Repros Therapeutics Inc. (NasdaqGM:RPRX) today released strong results from its completed extension safety study of Proellex in the chronic treatment of the symptoms associated with uterine fibroids. To date there have been no abnormal histological findings from the endometrial biopsies taken post menses after cessation of drug administration.
As of this release, results from 13 women who had endometrial biopsies post menses following last dose of drug in a two-drug cycle extension study of Proellex in the treatment of symptoms associated with uterine fibroids are available. These women have been exposed to Proellex for one three-month and two four-month drug cycles to help control the symptoms of their uterine fibroids. These three cycles have covered a span of two and one half years which exceeds current FDA guidance for the duration of exposure to hormonal drugs.
The biopsies have been read by a panel of three expert pathologists all of whom will remain blinded to the treatment allocations until all of the final biopsies from this study have been read. The panel is led by Dr. George Mutter, Associate Professor of Pathology at Harvard Medical School, Department of Pathology, Brigham and Women's Hospital. Dr. Mutter is a leading expert in the interpretation of gynecological histology and pathology.
Results of assessments of the post menses tissues are that of a benign endometrium. While previous end of drug cycle biopsies from these subjects all had histological changes consistent with those induced by progesterone receptor modulators (Proellex class of drugs), none of these post drug cessation biopsies reflected any of those histological changes. These key findings indicate that the effects of Proellex on the endometrium are present during drug exposure and are reversible upon cessation of drug treatment.
Repros has described in previous communications that it had developed a unique approach to dosing with Proellex which treats women for four months (16 weeks) and then stops treatment to create an "off drug interval" until the next menstrual period commences at which time treatment recommences for four months. These cyclical treatments are designed to be used for chronic treatment of symptomatic uterine fibroids and endometriosis. The rationale for this treatment regimen is that most of the reported bleeding events in previous studies occurred after 16 weeks of continuous treatment and were accompanied by endometrial thickening. By allowing a menstrual flow to occur after treatment withdrawal, the endometrium is essentially refreshed and the tendency toward a progressive endometrial thickening eliminated.
Joseph S. Podolski commented, "The importance of these findings can not be overstated. We believe this is a key finding. The consistency of endometrial effects on and off Proellex are strong and suggestive of a therapy that may have far reaching potential in diseases where progesterone has been implicated. The underlying theme for the action of Proellex is one of an agent that is anti-proliferative and pro-apoptotic and not the proliferative effects noticed in the development of some of the selective estrogen receptor modulators." He further noted that the Company's pivotal Phase 3 efficacy and long-term safety studies all include endometrial biopsies and these findings will be strengthened by continued observations which should further support Proellex as an effective and safe therapy in the treatment of a variety of female disorders.
About Repros Therapeutics Inc.
Repros Therapeutics focuses on the development of oral small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.
Our lead drug, Proellex®, is a selective blocker of the progesterone receptor and is being developed for the treatment of symptoms associated with uterine fibroids and endometriosis. We are also developing Proellex as a short course pre-surgical treatment for anemia associated with excessive menstrual bleeding related to uterine fibroids. There is no currently-approved effective long-term orally administered drug treatment for uterine fibroids or endometriosis. In the United States alone, 300,000 women per year undergo a hysterectomy as a result of severe uterine fibroids.
Our second product candidate, Androxal®, is a single isomer of clomiphene citrate and is an orally active proprietary small molecule compound. We are developing Androxal for men with low testosterone and adult-onset idiopathic hypogonadotrophic hypogonadism ("AIHH") with concomitant plasma glucose and lipid elevations, all of which are components of Metabolic Syndrome. We are also developing Androxal for men of reproductive age with low testosterone levels who want to improve or maintain their fertility and/or sperm function while being treated for low testosterone.
Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Repros' ability to raise additional capital in a timely manner and on acceptable terms or at all, Repros' ability to have success in the clinical development of its technologies, the timing of enrollment and release of data in such clinical studies and the accuracy of such studies, limited patient populations of clinical studies to date and the possibility that final data may not be consistent with interim data and such other risks which are identified in the Company's most recent Annual Report on Form 10-K and in any subsequent quarterly reports on Form 10-Q. These documents are available on request from Repros Therapeutics or at www.sec. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For more information, please visit the Company's website at www.reprosrx.
четверг, 7 июня 2012 г.
четверг, 31 мая 2012 г.
