CHICAGO, Oct 13 (Reuters) – Medical device maker Medtronic Inc (MDT.N) on Tuesday said it has begun a feasibility study for a treatment for erectile dysfunction that uses a specially designed drug-eluting stent.
The study, called Zen, is expected to enroll 50 subjects at up to 10 U.S. medical centers over the next year.
“The link between erectile dysfunction and coronary artery disease has been well established. Based on this evidence, we are investigating the use of stents in pelvic arteries to determine whether it may provide a new treatment approach and enable better response to drug therapies,” Dr. Jason Rogers, director of interventional cardiology at UC Davis Medical Center in Sacramento and a lead investigator for the study, said in a statement.
The study is intended for men who have not responded well to PDE5 inhibitors such as Viagra, Cialis and Levitra.
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The study will evaluate the safety and improved erectile function of pelvic artery stenting. Results are expected in 2011. (Reporting by Susan Kelly; Editing Bernard Orr)
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CHICAGO, April 13 (Reuters) – Healthy men who took Cialis or Viagra daily for six months did not develop any significant vision problems, U.S. researchers said on Monday in a company-funded study aimed at addressing concerns about the popular impotence treatments.
Pfizer Inc’s (PFE.N) Viagra or sildenafil and Eli Lilly and Co’s (LLY.N) Cialis or tadalafil treat impotence by increasing blood flow to the genitals, but some men taking the drugs have reported blurred vision, blue-tinged vision or altered light perception.
The drugs work by blocking the action of the enzyme phodiesterase type 5 or PDE5 on the blood vessels in the penis. But PDE5 inhibitors may also act on blood vessels in the retina, which could explain some of the reports of vision problems.
To test this, a team led by Dr. William Cordell of Lilly Research Laboratories in Indianapolis and colleagues conducted a randomized study to look for changes in the retina among men taking Viagra tablets or Cialis.
They studied 244 healthy men or those with mild erectile dysfunction aged 30 to 65 who had no vision problems. Of these, 85 took 5 milligrams of Cialis, 77 took 50 milligrams of sildenafil and 82 took a dummy pill daily for six months.
The men underwent comprehensive eye exams, including electroretinography, a test to measure the electrical response of the light-sensitive cells in the eye, before, during and after treatment.
Among the 194 men who completed the study, the researchers found no significant differences between treatment and placebo groups on electroretinography, visual function tests, measurements of pressure within the eyeball or assessments of the anatomy of the eye.
“Our results indicate that there is no cumulative damage or effect of clinical significance,” for the studied doses of either drug, the researchers wrote in the Archives of Ophthalmology.
They said their study was limited because the doses used were lower than some other studies that did find retinal changes. And they said the results could not be generalized to men with eye problems, who were excluded from the study.
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Eli Lilly designed and paid for the study, which did not evaluate Bayer AG’s BAYG.DE Levitra or vardenafil, a similar drug. (Reporting by Julie Steenhuysen; Editing by Michael Conlon and Eric Walsh)
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