April 13, 2001 -- Caverject (Alprostadil) Effective In Erectile Dusfunction
A clinical trial in men with a history of erectile dysfunction showed a return of spontaneous erections in 85 percent of the men using Caverject(R) (alprostadil for injection) over a 12-month period, a significant improvement from a baseline of 37 percent. The study was published in the March issue of Urology, (57:536-541, 2001). The study specifically looked at the flow of blood into the arteries of the penis. Blood flow through the cavernosal arteries engorges the penis, creating an erection suitable for sexual intercourse. Caverject works by relaxing the smooth muscle of the penis and the muscles surrounding the arteries, allowing for an increase in blood flow to the penis. "A significant number of men in this study experienced a measurable improvement in blood flow, one of the most common physical contributors to erectile dysfunction," said Gerald Brock, MD, associate professor, Department of Urology, at the University of Western Ontario, St. Joseph's Health Care, London, and lead study investigator. "A significant number of men also reported an increase in return of spontaneous erections. Both of these results offer particularly encouraging news for the many millions of men worldwide that suffer regularly from erectile dysfunction," he added.

March 7, 2001 -- Viagra (Sildenafil Citrate) Safe, Effective For Men Taking Antihypertensives
An important study recently published in the American Journal of Hypertension shows that Viagra (sildenafil citrate), the breakthrough oral treatment for erectile dysfunction (ED), has comparable efficacy for ED for men taking antihypertensive (high blood pressure) medications concurrent with Viagra, as for men treated with Viagra alone. As the largest analysis of clinical trial data to date, the study assessed the efficacy and safety of Viagra in men with ED who were already taking one or more antihypertensive medications. Erectile dysfunction -- the inability to achieve or maintain an erection sufficient for satisfactory sexual activity -- is a common problem in men with high blood pressure. In fact, some studies report that one-in-five men with high blood pressure suffer from ED. According to the published study results, taking one or more antihypertensive medications (diuretics, beta blockers, alpha blockers, ACE inhibitors or calcium channel blockers) had no effect on the effectiveness or side effect profile of Viagra. "Along with the effect of hypertension itself, some of the medicines used to treat high blood pressure are felt to have a negative impact on erectile function," said Dr. John Parker, Cardiologist, Mount Sinai Hospital and University Health Network Hospitals, Toronto, Ontario. "The results of this study of hypertensive men confirm that Viagra is safe and effective in a wide variety of men who suffer from ED, including those with high blood pressure," said Dr. Parker.

November 2, 2000 -- Topical Alprox-TD (Alprostadil) Effective For Erectile Dysfunction
A multicenter study, conducted at 12 clinical sites in the U.S., indicated that three different dose levels of Alprox-TD (alprostadil) were shown to be effective in sexual function over placebo as a topical treatment for male erectile dysfunction (ED). The study was randomized, parallel, double-blind, placebo-controlled, and designed to investigate the dose-response relationships of the efficacy and safety of three different doses of Alprox-TD versus a placebo in 161 men with mild to moderate ED. The patients were required to apply up to ten (10) doses at home over a nine-week period and keep a daily diary. The Phase II study results indicated that three different dose levels of Alprox-TD were shown to be effective over placebo in sexual function endpoint analyses, with the highest dose showing a highly significant (p=0.001) increase in Erectile Function Domain scores under the International Index of Erectile Function (IIEF), which is the primary efficacy endpoint for the assessment of ED. The response to the Global Assessment Questionnaire, which measures improvement in erectile function, indicated an efficacy rate of 73 percent in the highest dose group compared to 23 percent in the placebo group. Other secondary efficacy endpoints also showed statistically significant improvements when the highest dose was compared with the placebo. Overall, the vast majority of the side-effects observed in the study were mild in nature and consisted of a transient burning sensation at the application site.

