New Vardenafil Formula: Oral Dispersible Tablets Levitra (ODT)
Constantly increasing pace of life of a modern man claims new requirements to medicinal products for treatment of erectile dysfunction: patient demand not only efficiency and safety, but also convenience of application.
Oral Dispersible Tablets (ODT) Levitra: Real and Unreal Clinical Setting
It is well known that erectile dysfunction (ED) means incapacity of a man to achieve or preserve erection sufficient for sexual activity which is observed within at least three months. The causes of sexual issues may be different: endocrinological disorders, psychological problems, vascular pathology, etc. In this regard, the questions of diagnostics and treatment of erectile disorders are studied by specialists in various areas – not only urologists, but also endocrinologists, cardiologists, therapists, and psychologists. Very often aged patients complain of erectile dysfunction combined with accompanying pathology: hypertension, cardio-vascular diseases, and metabolic syndrome. According to some data, men of 60-65 years of age suffer from 5-6 disorders and enter the risk group for ED development.
Thus, sexual impairments are observed in 87,5% of patients with atherosclerotic cardiovascular disease, arterial hypertension and diabetes; around 77% of patients have erectile problems on the setting of atherosclerotic cardiovascular disease and in combination with hypertension and diabetes. Unfortunately, patients belonging to the risk group of ED development are generally not detected by therapists. In the meantime, therapist who knows of the possibility of accompanying development of indicated pathologies may recommend a patient to consult urologist, since simultaneous ED treatment with other vascular diseases is more effective than separate therapy of these pathologies. This is connected with the fact that regular intake of low doses of PDE5 inhibitors is beneficial for endothelial function.
It goes without saying that a man suffering from ED who was recommended taking PDE5 inhibitors puts hopes on this remedy. Very often patients expect medicine for normalization of fail-proof efficiency (70%) and fast onset time (69%). Convenience of application (65%), independence on food intake (54%), insensible intake (52%) and inconspicuous package (45%) are also important. These expectations are lived up by a new vardenafil formula in the form of oral dispersible tablets Levitra, Levitra ODT.
What Is Levitra ODT?
Active substance contained in Levitra ODT gets partially absorbed in mouth cavity which allows a patient to avoid the problem of drug’s initial passing via liver and to draw the onset of action nearer. Besides, clinically significant interaction of Levitra ODT with food is absent which means that men may not change their lifestyle.
Convenient presentation form provides absence of necessity to drink the medication with water and allows taking it unnoticed at any time and any place. Levitra ODT reaches minimal concentration in blood plasma quicker than tableted Levitra which results in a faster effect. It is clinically confirmed that erection occurs within 15 minutes even before reaching maximal concentration of vardenafil in blood.
The quantity of successful sexual intercourses after Levitra ODT intake was in average 62,5% in comparison with 29,4% of placebo. This may be explained by the fact that ODT form provides partial absorption of vardenafil via mucous membrane in mouth cavity and this part is not affected by inactivation in liver or gastro-intestinal tract.
Vardenafil concentration in blood exceeding minimally effective one is preserved within 10-12 hours. This is especially important for patients who do not want to depend on the time of tablet’s administration.
Levitra ODT: New Form of ED Treatment
In order to understand how PDE5 inhibitors function and the way they can help a patient, it is better to study the history of their discovery. First, PDE5 inhibitors were considered to be medicines for cardio-vascular disorders, but now they play the main role in therapy of erectile diseases. As to vardenafil, its molecule was chosen by scientists from Bayer from 4000 of other molecules of PDE5 inhibitors as the most selective one. Pre-clinical and clinical trials of new inhibitor began in 1997. It was confirmed that vardenafil is characterized by the strongest connectivity with phosphodiesterase-5 molecule. This fact allows reducing the dose of the medicine and adverse effects of its intake.
