil in Patients With Vascular Erectile Dysfunction

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.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: tadalafil

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 176

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34433
      • Taksim Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Men aged 40 years or older presenting consecutively to the outpatient urology clinic with erectile dysfunction symptoms for at least 3 months, an IIEF-EF score below 26, and predominantly vasculogenic erectile dysfunction based on clinical assessment were enrolled. Tadalafil 5 mg orally once daily was prescribed as part of routine clinical care, independently of study participation, and participants were prospectively followed for 12 weeks. Patients with contraindications to tadalafil, major nonvasculogenic causes of erectile dysfunction, or predefined unstable systemic or metabolic conditions were excluded.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: tadalafil; Tadalafil 5 mg was prescribed orally once daily for 12 weeks as part of routine clinical care, independently of study participation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association Between Baseline Atherogenic Index of Plasma and Tadalafil Nonresponse at 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.	Baseline and Week 12

Collaborators and Investigators

• Sponsor: Taksim Egitim ve Arastirma Hastanesi

Publications and helpful links

General Publications

• Sambel M, Erdogan A, Caglayan V, Avci S, Kilic S, Yildiz HE, Keskin E. Can atherogenic indices and the triglyceride-glucose index be used to predict erectile dysfunction? Sex Med. 2024 Jan 19;11(6):qfad069. doi: 10.1093/sexmed/qfad069. eCollection 2023 Dec.
• Culha MG, Canat L, Degirmentepe RB, Albayrak AT, Atalay HA, Merder E, Ariman A, Altunrende F. The correlation between atherogenic indexes and erectile dysfunction. Aging Male. 2020 Dec;23(5):1232-1236. doi: 10.1080/13685538.2020.1749996. Epub 2020 Apr 8.

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2025
• Primary Completion (Actual): February 21, 2026
• Study Completion (Actual): February 21, 2026

Study Registration Dates

• First Submitted: March 14, 2026
• First Submitted That Met QC Criteria: March 14, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 27, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Tadalafil; Treatment Response; International Index of Erectile Function; Atherogenic Index of Plasma; Phosphodiesterase Type 5 Inhibitor; Vasculogenic Erectile Dysfunction
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Erectile Dysfunction; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Indole Alkaloids; Heterocyclic Compounds, 3-Ring; Carbolines; Tadalafil
• Other Study ID Numbers: 29 (2022)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data underlying the results reported in the primary publication will be made available upon reasonable request. These data may include baseline demographic, clinical, laboratory, lipid-profile, Atherogenic Index of Plasma (AIP), and International Index of Erectile Function-Erectile Function domain (IIEF-EF) data collected at baseline and Week 12. Direct identifiers and other information that could permit participant re-identification will not be shared.
• IPD Sharing Time Frame: Data will be available beginning 3 months after publication of the primary study results and will remain available for 5 years, upon reasonable request and subject to applicable ethical and privacy requirements.
• IPD Sharing Access Criteria: Researchers who submit a methodologically sound proposal may request access to deidentified individual participant data from the corresponding author. Requests will be reviewed by the study investigators and, where applicable, the relevant institution and ethics committee. Data will be provided only for approved research purposes and may be subject to a data-use agreement. Approved data will be shared using a secure electronic transfer method.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No