| Levitra helps diabetics not aided by Viagra - trial
NEW YORK (Reuters) - Impotence drug Levitra proved effective in
men with diabetes who had not been helped by Viagra, according to
results from a clinical trial, Levitra's makers said.
Doctors estimate that half of all diabetic men will eventually
develop erectile dysfunction.
The results - presented by researchers on Monday at the American
Diabetes Association Scientific Session in Orlando, Florida - could
provide a boost for Levitra makers GlaxoSmithKline Plc and Bayer
AG. The two companies paid for the trial and issued a press release
announcing the results.
The British and German drug makers have seen their product overtaken
by newer entry Cialis from U.S. companies Eli Lilly and Co. and
Icos Corp. in the battle for market share and new prescriptions.
Pfizer Inc.'s Viagra, with its five-year head start on the market
and nearly universal name recognition, still dominates the impotence
arena with nearly $2 billion in annual sales. But Viagra is feeling
the heat from the new competition, with sales down 12 percent in
the last quarter.
The trial tested Levitra against a placebo in 463 men with moderate
to severe erectile dysfunction (ED) who had not responded well to
previous treatments with Viagra.
Within the trial, researchers looked at a subset of 138 patients
with diabetes. Urologists say they are among the most difficult
erectile dysfunction sufferers to treat.
Researchers said diabetic men who took Levitra showed a statistically
significant advantage over placebo.
Men with diabetes were able to engage in successful intercourse
on 33 percent of attempts with Levitra, compared with only 6 percent
of attempts before treatment.
All study participants had previously failed in at least four of
the prior six attempts at successful intercourse with Pfizer Viagra
- including at least one unsuccessful attempt with 100 milligrams
of Viagra, the highest available dose.
"This study is important because it shows that vardenafil
(Levitra) is a successful treatment option for ED in the difficult-to-treat
diabetic population, in whom other treatments often have not been
successful," said Dr. Alan Garber, professor of medicine, biochemistry
and molecular biology at Baylor College of Medicine.
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