Viardot-forte capsules 1g No. 18 available in 109 pharmacies in Moscow and St. Petersburg

Component Properties

The substances included in the dietary supplement actively participate in metabolism throughout the body. They most strongly affect the reproductive and cardiovascular systems.

Vitamin E (natural tocopherols) stimulates sexual and reproductive function, has a positive effect on potency, helps increase the number of sperm and improve their motility. Vitamin E improves blood circulation, incl. and in the heart muscle. It prevents pathological blood clotting and significantly reduces the risk of blood clots, which are very dangerous and can block blood vessels.

PUFAs have a protective effect on sperm membranes and cells of the reproductive system. They help reduce the level of LDL (“bad” cholesterol) in the blood and prevent their deposition on the walls of blood vessels.

Wheat germ phytosterols help normalize the body's hormonal functions, because are precursors of steroid sex hormones: male - testosterone and female - progesterone and estradiol.

Zinc affects the activity of sex hormones and spermatogenesis, participates in the synthesis of testosterone, and inhibits the development of prostate hyperplasia (adenoma).

Selenium is an important trace element for the functioning of the reproductive system. It is part of sperm selenoproteins, improves sperm production and quality, and increases libido. Selenium also protects the heart muscle from damage, prevents the oxidation of cholesterol and its carrier proteins, protects the walls of blood vessels, and reduces the formation of cholesterol plaques.

The discussion of the results

Patients in the CG (n=20) and OG (n=30) did not differ significantly in age, composition, severity of ED and duration of treatment. When studying the hormonal status of patients in both groups, the concentration of sex hormones in the blood did not exceed normal levels. According to the results of the intracavernous test, all patients were in the E1-E4 interval on the erection quality assessment scale and were promising for drug treatment. Doppler examination of the penis and pharmacocavernosography only detailed the diagnosis of vasculogenic erectile dysfunction and made it possible to identify the disorder and severity of the disorder of the veno-occlusive mechanism. Of particular interest is a non-invasive study - LOD test, which allows you to determine the severity of venous leakage (severe, moderate, mild) taking into account the severity of patient complaints.

The main method for assessing the quality of erection in patients with erectile dysfunction of vasculogenic origin remains the study of nocturnal penile tumescence of the NPT using the RigiScan Plus hardware-software complex (HPC) (Dacomed, USA), which allows one to determine the most integral indicator - the coefficient of maximum rigidity.

As a result of complex rehabilitation treatment using the VIARDO-Forte dietary supplement in patients from the OG (n=30) compared to the CG (n=20), the following trends were identified: the quality of erection (penile tension), its duration, the quality of sexual intercourse, improved The psychological state of most patients normalized. According to a control study of hormonal status (sex hormones) in patients with vasculogenic erectile dysfunction, a tendency to increase testosterone levels in the main group of MG (n=30) is determined.

To improve the quality of treatment and increase the effectiveness of complex rehabilitation treatment for patients with erectile dysfunction, it is advisable to conduct 3-week courses of taking the VIARDO-Forte dietary supplement 2 - 3 times with an interval of 1-2 months.

Monotherapy with the use of the VIARDO-Forte dietary supplement in young patients with psychogenic erectile disorders cannot be ruled out.

Research methods

Upon admission to the department, all patients were examined according to a developed comprehensive program. Along with a thorough study of complaints, anamnesis of illness and life, the dynamics of objective data, a study of the state of erection was carried out.

Laboratory methods, along with general clinical examinations of blood and urine, included the study of biochemical parameters (bilirubin, AST, ALT, amylase, urea, creatinine) on an automatic blood analyzer (USA), blood hormones (testosterone, prolactin, lutein-stimulating and follicle-stimulating hormones) on device СENTAYR – CP (Bauer USA).

