Estrogel Available In Canada For ERT

MONTREAL, QC -- Feb. 17, 1999

Schering Canada's Estrogel(R), the first and only estrogen gel for naturally or surgically-induced estrogen deficiency and the relief of menopausal symptoms such as hot flushes, vaginal atrophy, mood swings and sleep disturbances, is now available in Canada as estrogen replacement therapy (ERT)

Estrogel, which comes in a bottle with a metered-dose pump, is a transdermal preparation combining a hydro-alcoholic gel and 0.06% of the physiological hormone 17beta-estradiol, derived from yam. A correct dose of Estrogel is dispensed from the pump and then spread over the surface of the skin, usually on the arms, once a day. The gel is absorbed quickly into the skin, in under two minutes, leaving no sticky residue.

What's particularly interesting about Estrogel is the novel way in which the estradiol accumulates in the skin creating an intra-dermal reservoir that provides a relatively stable passage of estradiol into the blood system over several hours.

"Estrogel has a very low incidence of skin irritation compared to transdermal estrogen patches, where it is common," said Dr. Céline Bouchard, associate professor of obstetrics and gynaecology at Université Laval and the director of a private menopause clinic. "With Estrogel, the physician can easily adjust the dosage on a daily basis."

Estrogel has been safely used in Europe for more than 20 years and is currently the most prescribed estrogen in France. This has given physicians the opportunity to gain experience with this form of ERT and study its unique mechanism of action.

ERT and hormone replacement therapy (HRT), which combines estrogen and progesterone, are generally recognised as providing relief from the symptoms of menopause and helping to prevent bone loss which can lead to osteoporosis. Studies conducted during the last decade show that ERT/HRT can also help to reduce the relative risk of heart disease by 50 percent.

The Osteoporosis Society of Canada recommends ERT/HRT be taken for 10 years for maximum protection from bone loss. Studies show that the benefits of ERT/HRT for disease prevention are highest in women who continue their therapy for five years or more.

"It is unfortunate that up to one third of women do not get their initial HRT prescription filled and that only 15 to 20 per cent of Canadian women in their menopausal years will start on HRT at some point," said Dr. Robert Lea, associate professor in the department of obstetrics and gynaecology at Dalhousie University. "Only eight percent continue on HRT for as long as two years."

Non-compliance with prescription medications, in general, increases with the incidence of side-effects. Estrogel's low-side effect profile is a benefit in this regard. Patients who must remember to take many prescription tablets and follow complicated treatment schedules, tend to make mistakes, especially older patients. For women in this situation, estrogen gel is a simple, easy-to-remember option .

"Medications with novel delivery methods, such as Estrogel, that can be easily applied during a woman's daily morning or evening routine are believed to encourage compliance with treatment. Because Estrogel won't be confused with other medications a woman might be taking in tablet form, it is more likely to be remembered," said Dr. Lawrence Komer, an obstetrician and gynaecologist at Joseph Brant Memorial Hospital in Burlington, ON. "Offering women choices and finding a therapy that fits each woman's needs is very important in improving compliance."

The report from the Canadian Consensus Conference on Menopause and Osteoporosis states that a recent meta-analysis of studies examining HRT found no increase in breast cancer risk with short term use (less than five years). This same study found that, after more than five years of HRT use, the relative risk did increase over time. The relative risk of breast cancer with HRT would account for an excess of two, six or 12 cases per 1,000 HRT users after five, 10 or 15 years of use, respectively. This increased relative risk virtually disappeared within five years of stopping HRT use.

To put breast cancer risk in context, there appears to be a greater risk of developing breast cancer by drinking two alcoholic beverages a day, reaching menopause later in life, or by not exercising regularly, than by taking HRT.

Estrogen taken alone can also increase the risk of cancer of the endometrium but this risk is completely offset by taking progesterone with the estrogen. Current guidelines state that a woman who has not had her uterus removed and is taking estrogen should also take progesterone. For some women, estrogen can cause breast tenderness or swelling, sometimes accompanied by increased vaginal discharge. Progesterone causes monthly vaginal bleeding in most women and can cause some women to experience headaches, bloating, mood swings or depression.

An estimated four million women in Canada are approaching or are already going through menopause and the number of women over the age of 50 is projected to increase to more than 5.6 million by the year 2006.

The onset of menopause is linked to a major decline in estrogen production by the ovaries and is associated with increased loss of bone mineral density, various symptoms such as hot flushes, sleep disturbances and vaginal dryness. Because endogenous estrogens (naturally produced by the ovaries) actually protect the heart and blood vessels, women are also at greater risk for cardiovascular diseases such as heart attack, heart failure and stroke.

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