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Looking at the results, this does not seem a major issue, as the difference in the primary and secondary endpoints between 1 mgTID and 20 mg TID is statistically significant and coherent. Regarding the comparison between the 5-mg and 20-mg groups, the differences were small enough that, even with the completion of the study, similar results may have been observed.

A noninferiority study comparing sildenafil 5 mg TID versus 20 mg TID would require an unrealistically large sample size for a rare disease like PAH. Estimating from the results of the current study, 382 patients would be required for a study with a noninferiority margin of 15 m at 90% power and a 1-sided significance level of 0.05, assuming a true difference (5 vs 20 mg TID) of 0 m and a standard deviation of 50 m. The required sample size would increase if patient dropout was considered or if a smaller noninferiority margin was desired.

Despite this study having the limitation of premature termination, sildenafil 1 mg TID, but not 5 mg TID, was shown to be inferior to 20 mg TID for improvement in 6MWD in patients with PAH. Sildenafil 5 mg TID appeared to have similar clinical and hemodynamic effects as 20 mg TID.

Interestingly, 6MWD results from the open-label phase of the study suggest that patients on the approved sildenafil dose (20 mg TID) continued to show clinical improvement after the first 12 weeks of treatment. Hence, order viagra pills the question remains whether doses lower than 20 mg TID have therapeutic value and needs to be seen in light of the current therapeutic approach in PAH.

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VIAGRA BLUNTS EFFECTS OF STRESS ON THE HUMAN HEART. Johns Hopkins Medicine Office of Corporate Communications Media contact: David March 410-955-1534; dmarch1@jhmi.edu October 24, 2005. VIAGRA BLUNTS EFFECTS cenforce 200mg pills OF STRESS ON THE HUMAN HEART. Sildenafil citrate (Viagra), a drug used to treat erectile dysfunction (ED) in millions of men, reduces the stimulatory effects of hormonal stress on the heart by half, according to results of a new study by researchers at Johns Hopkins.

While sildenafil is more widely known for helping genital blood vessels expand to maintain an erection and, more recently, as a treatment for pulmonary hypertension, it has been thought to have little direct effect on the human heart. In the heart, sildenafil blunts the strengthened heartbeat caused by chemically induced stress, thereby lessening the excess amount of blood and force used to pump it to the body, according to study senior author and cardiologist David Kass, M.D., a professor at The Johns Hopkins University School of Medicine and its Heart Institute.

“Sildenafil effectively puts a ‘brake’ on chemical stimulation of the heart,” says Kass. The researchers’ findings, which appear in the journal Circulation online Oct.

24, are believed to be the first confirmation in humans that sildenafil has a direct effect on the heart.

Previous research by Kass and his team showed that sildenafil had such effects in mice, blocking the short-term effects of hormonal stress in the heart.

Related studies by the group also showed that sildenafil prevents and reverses the long-term effects in the heart from chronic high blood pressure.

Moreover, Kass adds, the latest Hopkins results confirm that sildenafil helps control heart function only when

the

“But we had no firm evidence as to whether or how this therapy might work in the human heart.

Our latest research provides firm evidence this drug does indeed have an important impact on the heart.” Thirty-five healthy men and women, with an average age of 30 and no previous signs of coronary artery disease, participated in the six-month study. Within a three-hour timeframe, each participant received two separate injections of dobutamine (5 micrograms per kilogram for five minutes), a synthetic, adrenaline-like chemical that increases heart rate and pumping strength.

Between injections, study participants were randomly assigned to a group that was treated with sildenafil (100 milligrams taken orally) or to a group given a sugar pill placebo. All participants were then given the second dobutamine injection to see what effects sildenafil or placebo had on the heart.

Measurements of heart function were made before and after each injection. This included blood pressure readings, electrocardiograms and echocardiograms, as well as blood samples to confirm relatively equal levels of sildenafil and other

enzymes

the

the

However, in the group treated with sildenafil, the increased heartbeat was slowed by 50 percent, resulting in a smaller increase in blood flow and blood pressure generated by the heart in response to chemical stimulation. Between injections, heart function was not altered in the sildenafil group, demonstrating the absence of adverse side effects on the resting human heart.

“Knowing more about the effects of sildenafil on heart function will allow for safer evaluation of its use as a treatment for heart problems,” says Kass. “Until now, it was widely thought that drugs like sildenafil had no effects on the human heart and that its only purpose was vasodilation in the penis and the lungs. “Our

results

While the precise biological actions of sildenafil in the heart are not fully understood, the drug is known to work by stopping the action of an enzyme, called phosphodiesterase 5 (PDE5A), the researcher says.

This enzyme is involved in the breakdown of a key molecule, cyclic GMP, which helps control stresses and limit overgrowth in the

heart

PDE5A is also the biological pathway blocked in the penis by sildenafil to promote the relaxation of blood vessels and maintain erections.

Funding for this study was provided by the National Institutes of Health (NIH), the Peter Belfer Laboratory Foundation and the Bernard Family cenforce 200mg pills Foundation. The makers of the drug had no involvement in the design or support of the research. Viagra is now being used to treat not only erectile dysfunction (ED) but also pulmonary hypertension.

And the drug may have potential for treating several other conditions, according to a recent report.

The three ED medications currently on the market—Viagra, Levitra, and Cialis—all work by the same means, and they have similar side effects.