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Erectile dysfunction is a chronic disease and is detected in 9.5% of 40-year-old men, reaching 71.2% of the prevalence in men aged 71-80 years. For the therapy of ED, inhibitors of phosphodiesterase-5 (PDE-5) sildenafil, tadalafil and vardenafil are currently used. Cialis Super Active (Tadalafil) has the greatest half-life in comparison with other PDE-5 inhibitors and is recommended for ED therapy on demand at a dose of 20 mg. Cialis begins to have an effect in 16-30 minutes. After administration and the duration of its effect is maintained up to 36 hours. However, even with this duration of action, the use of the drug on demand only temporarily improves sexual function. In this regard, some sexologists observe and express concern that the planning of sexual activity associated with ED therapy on demand may negatively affect the psychological status and quality of life of patients, as well as their partners, especially those for whom spontaneity of relationships or round-the-clock Efficiency is important. There is evidence that the regular use of cialis super active in experimental animals contributes to partial regression of changes in cavernous bodies and improvement of their oxygenation after selective bilateral neuroectomy of the cavernous nerves. Thus, the concept of constant continuous daily admission tadalafil actively discussed in recent years by various researchers.
With this therapeutic approach, taking 5 mg of Cialis super active is recommended 1 time / day, with a possible dose reduction of up to 2.5 mg, taking into account individual efficacy and tolerability. The researchers found that after 5 days of continuous administration of tablets tadalafil in plasma, an equilibrium concentration of the drug is achieved, sufficient for the development and maintenance of the effect with a slight individual variability. An important advantage of this type of therapy is the possibility of using cialis super active in combination with adrenoblockers without any dose adjustment. In addition, dose adjustment is not required in patients with moderate renal and hepatic impairment, as well as in those patients receiving protease inhibitors or the enzyme system CYP3A4 (ketoconazole). However, daily administration of cialis is not recommended for patients with severe renal insufficiency.
Effectiveness and safety of cialis super active therapy 1 time / day. Were evaluated in various multicenter, randomized, placebo-controlled studies in men with ED both in the general population and in patients with diabetes mellitus.
So, in one of the studies, the effectiveness and safety of daily therapy with tadalafil 5 and 10 mg was compared with placebo. The study included heterosexual men over the age of 18 years with ED who developed at least 3 months. Before inclusion in the study. Patients did not use any other therapy for ED. Patients with ED who developed due to hypogonadism, radical prostatectomy (except bilateral nerve-preserving surgery), severe renal or hepatic insufficiency, decompensation of diabetes mellitus (DM), unstable angina pectoris requiring nitrate intake, and heart failure were not included in the study. Thus, the study included 268 men who received placebo, tadalafil 5 and 20 mg in a ratio of 1: 2: 2, respectively. The therapy lasted for 12-15 weeks. Of the 280 patients, 234 completed the study (50 of them received a placebo, 93 cialis super active 5 mg and 91 tadalafil 10 mg). Daily administration of cialis in a dose of 5 and 10 mg significantly improved the erectile function of patients compared with placebo. It is important to note that the effectiveness of the drug did not depend on the initial severity of ED. So, against the background of placebo, the increase in the ICEF score averaged 0.9 – while against the background of 5 and 10 mg of tadalafil – 9.7 and 9.4, respectively (p <0.001). At the same time, the percentage of patients who answered “yes” to SEPQ2 question against the background of placebo therapy increased by 11.2%, and against cialis super active therapy 5 and 10 mg – by 36.5 and 39.4%, respectively. In addition, the percentage of patients who answered “yes” to the question of SEPQ3 against the background of placebo therapy increased by 13.2%, and against the background of tadalafil therapy 5 and 10 mg at 45.5 and 50.1%, respectively (p <0.001).
It should be noted that complete elimination of ED was achieved only in 8.3% of men receiving placebo, while in men receiving tadalafil in doses of 5 and 10 mg, complete elimination of ED was achieved in 51.5 and 50.5% respectively. In this case, 28.3% of patients receiving placebo responded positively to the question of GAQ, while against the background of taking cialis super active in a dose of 5 and 10 mg, this indicator was 84.5 and 84.6%, respectively.
