Author Interviews, Hormone Therapy, Menopause / 25.03.2018

MedicalResearch.com Interview with: [caption id="attachment_40771" align="alignleft" width="133"]Jerilynn C. Prior, MD Professor in the Department of Medicine Division of Endocrinology and Metabolism University of British Columbia in Vancouver Dr. Prior[/caption] Jerilynn C. Prior, MD Professor in the Department of Medicine Division of Endocrinology and Metabolism University of British Columbia in Vancouver Dr. Prior has written the second edition of the award-winning book, Estrogen’s Storm Season—Stories of Perimenopause this year as an ebook on Google Play. MedicalResearch.com: What is the background for this study? Response: There is an urgent need for an effective therapy for perimenopausal hot flushes/flashes and night sweats (vasomotor symptoms, VMS). Although often considered “estrogen deficiency symptoms” VMS are common and very problematic for women in the menopause transition and who have not yet been one year without flow. About 23% of North American women are now in the perimenopausal age range. Surprisingly VMS are more common in perimenopause than in menopause; 9% of perimenopausal women have severe VMS as classified by the FDA, meaning more than 50 VMS per week of moderate to intense severity. The commonly used therapies for VMS in midlife women have not been proven more effective than placebo! That includes combined hormonal contraceptives (CHC) and menopausal-type hormone therapy (MHT) as well as the SSRI/SNRI anti-depressants and gabapentin. 
Author Interviews, Thyroid Disease / 22.03.2018

MedicalResearch.com Interview with: [caption id="attachment_40735" align="alignleft" width="200"]Begoña Ruiz Núñez PhD (c) Laboratory Medicine UMC Groningen Co-directora de Healthy Institute President of the Asociación Española de Psico-Neuro-Inmunologí Begoña Ruiz Núñez[/caption] Begoña Ruiz Núñez PhD (c) Laboratory Medicine UMC Groningen Co-directora de Healthy Institute President of the Asociación Española de Psico-Neuro-Inmunologí MedicalResearch.com: What is the background for this study? Response: The diagnosis of Chronic Fatigue Syndrome (​CFS)​ is based on the Fukuda criteria, i.e. symptoms, disability, and exclusion of explanatory illnesses, and not by means of physical signs or abnormalities in laboratory test results​. CFS has been described as a ´allostatic overload condition´, where the physiological mechanisms employed to deal with stress contribute to the perpetuation of the disorder. Chronic Fatigue Syndrome patients are 1.9 times more likely to have a high allostatic load index than healthy controls. Thyroid allostasis-adaptive responses, presenting as ​non-thyroidal-illness syndrome, have been found in many conditions, ranging from critical illness, uremia and starvation to tumor​s​. Taken together, it is possible that, despite TSH and T4 levels within reference ranges, Chronic Fatigue Syndrome symptoms may be attributable in part to allostatic responses, i.e. lower thyroid hormone activity, secondary to chronic (low-grade) inflammation caused by e.g. a compromised gut microbiome and gut wall integrity.
Author Interviews, Brigham & Women's - Harvard, Endocrinology, OBGYNE, Weight Research / 20.03.2018

MedicalResearch.com Interview with: [caption id="attachment_40663" align="alignleft" width="200"]Madhusmita Misra, MD, MPH Division Chief, Pediatric Endocrinology Fritz Bradley Talbot and Nathan Bill Talbot Professor of Pediatrics, Harvard Medical School Dr.Madhusmita Misra[/caption] Madhusmita Misra, MD, MPH Division Chief, Pediatric Endocrinology Fritz Bradley Talbot and Nathan Bill Talbot Professor of Pediatrics, Harvard Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Response: Disordered eating behavior is common in conditions of functional hypothalamic amenorrhea, such as anorexia nervosa and exercise-induced amenorrhea, which are also associated with anxiety and depression. In hypoestrogenic rodents, estrogen replacement reduces anxiety-related behavior. Similarly, physiologic estrogen replacement in adolescents with anorexia nervosa reduces anxiety and prevents the increased body dissatisfaction observed with increasing weight. However, the impact of estrogen administration on disordered eating behavior and psychopathology in normal-weight young women with exercise-induced amenorrhea is unknown. Adolescent and young adult normal-weight athletes 14-25 years old with irregular periods were randomized to receive (i) physiologic estrogen replacement using a transdermal patch with cyclic progesterone, or (ii) an oral estrogen-progesterone containing pill (an oral contraceptive pill), or (iii) no estrogen for 12-months. The Eating Disorder Inventory-2 (EDI-2) and Three-Factor Eating Questionnaire (TFEQ) were administered ag the beginning and the end of the study to assess disordered eating behavior and psychopathology. We found that the group that did not receive estrogen had a worsening of disordered eating behavior and psychopathology over the 12-months duration of the study, but this was not observed in the group that received estrogen replacement. Further, body dissatisfaction scores improved over 12-months in the groups receiving estrogen replacement, with the transdermal estrogen group showing the strongest effect.
Author Interviews, Brigham & Women's - Harvard, Endocrinology, Environmental Risks, PLoS, Weight Research / 15.02.2018