Intracavernous test. Assessing the condition of the corpora cavernosa by introducing vasoactive substances into them today occupies a central place in the diagnosis of erectile dysfunction. Injection of such substances activates local erectile mechanisms and allows assessment of vascular reserves and functional integrity of the smooth muscle cells of the corpora cavernosa (i.e., the mechanism of cavernous occlusion) in the absence of neural stimuli.

The test result was assessed on the Yunema scale after 15 minutes with the patient in an upright position according to the degree of swelling and rigidity of the penis:

Dopplerography of the penis (study of blood flow in the penis using ultrasound) was performed using a LOGIC – 5 ultrasound machine (Korea). We assessed the maximum systolic blood flow velocity (MSSV) in the arteries of the penis (normally 25-30 cmsec), end-diastolic blood flow velocity (EDSV) (normally up to 5 cmsec at a pressure level of 120 mm Hg, values more than 5 cmsec - venous-occlusive dysfunction).

Doppler ultrasound is a highly informative non-invasive method for diagnosing the nature of erectile dysfunction and allows identifying violations of veno-occlusive function in most cases.

Pharmacocavernosography - an x-ray technique - serves to determine the type of venous leakage-discharge [distal - along the deep dorsal vein system, proximal - from the crura of the penis, mixed discharge = DU (distal leakage) + PU (proximal leakage)], as well as the degree of its severity (moderate, average, pronounced). The study was carried out on a SIMENS X-ray machine (Germany) using an electron-optical converter (EOC) and a digital attachment that allows you to take pictures and record on an electronic converter with further viewing of X-ray examination data at any time interval.

Conclusions:

1. In patients with ED of vasculogenic origin, in 92% of cases there was insufficient or short-term erection, in 76% of patients, violations of venous-occlusive function were detected, in 100% of patients there was a decrease in the coefficient of maximum rigidity of the penis. The level of sex hormones in all patients with ED was within normal values. 2. The use of the VIARDO-Forte dietary supplement in complex programs of medical rehabilitation of patients with erectile dysfunction of vasculogenic origin in a rehabilitation center increases the effectiveness of their rehabilitation by improving the quality of erection, its duration, the quality of sexual intercourse, and improving the psychological state of patients.

Storage conditions

In a dry, dark place, at room temperature.

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On-demand use of tadalafil for erectile dysfunction in special categories of patients

S.I. Gamidov1, 2, T.V. Shatylko3, N.G. Hasanov1, N.A. Naumov1

1 Federal State Budgetary Institution Scientific Center for Obstetrics, Gynecology and Perinatology named after. IN AND. Kulakov" of the Ministry of Health of Russia; Russia, 117997 Moscow, st. Academician Oparina, 4; 2 Federal State Autonomous Educational Institution of Higher Education First Moscow State Medical University named after. THEM. Sechenov Ministry of Health of Russia; Russia, 119991 Moscow, st. Bolshaya Pirogovskaya, 2, building 4; 3 Federal State Budgetary Educational Institution of Higher Education “Saratov State Medical University named after. IN AND. Razumovsky" of the Ministry of Health of Russia; Russia, 410012 Saratov, st. Bolshaya Kazachya, 112 Contacts: Taras Valerievich Shatylko

Introduction

Erectile dysfunction (ED) is one of the most common and widely discussed types of sexual dysfunction in men. Worldwide, 5–20% of men have moderate or severe ED [1]. The prevalence of ED is constantly increasing, and by 2025, according to projections, 322 million men will suffer from this disorder [2]. Despite the fact that ED as such does not affect life expectancy, it significantly worsens the quality of life not only for the patient himself, but also for his partner.

Currently, there are several treatment strategies for ED, which involve non-invasive and invasive methods. According to the recommendations of the European Association of Urology, the 1st line of therapy includes oral administration of phosphodiesterase type 5 inhibitors (PDE-5) [3]. From a chemical point of view, the IPDE-5 molecules are similar in structure to cyclic guanosine monophosphate. Therefore, they can competitively bind to phosphodiesterase and suppress the hydrolysis of guanosine monophosphate, which facilitates the development of erection [4]. Currently, a large number of drugs of the PDE-5 class are proposed, although not all of them have undergone clinical trials and have been approved by the relevant regulatory authorities. Thus, in Russia, drugs are available based on one of 4 active ingredients: sildenafil, tadalafil, vardenafil and udenafil. Their effectiveness and safety are comparable; some unprincipled differences are noted in the structure of adverse events during use [5–7].