The side effects of therapy were mild in 53.8% and in modest extent in 32.8% of patients. In this case, dyspepsia, headache, back pain, abdomen and myalgia were less common in patients who received tadalafil 20 mg (2.8 to 6.4%) compared with patients receiving tadalafil 10 mg (from 6.7 to 11.4%). Of the 34 patients who discontinued the study, 9 (3.4%) discontinued the study due to side effects (1 due to a headache in the placebo group, 1 due to headache and dizziness in the tadalafil group of 5 mg; 1 – due to myalgia, headache, dyspnea, and dyspepsia and 2 – due to abdominal pain in the tadalafil group of 10 mg).
In another multicenter, placebo-controlled study, the efficacy and safety of daily administration of tadalafil 2.5 and 5 mg in ED therapy was evaluated. The study included 287 men. The exclusion criteria corresponded to those in the above study. Men who had previously received PDE-5 inhibitors without effect were also excluded from the study. Patients were randomized into 3 groups: placebo (n = 94), tadalafil 2.5 mg (n = 96), and tadalafil 5 mg (n = 97). The therapy continued for 24 weeks, with patients taking the drug at the same time, regardless of sexual activity. Against the background of daily administration of tadalafil erectile function of patients has improved significantly. Thus, the increase in the ICEF score among patients receiving placebo, tadalafil 2.5 and 5 mg averaged 1.2, 6.1 and 7.0, respectively, while the percentage of patients who answered yes to the question SEPQ2, against the background The results of the therapy were 5.2, 24.3 and 26.2%, respectively, while for the SEPQ3 question the figures were 9.5, 31.2 and 35.1% (p <0.001 for all parameters of the comparisons). 26.1% of patients receiving placebo responded positively to the question of GAQ, while against the background of taking tadalafil 2.5 and 5 mg, the figure was 62.8 and 72.8%, respectively.
The side effects revealed during the study were, in most cases, insignificant or moderate in severity, transient and decreased with continued use of the drug. The most common side effects were headache and dyspepsia, as well as back pain, myalgia and nasal congestion.
Along with studies devoted to the study of the efficacy and safety of tadalafil in the general population, a 12-week multicenter, randomized, placebo-controlled trial of tadalafil therapy in the once-daily regimen was conducted. In patients with diabetes and ED. The study included men with diabetes mellitus type 1 and type 2 and ED at the age of over 18 years (mean age 57 ± 9 years) with an ED history of at least 3 months. At the same time, 42.6% of patients had severe ED. Patients did not receive any ED therapy during screening and research prescription. Patients with HbA1c> 13.0%, clinically significant renal or hepatic insufficiency, uncontrolled hypertension, unstable angina, acute myocardial infarction or stroke, and those receiving nitrate therapy were not included in the study. In addition, the study did not include patients with surgical causes of ED. A total of 298 patients were included in the study: 100 of them received a placebo, 100 – tadalafil 2.5 mg, and 98 – tadalafil 5 mg daily, once for 12 weeks. Of these, 254 (85.2%) completed the study. Against the background of taking a placebo, the increase in the ICEF score averaged 1.3, while against the background of 2.5 and 5 mg of tadalafil, 4.8 and 4.5, respectively. At the same time, the percentage of patients who answered “yes” to SEPQ2 question against the background of placebo therapy increased by 5.3%, and against the background of tadalafil therapy 2.5 and 5 mg – by 20.5 and 28.9%, respectively. In addition, the percentage of patients who answered “yes” to the question of SEPQ3, compared with placebo therapy, increased by 8.2%, and against the background of tadalafil 2.5 and 5 mg therapy by 25.9% and 25%, respectively (p <0.005).
The study assessed the effect of pills therapy on serological biomarkers of endothelial dysfunction, which reflect inflammatory and oxidative processes in the arteries. The study found no statistically significant changes in the levels of C-reactive protein, nitrotyrosine, and other markers in any of the treatment groups. The absence of such an effect can be explained by the presence of several factors: severe pathology of the vascular bed in the patients being examined; Low sensitivity of methods, short observation period or low dose of cialis super active 20 mg. No significant changes in carbohydrate metabolism were also noted during the study. Of the side effects found in patients, there was headache, back pain and indigestion. Lower back pain was significantly more frequent in patients receiving 5 mg of tadalafil (Cialis), compared with patients receiving 2.5 mg of tadalafil (p = 0.028) Prescription. Of the study, 4% of patients who received tadalafil 2.5 mg dropped out; 3.1% – tadalafil 5 mg; 4% – placebo.
