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Vardenafil, a New Phosphodiesterase Type 5 Inhibitor, in the Treatment of Erectile Dysfunction in Men With Diabetes.

A multicenter double-blind placebo-controlled fixed-dose study.

Young , MD 2, Jerome Fischer , MD 3, Keith Bangerter , PHD 4, Thomas Segerson , MD 4, Terry Taylor , MD 4 and The Vardenafil Diabetes Study Group 1 Boston University Medical Center, Boston, Massachusetts 2 South Coast Urological Medical Center, Laguna Hills, California 3 Diabetes and Glandular Disorders Clinic, San Antonio, Texas 4 Bayer Corporation, West Haven, Connecticut. A multicenter double-blind placebo-controlled fixed-dose study.

OBJECTIVE —This study evaluated the efficacy and safety of vardenafil treatment for erectile dysfunction (ED) in men with diabetes. RESEARCH DESIGN AND METHODS —In this prospective multicenter double-blind placebo-controlled fixed-dose parallel-group phase III trial, 452 patients with diabetes (type 1 or type 2) and ED were randomized to take 10 or 20 mg vardenafil or placebo as needed for 12 weeks.

Efficacy responses were assessed by International Index of Erectile Function domain scores, rates of vaginal penetration and successful intercourse, and a global assessment question (GAQ)

about

reporting

The prevalence of ED increases with age, from 9% in diabetic men ages 20–29 years to 95% in diabetic men >70 years (5), and increases with duration, poor control, and complications of diabetes (such as vascular and microvascular disease and neuropathies) (6). Diabetic men with ED tend to be less responsive to treatment perhaps because the pathogenesis of diabetes-associated ED is likely to be multifactorial (7,8). Although treatment with phosphodiesterase type 5 (PDE5) inhibitors is less effective in the diabetic patient than in the nondiabetic ED patient, the convenience of an orally formulated PDE5 inhibitor has popularized treatment in a large number of men with diabetes and ED (9,10). Vardenafil, a new PDE5 inhibitor, is more selective for PDE5 and more biochemically potent than sildenafil in in vitro and in vivo studies when tested under the same conditions (11–13).

These properties suggest that vardenafil may be a highly efficacious oral treatment in the difficult-to-treat ED patients with diabetes.

The objective of this study was to assess the efficacy, tolerability, and safety of vardenafil in the treatment of ED in men with diabetes.

The study was a randomized double-blind fixed-dose parallel-group trial conducted at 47 centers in the U.S.

Baseline characteristics were assessed after a 4-week unmedicated phase during which time patients had to have attempted intercourse on at least 4 separate days and had to have been unsuccessful in at least half of these attempts. Lack of success was defined as failure to penetrate their partner buy generic viagra without a prescription or to maintain an erection to successful intercourse. Patients were then randomized to 10 or 20 mg vardenafil or placebo treatment arms for 12 weeks.

Patients were instructed to take the study drug as needed, but no more than once a day and ?1 h before intercourse.

No specific instructions were given with regard to food or alcohol use.

Efficacy and safety data were collected at 4-week intervals.

After the active treatment phase, patients had the option of participating in a 12-week extension phase in which all patients received either 10 or 20 mg vardenafil.

Safety and efficacy from the extension phase will be reported elsewhere.

Vardenafil hydrochloride (vardenafil) was supplied by Bayer AG. Men over age 18 years who were in a stable heterosexual relationship, who had a clinical diagnosis of type 1 or type 2 diabetes, and who had experienced ED for longer than 6 months were included. Patients were excluded if their ED was the result of radical prostatectomy, primary hypoactive sexual desire, or spinal cord injury. Patients with previous myocardial infarction, stroke, ischemia by electrocardiography, or life-threatening arrhythmia were allowed to participate if buy generic viagra without a prescription these events had not occurred in the 6 months before the trial.

Specific exclusion criteria at screening included uncontrolled atrial tachyarrhythmia, unstable angina pectoris, severe chronic liver disease, clinically significant chronic hematological disease or bleeding disorder, resting hypotension or hypertension, symptomatic postural hypotension within 6 months before screening, retinitis pigmentosa, proliferative diabetic retinopathy that progressed within 6 months before screening, autonomic (but not peripheral sensory) neuropathy associated with clinically significant gastroparesis, hypo- or hyperthyroidism, and recent severe uncontrolled migraine headaches.

