Effects of Tadalafil on LMR and MHR in Patients With ED

Evaluation of the Effects of a Daily Dose of 5 mg of Tadalafil on Lymphocyte to Monocyte Ratio and Monocyte to High-Density Lipoprotein Ratio in Patients With Erectile Dysfunction

The aim of the study was to investigate whether daily 5 mg tadalafil over eight weeks affects to Lymphocyte/Monocyte ratio (LMR) and Monocyte/High-Density Lipoprotein ratio (MHR) in patients with erectile dysfunction (ED).

Thirty-one patients with organic ED and 31 healthy controls between July 2017 and November 2018 were included in this retrospective study. To avoid bias, the patients were randomly selected and the controls were also incorporated consecutively. The presence of ED was determined according to the International Erectile Function Index-5 (IIEF-5). The patients and the controls were evaluated in terms of IIEF-5, complete blood count, serum biochemistry, LMR, and MHR.

Study Overview

• Status: Completed
• Conditions: Inflammation; Erectile Dysfunction
• Intervention / Treatment: Drug: Tadalafil 5mg tablet

Detailed Description

The medical records of the heterosexual men treated with the diagnosis of organic ED in the Urology department of a private hospital between July 2017 and October 2018 were evaluated retrospectively. The number of samples to be included in the study was determined by the help of the computer-assisted power analysis. Random sampling was performed from all cohorts of patients with ED. Thirty-one male patients between the ages of 39-65 with organic erectile dysfunction more than one year and treated with OAD 5 mg dose of tadalafil for eight weeks were selected as the treatment group (group T)The patients in group T have been assessed both before (T1) and after (T2) the treatment.

Between the ages of 39-65, thirty-one healthy men who were admitted to the internal medicine outpatient clinic for their annual follow-up were selected consecutively and the control group (group C) was formed. All subjects in the control group were sexually active men with regular monogamous heterosexual relationships during the last one year.

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• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• Turkey
  • Samsun, Turkey, 55020
    • Samsun Liv Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 39 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Between the ages of 39-65, thirty-one healthy men who were admitted to the internal medicine outpatient clinic for their annual follow-up were selected consecutively and the control group Thirty-one male patients with organic erectile dysfunction more than one year between 39 and 65 years of age which were treated with OAD 5 mg dose of tadalafil for eight weeks were selected as the treatment group

Description

Inclusion Criteria:

• 39-65 years old men with ED
• 39-65 years old, haelthy men
• Patients that have received 5 mg tadalafil/day for 8 weeks
• Patients with informed consent forms
• Patients with no missing variables

Exclusion Criteria:

• Patients with systemic autoimmune and inflammatory disease,
• congestive heart failure,
• chronic renal failure, and chronic hepatobiliary disease,
• chronic lung disease, and thyroid dysfunction,
• patients with acute infection,
• patients with neurological deficits,
• metabolic syndrome and malignancy
• Patients with a history of prostate, penile or pelvic surgery or radiotherapy,,
• patients receiving anticoagulant, beta-blocker, antidepressants and antipsychotics, hormonal therapy,
• patients with alcohol and smoking

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group T; 31 Patients with ED who receiving 5 mg/day of Tadalafil for 8 weeks.	Drug: Tadalafil 5mg tablet; Once-a-day 5 mg dose of tadalafil for 8 weeks; Other Names: phosphodiesterase type 5 (PDE5) inhibitor
Group C; Thirty-one healthy men who were admitted to the internal medicine outpatient clinic for their annual follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lymphocyte to Monocyte Ratio	ratio of values in complete blood count	up to 8 weeks
monocyte to HDL ratio	an inflamamtoy marker	up to 8 weeks
The International Index of Erectile Function (IIEF-5) Questionnaire	IIEF-5 scoring: The IIEF-5 score is the sum of the ordinal responses to the 5 items. 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunctio	up to 8 weeks
monocyte count	complete blood count	up to 8 weeks
lymphocyte count	complete blood count	up to 8 weeks
HDL cholesterol	serum lipid profile	up to 8 weeks
Testosteron	hormonal evaluation	up to 8 weeks
fasting glucose	serum glucose level	at the 1st day

Collaborators and Investigators

• Sponsor: Samsun Liv Hospital
• Collaborators: Ondokuz Mayıs University
• Investigators: Study Chair: Yakup Bostancı, MD, Ondokuz Mayıs University

Publications and helpful links

General Publications

• Gupta BP, Murad MH, Clifton MM, Prokop L, Nehra A, Kopecky SL. The effect of lifestyle modification and cardiovascular risk factor reduction on erectile dysfunction: a systematic review and meta-analysis. Arch Intern Med. 2011 Nov 14;171(20):1797-803. doi: 10.1001/archinternmed.2011.440. Epub 2011 Sep 12.
• Kadihasanoglu M, Karabay E, Yucetas U, Erkan E, Ozbek E. Relation between Monocyte to High-Density Lipoprotein Cholesterol Ratio and Presence and Severity of Erectile Dysfunction. Aktuelle Urol. 2018 Jun;49(3):256-261. doi: 10.1055/s-0042-123163. Epub 2017 Nov 16.
• Cimen S, Dursun M, Sulukaya M, Besiroglu H. Could the monocyte/HDL cholesterol ratio be an early marker of erectile dysfunction? Aging Male. 2020 Dec;23(5):694-699. doi: 10.1080/13685538.2019.1574735. Epub 2019 Feb 19.

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2019
• Primary Completion (Actual): March 10, 2019
• Study Completion (Actual): April 5, 2019

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 23, 2019
• Last Update Submitted That Met QC Criteria: April 20, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Erectile Dysfunction; lymphocyte to monocyte ratio; monocyte to HDL ratio
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Inflammation; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Tadalafil
• Other Study ID Numbers: OMU KAEK 2019/158

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No