Given that ED is a chronic disease requiring constant therapy, along with the above studies, the efficacy and safety of longer-term use of tadalafil in patients once a day was studied. In the study, patients over 18 years of age with varying degrees and etiology of ED received 5 mg of tadalafil daily for 1 year (n = 234) or 2 years (n = 238). The parameters of erectile function in patients receiving tadalafil during the year improved by an average of 9.6 and 8.4 points, of sexual satisfaction by 3.6 and 3.0 points, of overall satisfaction by 2.7 and 2.8 points respectively. In addition, in a 2-year study, 78.9% of patients responded positively to the question of GAQ.
During the study, no serious side effects were found, the most frequent were: in a 1-year study: dyspepsia (9.4%), headache (9.4%), back pain (7.3%), Influenza-like symptoms (5.6%); In a 2-year study – arterial hypertension (6.3%), rhinopharyngitis (5.9%), sinusitis (5.9%) and back pain (5.0%).
It should be noted that one of the important aspects of therapy is super active cialis in the regime of 1 time / day. Is the time of onset of the clinical effect of the drug. A multicenter, randomized, placebo-controlled study was devoted to this aspect. 331 men (2 groups – placebo, n = 138 and tadalafil 5 mg, n = 193) attempted sexual intercourse within the first 10 days from the start of the drug use. At the same time, the number of patients who had a successful sexual intercourse during the period from the 2nd to the 10th day of tadalafil administration was statistically significantly higher compared with placebo (p <0.001). On the 10th day of 131/193 therapy (67.9%) of patients receiving 5 mg of tadalafil 20 mg reported successful sexual intercourse compared with 52/138 (37.7%) in patients receiving placebo (p <0.0001 ). Thus, the administration of Cialis in a dose of 5 mg – 10 mg / day. Significantly improves sexual function after 2 days of therapy.
The effect of regular admission of tadalafil on vascular endothelial function and its ability to improve its own erection after drug withdrawal was studied in an open cross-over study comparing regular tadalafil administration at a dose of 20 mg every other day using the same dose of the drug on request. In this paper, the advantage of regular admission of tadalafil from the point of view of its positive effect on such characteristics of endothelial function of vessels of cavernous bodies as data of penile dopplerography (peak systolic velocity and dilatation rate of cavernous bodies) was shown. In the group of patients taking tadalafil, a more significant improvement in spontaneous erections was regularly observed, and positive effects of the drug were observed after 2 weeks.

In one of the experimental studies, it was shown that tadalafil Super Active is able to reduce the intensity of apoptosis in cells of denervated cavernous tissue of experimental animals, i.e. Has a cytoprotective effect on the vascular endothelium. This finding can be considered as a basis for the early regular use of the drug in sexual rehabilitation programs after operations on the pelvic organs that can damage the innervation of the cavernous bodies and cause ED.
Thus, according to current experimental and clinical studies, tadalafil therapy is 1 time / day. Is effective and safe, while the efficacy does not decrease with prolonged use of the drug, and the incidence of side effects is comparable to that of both tadalafil on demand and other PDE-5 inhibitors.
The absolute absence of psychological dependence on the time of taking the drug, including the round-the-clock effectiveness, the positive impact on the quality of life of patients, as well as their partners, and, of course, the independence of the effect of eating and drinking, allowing the patient to lead a normal lifestyle, Not changing their habits and preserving the spontaneity of sexual activity. The effect of regular admission tadalafil in relatively small doses develops quickly enough and persists throughout the duration of the drug. The positive effect observed in the experiment on the endothelial function of the cavernous bodies suggests that tadalafil with prolonged regular administration can improve the erection even after withdrawal, although this assumption requires confirmation in further clinical studies.

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