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Stroke Patients Could Recover With Viagra

Is it possible for viagra to help stroke patients in the same manner it has been a help for a number of men in America?

Henry Ford Hospital is putting out the call to find out.

It needs 62 more volunteers for a study to find out whether Viagra improves recovery in people with moderate symptoms from stroke within seven days or less.

Ford got federal approval two years ago to use the little blue pill, as some call it, for an early, experimental study in people who have had a moderate ischemic stroke - one caused by a blockage, the most common kind.

Ford promoted the study Wednesday with a news release because only 10 patients have enrolled so far, said Dr. Brian Silver, a Ford neurologist heading the study. Some patients and families worried about side effects associated with the drug, including "inappropriate behaviors," increased sex drive and disruptiveness, he said.

Finding new uses for a drug are important to patients and pharmaceutical firms, particularly as companies look for ways to offset losses for profitable drugs like Viagra as they lose patent protection. Pfizer's Viagra is expected to go generic in the next few years, unless the company wins longer patent protection.

Pfizer gained federal approval in 2005 to sell Viagra, repackaged and renamed as Revatio, in a white, 20-milligram pill to treat pulmonary hypertension, a lung disorder in children and adults. Prescribed three times a day, Revatio costs $10,271 a year, or about $33.49 a day - costs exceeding those paid for by insurers or men taking Viagra for erectile dysfunction.

When taken to enhance sexual performance, Viagra typically costs $112 for 10 100-milligram pills.

The higher cost of a single dose of Revatio reflects costs Pfizer incurred to study its use in an entirely different group of patients, gain federal approval and remarket it to a different audience.

A Pfizer spokesman said in an e-mail that the company "routinely supports clinical studies either directly or through independent research grants to expand scientific knowledge about Pfizer products and promising medical interventions."

More than two dozen clinical studies are under way using Viagra for a variety of problems, from high blood pressure during pregnancy to menstrual bleeding and heart failure. For a list, go to www.clinicaltrials.gov.cqendnuWork by Michael Chopp, chief of neurology at Ford, could build the basis that Viagra may have therapeutic benefits beyond treating erectile dysfunction.

Chopp's research centers on the brain's capability to form new blood vessels and nerve connections, a process known as remodeling.

Chopp first gave Viagra to rats to see if those that had strokes recovered movement and memory. Viagra-fed rats were able to find a hidden escape platform, showed better footwork when walking over elevated grids and turned in both directions, instead of the one-way movements found in rats not on the drug after a stroke.

Silver said Viagra may produce a molecule, cGMP, or cyclic guanosine monophosphate, which sends signals to brain cells to create new nerve cells and connections, or synapses.

Patients in the Ford study get Viagra daily for two weeks and are followed for three months. The first dozen receive a 25-milligram pill; each dozen after that gets a higher dose, until the final group receives 150 milligrams in two doses a day, Silver said. The study is randomized, so half of the patients in phase-one will get a sugar pill.

Silver warns people not to give Viagra to stroke patients randomly because it could cause loss of vision and other problems.

Rene Jarinski of Owosso was the first Ford patient to get Viagra after she took a migraine medicine on July 28, 2003, and ended up with a rare disorder known as locked-in syndrome, a severe type of stroke.

She was unable to talk or move except to nod her head slightly or to glance sideways a little.

It affects about 200 people worldwide every year and often is fatal, said Silver, Jarinski's doctor.

Jarinski has started showing a lot of improvement after nine months of therapy. Silver also said that "is beginning to work on standing," and is quite successful in using the computer.