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An open-label, non-comparative study of impaza for the treatment of erectile dysfunction.

E. B. Mazo, S. I. Gamidov, R. I. Ovchinnikov

OPEN, NON-COMPARATIVE STUDY OF IMPAZA FOR THE TREATMENT OF ERECTILE DYSFUNCTION

Urological Clinic (Head - Corresponding Member of the Russian Academy of Medical Sciences, Prof. E. B. Mazo) Russian State Medical University, Moscow

Introduction. Erectile dysfunction (ED) is a chronic condition and can be defined as the inability to achieve and/or maintain an erection sufficient to satisfy sexual activity. The prevalence of ED among men of all ages is 10%, and in the group of men 40–70 years old it reaches 52% [1].

Of all the mechanisms of ED, one of the most common is endothelial dysfunction, which consists of inadequate production of nitric oxide (NO) by the vascular endothelium in response to adequate stimuli (hemodynamic effects, cholinergic stimulation, etc.).

In recent years, ED has been shown to be a largely treatable condition. The requirements for drugs intended for the treatment of ED are formulated: high efficiency, reliability, good tolerability, painlessness, non-invasiveness.

The targets of the most effective modern drugs for the treatment of ED are, firstly, endothelial function (for phosphodiesterase type 5 inhibitors), and, secondly, central dopaminergic mechanisms (for apomorphine).

Studies conducted on the use of sildenafil citrate - SC (Viagra) for ED have shown high effectiveness (58-85%) of the drug in the treatment of ED [2, 3]. At the same time, the high cost of the drug and the significant risk of developing adverse drug reactions, especially in patients with cardiovascular diseases, limit the widespread use of this drug. In addition, there is a group of patients (15-42%) in whom the use of SC is ineffective [4, 5]. The above dictates the need to search for new highly effective, safe and affordable drugs for the treatment of ED.

Since 2002, a new domestic drug for the treatment of ED, Impaza, has been introduced into practice. The theoretical prerequisite for the creation of impase (the active substance is antibodies to endothelial NO synthase in ultra-low doses) was the discovery of the modifying properties of ultra-low doses of antibodies (O. I. Epshtein, M. B. Stark, T. M. Vorobyova, 1999).

The mechanisms of action of impase as a representative of a new class of drugs based on ultra-low doses of antibodies, on the one hand, and a fundamentally new means of restoring erectile function, on the other, can be judged with sufficient confidence on the basis of experimental studies.

Preclinical studies allowed us to draw the following conclusions. When administered orally to male rats under conditions of physiological (seasonal) and age-related suppression of reproductive function, impaza reliably stimulates sexual behavior and increases the copulatory function of animals. At the same time, changes in some indicators indicate that the drug has central effects on erection mechanisms [6, 7].

During the administration of impase, a significant increase in the intracellular level of cyclic guanosine monophosphate in the tissue of the corpora cavernosa was detected (similar data were obtained for SC) [8]. Both single and course administration of impase (as opposed to SC) increases the content of NO derivatives in the tissues of the corpora cavernosa.

The increase in NO content in the tissue of the corpora cavernosa of animals treated with impaza is due to a twofold increase in the activity of NO synthases (the sources of NO in the corpora cavernosa are neuronal and endothelial NO synthases).

Thus, the main peripheral mechanism of action of impase has been experimentally confirmed: an increase (restoration) of the activity of NO synthase, the key enzyme that determines the maintenance of an erection, i.e., with the administration of the drug, the ability of the endothelium to produce NO increases (restores), which means that impase helps restore endothelial function.

The results of preclinical and clinical studies of the new Russian homeopathic drug anti>Yusynthase C12 + S3O + C200 (impaza) suggest that the drug has the ability not only to improve, but also to restore erectile function.

Material and methods. Employees of the urological clinic of the Russian State Medical University, together with the NPO Materia Medica, conducted an open, non-comparative study of the drug impaza as a treatment for ED, the purpose of which was to assess the clinical effectiveness and safety of the drug.

According to the protocol, men with complaints of decreased erection were included in the study. The inclusion criteria for the study were: patients aged 45 to 65 years with symptoms of ED. Assessment of erectile function on the IIEF scale (International Index of Erectile Function) from 10 to 25 points, availability of a protocol of informed consent for the study. Treatment was carried out on an outpatient basis and in a hospital. Exclusion criteria: regular use of medications leading to the development of ED during the study period; simultaneous use of SC or other drugs intended for the treatment of ED, chronic alcoholism; confirmed endocrine causes of ED development. And also if the erectile function score on the IIEF scale is less than 10 points, in the presence of sexually transmitted diseases, the patient’s inability to adequately fill out the IIEF questionnaire; decompensated diseases that may affect the conduct of the study; hypersensitivity to any of the components of the drugs used in the study; participation in other clinical trials within the last month or currently.

The study was conducted in 30 patients with ED aged 45-65 years (average age 52.09 ± 4.75 years), of which 11 suffered from arterial hypertension, 7 from spinal osteochondrosis, 3 from diabetes mellitus, 2 had a history of blunt perineal trauma , 1 - multiple sclerosis, 1 underwent radical prostatectomy, 5 were diagnosed with psychogenic ED.

