Nutritional Supplement Enhances Response to Viagra; Report of Landmark Double-Blind Placebo-Controlled Study at American Urological Association Meeting

SUNNYVALE, Calif.--(BUSINESS WIRE)--Oct. 22, 2002--The results of a double-blind placebo-controlled study on the role of a nutritional supplement (ArginMax(R) for Men) enhancing the response to Viagra(R) in men who are poor-responders to Viagra(R) will be presented at the American Urological Association Western Section Meeting, October 20-25, 2002 in Kauai, Hawaii.

The study reports significant improvement in sexual performance and satisfaction for men who did not previously respond sufficiently to Viagra(R) (Pfizer), according to the lead author, William C. Baker MD, FACS, Assistant Professor of Urology at the U.C. Davis School of Medicine and Chief of Urology at the Veterans Administration Medical Center in Sacramento, California.

Approximately 25 million men in the U.S. today have some form of erectile dysfunction. Viagra(R), introduced in 1998, has provided a non-invasive, reasonably well-tolerated, and important solution for the condition. However, the scientific literature shows as many as 43 percent of men using Viagra(R) did not achieve a satisfactory clinical response. In a review of 27 clinical trials conducted on Viagra(R) involving 6659 subjects, only 57 percent of men had a higher percentage of successful intercourse while taking Viagra(R) (Archives of Internal Medicine, 2002).

In the double-blind placebo-controlled study that was conducted by Dr. Baker at the Sacramento VA Medical Center, subjects with mild, moderate, to severe erectile dysfunction who indicated they were not satisfied with the outcome of Viagra(R) use were recruited. They were first placed on a four-week run-in period with Viagra(R) (50mg) to establish their response to Viagra(R) alone. Following the four-week period, subjects were assigned, in a randomized, double-blind fashion, into a daily regimen of ArginMax(R) or placebo (sugar pill). Concurrently, they were allowed to use Viagra(R) on an as-needed basis during the four-week period while they took ArginMax(R) or the placebo on a daily basis.

Subjects were evaluated at various points of the study using the International Index of Erectile Function (IIEF), a standardized and validated multi-dimensional instrument used in the clinical assessment of erectile function. Of the 26 subjects that successfully completed the protocol, 60 percent of the men on ArginMax(R) reported a clinically significant increase in their sexual response versus 22 percent on placebo.

While using Viagra alone during the first four weeks of the study, the subjects showed only a modest improvement in erectile function and were able to achieve an erection sufficient to have satisfactory intercourse about half of the time. (IIEF erectile domain parameters #1-5, with a mean improvement of 1.16 points over baseline scores).

However, during the subsequent four weeks when these same subjects were given ArginMax(R) or placebo (sugar pill) on a daily basis while taking Viagra concurrently, 60 percent of the individuals in the active group (ArginMax(R) + Viagra(R)) were able to achieve a satisfactory erection much more than half the time (IIEF erectile domain parameters #1-5, with a mean improvement of 2.22 points over baseline scores), while only 22 percent of those in the placebo group (placebo + Viagra(R)) were able to reach this level (IIEF erectile domain parameters #1-5, with a mean improvement 1.23 point improvement over baseline scores). There were no significant side effects noted in either group.

"These results point to the importance of nutrition and lifestyle factors in sexual health and wellness," says Dr. William C. Baker, Chief of Urology at the Veterans Administration Medical Center in Sacramento, California and lead author of the study. "Nutritional supplementation may play a role in enhancing the sexual function of patients who are poor-responders to Viagra(R) which could account for as many as 43 percent of men, and it may also make a satisfactory sexual function improvement possible requiring lower doses of Viagra(R)."

Given the strong consumer interest in nutritional supplementation for sexual health and function, this is an extremely important area of research for the future. As the nutritional category leader in the United States for sexual health and wellness, the Daily Wellness Company is committed to scientific excellence, and continues to expand clinical research of ArginMax(R) in collaboration with leading physicians and medical institutions to establish the highest level of credibility and consumer trust.

ArginMax(R) is a patented nutritional supplement that contains ginseng, ginkgo, L-arginine, and 13 vitamins and minerals. ArginMax(R) is available nationwide in leading drug stores, GNC, online at www.arginmax.com, or at 800/STAMINA.

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