MedicalResearch.com Interview with: [caption id="attachment_40057" align="alignleft" width="125"]Gang Liu, PhD Postdoctoral Research Fellow Department of Nutrition Harvard T.H. Chan School of Public Health Dr. Gang Liu[/caption] Gang Liu, PhD Postdoctoral Research Fellow Department of Nutrition Harvard T.H. Chan School of Public Health  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Although many approaches can be used to achieve a short-term weight loss, maintenance of weight loss has become a key challenge for sustaining long-term benefits of weight loss. Accumulating evidence has suggested that certain environmental compounds may play an important role in weight gain and obesity development. The potential endocrine-disrupting effects of perfluoroalkyl substances (PFASs), which are extensively used in many industrial and consumer products including food packaging, paper and textile coatings, and non-stick cookware, have been demonstrated in animal studies, but whether PFASs may interfere with body weight regulation in humans is largely unknown. In a 2-year POUNDS Lost randomized clinical trial that examined energy-restricted diets on weight changes, baseline plasma concentrations of major PFASs were measured among 621 overweight and obese participants aged 30-70 years. Body weight was measured at baseline, 6, 12, 18, and 24 months. Resting metabolic rate (RMR) and other metabolic parameters, including glucose, lipids, thyroid hormones, and leptin, were measured at baseline, 6, and 24 months. We found that higher baseline levels of PFASs were significantly associated with a greater weight regain, primarily in women. On average, women in the highest tertile of PFASs regained 1.7-2.2 kg more body weight than women in the lowest tertile. In addition, higher baseline plasma PFAS concentrations, especially perfluorooctanesulfonic acid (PFOS) and perfluorononanoic acid (PFNA), were significantly associated with greater decline in RMR during the first 6 months and less increase in RMR during weight regain period. 
Author Interviews, Endocrinology, JCEM, OBGYNE, Testosterone, UCSD / 24.01.2018

MedicalResearch.com Interview with: [caption id="attachment_39566" align="alignleft" width="133"]Varykina Thackray, Ph.D. Associate Professor of Reproductive Medicine University of California, San Diego Dr. Thackray[/caption] Varykina Thackray, Ph.D. Associate Professor of Reproductive Medicine University of California, San Diego MedicalResearch.com: What is the background for this study? What are the main findings? Response: Previous studies have shown that changes in the composition of intestinal microbes (gut microbiome) are associated with metabolic diseases. Since many women with polycystic ovary syndrome (PCOS) have metabolic dysregulation that increases the risk of developing type 2 diabetes and cardiovascular disease, we wondered whether PCOS was associated with changes in the gut microbiome and if these changes were linked to any clinical features of PCOS. We collaborated with Beata Banaszewska and her colleagues at the Poznan University of Medical Sciences in Poznan, Poland to obtain clinical data and fecal samples from 163 premenopausal women recruited for the study. In collaboration with Scott Kelley at San Diego State University, we used 16S ribosomal RNA gene sequencing and bioinformatics analyses to show that the diversity of the gut microbiome was reduced in Polish women with PCOS compared to healthy women and women with polycystic ovaries but no other symptoms of PCOS. The study confirmed findings reported in two other recent studies with smaller cohorts of Caucasian and Han Chinese women. Since many factors could affect the gut microbiome in women with PCOS, regression analysis was used to identify clinical hallmarks that correlated with changes in the gut microbiome. In contrast to body mass index or insulin resistance, hyperandrogenism was associated with changes in the gut microbiome in this cohort of women, suggesting that elevated testosterone may be an important factor in shaping the gut microbiome in women.
Author Interviews, Cancer Research, Endocrinology, Nutrition / 18.01.2018