The intake of tableted PDE5 inhibitors is connected with a number of restrictions, resulting in the fact that 40% of patients taking PDE5 inhibitors consider this method of administration inconvenient. In this regard, Levitra ODT has a lot of advantages. This remedy is comparable to traditional Levitra in safety and effectiveness. It was experimentally confirmed that neither bioaccessibility nor other pharmacokinetic parameters of Levitra ODT used by elderly patients do not aggravate. Besides, Levitra ODT deprives a patient of main inconveniences connected with ED treatment, since there is no dependence on food intake, it shouldn’t be drunk with water and it may be taken inconspicuously until the tablet takes its action (within 15 minutes).
Moreover, Levitra ODT has a pleasant mint flavor. This new form of Levitra was highly appraised by both therapists and patients. Thus, more than 90% of patients using PDE5 inhibitors have positive feedback about ODT form administration.
Levitra ODT: Efficiency and Safety as per Clinical Trials
The effectiveness of any medicinal product must be approved by large clinical research studies and Levitra ODT is no exclusion. This remedy has a considerably grounded scientific base. Thus the efficiency of Levitra ODT was confirmed by multicenter double randomized placebo-controlled research studies. The first work united forty medical centers located in France, Germany, Belgium, Spain, and South Africa; the second trial was conducted in thirty-five centers in Canada, Mexico, the USA and Australia. The main aim of the trials was esteem of efficiency and safety of Levitra ODT in dose of 10ng by entire population of men suffering from ED. The uniqueness of the studies conducted lies in the fact that neither of them were administered by elderly patients. The efficiency of men above 65 years was conducted separately. Besides, the efficiency of the medication in patients with accompanying diseases was studied (diabetes, dyslipidemia, arterial hypertension). All patients participating in research studies during 12 weeks were recommended taking Levitra ODT (or placebo) one hour prior to sexual activity without drinking it with water (not more than 1 dose of the drug per day). In comparison with placebo, Levitra ODT has shown statistically significant advantage over placebo pills. It is worth mentioning that analogous result was observed in patients at the age of 65 and older.
Levitra ODT safety was thoroughly tested like its efficiency. For estimation of side-effects frequency, patients were also divided into subgroups due to age and accompanying diseases. A number of undesired conditions were even developed in placebo-controlled groups. But in total, frequency of adverse effects of participants was insignificant. Levitra ODT was well tolerated, whereas side-effects were characterized to be of mild and moderate severity levels. Significantly, the frequency of adverse condition in a group of men under and above 65 was comparable to the main indexes of organism state. Thus, the effectiveness of Levitra ODT in patients with erectile dysfunction including those who suffered from accompanying disorders was proven. Levitra ODT is a widening of possibilities in treatment of patients who can experience not only high-performance of treatment, but convenience of PDE5 inhibitor application.
ED causes may depend or not depend on current relations in a couple. Patients of middle age very often complain of stress as a factor damaging erectile function (26%) and dullness in relationship (16%) leading to sexual disorder. Erectile dysfunction ruins communication between partners. A man with ED feels shame and awkwardness, he is afraid of sexual frustration and gets emotionally and physically estranged from his partner. He shrinks into himself. A woman is afraid that her partner doesn’t love her anymore and finds her unattractive. This leads to aggravation of relations in a couple. Thus, prescription of PDE5 inhibitors in such cases allows enhancing the quality of couple’s sexual life belonging to any age group. These medications improve male sexual function and partners’ relations work out for the best. It is confirmed that ED treatment with efficient PDE5 inhibitors, such as Levitra and Levitra ODT increases life quality of both partners.
All in all, millions of men all around the world suffer from erectile dysfunction. In some cases, sexual issues are resulted from problems in relations, but more often – they become their cause. Prescription of oral dispersible form of Levitra allows solving problem of erectile dysfunction quickly and with minimal number of side-effects. Efficiency and safety of Levitra ODT were approved by a number of international clinical trials including middle-aged men and men suffering from accompanying disorders. Moreover, in comparison with classical tableted PDE5 inhibitors, Levitra ODT may be used regardless of fatty food intake, doesn’t require drinking with water and its package is developed in such manner as not to attract undesired attention.