According to the protocol, previous exposure to sildenafil was allowable. However, if patients had discontinued sildenafil because of significant side effects or because of dissatisfaction with its efficacy, they were excluded. Anti-androgens, anti-coagulant androgens, and trazodone hydrochloride were not allowed.

The primary measures of efficacy were the erectile function (EF) domain of the validated International Index of Erectile Function (IIEF) questionnaire (14) and two diary questions concerning sexual encounter: “Were you able to insert your penis in your partner’s vagina?” and “Did your erection last long enough for you to have successful intercourse?” The secondary efficacy variable reported here is the global assessment question (GAQ), “Has the treatment you have been taking over the past 4 weeks improved your erections?” Safety.

The safety population included all patients who took at least one dose of study medication and who had any postrandomization safety data collected. Blood chemistries, vital signs, and 12-lead electrocardiograms (ECGs) were evaluated at 0, 4, and 12 weeks of treatment.

In ?61–75 men in each group, the vital signs and ECGs were obtained within 11 min

and

Treatment-emergent adverse events were recorded at 4-week intervals.

Events were determined by each blinded investigator to be probably, possibly, unlikely, or not related to the study drug.

Patients who did not enter the extension study were followed for 7 days after the last dose to record any serious adverse events and for 30 days after the last dose to record any deaths.

The intent-to-treat population, defined as individuals who took at least one dose of study medication and who had baseline and any post-baseline efficacy data, was used to calculate all the efficacy variables. For EF domain scores, the last observation carried forward (LOCF) approach was used to account for missing values.

For both diary questions, the mean success rate of each individual patient over the entire treatment period was averaged across all patients and is reported as the mean success rate for each man. For the GAQ, values were obtained from patients who completed 12 weeks of treatment; an LOCF value was also calculated. The primary efficacy variables were analyzed with ANCOVA, with baseline response as a covariate and with terms for center and treatment.

The GAQ was analyzed using logistic regression with terms for center and treatment. Download figure Open in new tab Download powerpoint.

Download figure Open in new tab Download powerpoint. Download figure Open in new tab Download powerpoint.

Relationship between response to treatment and baseline plasma HbA 1c levels. There was no correlation between individual success rate of erections with a duration sufficient to complete intercourse from diary question sexual encounter profile 3 (SEP3) and baseline plasma levels of HbA 1c . Demographic and baseline characteristics (safety population) Incidence of treatment-emergent adverse events occurring in ?5% of any treatment group.

Helene Dassule, John Firrell, Andre Guay, and Ken Snow for their contributions to the manuscript.

Results were presented at the American Diabetes Association 61st Scientific Sessions, 22–26 June 2001, Philadelphia, Pennsylvania. Address correspondence and reprint requests to Irwin Goldstein, MD, Boston University Medical Center, Department of Urology, 720 Harrison Ave., Suite P-606, Boston, MA 02118.

Received for publication 11 June 2002 and accepted in revised form 13 November 2002.

has received honoraria for serving on the Western Section Advisory Panel.

serves on advisory panels for Bayer, Abbott, Wyeth-Ayerst, Pharmacia, MacroChem, NexMed, Urometrics, Pfizer, and Lilly; has received honoraria for speaking engagements from Bayer, Pfizer, and Mentor; is a paid consultant for Bayer, MacroChem, Urometrics, Mentor, and Wyeth-Ayerst; and has received funds for clinical studies from Bayer, Pfizer, NexMed, and Vivus.

is a study site investigator and a speaker for Bayer, and is an investigator for Pfizer and Lilly-Icos.

A table elsewhere in this issue shows conventional and Systeme International (SI) units and conversion factors for many substances. Vardenafil Hydrochloride (Levitra®) Classification: Phosphodiesterase Inhibitor.

About: Vardenafil Hydrochloride (Levitra®) Vardenafil is a medication that is taken before sexual activity and allows men with erectile dysfunction (ED) to achieve and maintain an erection. ED or impotence is a condition in which a man is unable to achieve or maintain an erection long enough for sexual intercourse.