The average body weight of patients was 84.58 ± 15.98 kg (60–125 kg). Heart rate 71.6 ± 4.67 beats/min (62–82 beats/min). Systolic blood pressure 127.75 ± 15.37 mmHg. Art. (110-170 mm Hg), diastolic - 84.1 ± 11.11 mm Hg. Art. (70-110 mmHg). The duration of ED was 2.11 ± 1.76 years (0.2–7 years). The majority of patients (24 patients - 80%) experienced a gradual increase in signs of ED, which indicated the organic nature of ED. Only in 6 (20%) patients was it possible to establish a connection between ED and a specific event. The most common events associated with ED were stress, job change, divorce, or death of a sexual partner. The vast majority of patients (28 people - 93.3%) had only one sexual partner.

All patients underwent an examination, which included an analysis of medical history data, a history of sexual activity, a questionnaire on the IIEF scale, an intracavernosal pharmacological test, Doppler ultrasound of the vessels of the penis before and after simulated artificial erection, electromyography of the penis, a study of blood hormones (testosterone, prolactin, thyroid-stimulating hormone , triiodothyronine, thyroxine) and standard laboratory tests (complete blood count, urinalysis, blood glucose, creatinine, lipid profile) to exclude chronic diseases.

All patients took 1 tablet of Impaza every other day, regardless of sexual intercourse (it was recommended to keep the tablet in the mouth until completely absorbed) for 12 weeks. The number of attempts at sexual intercourse is at least 4 per month.

The effectiveness of treatment was assessed by changes in IIEF indicators, subjective assessment of clinical effectiveness by the patient, assessment of clinical effectiveness by the doctor (excellent effect - an increase in the “erectile function” indicator by more than 50% or achieving a scale value of 25 points or higher, a good response - an increase in the indicator by 30– 50%, satisfactory response - by 10-30%, without effect - a change in the indicator by ± 10%, deterioration - a decrease in the indicator by 10% or more), assessment of the patient’s tolerability of therapy, the presence and nature of adverse events during the period of active therapy.

The effectiveness of impase depending on the pathogenesis of ED

Pathogenesis of ED	Efficiency
Pathogenesis of ED	excellent	good	satisfactory	ineffective
Psychogenic (n = 5)	4	1	1	—
Arterial (n = 10)	3	—	1	5
Veno-oculosal (n = 1)	—	2	—	1
Neurogenic (n =	4	—	1	1
Nsyroartsrial (n =4)	—	1	2	2
Arteriovenous (n=2)	—	—	—	1
Total…	11	4	5	10

23 (76.7%) patients received regular drug therapy for concomitant diseases (nitrates, angiotensin-converting factor inhibitors, calcium antagonists, blockers, non-steroidal anti-inflammatory drugs, hypoglycemic drugs), the volume of which did not change during the study. About half of the patients (14 people - 46.7%) were active smokers. 13 (43.3%) patients did not drink alcohol at the time of the study, 14 (46.7%) drank alcohol occasionally (once a week or less), 3 (10%) drank alcohol more than once a week. The vast majority of patients included in the study (27 people (90%) had not previously received specific treatment, 3 (10%) patients had previously received SC with a positive effect, but stopped treatment due to its high cost.

According to the results of a comprehensive andrological examination, ED in pathogenesis was psychogenic in 5 (16.7%), organic in 25 (83.3%) patients, of which arteriogenic in 10 (33.3%), veno-occlusive in 1 (3.3%). ), neurogenic in 8 (26.7%), neuroarterial in 4 (13.3%), arteriovenous in 2 (6.7%) patients. The level of hormones in the blood was within the age norm in all cases.

Results and discussion. Before treatment, the average “erectile function” score on the IIEF scale

was 18.89 + 5.25 points (10-25 points), after 3 months 22.50 ± 4.86 points (10-29 points). At the same time, in 11 (36.7%) patients the effectiveness of treatment was assessed as excellent (mainly due to the achievement of the “erectile function” indicator value of 25 points or more), in 4 (13.3%) - as good, in 5 ( 16.7%) - as satisfactory, in 10 (33.3%) - without effect, no deterioration was recorded in any patient.

Basically, an excellent effect was noted in patients with psychogenic, neurogenic and subcompensated arterial ED (see table). Impase therapy was ineffective in patients with decompensated arterial insufficiency, veno-occlusive and mixed ED (neuroarterial, arteriovenous).

There was no significant correlation between the effect of impaza and the body weight of the patients.

The effectiveness of impase therapy varied from 60 to 66.7% depending on the etiology and pathogenesis of ED.