European Menopause And Andropause Society Publishes Four Position Statements About The Post-reproductive Health Of Women
Elsevier announced the publication of four important position statements from the European Menopause and Andropause Society (EMAS) in the journal Maturitas on common management problems in the post-reproductive health of women. The statements cover the management of the menopause in the context of obesity, epilepsy, endometriosis and premature ovarian failure. Each statement has summary recommendations as a quick aid for the busy clinician.
"The expanding ageing female population means that clinicians increasingly have to deal with post-reproductive health problems," said Professor Serge Rozenberg, President of EMAS. "EMAS has risen to the challenge and is providing clear guidance on the position statements covering both hormone and non hormone therapy (HT) options, as well as complementary and alternative therapies."
The statements were published in the July 2010 issue and are summarized as follows:
(1) Obesity: Obesity affects about 20% of the adult world population and 44% of postmenopausal women. Obesity is a major risk factor for many diseases including diabetes mellitus, dyslipidemia and hypertension resulting in cardiovascular disease, as well as venous thromboembolism and breast and endometrial cancer. Thus transdermal (patch, gel) HT is preferred over oral tablets because of the reduced risk of venous thromboembolism. (doi:10.1016/j.maturitas.2010.03.025)
(2) Epilepsy: Women with epilepsy may undergo the menopause 3- 5 years early and can be at increased risk of osteoporortic fracture depending on their antiepileptic drug use. If HT is used, these women need to be closely monitored by specialists. Calcium and vitamin D supplements should be considered. Herbal preparations should be avoided as their efficacy is uncertain and they may interact with anti epileptic drugs. (doi:10.1016/j.maturitas.2010.03.026)
(3) Endometriosis: Endometriosis is a debilitating gynaecological condition frequently associated with infertility and abdominal pain. A major concern with HT is disease recurrence and the authors conclude that, although the available data are limited, it may be safer to prescribe either continuous combined estrogen progestogen hormone therapies or tibolone in both hysterectomised and non-hysterectomised. Women not needing or not wanting HT or those who are advised against should be offered alternative treatment for climacteric symptoms or skeletal protection. (doi:10.1016/j.maturitas.2010.04.018)
(4) Premature ovarian failure: Premature ovarian failure (POF) is the menopause before the age of 40 which may occur naturally or after surgery or chemotherapy. Untreated, it increases the risk of osteoporosis, cardiovascular disease, dementia, Parkinsonism, and general cognitive decline. Therefore, the statement clearly recommends the use of HT until the average age of the natural menopause, i.e. the early 50s. (doi:10.1016/j.maturitas.2010.04.011)
Source: Elsevier
"The expanding ageing female population means that clinicians increasingly have to deal with post-reproductive health problems," said Professor Serge Rozenberg, President of EMAS. "EMAS has risen to the challenge and is providing clear guidance on the position statements covering both hormone and non hormone therapy (HT) options, as well as complementary and alternative therapies."
The statements were published in the July 2010 issue and are summarized as follows:
(1) Obesity: Obesity affects about 20% of the adult world population and 44% of postmenopausal women. Obesity is a major risk factor for many diseases including diabetes mellitus, dyslipidemia and hypertension resulting in cardiovascular disease, as well as venous thromboembolism and breast and endometrial cancer. Thus transdermal (patch, gel) HT is preferred over oral tablets because of the reduced risk of venous thromboembolism. (doi:10.1016/j.maturitas.2010.03.025)
(2) Epilepsy: Women with epilepsy may undergo the menopause 3- 5 years early and can be at increased risk of osteoporortic fracture depending on their antiepileptic drug use. If HT is used, these women need to be closely monitored by specialists. Calcium and vitamin D supplements should be considered. Herbal preparations should be avoided as their efficacy is uncertain and they may interact with anti epileptic drugs. (doi:10.1016/j.maturitas.2010.03.026)
(3) Endometriosis: Endometriosis is a debilitating gynaecological condition frequently associated with infertility and abdominal pain. A major concern with HT is disease recurrence and the authors conclude that, although the available data are limited, it may be safer to prescribe either continuous combined estrogen progestogen hormone therapies or tibolone in both hysterectomised and non-hysterectomised. Women not needing or not wanting HT or those who are advised against should be offered alternative treatment for climacteric symptoms or skeletal protection. (doi:10.1016/j.maturitas.2010.04.018)
(4) Premature ovarian failure: Premature ovarian failure (POF) is the menopause before the age of 40 which may occur naturally or after surgery or chemotherapy. Untreated, it increases the risk of osteoporosis, cardiovascular disease, dementia, Parkinsonism, and general cognitive decline. Therefore, the statement clearly recommends the use of HT until the average age of the natural menopause, i.e. the early 50s. (doi:10.1016/j.maturitas.2010.04.011)
Source: Elsevier
четверг, 24 мая 2012 г.
