SATURDAY, Sept. 29, 2001 (HealthDayNews) -- An experimental drug for impotency helps men with diabetes improve their erections, a new study says.
The first Phase III trial results for vardenafil showed improved erectile function in 72 percent of patients with Type I and Type II diabetes. Men with diabetes are three times more likely to have problems with erections because of complications related to the disease.
About 7.5 million American men have diabetes. And between 50 and 60 percent of men over age 50 who have diabetes have problems with impotency.
The study included 452 diabetic men who were 18 and older and who had had mild to severe erectile problems for at least six months. The men were divided into three groups and given either a 10 milligram (mg.) or 20 mg. pill of the drug vardenafil or a placebo.
In the group that received the 20 mg. doses, 72 percent reported a significant improvement in their erections, compared to 57 percent in the 10 mg. group and 13 percent in the placebo group.
Also, 64 percent of the men who received the 20 mg. doses reported erections hard enough for penetration; 54 percent were able to maintain erections to successfully complete intercourse. That compared to 36 percent and 23 percent, respectively, for the placebo group.
The most commonly reported side effects included headaches, flushing and nasal congestion.
The men in the study kept a diary of their intercourse attempts. After four weeks and again at the end of 12 weeks, the men were asked if treatment had improved their erections over the previous four weeks.
Along with the diary, the men were evaluated using a standard sexual function questionnaire used by urologists. It includes questions ranging from the ability to achieve and maintain erections to the completion of sexual intercourse.
The study was presented at the recent annual American Diabetes Association Scientific Sessions.
Vardenafil is made by Bayer, which plans to submit the drug for Food and Drug Administration approval later this year.
"It's a better Viagra. I don't know how else to say it," says Dr. Irwin Goldstein, a professor of urology at the Boston University School of Medicine and a member of the International Vardenafil Study Group.
Although it works much the same as Viagra, vardenafil is more potent and requires lower dosages, Goldstein says. While Viagra doses are 50 to 100 mgs., the vardenafil dosage range is between 5 and 20 mgs.
Vardenafil offers diabetic men another choice, Goldstein adds.
"Viagra is unique in that it's the only pill for its field. There's no other choice for a patient. We have plenty of patients who do relatively well on Viagra, and we have a group of patients who don't do relatively well and would like a better, stronger agent," he says.
Dr. Ira Sharlip, president of the Sexual Medicine Society of North America, says vardenafil seems effective and has great potential. But it is difficult to say how it compares to Viagra, he adds.
"The only way to make a valid judgment is to do a head-to-head study -- you compare the two directly. If you don't do that, then you're always dealing with slightly different patient populations, and you can't draw absolutely firm conclusions," Sharlip says.
What to Do: It's estimated that more than 30 million American men suffer from some form of impotence. For more information, go to the Impotence Institute of America, or the National Institute of Diabetes & Digestive & Kidney Diseases.
