Levitra: New Impotence Drug Christened
Like Viagra, Levitra 'Amplifies' Small Erections
Sept. 23, 2002 -- The long-awaited competitor to Viagra -- christened Levitra today -- inches its way to final FDA approval. Two early studies suggest it's longer lasting, has fewer side effects, and is safe for virtually everyone, including those with heart problems. Similar drugs approved in this class of medication carry warnings for men with heart disease.
However, one urologist advises men not to get their hopes up. "That's not to say new drugs won't be exciting and wonderfully worthwhile," Larry Lipshultz, MD, professor of urology at Baylor College of Medicine in Houston. "The data is interesting. Let's see if the drug holds up to the claims."
Levitra was developed by Bayer and GlaxoSmithKline and is scheduled for U.S. launch in 2003.
Viagra, produced by Pfizer Inc., revolutionized the treatment of male sexual dysfunction, allowing men for the first time to pop a pill to get an erection -- rather than trying various devices, having a drug injected into the penis, or having a pellet inserted into it.
By some estimates, some degree of ED affects more than 50% of men over the age of 40. In the U.S., alone 30 million men are affected.
However, statistics show that only about 10% of men seek help. So 90% of men out there still aren't getting treated for impotence, says Irwin Goldstein, MD, director of the Institute for Sexual Medicine at the Boston University Medical Center and a leader of the Massachusetts Male Aging Study.
"In the early days of Viagra, many men got turned off -- largely because reports of heart attacks that were shown later not to be related to the drug," Goldstein tells WebMD. Today, Viagra carries only an advisory for people with high blood pressure who are taking particular types of blood pressure-lowering medication, and patients with angina or heart disease who take nitrates.
The preliminary data on Levitra:
A phase III clinical trial enrolled 440 men with erectile dysfunction between 44 and 77 years old, most of whom had undergone nerve sparing prostatectomies six or more months before entering the study. (About a third of men who have had a prostatectomy -- removal of the prostate gland -- develop ED.) After 12 weeks of Levitra, 71% of the men had improved erections. And a subset of men experiencing depression related to their impotence reported fewer symptoms of depression after taking Levitra.
In a 26-week phase III trial of 805 men, about 74%-77% of men taking 10-20 mg of Levitra reported successful penetration on their first attempt, compared with 46% of men taking placebo. Also, the men who were successful the first time reported successful penetration in about 85%-91% of subsequent attempts, compared with 77% of those taking placebo. Side effects were mild to moderate headache, flushing, and nasal congestion -- "mild stuff," says Goldstein.