Being In Debt May Increase Risk For Preterm Delivery In Some Women
Some types of stress may increase risk for preterm delivery, but many stressful events do not, according to study by a researcher at RTI International.
The study, published in RTI Press, found that being in debt, being injured by a partner, having someone close attempt suicide, and being divorced were associated with an increase risk of preterm delivery, but 13 other events were not.
"Stressful life events have been associated with preterm delivery in some studies but not in others," said Nedra Whitehead, Ph.D., an epidemiologist at RTI International and the paper's author. "This study provides some limited support for an association of some life events with preterm delivery, but it is not clear why only these four of the 18 events studied were associated with preterm deliver as they are not similar in type of stress or expected severity."
According to the research, women who reported being in debt were the most consistently at risk for preterm delivery. They were 9 percent more likely to deliver at 35 to 36 weeks of gestation, 14 percent more likely to deliver at 33 to 34 weeks, and 16 percent more likely to deliver at less than 33 weeks.
However, having a partner who lost his (or her) job was associated with a decreased risk of preterm delivery.
The researcher examined 18 categories associated with an increased risk of at least one category of preterm delivery. The events include legal conflicts, changes in relationships, financial difficulties, physical conflicts, and family illness or death.
The author used data collected by the Pregnancy Risk Assessment Monitoring System, a survey of American women with a recent live birth, for 1990 - 1995 to examine the relationship between individual life events and the risk of preterm delivery overall and by levels of severity.
About RTI International:
RTI International is one of the world's leading research institutes, dedicated to improving the human condition by turning knowledge into practice. Our more than 3,800 professionals provide research and technical services to governments and businesses in more than 40 countries in the areas of health and pharmaceuticals, education and training, surveys and statistics, advanced technology, international development, economic and social policy, energy, and the environment. For more information, visit rti.
RTI International
3040 Cornwallis Rd.
Research Triangle Park, NC 27709-2194
United States
rti
The study, published in RTI Press, found that being in debt, being injured by a partner, having someone close attempt suicide, and being divorced were associated with an increase risk of preterm delivery, but 13 other events were not.
"Stressful life events have been associated with preterm delivery in some studies but not in others," said Nedra Whitehead, Ph.D., an epidemiologist at RTI International and the paper's author. "This study provides some limited support for an association of some life events with preterm delivery, but it is not clear why only these four of the 18 events studied were associated with preterm deliver as they are not similar in type of stress or expected severity."
According to the research, women who reported being in debt were the most consistently at risk for preterm delivery. They were 9 percent more likely to deliver at 35 to 36 weeks of gestation, 14 percent more likely to deliver at 33 to 34 weeks, and 16 percent more likely to deliver at less than 33 weeks.
However, having a partner who lost his (or her) job was associated with a decreased risk of preterm delivery.
The researcher examined 18 categories associated with an increased risk of at least one category of preterm delivery. The events include legal conflicts, changes in relationships, financial difficulties, physical conflicts, and family illness or death.
The author used data collected by the Pregnancy Risk Assessment Monitoring System, a survey of American women with a recent live birth, for 1990 - 1995 to examine the relationship between individual life events and the risk of preterm delivery overall and by levels of severity.
About RTI International:
RTI International is one of the world's leading research institutes, dedicated to improving the human condition by turning knowledge into practice. Our more than 3,800 professionals provide research and technical services to governments and businesses in more than 40 countries in the areas of health and pharmaceuticals, education and training, surveys and statistics, advanced technology, international development, economic and social policy, energy, and the environment. For more information, visit rti.
RTI International
3040 Cornwallis Rd.
Research Triangle Park, NC 27709-2194
United States
rti
четверг, 17 мая 2012 г.
Women With Sexual Dysfunction Respond Well To Placebo Therapy
Women with sexual dysfunction - low sexual arousal and/or sexual desire - appear to experience clinically significant symptom changes when given a placebo, according to a study published in the Journal of Sexual Medicine. Female sexual dysfunction is a recurrent problem with sexual desire or response, to such an extent that the woman becomes distressed, or/and it is having an effect on her relationship with her partner.