MedicalResearch.com Interview with: [caption id="attachment_39386" align="alignleft" width="200"]Benedikt Warth, PhD, Assistant Professor Department of Food Chemistry and Toxicology University of Vienna Vienna, Austria  Dr. Warth[/caption] Benedikt Warth, PhD, Assistant Professor Department of Food Chemistry and Toxicology University of Vienna Vienna, Austria  MedicalResearch.com: What is the background for this study? Response: The palbociclib/letrozole combination therapy was granted accelerated approval by the U.S. Food and Drug Administration in 2015 after a clinical trial showed it doubled the progression-free survival time in postmenopausal women with estrogen receptor (ER) positive, metastatic breast cancer. Letrozole blocks the production of estrogen, thus reducing the growth-promoting stimulation of ERs on breast cancer cells. Palbociclib blocks a different signaling pathway to impede cell division. The combination is now one of the standard therapies for ER-positive breast cancers. The aim of our study was twofold: Firstly, we investigated the drugs synergism at the metabolome level in MCF-7 cells to unravel the unknown underlying metabolic effects of palbociclib/letrozole mechanism of action. We used a global metabolomics approach to analyze the effects of palbociclib and letrozole individually and in combination on breast cancer cells. Metabolomics studies detail cells’ metabolomes—populations of metabolites, the small-molecule end products of cellular processes. Secondly, we aimed at deciphering the impact of the two model xenoestrogens frequently present in our diet, zearalenone and genistein, on this chemotherapy. Since these chemicals interact with the estrogen receptor we hypothesized that they may interfere with the new treatment.
Author Interviews, Endocrinology, JAMA, Menopause, OBGYNE / 13.12.2017

MedicalResearch.com Interview with: [caption id="attachment_38906" align="alignleft" width="200"]Dr-Suzanne Fenske.jpg Dr. Fenske[/caption] Dr. Suzanne Fenske, MD Assistant Professor of Obstetrics, Gynecology and Reproductive Science Icahn School of Medicine at Mount Sinai  MedicalResearch.com: What is the background for this study? What are the main findings? Response: USPSTF recommendations are based off several studies, but is mainly based off of the Women's Health Initiative. The Women's Health Initiative was a 15 year prevention study with a focus on death, disability and impaired quality of life in postmenopausal women. This study was originally performed in 1991. The USPSTF reevaluated the data along with several other studies to assess the role of hormone replacement therapy in prevention of chronic diseases such as heart disease, stroke, blood clot, gallbladder disease, dementia.  The USPSTF has found that hormone replacement therapy has some benefit in reducing the risk of fractures, and, potentially, diabetes.  The USPSTF has found that hormone replacement therapy can increase the risk of coronary artery disease, stroke, blood clot, gall bladder disease, urinary incontinence and dementia. With these risks, the USPSTF states that hormone replacement therapy should not be used as a preventative medicine, but, rather, used for treatment of symptomatic menopause and not prevention of osteoporosis or heart disease.
Author Interviews, Endocrinology, Fertility, JAMA, OBGYNE, Thyroid Disease / 13.12.2017

MedicalResearch.com Interview with: Professor Tianpei Hong, MD, PhD Of behalf of Prof. Jie Qiao and all the coauthors, Director, Department of Endocrinology & Metabolism Director, Department of Laboratory Medicine Peking University Third Hospital Beijing, China MedicalResearch.com: What is the background for this study?
  • Ÿ           Women who test positive for thyroid autoantibodies have been reported to be at 2- to 3-fold higher risk of spontaneous miscarriage than those who test negative. However, the effect of levothyroxine on miscarriage among women with positive thyroid autoantibodies and normal thyroid function has been documented in limited studies with conflicting results.
  • Ÿ           Given the substantial difficulty achieving successful pregnancy among infertile women, identifying optimal treatment for infertile women who test positive for thyroid autoantibodies is particularly important. There are a few randomized clinical trials showing a beneficial effect of levothyroxine treatment on pregnancy outcomes among women undergoing in vitro fertilization and embryo transfer (IVF-ET). However, the sample size of those trials was rather small which may weaken the quality of the evidence.
  • Ÿ           Therefore, the Pregnancy Outcomes Study in euthyroid women with Thyroid Autoimmunity after Levothyroxine (POSTAL) study was conducted in Peking University Third Hospital to evaluate whether levothyroxine treatment initiated before IVF-ET could decrease the miscarriage rate and improve the live birth rate in infertile women who tested positive for antithyroperoxidase antibody but had normal thyroid function.
Author Interviews, Bone Density, Dermatology, Endocrinology, Osteoporosis, Pediatrics / 03.12.2017

