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

by
Goldstein I, Young JM, Fischer J,
Bangerter K, Segerson T, Taylor T.
Boston University Medical Center,
Boston, Massachusetts.
South Coast Urological Medical Center,
Laguna Hills, California.
Diabetes and Glandular Disorders Clinic,
San Antonio, Texas. Bayer Corporation,
West Haven, Connecticut.
Diabetes Care 2003 Mar;26(3):777-83


ABSTRACT

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 erection improvement during the previous 4 weeks. RESULTS-After 12 weeks of treatment, a dose-dependent (P = 0.02) improvement in erections was noted for the GAQ, with 57 and 72% of men taking 10 mg or 20 mg vardenafil, respectively, reporting improved erections, in contrast to 13% after taking placebo (P < 0.0001). For the erectile function domain, dose-dependent (P = 0.03) final scores for the 10- and 20-mg dose were 17.1 and 19.0 compared with 12.6 for placebo (P < 0.0001). Both vardenafil doses significantly enhanced the rates of successful penetration (P < 0.0001) and successful intercourse (P < 0.0001) compared with placebo. Vardenafil treatment was effective in increasing intercourse success rates at all levels of baseline ED severity, at each level of plasma HbA(1c), and for type 1 and 2 diabetes. Treatment-emergent adverse events were primarily mild to moderate headache (< / =13%), flushing (< / =10%), and rhinitis (< / =10%). CONCLUSIONS-Vardenafil statistically improved erectile function and was generally well tolerated in these diabetic patients with ED.


Vardenafil
Delequamine
Apomorphine
Testosterone
Phentolamine
Coolidge effect
PT-141 ('Passion')
Sexual pharmacology
Vardenafil and the heart
Drugs for impotent rabbits
Semen as an antidepressant?
Yohimbine and sexual performance
The pharmacology of penile erection
Vardenafil (Levitra, Nuviva) and sexual satisfaction
Vardenafil (Levitra): prescribing information (PDF)
Vardenafil (Levitra, Nuviva) and penile tumescence


Refs
and further reading

HOME
HedWeb
Nootropics
erythroxylum-coca.com
Future Opioids
BLTC Research
MDMA/Ecstasy
Superhapiness?
Utopian Surgery?
The Abolitionist Project
The Hedonistic Imperative
The Reproductive Revolution
Critique of Huxley's Brave New World

The Good Drug Guide
The Good Drug Guide

The Responsible Parent's Guide
To Healthy Mood Boosters For All The Family