Andrea Bradford, Ph.D., psychologist, Baylor College of Medicine, and Cindy Meston, Ph.D., the University of Texas at Austin, examined the symptoms and behaviors of 50 adult females - they were randomly selected to receive a placebo in a large trial which was investigating a medication for low sexual arousal. It was a double-blind trial - this means that neither the doctors not the women knew whether they were taking a placebo or the real medication.
The researchers report that approximately one third of the women on a placebo had a "meaningful change" in their condition after 12 weeks of treatment, with most of the improvement occurring during the first month.
The main predictor of symptom change was an increase in the number of times they experienced satisfying sexual encounters during the treatment period.
A significant number of them said they received more stimulation during sex while they took part in the trial - their partners were not given any special instructions or counseling.
Bradford said:
It's important to note that, even though these women received placebo, they all had an opportunity to talk to a health provider about their difficulties and were asked to closely monitor their sexual behavior and feelings over a 12-week period. Just taking part in this study probably started some meaningful conversations. Our study shows that even a limited intervention can have a positive effect in many women with sexual dysfunction. This comes as no surprise to sex therapists, but it does suggest a need to investigate behavioral factors more closely in clinical trials.
Female sexual dysfunction is more common than people realize. Some women experience temporary problems, while for others the condition may persist throughout their lives. There are several causes and symptoms for female sexual dysfunction. Experts say that in most cases the condition is treatable.
Female sexual dysfunction can occur at any age during a woman's life, but are more likely to occur when hormone levels change, such as during pregnancy or the menopause. Major illnesses are sometimes linked to sexual concerns, maybe for physical or mental reasons, or a combination of both.
According to the Mayo Clinic, USA, if a woman experiences at least one of the following and she is distressed about it, her problem(s) might be classified as female sexual dysfunction:
Low or absent libido (sex drive, desire to have sex)
Although she may want to have sex, the woman does not become aroused, or she cannot maintain arousal during sexual activity
The woman cannot reach orgasm
Sexual contact is physically painful
A number of factors, which are often interrelated, may contribute towards female sexual dysfunction. The main factors are usually physical, hormonal and psychological/social.
Physical factors may include arthritis, bowel problems, urinary problems, fatigue, persistent pain, multiple sclerosis and some other neurological disorders, taking antidepressants or medications for hypertension, some chemotherapies, and antihistamines.
Hormonal factors may include alterations in estrogen levels during the menopause which may eventually lead to physical changes in the genital region.
A woman with depression or anxiety which is untreated has a higher risk of experiencing sexual dysfunction. Some pregnant women report that the worry of becoming a parent may persist and affect their libido and their arousal during sex. Experts say that emotional distress may be a cause of sexual dysfunction as well as a result of it.
Correlates of Placebo Response in the Treatment of Sexual Dysfunction in Women: A Preliminary Report
Andrea Bradford MA, Cindy Meston PhD
Journal of Sexual Medicine DOI: 10.1111/j.1743-6109.2007.00578.x
Andrea Bradford, Ph.D., psychologist, Baylor College of Medicine, and Cindy Meston, Ph.D., the University of Texas at Austin, examined the symptoms and behaviors of 50 adult females - they were randomly selected to receive a placebo in a large trial which was investigating a medication for low sexual arousal. It was a double-blind trial - this means that neither the doctors not the women knew whether they were taking a placebo or the real medication.
The researchers report that approximately one third of the women on a placebo had a "meaningful change" in their condition after 12 weeks of treatment, with most of the improvement occurring during the first month.
The main predictor of symptom change was an increase in the number of times they experienced satisfying sexual encounters during the treatment period.
A significant number of them said they received more stimulation during sex while they took part in the trial - their partners were not given any special instructions or counseling.
Bradford said:
It's important to note that, even though these women received placebo, they all had an opportunity to talk to a health provider about their difficulties and were asked to closely monitor their sexual behavior and feelings over a 12-week period. Just taking part in this study probably started some meaningful conversations. Our study shows that even a limited intervention can have a positive effect in many women with sexual dysfunction. This comes as no surprise to sex therapists, but it does suggest a need to investigate behavioral factors more closely in clinical trials.
Female sexual dysfunction is more common than people realize. Some women experience temporary problems, while for others the condition may persist throughout their lives. There are several causes and symptoms for female sexual dysfunction. Experts say that in most cases the condition is treatable.
Female sexual dysfunction can occur at any age during a woman's life, but are more likely to occur when hormone levels change, such as during pregnancy or the menopause. Major illnesses are sometimes linked to sexual concerns, maybe for physical or mental reasons, or a combination of both.
