Fast-acting PDE-5 inhibitor shows positive results
Agent demonstrates quick onset, short half-life, dose-linked efficacy in phase II study
Avanafil, an investigational, fast-acting phosphodiesterase type-5 inhibitor, has been successful in its first large-scale trial. Joel M. Kaufman, MD, reported at the Sexual Medical Society of North America annual meeting here.
The study, led by Dr. Kaufman, associate clinical professor of urology at the University of Colorado School of Medicine. Denver, was a phase II trial in the sequence of protocols needed to obtain FDA approval for drugs. Plans for a phase III trial, the last step in that sequence, are being made for 2006, according to VIVUS, Inc.. which is developing the drug.
Oral ED agent has rapid onset of action, study shows
The onset of action may be very rapid—within 10 minutes—in some men who take vardenafil (Levitra) to treat erectile dysfunction, according to the results of a multinational study.
Designed to identify the earliest time to onset of action leading to successful sexual intercourse after vardenafil dosing, the “Onset of vardenafil in men with erectile dysfunction” (ONTIME) trial—overseen by Luc Valiquette. MD, professor of urology at the Hospital Saint-Luc du CHUM in Montreal—randomized 732 patients to treatment with vardenafil, 10 mg; vardenafil, 20 mg; or placebo. The study participants had a baseline International Index of Erectile Function score of 13.4 (moderate severity), and all had demonstrated u response to vardenafil.
,p> Each participant was instructed to initiate sexual activity immediately after taking the medication and was issued a stopwatch to time the interval between dosing and attainment of erection perceived to be adequate for penetration with subsequent intercourse completion—recorded as a positive response to question 3 in the Sexual Encounter Profile (SEP3). Read the rest of this entry »
Viagra: what every physician and patient shouid know
Viagra, an oral drug taken one hour prior to sexual activity, improves erectile function in the majority of men with erectile dysfunction who receive it. It is not an aphrodisiac and therefore will not work without sexual stimulation. The drug is absolutely contraindicated in patients on organic nitrates, as this combination can lead to severe drops in blood pressure. Patients with heart disease, suspected heart disease and riskfactors for heart disease should discuss with their physicians the safety of resuming sexual activity. A cardiac work-up, including exercise treadmill testing, should be considered in appropriate patients.
Introduction
On March 27,1998, the FDA approved sildenafil (Viagra) as the first oral agent for the treatment of male erectile dysfunction. This new drug has received wide coverage in the media and on talk shows and has spurred an entire generation of new jokes; most importantly, however, it has awakened the public consciousness to the problem of erectile dysfunction (ED). This issue is now being discussed openly by patients, spouses and healthcare providers. The purpose of this article is to describe ED, and to discuss the various treatment options and the efficacy and warnings regarding this remarkable new drug.
What to do if Viagra won’t do
Erectile dysfunction (ED) — impotence — is an extremely common problem that affects up to 22% of American men, mostly in the older age groups. Once considered primarily a psychological disorder, it is now clear that most cases of impotence have a physical basis. The leading causes are the chronic diseases that damage blood vessels and nerves vital for normal erectile function; diabetes, atherosclerosis, and hypertension head the list (see last month’s Harvard Men’s Health Watch). The medications used to treat these problems and other ailments can also contribute to impotence. Hormonal abnormalities are less common, but they are particularly important to detect since they can be corrected. That’s also true of the psychological problems that cause up to 15% of impotence; table 1 summarizes some of the differences between psychological and physical impotence.