Aim. To study the effect of different intensities of statin therapy on androgen status and erectile function in men aged 40-65 years with high and very high cardiovascular risk. Additionally, to assess the association between sex hormone levels, erectile function parameters, and traditional cardiovascular risk factors, arterial stiffness, and endothelial function in this patient category.
Material and methods. It is planned to conduct a prospective randomized controlled trial, including 150 male patients aged 40-65 years, undergoing routine preventive examinations in the clinic of Moscow State University, having a high and very high risk of cardiovascular diseases and meeting the inclusion criteria. Group Pit (n=75) will receive pitavastatin at a starting dose of 1 mg/day. Group Ros (n=75) will receive rosuvastatin 20 mg/day. After 3 months, the biochemical parameters will be monitored, and dose titration of pitavastatin to 2-4 mg/day and/or rosuvastatin to 40 mg/day will be performed if necessary. Patient recruitment to the study will occur over 9 months at a single research center. Patients will be monitored with an objective assessment of erectile function parameters, blood analysis (including androgen status), central arteries stiffness, and endothelial function for 6 months from the moment of activation. Follow-up visits are scheduled at 1, 3 and 6 months.
Results. The expected result of testing the research hypothesis is that statin therapy will not have a negative effect on androgen status and erectile function in men. Intensive statin therapy will have a greater positive effect on endothelial function, which may lead to an improvement in men's erectile function.
Conclusion. The study was planned under the assumption that statin therapy would not have a negative effect on androgen status and erectile function in men aged 40-65 years. It is also suggested that the positive effect of statins on endothelial function and vascular stiffness may lead to an improvement in erectile function among men with high and very high cardiovascular risk. If the hypothesis is confirmed, the results obtained will help improve statin treatment adherence in male patients and, as a result, increase the effectiveness of prevention of cardiovascular events.
male patients aged 40-65 years, sexually active
high and very high risk of cardiovascular events (The Systematic Coronary Risk Evaluation 2 (SCORE2))
absence of previous statin therapy for 3 months
there are no known cardiovascular diseases requiring the appointment of statins in high doses from the start of treatment
known statin intolerance
known hypogonadism
persistent forms of atrial fibrillation
active malignant neoplasm requiring treatment at the time of screening
Parallel
Pitavastatin 1-4 mg daily
DrugGroup Pit (n=75) will receive pitavastatin at a starting dose of 1 mg/day. After 3 months, the biochemical parameters will be monitored, and dose titration of pitavastatin to 2-4 mg/day will be performed if necessary.
Rosuvastatin 20-40 mg daily
DrugGroup Ros (n=75) will receive rosuvastatin 20 mg/day. After 3 months, the biochemical parameters will be monitored, and dose titration of rosuvastatin to 40 mg/day will be performed if necessary.
objective assessment of erectile function parameters
The relative increase in the diameter of the penis, the duration of the relative increase in the diameter of the penis is more than 20%, the duration of the relative increase in the diameter of the penis is more than 30%. The assessment is carried out using the Androscan nocturnal penile tumescence recorder.
androgen status
Concentration of male sex hormones: testosterone, estradiol, dihydrotestosterone, sex hormone binding globulin.
central arteries stiffness
To determine the stiffness of the wall of the main vessels, measurement of the pulse wave velocity (m / s) using a single-socket device "BPLab Vasotens® Office" will be used
endothelial function
a study of flow-dependent vasodilation of the brachial artery with an assessment of endothelial function according to a standard procedure. The diameter of the brachial artery is compared at rest and after 5 minutes from the moment of termination of the functional test. An increase in the diameter of the brachial artery of 10% or more indicates the absence of endothelial dysfunction
subjective assessment of erectile function parameters
The subjective assessment of the parameters of erectile function is planned to be assessed using the International Index of Erectile Function (IIEF) Questionnaire, which is recognized as the "gold standard" for evaluating erectile function in clinical trials. During the study, the scores obtained in this questionnaire will be compared. SCORING: 1-10: Severe Erectile Dysfunction 11-16: Moderate dysfunction 17-21: Mild to moderate dysfunction 22-25: Mild dysfunction 26-30: No dysfunction
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