According to the Mayo Clinic, USA, if a woman experiences at least one of the following and she is distressed about it, her problem(s) might be classified as female sexual dysfunction:
Low or absent libido (sex drive, desire to have sex)
Although she may want to have sex, the woman does not become aroused, or she cannot maintain arousal during sexual activity
The woman cannot reach orgasm
Sexual contact is physically painful
A number of factors, which are often interrelated, may contribute towards female sexual dysfunction. The main factors are usually physical, hormonal and psychological/social.
Physical factors may include arthritis, bowel problems, urinary problems, fatigue, persistent pain, multiple sclerosis and some other neurological disorders, taking antidepressants or medications for hypertension, some chemotherapies, and antihistamines.
Hormonal factors may include alterations in estrogen levels during the menopause which may eventually lead to physical changes in the genital region.
A woman with depression or anxiety which is untreated has a higher risk of experiencing sexual dysfunction. Some pregnant women report that the worry of becoming a parent may persist and affect their libido and their arousal during sex. Experts say that emotional distress may be a cause of sexual dysfunction as well as a result of it.
Correlates of Placebo Response in the Treatment of Sexual Dysfunction in Women: A Preliminary Report
Andrea Bradford MA, Cindy Meston PhD
Journal of Sexual Medicine DOI: 10.1111/j.1743-6109.2007.00578.x
четверг, 10 мая 2012 г.
Cook Medical Reports Positive Results From Clinical Trial Designed To Evaluate Safety And Efficacy Of Biodesign™ Vaginal Erosion Repair Graft
An 11-month clinical study led by Manish P. Patel, M.D., generated positive results on Cook Medical's Biodesign™ Vaginal Erosion Repair Graft for the treatment of vaginal mesh exposures, a common complication resulting from the use of synthetic mesh in pelvic floor repair, the procedure used to treat pelvic organ prolapse. The results, which confirmed the safety and efficacy of Biodesign, were presented at the 2009 Society for Urodynamics and Female Urology Winter Meeting in Las Vegas.
The study examined the efficacy of the Biodesign Vaginal Erosion Repair Graft in treating 10 women with large, symptomatic extrusions that resulted from the use of polypropylene or synthetic mesh in a previous pelvic floor reconstruction procedure. To treat the complication, the exposed synthetic mesh was completely removed and the Biodesign graft was implanted to help fully restore and repair the pelvic floor. Research findings showed that all 10 large mesh exposures were successfully repaired with the Biodesign graft with no evidence of recurrence or further complication.
According to the National Institute of Health, an estimated one-third of all U.S. women are affected by pelvic floor disorders including pelvic organ prolapse, a condition that occurs when the pelvic muscles become weakened and stretched, often as a result of childbirth. Although pelvic floor reconstruction is the most common form of treatment, synthetic mesh-based procedures have recently come under scrutiny after the FDA received more than 1,000 reports of rare but serious complications, including vaginal erosion, linked specifically to the use of synthetic mesh. Cook's Biodesign Vaginal Erosion Repair Graft will play an especially important role in treating these synthetic mesh-based complications and more.
"The surgical repair of prolapse remains one of the most difficult challenges in pelvic floor reconstruction due to the large recurrence rate and postoperative complications including foreign body reaction and mesh extrusion," said Patel, who is a physician at Piedmont Urology Associates in North Carolina. "I'm pleased that Biodesign has proven to be an effective and lasting treatment option for patients suffering from painful, large-scale vaginal mesh exposures."
The Biodesign Vaginal Erosion Repair Graft incorporates the best attributes of a biologic graft - resistance to infection and complete remodeling - with the added benefits of moderate price, ease of use and ample shelf life for on-site availability. Upon deployment, the graft reinforces the pelvic floor or vaginal wall and, over time, communicates with the patient's body, signalling surrounding tissue to grow across the scaffold where the pelvic floor needs to be repaired. Unlike synthetic mesh, Biodesign is resistant to infection, encapsulation and erosion into surrounding tissue.
"The complications associated with the use of synthetic mesh in treating pelvic organ prolapse can clearly cause a significant decrease in quality of life for women," said Andy Cron, vice president of Cook Medical's Surgery strategic business unit. "The results of this study come at a very important time, as reports continue to surface around the complications resulting from synthetic mesh treatments. We are excited by the results of Dr. Patel's research and look forward to providing many women with a natural, lasting solution."
