Levitra (Vardenafil HCI) Can Improve Erections in 80% of Men With Erectile Dysfunction due to Spinal Cord Injury

LONDON, Dec. 8, 2004 – Treatment with Levitra improved erections in 80% of men with erectile dysfunction (ED) specifically related to traumatic spinal cord injury, according to data released today at a major European sexual medicine congress.

The RESPITE study (REsults in SPinal Cord Injury PaTiEnts: Vardenafil for Erectile Dysfunction) demonstrated that Levitra produced statistically and clinically significant results compared to placebo in subjects suffering from ED following traumatic spinal cord injury. The IIEF EF domain score improved from a baseline of 11.6 to 22.0 in men treated with vardenafil compared to an improvement from12.1 to 13.5 for placebo. 80% of the 196 patients taking Levitra reported improved erections (as measured by GAQ) compared to 26% of the 198 patients on placebo. 52% of the treated population reported that their erectile function returned to normal (an IIEF-EF domain score of >25ii) compared to 9% who took placebo. Study results also show a significant increase in the ejaculation success rate of the vardenafil group (18%) compared to the placebo group (12%), as recorded in patients’ diaries. Baseline IIEF-EF domain scores were 12 for the Levitra and placebo groups.

Lead author of the study, François Giuliano, MD, PhD, a professor at the department of urology, CHU de Bicetre, in Paris said: "These results are very encouraging for the many men who suffer from spinal cord injury. The recorded levels of improvement in erectile function and ejaculation rates during the study period were impressive. This is great news for men suffering with ED resulting from spinal cord injury who wish to father children."

Other study primary endpoints were measurements of improvements in erectile function as measured by SEP. In the study:

76% of those treated with Levitra were able to successfully insert their penis into their partner’s vagina compared to 41% of those taking placebo
59% of those treated with Levitra were able to maintain erections long enough to successfully complete intercourse compared to 22% of those taking placebo
A secondary objective of the study was to assess the tolerability of Levitra in men with ED following traumatic spinal cord injury. Adverse events were reported by a low percentage of subjects and these included headache, urinary tract infection and flushing. The study concluded that Levitra was well tolerated in this patient population.

The findings of the RESPITE study were released at the VII Congress of the European Society of Sexual Medicine (ESSM), held in London, UK. The ESSM is a multidisciplinary, academic and scientific organisation dedicated to male and female sexual function and dysfunction.

About the Study
The RESPITE study was a 12-week randomised, double blind, parallel group, multicentre trial, which studied men with ED (baseline of IIEF-EF score ~12.0 [moderate severity], ITT population) in an at-home setting. Dosage was titrated at weeks four and eight and subjects were closely monitored including a follow-up phone call after week 12 visit.

The men recruited to the RESPITE study suffered with varying degrees of severity of spinal cord injury as measured by the American Spinal Injury Association (ASIA) impairment scale. This scale measures the level of impairment and categorises from A to E – where Category "A" is complete impairment with no motor function or sensation preserved in sacral segments S4 – S5 and Category "E" is normal motor and sensory function. In the study, approximately half of the subjects were categorised as "A" and half were categorised as "B-D".

Notes to Editors

Erectile dysfunction (ED) is defined as the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance.

It is estimated that some degree of ED affects more than one half of all men over the age of 40 and that worldwide an estimated 152 million men suffer from ED. The number of men with ED is expected to more than double to 322 million by 2025. Despite the high prevalence of sexual dysfunction, experts estimate that only 15-20 percent of men with ED are currently treated.

Phosphodiesterase type 5 (PDE-5) is the predominant enzyme found in human penile erectile tissue and is associated with erections. PDE-5 inhibitors typically work by blocking this enzyme to enhance or prolong the erectile response.

Levitra was specifically selected for development as an ED therapy because of its in vitro potency and high selectivity for the inhibition of the PDE-5 enzyme.

Levitra is contraindicated in men taking nitrates and nitric oxide donors (a group of medications used to treat angina pectoris, or chest pain) and in patients with a known hypersensitivity to any component of the tablet. Please refer to individual country labels for other important prescriber information.

Levitra, researched and discovered by Bayer AG, is marketed by Bayer and GlaxoSmithKline plc (GSK) through a worldwide co-promotion and co-development agreement. Levitra was approved on 6 March 2003 by the European Commission based on the quality, safety and efficacy data submitted. These data included results from more than 3,750 men representing a broad patient population. The US Food and Drug Administration (FDA) approved Levitra for the treatment of ED on 19 August 2003.
About Bayer Pharmaceuticals Corporation
Bayer Pharmaceuticals Corporation is part of the worldwide operations of Bayer HealthCare, a subgroup of Bayer AG. Bayer HealthCare is one of the world's leading innovators in the health care and medical products industry.

Bayer HealthCare combines the global activities of the business groups of Bayer AG in the fields of Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceuticals. More than 34,000 employees support the worldwide operations of Bayer HealthCare.

Our work at Bayer HealthCare is to discover and manufacture innovative products for the purpose of improving human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease.

About GSK
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

Vivanza is the vardenafil brand marketed by GSK in Italy.

For further information about ED, please visit: www.All-About-ED.com.

References:

I. Efficacy and tolerability of vardenafil in men with erectile dysfunction consequent to traumatic spinal cord injury. François Giuliano et al. Abstract to be presented at the 7th Congress of the European Society for Sexual Medicine (ESSM), 8 December 2004, London.

II. International Index of Erectile Function (IIEF) EF domain score: One of five areas of the International Index of Erectile Function (IIEF) used to measure quantity and quality of erections. It includes questions about the ability to achieve and maintain erections to the completion of sexual intercourse.

III. The Global Assessment Question (GAQ): ‘Has the treatment you have been taking over the last 4 weeks improved your erections?’

IV. Sexual Encounter Profile (SEP): A questionnaire containing seven patient diary questions that allow patients to record sexual events. The most pertinent and widely used SEP questions to diagnose and evaluate ED treatments are:

SEP2 Patient Diary: Were you able to insert your penis into your partner’s vagina?
SEP3 Patient Diary: Did your erection last long enough to satisfactorily complete sexual intercourse?
V. The intent to treat (ITT) population included those patients who met the following criteria:

Valid for safety
Received at least one dose of study medication
Answered one valid diary after randomisation
VI. http://www.nrhhealthtown.com/healthtown/Library/Content/Spinal%20Cord%20Injury%20Topics/assessment_and_classification.aspx 03 November 2004