Meta-analysis by L. Chen et al. in 2015, showed that sildenafil is characterized by the highest effectiveness and the highest frequency of adverse events, and tadalafil is characterized by average effectiveness and the minimum frequency of adverse events [8]. However, these data require revision, since the meta-analysis included all studies on these drugs. B. Gong et al. conducted a more statistically rigorous meta-analysis, including only those studies that directly compared sildenafil and tadalafil [9]. It turned out that their effectiveness is approximately the same, but patients and their partners prefer tadalafil because of its ease of administration.

An important factor when choosing a drug is its pharmacokinetics. Tadalafil is a selective long-acting PDE-5 inhibitor. Tadalafil should be taken at least 16 minutes before intended sexual intercourse. The half-life of tadalafil in healthy men is 17.5 hours, and it is this pharmacokinetic parameter that makes tadalafil attractive for the symptomatic treatment of ED. Due to its long half-life, it has the longest duration of action of any PDE-5 inhibitor, which can be up to 36 hours. The patient can attempt sexual activity at any time within 36 hours after taking the drug to determine the optimal time for response development. About 52% of patients with severe ED can successfully have sexual intercourse within 30 minutes after taking tadalafil at a standard dose [10]1.

Probably, thanks to these qualities, in the near future, tadalafil will be able to occupy the niche of the main IPDE-5 for the treatment of ED. Drugs based on it entered the market in 2003.

However, it would be wrong to assume that any one drug can be equally suitable for all patients with ED, especially considering the polyetiology and heterogeneity of this syndrome. This article is devoted to the use of tadalafil in special categories of patients with ED.

Tadalafil in patients with metabolic syndrome

There are several different definitions of metabolic syndrome, but they all include 4 features: abdominal obesity, hypertension, dyslipidemia and carbohydrate metabolism disorders. In the absence of therapy and lifestyle correction, impaired glucose tolerance can develop into type II diabetes mellitus. Treatment of ED in patients with diabetes mellitus is not an easy task due to the combination of vasculogenic and neurogenic components of the pathogenesis of ED, as well as the need to take into account the associated cardiovascular risks and the interaction of prescribed drugs with hypoglycemic agents. Despite this, on-demand tadalafil therapy was effective in patients with diabetes mellitus. We note that the effect on lower urinary tract symptoms (LUTS) in these patients was greater with 5 mg tadalafil daily, although this is not the purpose of this article. Interestingly, tadalafil also improved ejaculatory function in patients with diabetes [11]. There are indications that tadalafil reduced fat-to-muscle ratio and waist circumference in men; Presumably, this occurs due to improved insulin secretion, an increase in the number of androgen receptors and inhibition of testosterone aromatization. In addition, an improvement in endothelial function has been confirmed using the Endo-Pat2000 device [12]. Molecular cellular study by E. Maneschi et al. demonstrated that tadalafil influenced the differentiation of preadipocytes and promoted a healthy phenotype by enhancing the expression of genes characteristic of brown adipose tissue, improving mitochondrial structure and normalizing insulin sensitivity in animal models [13].

In addition, metabolic syndrome may be associated with hypogonadism. A significant decrease in testosterone levels in the blood serum can weaken libido, and this turns out to be an additional pathogenetic factor in the development of ED in metabolic syndrome. There is a hypothesis according to which a regular rhythm of sexual activity helps to normalize the level of endogenous testosterone. In a study by L. Ozcan et al. Long-term use of tadalafil increased testosterone levels in patients with ED and metabolic syndrome without hormone replacement therapy [14]. L. Maresca et al. showed that taking tadalafil and regular exercise enhanced each other's effect in patients with ED and metabolic syndrome [15].