About Cook Medical
Cook Medical was one of the first companies to help popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures. Today, the company integrates minimally invasive medical device design, biopharma, gene and cell therapy, and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; interventional cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Founded in 1963 and operated as a family-held private corporation, Cook is a past winner of the prestigious Medical Device Manufacturer of the Year Award from Medical Device & Diagnostic Industry magazine.
Cook Medical
The study examined the efficacy of the Biodesign Vaginal Erosion Repair Graft in treating 10 women with large, symptomatic extrusions that resulted from the use of polypropylene or synthetic mesh in a previous pelvic floor reconstruction procedure. To treat the complication, the exposed synthetic mesh was completely removed and the Biodesign graft was implanted to help fully restore and repair the pelvic floor. Research findings showed that all 10 large mesh exposures were successfully repaired with the Biodesign graft with no evidence of recurrence or further complication.
According to the National Institute of Health, an estimated one-third of all U.S. women are affected by pelvic floor disorders including pelvic organ prolapse, a condition that occurs when the pelvic muscles become weakened and stretched, often as a result of childbirth. Although pelvic floor reconstruction is the most common form of treatment, synthetic mesh-based procedures have recently come under scrutiny after the FDA received more than 1,000 reports of rare but serious complications, including vaginal erosion, linked specifically to the use of synthetic mesh. Cook's Biodesign Vaginal Erosion Repair Graft will play an especially important role in treating these synthetic mesh-based complications and more.
"The surgical repair of prolapse remains one of the most difficult challenges in pelvic floor reconstruction due to the large recurrence rate and postoperative complications including foreign body reaction and mesh extrusion," said Patel, who is a physician at Piedmont Urology Associates in North Carolina. "I'm pleased that Biodesign has proven to be an effective and lasting treatment option for patients suffering from painful, large-scale vaginal mesh exposures."
The Biodesign Vaginal Erosion Repair Graft incorporates the best attributes of a biologic graft - resistance to infection and complete remodeling - with the added benefits of moderate price, ease of use and ample shelf life for on-site availability. Upon deployment, the graft reinforces the pelvic floor or vaginal wall and, over time, communicates with the patient's body, signalling surrounding tissue to grow across the scaffold where the pelvic floor needs to be repaired. Unlike synthetic mesh, Biodesign is resistant to infection, encapsulation and erosion into surrounding tissue.
"The complications associated with the use of synthetic mesh in treating pelvic organ prolapse can clearly cause a significant decrease in quality of life for women," said Andy Cron, vice president of Cook Medical's Surgery strategic business unit. "The results of this study come at a very important time, as reports continue to surface around the complications resulting from synthetic mesh treatments. We are excited by the results of Dr. Patel's research and look forward to providing many women with a natural, lasting solution."
About Cook Medical
Cook Medical was one of the first companies to help popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures. Today, the company integrates minimally invasive medical device design, biopharma, gene and cell therapy, and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; interventional cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Founded in 1963 and operated as a family-held private corporation, Cook is a past winner of the prestigious Medical Device Manufacturer of the Year Award from Medical Device & Diagnostic Industry magazine.
Cook Medical
четверг, 3 мая 2012 г.
How Women In The Military Are Affected By War
WHAT: Recently convened symposium to examine how the current conflicts in Iraq and Afghanistan affect women who are serving and have served in the military
WHO: Nathan D. Ainspan, PhD, Department of Veterans Affairs
Walter Penk, PhD, Texas A&M College of Medicine
Jenna Ermold, PhD, Andrews AFB
Maj. Lisa Teegarden, Psyd, Walter Reed Army Medical Center
Ronald Drach, U.S. Department of Labor
Sharon Wills, PhD, U.S. Department of Veterans Affairs in Austin, TX
WHERE: American Psychological Association's 115th Annual Convention
Moscone Center
San Francisco
BACKGROUND: Do women experience war differently than men and do they handle injuries differently? These questions were addressed by psychologists who have been on the front lines of the war along with those who specialize in employing veterans and helping them recover from combat-related stress.
The panel explored the following issues:
* how women return to their roles of parent and spouse after experiencing war
* what are the employment opportunities for female veterans and will their combat experience be seen as a disadvantage
* how are female veterans with post-traumatic stress disorder (PTSD) treated when most of the research on PTSD has been conducted on and for male veterans
The American Psychological Association (APA), in Washington, DC, is the largest scientific and professional organization representing psychology in the United States and is the world's largest association of psychologists. APA's membership includes more than 148,000 researchers, educators, clinicians, consultants and students. Through its divisions in 54 subfields of psychology and affiliations with 60 state, territorial and Canadian provincial associations, APA works to advance psychology as a science, as a profession and as a means of promoting health, education and human welfare.
