Application of the complex Edelim in pathogenetic management of patients with erectile dysfunction
Abstract
AIM:To assess the degree of changes in complaints, dynamics of biochemical parameters of lipid metabolism, penile hemodynamics in patients with ED during therapy with EDELIM in comparison with PDE-5 inhibitors. Assess the tolerability of the drug based on the analysis of reported adverse events.
MATERIALS AND METHODS:The study was prospective comparative observational cohort. The study included 60 patients over 18 years old with complaints of persistent, at least 1 month, erectile dysfunction. The patients were divided into 2 groups: group 1 patients with ED received Edelim on a regular basis, one capsule 2 times daily for 3 months; group 2 patients with ED received generic tadalafil 5 mg daily for 1 month, then 1 month break, then 5 mg per day for 1 month.
RESULTS:The mean age of the patients was 38.4 9.2 years. In group 1, significant differences were noted in the all hemodynamic and biochemical indicators, except for HDL levels (2.2 0.4 vs. 2.3 0.4 mmol/L;p= 0.067). In group 2, significant differences were noted in the dynamics of the IIEF-5 scale, the level of HDL, and the blood flow velocity in the right and left cavernous arteries. There were no significant differences in blood flow in the left and right dorsal arteries, levels of total cholesterol, LDL, triglycerides, glucose, HbA1c, systolic blood pressure. In the 1st group of patients, there were no adverse events, in the 2nd group, in 3 patients mild side effects.
CONCLUSIONS:The improvement in the quality of…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 60 participants or records.
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