News Release

August 10, 2006

Contact: Maureen McGuire, 860-679-4523

Study Shows Investigational Hormone Therapy Significantly Reduces Blood Pressure in Post-Menopausal Women with Hypertension

UConn Expert and Lead Author Says Data are Compelling

Farmington, Conn. – A new study published in the journal Hypertension demonstrates that an investigational hormone replacement therapy significantly reduced both systolic and diastolic blood pressure in post-menopausal women with mild to moderate (stages 1 or 2) hypertension.

“The results of this study are compelling as they suggest that a hormone replacement therapy combining drospirenone and estradiol can provide significant blood pressure lowering benefits in symptomatic post-menopausal women with hypertension,” said the lead investigator of the study, William B. White, M.D., professor and hypertension specialist at the Pat and Jim Calhoun Cardiology Center at the University of Connecticut Health Center.

The study examined investigational dosages of the hormone replacement therapy drospirenone (DRSP)/estradiol (ANGELIQ), which included 1, 2, or 3 mg of drospirenone and 1 mg of estradiol. The reductions in blood pressure were dose-related to drospirenone – a progestin with the unique ability to block a steroid hormone in the body (aldosterone) linked to the development of cardiovascular disease. The 2 mg dose was found to be the lowest effective dose for reducing blood pressure in these women.

“It is important that we further our understanding of the potential role this hormone replacement therapy can play in a woman’s overall management of the disease, as this population of women is at increased risk for hypertension,” Dr. White added.

Study Results
A total of 750 post-menopausal women ages 45 to 75 were randomized to one of five eight-week daily treatment regimens: drospirenone (1, 2, or 3 mg) combined with estradiol, estradiol alone, or placebo. The most significant decreases in 24-hour systolic pressure were observed at doses of 2 and 3 mg of drospirenone combined with estradiol. There were no significant increases from baseline in serum potassium in any of the treatment groups. The incidence of adverse events was low and similar across treatment arms.

“Previous studies using 3 mg of drosperinone have established this progestin’s unique properties, but have lacked dose-ranging data specifically looking at its blood-pressure lowering effect,” Dr. White said. “Our study was a rigorously designed trial that used the gold standard for blood pressure monitoring, including 24-hour ambulatory blood pressure monitoring. This allowed us to track the extent and duration of the dose-response relationship for drospirenone as it pertains to blood pressure.”

Unlike other progestins, drospirenone is an analogue of spironolactone that exhibits anti-mineralocorticoid and anti-androgenic properties. Having anti-aldosterone activity, drospirenone may reduce excess water and sodium retention while maintaining potassium, or counter the water retention that is sometimes caused by estrogen intake. Blocking the effects of aldosterone leads to the antihypertensive properties of drospirenone.

The study was supported by Berlex, Inc., which currently markets ANGELIQ – a hormone replacement therapy that combines 0.5 mg drospirenone and 1 mg estradiol and is used to treat moderate-to-severe vasomoter and vaginal atrophy symptoms associated with menopause. The currently approved dose of ANGELIQ has not been shown to reduce blood pressure.

About Hypertension
Hypertension significantly increases the risk of cardiovascular disease and death in both men and women. The prevalence of hypertension increases with age, and women survive to older ages than men. According to the American Heart Association, heart disease is the number one killer of women in the U.S.

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