Source: Pam Willenz
American Psychological Association
WHO: Nathan D. Ainspan, PhD, Department of Veterans Affairs
Walter Penk, PhD, Texas A&M College of Medicine
Jenna Ermold, PhD, Andrews AFB
Maj. Lisa Teegarden, Psyd, Walter Reed Army Medical Center
Ronald Drach, U.S. Department of Labor
Sharon Wills, PhD, U.S. Department of Veterans Affairs in Austin, TX
WHERE: American Psychological Association's 115th Annual Convention
Moscone Center
San Francisco
BACKGROUND: Do women experience war differently than men and do they handle injuries differently? These questions were addressed by psychologists who have been on the front lines of the war along with those who specialize in employing veterans and helping them recover from combat-related stress.
The panel explored the following issues:
* how women return to their roles of parent and spouse after experiencing war
* what are the employment opportunities for female veterans and will their combat experience be seen as a disadvantage
* how are female veterans with post-traumatic stress disorder (PTSD) treated when most of the research on PTSD has been conducted on and for male veterans
The American Psychological Association (APA), in Washington, DC, is the largest scientific and professional organization representing psychology in the United States and is the world's largest association of psychologists. APA's membership includes more than 148,000 researchers, educators, clinicians, consultants and students. Through its divisions in 54 subfields of psychology and affiliations with 60 state, territorial and Canadian provincial associations, APA works to advance psychology as a science, as a profession and as a means of promoting health, education and human welfare.
Source: Pam Willenz
American Psychological Association
четверг, 26 апреля 2012 г.
Injectable Birth Control Causes Significant Weight Gain And Changes In Body Mass
Women using depot medroxyprogesterone acetate (DMPA), commonly known as the birth control shot, gained an average of 11 pounds and increased their body fat by 3.4 percent over three years, according to researchers at the University of Texas Medical Branch (UTMB).
However, women who switched to nonhormonal contraception began to slowly lose the weight and fat mass they gained - nearly four pounds over two years, while those who used oral contraception after the shots gained an average of four additional pounds in the same time span. The amount of weight gain was dependent on the length of time DMPA was used, as the rate of weight gain slowed over time.
The study, which appears in the March 4 issue of the American Journal of Obstetrics and Gynecology, is one of the most comprehensive studies of its kind.
DMPA is an injected contraceptive administered to patients every three months. More than two million American women use DMPA, including approximately 400,000 teens. DMPA is relatively inexpensive compared to some other forms of birth control, has a low failure rate and doesn't need to be administered daily, which contributes to the contraceptive's popularity.
"Women and their doctors should factor in this new data when choosing the most appropriate birth control method," said lead author Abbey Berenson, M.D., professor in the Department of Obstetrics and Gynecology and director of the Center for Interdisciplinary Research in Women's Health at UTMB.
"One concern is DMPA's link to increased abdominal fat, a known component of metabolic syndrome, which increases the risk of cardiovascular disease, stroke and diabetes," said Berenson.
The study followed 703 women in two age categories, 16- to 24-years-old, and 25- to 33-years-old, using DMPA, oral (desogestrel) or nonhormonal (bilateral tubal ligation, condom or abstinence) contraception for three years. DMPA users who discontinued this method and selected another form of birth control were followed for up to two additional years. Throughout the course of the study, researchers compared changes in body weight and composition and took into account the influence of age, race, caloric intake and exercise, among other factors.
When researchers compared all three groups, DMPA users were more than twice as likely as women using nonhormonal or oral birth control to become obese over the next three years. "The findings are worrisome; however, more research is needed to determine if DMPA use directly contributes to obesity-related conditions and puts patients' overall health at risk," said Berenson.
Women using oral contraception did not gain more weight than those using a nonhormonal form of birth control. However, the study found that their body fat increased slightly while their lean body mass (muscle) decreased. Researchers said this was less likely among those women who exercised regularly and consumed a healthy diet that included increased protein intake.
The study will enable physicians to counsel women accurately about the body changes associated with widely used forms of contraception and also shed light on how weight gain might be reversed, said Berenson.
According to Berenson, the mechanism by which DMPA causes an increase in weight gain and fat mass is not known, and no connection was found between DMPA use and caloric intake, fat consumption or amount of exercise on body mass changes. The findings seem to argue against the theory that weight gain could be due to the drug's perceived effects on increased caloric intake and decreased energy expenditure, but ongoing research is needed to confirm or discount varying possible explanations, she said.
