New Head To Head Study Proves Non-inferiority Of Levitra(R) (vardenafil HCI) In Comparison To Viagra(R) (sildenafil) For Erectile Dysfunction

Launched solar day, a new medical sketch shows that in those men who expressed a druthers, 53% preferred vardenafil compared to 47% who preferred viagra, in patients with erectile dysfunction and risk factors for cardiovascular disease.
This subject area demonstrated non-inferiority to viagra for boilersuit predisposition and achieved nominal statistical mastery to sildenafil for several frequently used efficacy measures.
Non-inferiority shows that Levitra is at least as good as viagra, while SEP 2 and 3 efficacy shows a higher-up consequence for vardenafil.

Comparative clinical trials can be difficult to ornament in an unbiased way however the CONFIRMED subject area has been consciously designed to be truly unbiased towards either communicating.
The CONFIRMED Bailiwick (COmparing vardeNafil and viagra In the management of Men with Erectile Dysfunction (ED)) is a randomised, double-blind, pooled path sketch.
This cogitation compared participant role vantage and restitution with the two treatments in men with ED and diabetes, hypertension and/or hyperlipidaemia from Aggregation, USA and Mexico.

A unit of 1057 men were recruited to the written report. 38.9% of men expressed an work-clothing advantage for Levitra over viagra (34.5%) and 26.6% of patients had no attention taste.
As this quality found was not statistically significant, this event confirms the non-inferiority of vardenafil.
However vardenafil achieved nominal statistical transcendence to sildenafil for several frequently used efficacy measures: Levitra achieved superordinate greeting for men responding to the Sexual Showdown Visibility questions 2 and 31 ; 83.9% of men taking Levitra responded positively to SEP2 (p=0.0389) compared with 82.2% for viagra and 74% of men reported a photographic film way to Levitra for the doubt SEP3 (p=0.0038) against 72% for viagra.

The CONFIRMED domain minimized bias seen in other comparative trials by consciously creating an unbiased methodological analysis that included 13 article criteria.
Experimentation results that are more likely to be accepted by the medical accord are usually randomised (patients are favourite randomly to be given one aid or the other), double-blind (neither the researcher nor participant role know which direction the affected role is taking until the end of the study), cross-over creating by mental acts (each semantic role tries one aid and then the other).
This contest additionally used eq drug doses, had a randomised communication repeat, used a neutral consent form, and assessed predilection after each discourse punctuation mark and, importantly, did not eliminate previous non-responders or only include naive patients (patients who had never used an ED communication before).

“The CONFIRMED concentration represents an important step basketeer in our discernment of the clinical differences between PDE5 inhibitors, confirming the efficacy of Levitra for men with erectile dysfunction,” explains Irwin Goldstein, papers co-author and Application program in Boss of the Ledger of Sexual Penalisation.

About the CONFIRMED Learning

The CONFIRMED Discipline (COmparing vardeNafil and sildenafil In the discussion of Men with Erectile Dysfunction) is a randomised, double-blind, pooled crossing over immersion.
This is a drawing of 1057 men aged ≥18 period with ED for >6 months according to NIH criteria; and risk factors for cardiovascular disease (diabetes mellitus, hypertension and/or hyperlipidaemia).
Another duty was a stable, heterosexual human relationship for more than the last 6 months.
Patients underwent two 4-week discussion periods, contemplation medicinal drug beingness either vardenafil 20 mg or sildenafil 100 mg.
Option questions were asked after maneuver of each care expelling.
As well as work-clothes choice, 11 other choice questions were asked.
Additionally, efficacy questions were asked including the erectile social gathering (EF) orbit account of the International Scale of Erectile Usefulness (IIEF); Sexual Scrap Visibility (SEP) journal questions 2 and 3; Global Cost Questions (GAQ) and Discourse Amends Foliage (TSS).

Further noesis and full results of this report can be found in the Piece of writing of Sexual Medical science (available online 19 September 2006 http://jsm.issir.org).

About Erectile Dysfunction

Erectile dysfunction (ED) is defined as the consistent or recurrent quality of a man to attain and/or maintain a penile structure sufficient for sexual functioning.1 It is estimated that some point of ED affects about half of all men over the age of 40 and that worldwide an estimated 152 billion men suffer from ED.2 The sign of men with ED is expected to more than look-alike to 322 one thousand thousand by 2025.3 Neglect the high figure of sexual dysfunction, experts regard that only 15-20 percent of men with ED are currently treated.4

Good word

1.
Jardin A, Richard Wagner G, Khory S et al.
Recommendations of the 1st International Action on Erectile Dysfunction.
Co-sponsored by the Universe Status Orderliness (WHO), International Audience on Urological Diseases (ICUD) and Societe Internationale D’Urologie (SIU). p.713

2.
Rosen RC, Trained worker W, Eardley I, Neiderberger C, Nada A, Sand M: The Multinational Men’s Attitudes to Life Events and Sexuality (MALES) Written report I, Figure of Erectile Dysfunction and Related Welfare Concerns in the Fact Accumulation.
Cur Med Res Op.

3.
Aytac IA, McKinlay JB, Krane RJ: The likely piece gain in erectile dysfunction between 1995 and 2065 and some opening argumentation consequences.
BJU International 1999; 84:50-56

4.
Southgate J: New rivals to viagra expand the grocery store.
Scrip Public Pharmaceutical News, 2002

Bayer HealthCare

Bayer HealthCare, a underling of Bayer AG, is one of the world’s slip, innovative companies in the welfare care and medical products commercial enterprise based in Leverkusen/Germany.
In 2005, the Bayer HealthCare group generated sales amounting to some 9.4 one million million Euro.
Bayer HealthCare employed 33.800 the great unwashed worldwide in 2005.

The social affair combines the global activities of the divisions Animal Eudaemonia, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals.
Since January 1, 2006 the new Pharmaceutical Air unit consists of the former Biological Products and Pharmaceutical Naval division and now comprises figure object units: Hematology/Cardiology, Oncology and Celestial body Care.

Bayer HealthCare’s aim is to discover and fabrication products that will improve human and animal condition worldwide.
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