October 10, 2000 -- Viagra (Sildenafil) Safety Profile Confirmed
Pfizer Inc. said results from the first stage of a large-scale, post-marketing study of Viagra (sildenafil citrate) in men with erectile dysfunction (ED) confirm the safety profile established by the extensive clinical trials program. The independently-conducted observational study of 5,391 men in the UK found no evidence of increased risk of heart attack or death from ischemic heart disease. The data were comparable to UK national health data of the general population of men of the same age. Men in the study had been prescribed Viagra in the general practice setting and had been taking the medicine for an average of five months. Among physicians who provided an opinion on effectiveness, Viagra was reported to be effective in 85 percent of patients. The study did not identify any safety issues.

June 1, 2000 -- No Direct Adverse Cardiovascular Effects From Viagra (Sildenafil) in Severe Coronary Artery Disease
Erectile dysfunction, which affects up to 30 million men in the United States, may be particularly common in patients with heart disease because of the presence of overlapping risk factors -- including age, diabetes, hypertension, hypercholesterolemia, and smoking. Following the approval by the Food and Drug Administration of oral sildenafil (Viagra) for the treatment of erectile dysfunction, a number of serious cardiovascular events -- including heart attack and sudden cardiac death -- were noted associated with the use of the drug. Consequently, physicians and patients have remained uncertain about whether these reported events were related directly (and solely) to the use of Viagra or to the patient's underlying cardiovascular disease; or, perhaps, some combination of these and other factors, including the physical exertion of sexual activity. To determine what adverse cardiovascular effects, if any, Viagra might produce in men with heart disease, Penn researchers identified and measured a number of systemic, pulmonary and coronary function variables -- including heart rate, blood pressure and coronary blood flow -- both before and after the oral administration of the drug in 14 male patients. "We found that Viagra had no direct adverse cardiovascular effects in men with severe coronary artery disease," said Howard C. Herrmann, MD, Professor of Medicine at the University of Pennsylvania Medical Center and lead author of the study, which appears in the June 1 issue of the New England Journal of Medicine. "In addition, we noted a small beneficial effect on coronary blood flow reserve.

"Our data support the consensus position of the American College of Cardiology and the American Heart Association that sildenafil is safe for patients with stable coronary artery disease who are not taking medications containing nitrates, " adds Dr. Herrmann.

May 2, 2000 -- Erectile dysfunction more likely in men with large waists
Men with large waistlines are more likely to suffer from erectile dysfunction than those of slimmer girth, according to new data presented today at the annual meeting of the American Urological Association. In a survey of 1,981 men aged 51 to 88, 34 percent reported moderate to severe erectile dysfunction. These men also were more likely to be older, have high blood pressure and to weigh more than their study counterparts. In fact, after adjusting for age, smoking and hypertension, men with a larger waistline were more likely to suffer from ED. Men with a waistline measuring 42 inches were nearly twice as likely to suffer from ED compared with men whose girth measured 32 inches. The data also showed that men who were inactive were more likely to suffer from ED than men who exercised at least 30 minutes per day.

April 26, 2000 -- Topical Verapamil Appears Effective In Peyronie's Disease
There is new hope today for the estimated 1.34 million American men who suffer from Peyronie's disease -- a painful condition which causes extreme curvature of the penis, often resulting in impotence and severe pain. Prescription Dispensing Laboratories (PDL) in San Antonio, has developed a topical compound from an existing calcium channel blocking drug known as Verapamil, which effectively breaks down the plaque which causes the curvature, and promotes healthy tissue to surface. A study conducted by Dr. William P. Fitch and released in the "International Journal of Impotence Research" treated 214 patients suffering from Peyronie's Disease for one to six months. The following results were noted: 

-- 71.4 percent noticed decreased curvature
-- 86.5 percent had measurable improvements in plaque buildup
-- 55.1 percent reported improvement of overall quality and rigidity of erection
-- 100 percent reported complete relief of pain

These results led Dr. Fitch to conclude, "Topical Verapamil appears to be an effective and well tolerated drug for the treatment of Peyronie's Disease. The only side effects we had were less than a 1 percent incidence of a contact dermatitis rash occurring. And most of those rashes were cleared up immediately by giving topical steroids at the time we gave the Topical Verapamil."