In 7 (23.3%) patients, improvement in IIEF indicators occurred gradually as they continued taking the drug impaza for 10-11 weeks, which may indicate a therapeutic effect and an ongoing therapeutic effect. In addition, there was an increase in the number of sexual intercourse and sexual activity from 5-6 to 7-10 attempts per month. The total score of the indicators “satisfaction with sexual intercourse” and “general satisfaction” of the ICEF questionnaire also increased from 7.15 ± 2.37 to 12.48 ± 3.54 and from 4.58 ± 1.52 to 7.42 ± 2.69 respectively. No significant changes in the “orgasm” and “sexual desire” indicators of the ICEF questionnaire were recorded.

The tolerability and safety of therapy are rated as “excellent.” During the study, not a single undesirable side effect was recorded, either as assessed by patients or as assessed by the physician. There were no negative effects on the course of concomitant diseases, and there was no need to change the treatment of these conditions.

Conclusion. The new domestic homeopathic drug impaza is an effective treatment for patients with organic and psychogenic ED. Its effectiveness reliably exceeds the “placebo” effect [9] and has been proven by preclinical experimental and clinical studies. The advantages of this drug are its effectiveness and high safety compared to other known drugs (SC, intracavernosal injections), the possibility of combining treatment with the treatment of concomitant diseases, including coronary heart disease, arterial hypertension, etc., the almost complete absence of side effects and systemic negative influences, relative low cost of the drug and course of treatment. In addition, the possibility of a course of use with a consistent increase in effectiveness in some patients also indicates the therapeutic effect of the drug impaza.

LITERATURE

Feldman N. A, Goldstein /., Hatzichristou DG et al. J. Urol. (Baltimore) 1994; 151:5461.
Goldstein I., Lue T. F., PadmaNathan H. et al. N.Engl. J. Med. 1998; 338:13971404.
Morales A, Gingell C, Collins M et al. Int. J. Impot. Res 1998′ 10:6974.
PadmaNathan H., Steers W. D., Wicker P. A. Int. J Clin Pract 1998; 52:375379.
Wespes E, Amar E. et al. Eur. Urol. 2002; 41:15.
Borovskaya T. G., Loskutova O. P., Epshtein O. I., Zak M. S. Bull. exp. biol. 2001; Adj. 3: 52-53.
Smolenov IV, Dygai A. M, Epstein O. I. et al. Pharmacologist 2002; 44 (2, suppl. 1): A167.PetrovV.I.Dygai A.M., Martyushev A.V. et al. In the book: Materials of the Medico-Pharmaceutical Forum. M.; 2002.8687.

Topics and tags

Erectile dysfunction
Impaza

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Effect of the drug

Effective drugs that increase potency should act on the mechanism of dilation of blood vessels responsible for blood supply to the penis. Over the course of many years of work and a large number of tests, it was revealed that the dilation of blood vessels is associated with the production of nitric oxide (NO), for which the enzyme endothelial NO synthase is responsible. In men, when this enzyme is disrupted, not only erectile dysfunction is observed, but also other diseases (atherosclerosis, diabetes, hypertension, etc.). If the function of the vascular endothelium is disrupted, then the production of factors that regulate the tone of the smooth muscles of the vascular wall is also disrupted. The main molecule responsible for muscle relaxation and vasodilation is NO (nitric oxide).

Many modern methods and drugs for increasing potency in men and restoring erections have no effect on stimulating the production of NO (nitric oxide), but only block the destruction of intracellular “messengers”. But the treatment of erectile dysfunction will be much more effective when using drugs based on the production of NO (nitric oxide).

The qualitative difference between Impase and most drugs is that the target of its action is the endothelial NO synthase (eNOS) molecule. Thus, weak erections can be cured by increasing the activity of endothelial NO synthase (eNOS) and restoring adequate NO (nitric oxide) production during sexual stimulation. The action of the drug Impaza helps to increase the content of cyclic guanosine monophosphate (cGMP) in smooth muscles and their relaxation, leading to improved blood supply to the cavernous bodies. It is necessary to pay attention to the fact that the earlier treatment is started, the faster the restoration of erection occurs. But the more the endothelium is damaged, the more time it takes to treat sexual dysfunction.

Erection mechanisms

Before describing the most effective methods and drugs that increase potency in men, it is worth examining in detail the process of erection. The male reproductive organ consists of a corpus spongiosum and two cavernous bodies, each of which has its own artery and vein, but has no connection with other bodies through blood vessels. The bodies of the penis contain a huge number of small cavities, with the help of which the phenomenon of erection is achieved. If a man has sexual desire, then there is an expansion of the arteries that carry blood to the cavernous and spongy bodies, and a simultaneous narrowing of the veins through which the blood flows. As a result, a significant amount of blood accumulates in the cavities, and an erection occurs. If for any reason this mechanism “breaks down,” they speak of “erectile dysfunction.”

Impaza is a new effective drug for increasing potency, which has a positive effect on all components of male sexual life.

Treatment with Impaza is indicated for disorders such as decreased libido and erectile dysfunction, and drugs of this group can be used not only for the treatment, but also for the prevention of disorders in intimate life. The effectiveness of this method of treating erectile dysfunction without surgery has been proven by numerous clinical studies that have revealed the peculiarities of the action of the drug.