MedicalResearch.com Interview with: [caption id="attachment_38688" align="alignleft" width="166"]Dr. Cousminer Dr. Cousminer[/caption] Diana L. Cousminer, PhD Division of Human Genetics Children's Hospital of Philadelphia Philadelphia, PA 19104 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Osteoporosis is a significant public health burden, with origins early in life. Later puberty and lower adolescent bone mineral density are both risk factors for osteoporosis. Geneticists have identified hundreds of genetic variants across the genome that impact pubertal timing, and we found that collectively this variation also plays a role in bone mineralization during adolescence. Additionally, we found that later puberty caused lower adult bone density.
Author Interviews, Endocrinology, Hormone Therapy, JCEM / 04.11.2017

MedicalResearch.com Interview with: [caption id="attachment_37876" align="alignleft" width="112"]Alexandra Ycaza Herrera, Ph.D. Postdoctoral Scholar Leonard Davis School of Gerontology Department of Psychology University of Southern California Los Angeles, Ca 90089 Dr. Herrera[/caption] Alexandra Ycaza Herrera, Ph.D. Postdoctoral Scholar Leonard Davis School of Gerontology Department of Psychology University of Southern California Los Angeles, Ca 90089  MedicalResearch.com: What is the background for this study? What are the main findings? Response: ​Previous research has shown that estradiol treatment after menopause can reduce the stress response when exposed to a stressor, including the cortisol response to stress. Other work has shown that stress can impair certain types of memory​. We wanted to test whether post-menopause estradiol treatment would not only attenuate the cortisol response to stress, but if it could also reduce the negative effects of stress on memory. In particular, we tested the effects on a type of memory called working memory. Working memory allows us to maintain and update information we need to readily access in short-term memory. For example, imagine you stop at the grocery store after work and only have a mental list of the items you need to make dinner. Working memory is the memory type engaged in helping you maintain and update your mental list of items as you grab items off the shelves and check them off your list. We recruited women through the Early versus Late Intervention Trial with Estradiol, a randomized, double-blinded, placebo-controlled clinical trial. Women who participated in our study had received nearly 5 years of either estradiol or placebo. We found that women receiving estradiol showed significantly smaller cortisol responses to stress and less of an effect of stress on working memory than women that had been receiving placebo.
Author Interviews, Endocrinology, Epilepsy / 17.10.2017

MedicalResearch.com Interview with: [caption id="attachment_21891" align="alignleft" width="125"]Dr. Samba Reddy, PhD, RPh, FAAPS Professor Neuroscience and Experimental Therapeutics College of Medicine Texas A&M University Health Science Center Bryan, TX Dr. Samba Reddy[/caption] Dr. Samba Reddy, Ph.D., R.Ph., FAAPS, FAAAS, FAES Professor Neuroscience and Experimental Therapeutics College of Medicine Texas A&M University Health Science Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: For the past two decades, D. Samba Reddy, PhD, RPh, professor of neuroscience and experimental therapeutics at the Texas A&M College of Medicine, has been searching for answers to catamenial epilepsy, a subset of chronic epilepsy that causes a dramatic increase in seizures during women’s menstrual periods. Although this condition has been documented for millennia, there is currently no effective treatment for catamenial seizures, leaving many women and their families desperate for answers. In this report, the researchers discovers the neuro-code for treating women with menstrual period-linked epilepsy. A unique platform has been created for clinical trials for catamenial seizures with synthetic neurosteroid agents.
Author Interviews, Endocrinology, JAMA / 19.09.2017