UTMB researchers are conducting follow-up studies to determine which subset of women is most likely to gain weight on DMPA. Berenson noted that in ongoing research, preliminary data has shown that approximately 25 percent of women on DMPA experience significant and potentially dangerous body composition changes.
Notes:
The study was supported by the National Institute of Child Health & Human Development. Mahburbur Rahman, MBBS, PhD, MPH, Research Scientist, Center for Interdisciplinary Research in Women's Health, contributed to this research.
About the University of Texas Medical Branch
The University of Texas Medical Branch at Galveston (UTMB) is a major academic health center dedicated to improving the lives of others through health sciences education, clinical care and biomedical research. Opened in 1891, UTMB combines a rich history of service with a forward-thinking spirit to define the future of health care nationally and internationally. www.utmb.edu
Source: Olivia Goodman
University of Texas Medical Branch at Galveston
However, women who switched to nonhormonal contraception began to slowly lose the weight and fat mass they gained - nearly four pounds over two years, while those who used oral contraception after the shots gained an average of four additional pounds in the same time span. The amount of weight gain was dependent on the length of time DMPA was used, as the rate of weight gain slowed over time.
The study, which appears in the March 4 issue of the American Journal of Obstetrics and Gynecology, is one of the most comprehensive studies of its kind.
DMPA is an injected contraceptive administered to patients every three months. More than two million American women use DMPA, including approximately 400,000 teens. DMPA is relatively inexpensive compared to some other forms of birth control, has a low failure rate and doesn't need to be administered daily, which contributes to the contraceptive's popularity.
"Women and their doctors should factor in this new data when choosing the most appropriate birth control method," said lead author Abbey Berenson, M.D., professor in the Department of Obstetrics and Gynecology and director of the Center for Interdisciplinary Research in Women's Health at UTMB.
"One concern is DMPA's link to increased abdominal fat, a known component of metabolic syndrome, which increases the risk of cardiovascular disease, stroke and diabetes," said Berenson.
The study followed 703 women in two age categories, 16- to 24-years-old, and 25- to 33-years-old, using DMPA, oral (desogestrel) or nonhormonal (bilateral tubal ligation, condom or abstinence) contraception for three years. DMPA users who discontinued this method and selected another form of birth control were followed for up to two additional years. Throughout the course of the study, researchers compared changes in body weight and composition and took into account the influence of age, race, caloric intake and exercise, among other factors.
When researchers compared all three groups, DMPA users were more than twice as likely as women using nonhormonal or oral birth control to become obese over the next three years. "The findings are worrisome; however, more research is needed to determine if DMPA use directly contributes to obesity-related conditions and puts patients' overall health at risk," said Berenson.
Women using oral contraception did not gain more weight than those using a nonhormonal form of birth control. However, the study found that their body fat increased slightly while their lean body mass (muscle) decreased. Researchers said this was less likely among those women who exercised regularly and consumed a healthy diet that included increased protein intake.
The study will enable physicians to counsel women accurately about the body changes associated with widely used forms of contraception and also shed light on how weight gain might be reversed, said Berenson.
According to Berenson, the mechanism by which DMPA causes an increase in weight gain and fat mass is not known, and no connection was found between DMPA use and caloric intake, fat consumption or amount of exercise on body mass changes. The findings seem to argue against the theory that weight gain could be due to the drug's perceived effects on increased caloric intake and decreased energy expenditure, but ongoing research is needed to confirm or discount varying possible explanations, she said.
UTMB researchers are conducting follow-up studies to determine which subset of women is most likely to gain weight on DMPA. Berenson noted that in ongoing research, preliminary data has shown that approximately 25 percent of women on DMPA experience significant and potentially dangerous body composition changes.
Notes:
The study was supported by the National Institute of Child Health & Human Development. Mahburbur Rahman, MBBS, PhD, MPH, Research Scientist, Center for Interdisciplinary Research in Women's Health, contributed to this research.
About the University of Texas Medical Branch
The University of Texas Medical Branch at Galveston (UTMB) is a major academic health center dedicated to improving the lives of others through health sciences education, clinical care and biomedical research. Opened in 1891, UTMB combines a rich history of service with a forward-thinking spirit to define the future of health care nationally and internationally. www.utmb.edu
Source: Olivia Goodman
University of Texas Medical Branch at Galveston
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