Tadalafil in patients with chronic prostatitis or benign prostatic hyperplasia

In 2007, SJ Grimsley et al. suggested that PDE-5 may mediate relaxation of the smooth muscle of the prostate ducts, facilitating the outflow of their contents, including those that initially entered the acini due to urethral-prostatic reflux [16]. M. Kurita et al. found that PDE-5 inhibitors, in particular tadalafil, relieve chronic pelvic pain [17]. Clinically, these results were confirmed in the work of Y. Nishino et al., who examined patients with benign prostatic hyperplasia (BPH), combined with chronic pelvic pain syndrome [18]. However, the above-described effects of taking tadalafil have not yet been widely confirmed and require further study [19]. P.V. Glybochko et al. demonstrated that PDE-5 increases blood flow not only in the arteries of the penis, but also in the prostate gland [20]. This direction is considered particularly promising, since chronic prostatitis can indirectly cause the development of various sexual dysfunctions [21].

We will not touch upon the issue of daily use of tadalafil for LUTS associated with BPH, as we believe that this issue deserves a separate comprehensive discussion. However, it is known that some men with prostate adenoma can obtain a positive clinical effect from taking PDE-5 on demand [22]. In particular, this applies to patients at high risk of progression of BPH who are prescribed 5-alpha reductase inhibitors (finasteride and dutasteride). These are drugs that can reduce the volume of the prostate gland with long-term use and reduce the risk of developing acute urinary retention in older men. The mechanism of action of these drugs is to inhibit the conversion of testosterone to the active metabolite dihydrotestosterone. It is the influence on testosterone metabolism that is often explained by the characteristic adverse events associated with taking finasteride and dutasteride - the appearance of persistent ED, decreased libido and impaired ejaculation. Several studies have confirmed that tadalafil, taken on demand at a dose of 20 mg, is effective against ED in patients taking dutasteride [23, 24].

Data on the effect on erection of another class of drugs actively used for BPH, namely selective alpha-1a blockers (tamsulosin and silodosin), are contradictory. There is a controversial opinion that they have little positive effect on erectile function. In any case, there is no convincing data on the negative effects of tamsulosin and silodosin on erectile function. Consequently, the question arises about their compatibility with IPDE-5, since both classes of drugs, to one degree or another, affect the tone of the vascular walls. Studies have confirmed the safety and good tolerability of combination therapy for LUTS with tamsulosin and tadalafil, which did not increase the risk of orthostatic collapse [25, 26]. The safety and effectiveness of the combination of tadalafil with silodosin has also been proven [27].

Tadalafil for neurogenic erectile dysfunction

Neurogenic ED is the most difficult form of ED to treat conservatively. The reason is that PDE-5, included in the 1st line of therapy, causes relaxation of the smooth muscles of the cavernous bodies as a result of the accumulation of cyclic guanosine monophosphate, formed due to the action of nitric oxide (NO). If the release of nitric oxide from the nitrergic synapses of parasympathetic nerve fibers does not occur, then IPDE-5 essentially has no point of application and is obviously ineffective. Therefore, for severe types of neurogenic ED, intracavernous injections remain the only effective method of conservative treatment [1]. Nevertheless, with at least partial preservation of the innervation of the penis, IPDE-5 have a certain effectiveness, which can be explained by their ability to biochemically amplify a weak NO signal and activate endothelial NO synthase. Thus, sildenafil, tadalafil and vardenafil are effective in some patients with traumatic spinal cord injury [28], the use of other PDE-5 inhibitors in this category of patients has not been studied.