MedicalResearch.com Interview with: [caption id="attachment_37034" align="alignleft" width="119"]Arjola Bano, MD, MSc, DSc Researcher in the Departments of Internal Medicine and Epidemiology, Erasmus Medical Center, Rotterdam the Netherlands Dr. Bano[/caption] Arjola Bano, MD, MSc, DSc Researcher in the Departments of Internal Medicine and Epidemiology, Erasmus Medical Center, Rotterdam the Netherlands MedicalResearch.com: What is the background for this study? What are the main findings? Response: Thyroid function is clinically defined by the measurements of serum thyroid stimulating hormone (TSH) and free thyroxine (FT4) levels. So far, abnormal TSH and FT4 levels as well as variations within the normal range have been linked to an increased risk of cardiovascular disease and death. However, it remains unclear whether there are differences in life span and years of life lived with and without cardiovascular disease, within the reference range of thyroid function. To investigate this, we performed a prospective study among 7785 middle-aged and elderly people with normal thyroid function. Participants were part of the Rotterdam Study, 65 years on average and 52% females. In our statistical analyses, we accounted for sociodemographic and cardiovascular risk factors. Over a median follow-up of 8.1 years, 789 incident cardiovascular deaths and 1357 deaths occurred. Analyses were performed separately among men and women. Our study found differences in life expectancy within the reference range of thyroid function. At the age of 50 years, people with low-normal thyroid function lived up to 3.5 years longer than those with high-normal thyroid function. Also, people with low-normal thyroid function lived a longer life without cardiovascular disease than those with high-normal thyroid function.
Author Interviews, Brigham & Women's - Harvard, Endocrinology, Hormone Therapy, JAMA, Menopause / 13.09.2017

MedicalResearch.com Interview with: [caption id="attachment_36873" align="alignleft" width="111"]JoAnn E. Manson, MD, DrPH Chief, Division of Preventive Medicine Brigham and Women's Hospital Professor of Medicine and the Michael and Lee Bell Professor of Women's Health Harvard Medical School Boston, Massachusetts  02215 Dr. Manson[/caption] JoAnn E. Manson, MD, DrPH Chief, Division of Preventive Medicine Brigham and Women's Hospital Professor of Medicine and the Michael and Lee Bell Professor of Women's Health Harvard Medical School Boston, Massachusetts  02215  MedicalResearch.com: What is the background for this study? Response: The current report provides new information on total mortality and the rates of death from specific causes (cardiovascular disease, cancer, other major illnesses) over 18 years of follow-up in the Women’s Health Initiative (WHI) randomized trials of hormone therapy (estrogen + progestin and estrogen alone). This is the first WHI report to focus on all-cause and cause-specific mortality. It includes all of the 27,347 women in the 2 hormone therapy trials with >98% follow-up over 18 years, during which time 7,489 deaths occurred. This is more than twice as many deaths as were included in earlier reports. The report also provides detailed information on differences in results by age group (ages 50-59, 60-69, 70-79) at time of study enrollment.
Author Interviews, Endocrinology, ENT, Surgical Research / 11.09.2017

MedicalResearch.com Interview with: [caption id="attachment_36879" align="alignleft" width="114"]Raymond L. Chai, MD Assistant Professor of Otolaryngology Icahn School of Medicine at Mount Sinai. Dr. Rai[/caption] Raymond L. Chai, MD Assistant Professor of Otolaryngology Icahn School of Medicine at Mount Sinai.  MedicalResearch.com: What is the background for this study? Response: Primary hyperparathyroidism is a common endocrine disorder affecting up to 1% of the general population. Surgical intervention is the only known durable cure for the disease. Untreated primary hyperparathyroidism can lead to number of health problems, including progressive osteoporosis and kidney stones. Although parathyroidectomy is a commonly performed surgical procedure by otolaryngologists, limited data exists regarding risk factors and rates of reoperation and readmission following surgery.
Annals Internal Medicine, Author Interviews, Brigham & Women's - Harvard, Hormone Therapy, Sexual Health, Testosterone / 27.07.2017

