To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ASRM: Femhrt And Estrostep (Norethindrone Acetate/Ethinyl Estradiol) Combat Osteoporosis And Acne URL: http://www.pslgroup.com/dg/20B7DE.htm Doctor's Guide October 23, 2001
ORLANDO, FL -- October 23, 2001 -- Pfizer unveiled new data on additional health benefits of two of its estrogen compounds at the 57th Annual American Society for Reproductive Medicine (ASRM) meeting in Orlando, Florida. Continuous-combined hormone replacement therapy (CCHRT), femhrt® (norethindrone acetate/ethinyl estradiol tablets), and Estrostep® (norethindrone acetate/ethinyl estradiol tablets), an estrophasic oral contraceptive (birth control pill), have proven successful in offering women additional benefits in preventing osteoporosis and treating moderate acne vulgaris, respectively. "Women are taking a more active role these days in managing their health," says Ruth Merkatz, Ph.D., Director, Pfizer Women's Health Team. "Secondary health benefits of standard products are helping drive women's decisions. We've found that women welcome products such as femhrt and Estrostep because they offer additional value and convenience." Combating osteoporosis with femhrt (norethindrone acetate/ethinyl estradiol tablets): A new study evaluating femhrt's ability to maintain bone mineral density (BMD) versus placebo found that significantly more subjects (over 70 percent) treated with femhrt maintained BMD at the lumbar spine, femur and total body, compared with placebo. All subjects were instructed to take 1 study medication tablet per day in the evening and 1000 mg of calcium per day, which was supplied. A total of 945 healthy, nonosteoporotic postmenopausal women, 40 to 62 years of age, enrolled at 57 centers across the United States entered the 12-month double-blind, placebo-controlled trial. All treatment groups were comparable with regard to age, time since menopause, body mass index (BMI), and racial composition. Continuous-combined hormone replacement therapy, femhrt, contains a combination of two hormones in a single tablet, an estrogen called ethinyl estradiol (EE) and a progestin called norethindrone acetate (NA), and is proven to relieve the vasomotor symptoms of menopause and to prevent osteoporosis. "One in two women will have an osteoporosis-related fracture in their lifetime. This is a staggering statistic," said lead investigator James Simon, M.D., Clinical Professor, George Washington University School of Medicine, Washington, DC and Medical Director, The Women's Health Research Center. "As many women entering menopause explore hormone replacement therapy options, my hope is that they will talk to their physician about taking an HRT with proven data in preserving bone, like femhrt." Osteoporosis is often called the "silent disease" because bone loss occurs without symptoms. People may not know that they have osteoporosis until their bones become so weak that a sudden strain, bump, or fall causes a fracture or a vertebra to collapse. It is considered a major public health threat for more than 28 million Americans, 80 percent of whom are women. In the United States, 10 million individuals already have the disease. Risk factors for developing osteoporosis include being female, having a thin and/or small frame, advanced age, family history of osteoporosis, diet, and race, specifically being Caucasian or Asian. In clinical trials, the most frequently reported adverse events associated with femhrt were headache, abdominal pain, and breast pain. Progestogens/estrogens should not be used in individuals with any of the following conditions or circumstances: sensitivity to these components; known or suspected pregnancy, breast cancer or estrogen-dependent neoplasia; undiagnosed abnormal genital bleeding; active or past history of thrombophlebitis or thromboembolic disorders. Managing moderate acne vulgaris with Estrostep (norethindrone acetate/ethinyl estradiol tablets): Recent studies evaluated Estrostep in the treatment of moderate acne vulgaris in women. This included an analysis of efficacy in those of different ages and races as well as additional analysis through the Facial Acne Global Assessment (FAGA), an instrument developed and implemented as an additional measure of efficacy. The study also evaluated the effect of Estrostep on weight. Both studies were randomized, double-blind, placebo-controlled trials involving nearly 600 women. Estrostep was shown to be equally efficacious in the treatment of moderate acne vulgaris in subjects across races and ages in terms of both lesion counts and FAGA. The importance of FAGA is that it is a subjective clinician's impression of change and is a static, validated measure, which together with lesion counts provides a further useful measure in assessing the acne patient. Estrostep is also indicated for the treatment of moderate acne vulgaris in women 15 years of age and older, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have begun menstruation, and are unresponsive to topical antiacne medications. Estrostep should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control and plans to stay on it for at least six months. "Acne vulgaris can be an emotionally debilitating condition to women of all ages, especially among adolescents and young adults," says lead investigator Michelle Warren, M.D., Medical Director Center for Menopause, Hormonal Disorders and Women's Health; Professor of Ob-Gyn and Medicine, Columbia University. "Estrostep is a great choice for women 15 years of age and older who want to prevent pregnancy and also benefit from its effect on acne with one convenient daily tablet." Acne vulgaris is a common skin disorder affecting approximately 17 million Americans, most commonly in adolescence and young adulthood. It affects nearly 85 percent of people aged 12 to 24 years. Acne, if untreated, can be associated with anxiety, depression, self-consciousness, and social withdrawal, all of which affect quality of life. Oral contraceptives (OCs) are not appropriate for all patients, and serious as well as minor side effects have been reported with the use of all OCs. OCs do not protect against HIV infection or AIDS and other sexually transmitted diseases. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women older than 35. Women who use OCs should be strongly advised not to smoke. SOURCE: Pfizer Related Link: Pfizer. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.