Source: DGNews  |  Posted 8 years ago

By Ed Susman

CHICAGO, IL -- April 4, 2003 -- Analysis of several key studies of the investigational anti-impotence drug vardenafil indicates that the medication will be safe with antihypertension treatments.

Researchers presented their findings here March 31st at the 52nd Annual Scientific Session of the American College of Cardiology.

"However, patients cannot use vardenafil with nitrates," said Robert Kloner, MD, of Good Samaritan Hospital, Los Angeles, California. "The warning that is in place for sildenafil is also in effect for this new drug."

He said nitrates and the phosphodiesterase-5 inhibitors appear to exert a synergistic effect on blood pressure that can cause severe symptoms, including death.

"What we can say is that vardenafil may be associated with small, transient variations in blood pressure and heart rate relative to placebo. Vardenafil exhibited a favorable cardiovascular safety profile with the overall incidence of cardiovascular-related events similar to placebo."

The serious adverse events in the analysis, which included studies involving 1,199 placebo patients and 2,203 men on vardenafil, amounted to about 2.5% in each group. One death occurred in the placebo patient group; no deaths occurred among patients on vardenafil. The patients were on study drugs from 12 to 26 weeks, depending on the study design.

Co-author Harin Padma-Nathan, MD, of The Male Clinic, Beverly Hills, California, said hypertensive patients in the study were taking angiotensin-converting enzyme inhibitors, calcium antagonists, beta blockers, diuretics, alpha-blockers, and angiotensin receptor blockers. When the patients also took vardenafil, systolic blood pressures fell between 3 and 7 points and diastolic blood pressures fell between 2.6 and 5 points.

About 4% of patients discontinued the drug because of adverse events, most often hypertension, tachycardia, palpitations, and peripheral edema.

The study was sponsored by the Bayer Pharmaceutical Division, West Haven, Connecticut.

[Study title: Cardiovascular Safety of Vardenafil in Patients Receiving Antihypertensive Medications: A Post-Hoc Analysis of Five Placebo-Controlled Clinical Trials. Abstract: 1133-148]