MedicalResearch.com Interview with: [caption id="attachment_34884" align="alignleft" width="160"]Carl G Streed Jr. M.D. Pronouns: he, him, his, himself Fellow, Division General Internal Medicine & Primary Care Brigham & Women’s Hospital Dr. Streed[/caption] Carl G Streed Jr. M.D. Pronouns: he, him, his, himself Fellow, Division General Internal Medicine & Primary Care Brigham & Women’s Hospital  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Recent reports estimate that 0.6% of adults in the United States, or approximately 1.4 million persons, identify as transgender. Despite gains in rights and media attention, the reality is that transgender persons experience health disparities, and a dearth of research and evidence-based guidelines remains regarding their specific health needs. The lack of research to characterize cardiovascular disease (CVD) and CVD risk factors in transgender populations receiving cross-sex hormone therapy (CSHT) limits appropriate primary and specialty care. As with hormone therapy in cisgender persons (that is, those whose sex assigned at birth aligns with their gender identity), existing research in transgender populations suggests that CVD risk factors are altered by CSHT.
Author Interviews, Diabetes, Endocrinology, Menopause / 20.07.2017

MedicalResearch.com Interview with: [caption id="attachment_36029" align="alignleft" width="159"]Eralda Asllanaj Department of Epidemiology Erasmus University Medical Center Rotterdamthe Netherlands Eralda Asllanaj[/caption] Eralda Asllanaj Department of Epidemiology Erasmus University Medical Center Rotterdamthe Netherlands MedicalResearch.com: What is the background for this study? What are the main findings? Response: It is known that women with early onset of menopause (age below 45 years) have an increased risk of cardiovascular disease and overall mortality. This increased risk is thought to be due to the adverse effects of menopause on cardiovascular risk factors. Type 2 diabetes is a major risk factor for cardiovascular disease, but it remains unclear whether age at menopause affects the risk of developing type 2 diabetes. Our study shows that women who experience menopause before the age of 40 were almost 4 times more likely to develop type 2 diabetes than those experiencing menopause after 55 years old. Moreover, those who had menopause between 40 to 44 years were 2.4 times more likely to have diabetes later in life. The risk of having diabetes reduced by 4 % per year older the women experienced menopause. Adjustment for the various confounding factors and differences in genetic predisposition to early menopause did not affect the results.
Author Interviews, OBGYNE, Testosterone / 23.06.2017