This can be a result of medical conditions such as high blood pressure, diabetes, prostate problems, and buy generic viagra without a prescription heart disease, or a side effect of

the

Personal lifestyle factors such as stress, alcohol and/or tobacco use can also play a contributing role. During surgery or radiation to the pelvic area (including prostate, bladder, and rectal procedures), damage can occur to the nerves that supply the penis. This can result in either temporary or permanent impotence. Some surgeons perform "nerve-sparing" surgeries in an attempt to preserve erectile function.

Even in these cases, however, the nerves will suffer some injury, and it can take 18-24 months or longer for erectile function to return. These men should be treated aggressively with oral or injectable medications for ED in order to speed recovery of the nerves and to prevent muscle wasting in the penis.

Vardenafil is taken by mouth up to once a day, at least 60 minutes before sexual activity, and works for up to 4 hours.

Your doctor will determine the dose that is best for you.

Some men require dose adjustments to find the dose that works best for them.

Men

Having multiple intercourse sessions with one dose has not been studied. Do not adjust your dose without talking to your provider first.

Men who take nitrates, such as nitroglycerin, Nitro-Bid, Isordil, or Deponit buy generic viagra without a prescription should not take vardenafil.

Men who take Cardura, Flomax, or Hytrin for urinary symptoms should not take vardenafil. This medication can affect how other medications work.

Be sure your provider and pharmacist know all the medication (prescription and over-the-counter) and supplements you take. Store your medication in the original, labeled container at room temperature and in a dry location (unless otherwise directed by your healthcare provider or pharmacist).

This medication should not be stored in a pillbox since it should only be taken prior to sexual activity. Ask your care team where to return any unused medication for disposal.

Do not flush down the toilet or throw in the trash.

Vardenafil is available through most retail pharmacies. This medication may be covered under your prescription drug plan.

Patient assistance may be available to qualifying individuals without prescription drug coverage through the pharmaceutical company that makes the medication.

Your care team can help you find these resources, if they are available. There are a few side effects experienced with vardenafil. Talk to your care team if you have concerns about these side effects. Do not take a higher dose of vardenafil than your provider orders for you.

Headache, facial flushing, stuffy or runny nose, and upset stomach can occur.

Less frequent side effects include blurry vision, a bluish hue to the field of vision, difficulty telling the difference between the colors blue and green, a buy generic viagra without a prescription sensitivity to light, or a sudden loss of vision or hearing.

If you experience any of the following while using vardenafil, seek immediate medical attention: An erection lasting more

than

Chest, arm or neck pain, or nausea during sexual activity.

Remember, vardenafil does not protect against sexually transmitted diseases, nor does it prevent pregnancy. Effective birth control is recommended during cancer treatment. Even if you are not producing sperm, you could still be fertile and conceive. Vardenafil (Levitra) is an oral therapy for the treatment of erectile dysfunction. It is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).

Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles.

During sexual stimulation, nitric oxide is released from nerve endings and endothelial cells in the corpus cavernosum.

Nitric oxide activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in erection.

The tissue concentration of cGMP is regulated by both the rates of synthesis and degradation via phosphodiesterases (PDEs).

The most abundant PDE in the human corpus cavernosum is the cGMPspecific phosphodiesterase type 5 (PDE5); therefore, the inhibition of PDE5 enhances erectile function by increasing the amount of cGMP. BAY 389456 BAY-389456 BAY38-9456 DE 19750085 1997 WO 99/24433 1999.

Associated Conditions Erectile Dysfunction Contraindications & Blackbox Warnings.

Learn about our commercial Contraindications & Blackbox Warnings data.

Vardenafil is used to treat male erectile dysfunction (impotence) and pulmonary arterial hypertension (PAH). Part of the physiological process of erection involves the release of nitric oxide (NO) in the corpus cavernosum.

This then activates the enzyme guanylate cyclase which results in increased levels of cyclic guanosine monophosphate (cGMP), leading to smooth muscle relaxation in the corpus cavernosum, resulting in increased inflow of blood and an erection.

Vardenafil is a potent and selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) which is responsible for degradation of cGMP in the corpus cavernosum.