All about Generic Levitra - Vardenafil.

Bayer and Glaxosmithcline had signed a combined promotional and developmental agreement for Levitra in November 2001. The new medication which was introduced as the first ED drug to rival Viagra which was introduced in 1998. Levitra received regulatory approval for the treatment of penile dysfunction in over sixty-three countries. It was approved by the U.S. Food and Drug Administration as one of the first oral drugs for the treatment of erectile dysfunction in the month of August 2003.

Levitra was appraised in placebo-controlled trials involving more than 2000 men with erectile dysfunction, of which, two trials had erectile dysfunction as a consequence of diabetes mellitus or prostate cancer. The effectiveness of the new ED medication was evaluated by questionnaire in which the patients were asked about their sexual functioning. In all the trials FDA found that Levitra improved all patients’ ability to achieve and maintain a strong penile erection. On 19 th August 2003 Levitra was approved by FDA as the second oral medication to treat erectile dysfunction or impotence.

FDA advised in its talk paper that the ED patients should undergo a thorough physical examination as well as medical history analysis by a registered health professional before taking Levitra. It is important to understand the original cause of the erectile dysfunction and to discover the suitable treatment for the same. It is also pointed out by FDA that Levitra does not protect from AIDS or any other sexually transmitted diseases (STDs).

The efficacy of Levitra to treat erectile dysfunction was enhanced by the fact that it has fewer side effects than Viagra and does not have any standing instance of vision problem called NAION. The most common side effects reported in clinical trials are flushing, headache, rhinitis, and dyspepsia. Two percent of the ED patient reported dizziness and in rare cases, a very small number of patients in that trial reported that they had blue tinge in vision.

The new erectile dysfunction therapy was introduced as a result of combined proficiency and expertise of two giants like GlaxoSmithKline and Bayer. Levitra is supposed to be more potent drug compared to Viagra as it was believed to work more efficiently than the diamond shaped blue pill. In other medical trials involving 1020 men with erectile dysfunction, the patients used Levitra for one year and the average success rate in erections improved to 87 % from 14 % and to 86 % from 16 % with the 10 mg dose and the 20 mg dose simultaneously. Levitra is available in as low dose as 2.5 mg where the lowest dose for Viagra is of 25 mg signifies that Levitra is a potent molecule which offers efficacy up to 24 hours. Andrew Witty, President, Europe , and GlaxoSmithKline had stated that they believed Levitra to offer increased satisfaction for many more men.
Home | About Levitra | Levitra Prescription | Levitra Precautions

Vardenafil is rapidly absorbed with approximately 15% absolute bioavailability. A single 20 mg dose of Levitra in healthy volunteers leads to maximum observed plasma concentrations between 30 minutes and 2 hours after oral administration in an empty stomach. In other food-effects, studies showed that fatty meals caused a reduction in C max by 18%-50%.

Vardenafil is approximately 95% bound to plasma proteins. This protein binding is reversible and independent of total drug concentrations. After 1.5 hours of dosing of20 mg Vardenafil dose, a mean of 0.00018% was found in semen of healthy volunteers. Hepatic enzyme CYP3A4 primarily metabolizes Vardenafil along with involvement of the CYP3A5 and CYP2C isoforms. Vardenafil is excreted as metabolites mainly around 91-95% of the dose taken in the feces and 2-6% of the dose taken in the urine.

Diabetes is one of the leading causes behind erectile dysfunction as a man with diabetes is three times more likely to have ED than any other person. Men with diabetes notice the onset of ED within 10 years of their diagnosis. Erectile dysfunction signs are visible in nine percent diabetic men between age 20 and 29 years and goes up to 95 percent by age 70. According to Martyn A. Vickers, MD, Chief of Surgery, Togus ( Maine ) VA Medical Center, and Associate Professor of Urology, University of Massachusetts Medical Center, ED is more frequent among men with diabetes type 2 than among those with type 1. Men whose sugar level in the blood is high or not well controlled are more prone to experience problems with erection in comparison to those who keep the glucose level under control.

There are many factors that contribute to ED in the diabetic population. The most common are physical problems such as

• Blood vessel and nerve damage. Blood sugar builds up in the blood causing damage to the blood vessels and nerves. The damaged nerves to the penis are not able to carry signals for an erection and also limit blood flow to the penis.
• Diabetes leads to low level of testosterone which is a risk factor for ED in diabetic men.
• Diabetic men have lower intracavernosal levels of nitric oxide synthase.
• Some treatments of diabetes cause high blood pressure, anxiety and ulcers which contribute to erectile dysfunction.

Study results presented at the American Diabetes Association in Orlando , Florida say that Bayer & GlaxoSmithKline’s Levitra (Vardenafil) is beneficial to diabetic men who are suffering from erectile dysfunction at mild to severe level.

The study is referred to as the PROVEN meaning Patient Response with VardENafil in Sildenafil Non-Responders trial. The research was an evaluation of the effects of Levitra on men with erectile dysfunction who did not respond to Viagra medication previously. It further reviewed the development of penile erection in a subcategory of 138 men with diabetes as well as ED and a history of unresponsiveness to Viagra. These category was classified on the basis of medical history of the diabetic patients, laboratory values (HbA1c>8%), and medication data.

All the participants had experienced at least one unsuccessful attempt with the highest available dose of Viagra which is of 100 milligrams. Moreover, they all had previously failed in at least four times of the prior six attempts to accomplish a successful intercourse with Viagra. The Levitra medication proved effective for men with diabetes on the very first attempt who had not been helped by Viagra.

The researchers found that the diabetic men who took Levitra showed a statistically significant improvement compared with those who were given placebo. The study results presented that 58% of diabetic men experienced superior erections with Levitra compared with placebo.

To conclude the results of PROVEN trial, men with diabetes were able to experience successful sexual intercourse on 33% of attempts with Levitra, in comparison with only 6% of attempts with other treatments. Dr. Alan Garber, professor of medicine, biochemistry and molecular biology at Baylor College of Medicine points out at the importance of the PROVEN trial which shows that Vardenafil is a successful treatment option for ED in the ‘difficult-to-treat’ diabetic population, in whom other treatments most of the time have not been successful.