MedicalResearch.com Interview with: David M. Kristensen, PhD Assistant Professor                                                                                                         Novo Nordisk Foundation Center for Protein Research Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3A, DK-2200 Copenhagen, Denmark MedicalResearch.com: What is the background for this study? What are the main findings? Response: We have demonstrated that a reduced level of testosterone during fetal life by paracetamol means that male characteristics do not develop as they should. This also affects sex drive. In the trial, mice exposed to paracetamol at the foetal stage were simply unable to copulate in the same way as our control animals. Male programming had not been properly established during their foetal development and this could be seen long afterwards in their adult life. Moreover, the area of the brain that controls sex drive - the sexual dimorphic nucleus - had half as many neurons in the mice that had received paracetamol as the control mice. The inhibition of testosterone seem to have led to less activity in an area of the brain that is significant for male characteristics.
Abuse and Neglect, Boehringer Ingelheim, Diabetes, Endocrinology, Lipids / 22.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35536" align="alignleft" width="131"]Dr-Robert-R-Henry.jpg Dr. Henry[/caption] Robert R. Henry, M.D. Professor of Medicine Member of the ODYSSEY DM Steering Committee and Director of the Center for Metabolic Research VA San Diego Healthcare System MedicalResearch.com: What is the background for this study? What are the main findings? Response: The ODYSSEY DM-DYSLIPIDEMIA trial was a randomized, open-label, parallel-group study designed to evaluate the superiority of Praluent versus usual care in 413 patients with type 2 diabetes with mixed dyslipidemia at high cardiovascular (CV) risk, not adequately controlled with maximally tolerated dose (MTD) statins. The primary endpoint was percent change in non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to week 24. In ODYSSEY DM-DYSLIPIDEMIA, Praluent 75 mg was added to MTD statins, with dose adjusted at week 12 to 150 mg every two weeks if their non-HDL-C was greater than or equal to 100 mg/dL at week 8. Approximately 64 percent of patients reached their lipid goals with the Praluent 75 mg dose. Results from the ODYSSEY DM-DYSLIPIDEMIA study found that Praluent added to MTD statins showed significant reduction in non-HDL-C and other lipid parameters compared to those on usual care. Praluent was superior to usual care in lowering non-HDL-C (37.3 percent and 4.7 percent, for the usual care arm). The mean difference between the two treatment arms was -32.5 percent (p<0.0001). Praluent in combination with MTD statins reduced LDL-C by 43 percent from baseline compared to a 0.3 percent increase for usual care (p<0.0001). Treatment with Praluent also improved the overall lipid profile. There is a large unmet need for improving cholesterol lowering in patients with diabetes. Despite current standard of care, nearly 70 percent of people age 65 or older with diabetes die from some form of heart disease; and 16 percent die of stroke. Furthermore, in spite of current standard of care, many people with diabetes continue to have persistent lipid abnormalities resulting in high residual CV risk.
Author Interviews, Endocrinology, Genetic Research / 21.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35490" align="alignleft" width="150"]Constantine A. Stratakis, MD, DMSci Section on Endocrinology and Genetics Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health, Bethesda Dr. Stratakis[/caption] Constantine A. Stratakis, MD, DMSci Section on Endocrinology and Genetics Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health, Bethesda MedicalResearch.com: What is the background for this study? Response: The pituitary and adrenal glands operate on a kind of feedback loop. In response to stress, the pituitary release ACTH (Adrenocorticotropic hormone), which signals the adrenal glands to release cortisol. Rising cortisol levels then act on the pituitary, to shut down ACTH production. In a previous study, Jacque Drouin of the Institute for Clinical Research in Montreal and colleagues had determined that the CABLES1 protein was a key player in this feedback mechanism, switching off pituitary cell division in cultures exposed to cortisol. Since this feedback mechanism appears to be impaired in many corticotropinomas, we investigated the presence of Cables1 gene mutations and copy number variations in a large group of patients with Cushing’s disease.
Author Interviews, Endocrinology, Genetic Research, NYU / 19.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35437" align="alignleft" width="150"]Constantine A. Stratakis, MD, DMSci Section on Endocrinology and Genetics Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health, Bethesda Dr. Stratakis[/caption] Constantine A. Stratakis, MD, DMSci Section on Endocrinology and Genetics Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health, Bethesda  MedicalResearch.com: What is the background for this study? Response: The pituitary and adrenal glands operate on a kind of feedback loop.  In response to stress, the pituitary release ACTH (Adrenocorticotropic hormone), which signals the adrenal glands to release cortisol.  Rising cortisol levels then act on the pituitary, to shut down ACTH production. In a previous study, Jacque Drouin of the Institute for Clinical Research in Montreal and colleagues had determined that the CABLES1 protein was a key player in this feedback mechanism, switching off pituitary cell division in cultures exposed to cortisol. Since this feedback mechanism appears to be impaired in many corticotropinomas, we investigated the presence of Cables1 gene mutations and copy number variations in a large group of patients with Cushing’s disease.