The pathogenesis of ED and concomitant sexual disorders in multiple sclerosis is very complex [29]. The effectiveness of tadalafil in multiple sclerosis has been demonstrated in several studies. G. Lombardi et al. reported good results with on-demand tadalafil 10 mg in men with ED and multiple sclerosis [30]. 1 patient developed headache during therapy, 1 patient developed tachycardia; These are expected side effects that also occur in people without neurological diseases.

Not a single case of autonomic dysregulation was reliably recorded. In a study by D. Francomano et al. The effect of tadalafil not only on erection, but also on the severity of LUTS, which often occurs in patients with multiple sclerosis, has been confirmed [31]. This study also found a change in the ratio of serum testosterone to estradiol levels with tadalafil.

The use of IPDE-5 may be effective in patients with ED due to Parkinson's disease. In patients with other pathologies of the central nervous system, the use of IPDE-5 is limited due to a possible decrease in libido, the development of endocrine disorders with damage to the hypothalamic-pituitary region, and the potential effect of drugs on the neurological status [32].

The use of tadalafil to regulate reproductive function

One of the debatable questions is how justified is the prescription of IPDE-5 to men with ED who are trying to conceive a child. On the one hand, erection is the most important component of the copulatory cycle, and without it natural conception is almost impossible. On the other hand, some experts express an opinion about the potential testicular and spermatological toxicity of IPDE-5.

Non-specific PDE inhibitors such as caffeine, pentoxifylline and theophylline are known to stimulate sperm motility in vitro. Moreover, pentoxifylline is widely used for this purpose as part of assisted reproductive technologies. The effect of these compounds on male fertility in vivo has not been proven [33].

In a study by Y. Yang et al. The effect of tadalafil on sperm motility and acrosome reaction was assessed [34]. Neither in vitro nor in vivo, tadalafil suppressed gamete motility or increased the incidence of premature acrosome activation. However, this study assessed only the immediate period after the introduction of tadalafil into the medium or after its oral administration, and therefore its results do not allow us to exclude late cumulative toxicity.

Attempts have been made to prove the positive effect of IPDE-5 on spermatogenesis. Thus, in a study by A. Corvasce et al. After 12 weeks of taking tadalafil, spermogram parameters in patients with psychogenic ED significantly improved [35], including an increase in ejaculate volume. This fact indicates that the positive effect on sperm parameters could be caused primarily by the normalization of ejaculation. As is known, phosphodiesterase type 5 is expressed in all muscle tissues of the male reproductive tract, which means that influencing the level of this enzyme makes it possible to pharmacologically regulate ejaculatory function [33].

Conclusion

The effectiveness of tadalafil depends on the etiology of ED, the presence of concomitant diseases and the nature of the therapy. Tadalafil can be used in men with diabetes and metabolic syndrome, as it has been shown to be effective in these groups of patients with ED. Tadalafil combines well with typical medications used for BPH. Tadalafil is effective in some cases for neurogenic ED, although with some limitations; Its most promising use is in spinal cord injury and multiple sclerosis. Convincing data indicating a negative effect of tadalafil on fertility has not been published, although it is also premature to draw a conclusion about its positive effect on spermatogenesis and sperm motility.

Undoubtedly, tadalafil at a dosage of 5 mg for daily use has the greatest potential among all the PDE-5 inhibitors on the market, which made penile rehabilitation after treatment for prostate cancer and single-component therapy for ED and LUTS possible. However, taking tadalafil on demand is acceptable and convenient for many men suffering from ED.

The appearance on the Russian market of a generic tadalafil – “Dynamico Long”, produced on the basis of an Israeli substance2 in compliance with modern requirements and quality standards3, may make this treatment option more accessible4 compared to the use of the original tadalafil. It is important that such treatment has a positive effect not only on erectile, but also on orgasmic and ejaculatory functions, and the long duration of the drug helps maintain spontaneity of sexual life and increases a man’s self-confidence [36, 37].

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The article was published in the journal “Andrology and Genital Surgery” issue No. 4 2021, pp. 15-20

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erectile disfunction

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Andrology and genital surgery 2021 No. 4

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