AHA Journals, Author Interviews, Heart Disease, Testosterone / 24.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34833" align="alignleft" width="149"]Rajat S. Barua, MD; PhD; FACC; FSCAI Associate Professor of Medicine (Cardiology), University of Kansas School of Medicine Director, Cardiovascular Research, Dept. of Cardiology, Kansas City VA Medical Center Director, Interventional Cardiology & Cardiac Catheterization Laboratory Kansas City VA Medical Center Dr. Barua[/caption] Rajat S. Barua, MD; PhD; FACC; FSCAI Associate Professor of Medicine (Cardiology), University of Kansas School of Medicine Director, Cardiovascular Research, Dept. of Cardiology, Kansas City VA Medical Center Director, Interventional Cardiology & Cardiac Catheterization Laboratory Kansas City VA Medical Center MedicalResearch.com: What is the background for this study? Response: Atrial fibrillation is the most common cardiac arrhythmia worldwide, with significant morbidity, mortality and financial burden. Atrial fibrillation is known to increase with age and is higher in men than in women. Although the underlying mechanisms of this sex difference are still unclear, one preclinical and several small clinical studies have suggested that testosterone deficiency may play a role in the development of atrial fibrillation. To date, no studies have investigated the effect of testosterone-level normalization on incidence of new atrial fibrillation in men after testosterone replacement therapy. In this study, we investigated the incidence of atrial fibrillation in hypogonadal men with documented low testosterone levels. We compared the incidence of atrial fibrillation among patients who did not receive any testosterone replacement therapy, those who received testosterone replacement therapy that resulted in normalization of total testosterone, and those who received testosterone replacement therapy but that did not result in normal total testosterone levels.
Author Interviews, Brigham & Women's - Harvard, Endocrinology, Hearing Loss, Menopause / 11.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34518" align="alignleft" width="164"]Sharon G. Curhan, MD, ScM Channing Division of Network Medicine Department of Medicine Brigham and Women's Hospital Harvard Medical School Boston, MA 02115 Dr. Curhan[/caption] Sharon G. Curhan, MD, ScM Channing Division of Network Medicine Department of Medicine Brigham and Women's Hospital Harvard Medical School Boston, MA 02115 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Hearing loss affects approximately 48 million Americans and the number is expected to increase as the population ages. Some previous studies suggested that menopause may increase the risk for hearing loss, presumably due to the reduction in circulating estrogen levels, and that postmenopausal hormone therapy might slow hearing decline by “replacing” estrogen. To evaluate the role of menopause and postmenopausal hormone therapy as risk factors for hearing loss, we examined the independent associations between menopausal status, oral hormone therapy, and risk of self-reported hearing loss in 80,972 women who are participants in the Nurses’ Health Study II, aged 27-44 years at baseline, and were followed from 1991 to 2013. After more than 1.4 million person-years of follow-up, 18,558 cases of hearing loss were reported (~23% of the women developed hearing loss). We did not observe an overall independent association between menopausal status and risk of hearing loss. However, the risk among women who underwent natural menopause at an older age was higher. Specifically, the risk among women who underwent natural menopause at age 50 or older was 10% higher than among those who underwent natural menopause before age 50 [multivariable-adjusted relative risk (MVRR): 1.10, 95% CI 1.03, 1.17]. When we conducted an analysis restricted to women who underwent natural menopause and did not use hormone therapy (HT), the multivariable-adjusted relative risk among women who underwent natural menopause at age 50-54 years was 21% higher (MVRR: 1.12, 95% CI: 1.10, 1.34), and among women who underwent natural menopause at age 55+ years was 29% higher (MVRR: 1.29, 95% CI: 1.11, 1.50), compared with women who underwent natural menopause before age 50. Among postmenopausal women, we also found that use of oral HT was associated with higher risk of hearing loss, and the magnitude of the risk tended to increase with longer duration of use (p-trend < 0.001). Compared with women who never used any type of HT, the MVRR of hearing loss among women who used oral HT for 5-9.9 years was 15% higher (MVRR: 1.15, 95% CI: 1.06, 1.24), and for 10+ years was 21% higher (MVRR: 1.21, 95% CI: 1.07, 1.37). When specific types of oral HT were examined, longer duration of use of either oral estrogen-only or of combined estrogen plus progestogen HT were each associated with higher risk. Fewer women reported use of progestogen-only oral HT, yet among these women a higher risk was suggested, but not significant (MVRR: 1.15, 95% CI: 0.98, 1.35). Transdermal HT use was less common, but the associations observed were similar to those with oral hormone therapy. When examined separately by type of menopause, the results for HT use were similar.
Author Interviews, Endocrinology, Heart Disease, Thyroid Disease / 09.04.2017

MedicalResearch.com Interview with: Arjola Bano, MD, DSc PhD candidate Departments of Internal Medicine and Epidemiology Erasmus Medical Center, Rotterdam, The Netherlands MedicalResearch.com: What is the background for this study? What are the main findings? Response: Atherosclerosis is a chronic condition, characterized by the accumulation of lipids and fibrous elements in the arterial walls. It can progress insidiously from an asymptomatic narrowing of the arterial lumen (subclinical phase) to the clinical onset of vascular events (as coronary heart disease or stroke) and death. Despite advances in prevention and treatment, atherosclerotic diseases remain a leading cause of mortality worldwide. Therefore, identifying additional modifiable risk factors for atherosclerosis is of major importance. So far, the role of thyroid hormone on atherosclerosis remains unclear. Moreover, a comprehensive investigation exploring the link of thyroid function with the wide spectrum of atherosclerosis, including subclinical atherosclerosis, clinical atherosclerosis and atherosclerotic mortality, within the same population is lacking. Therefore, in a prospective study of 9231 middle-aged and elderly people, we explored the association of thyroid function with subclinical atherosclerosis (coronary artery calcification), atherosclerotic events (fatal and nonfatal coronary heart disease or stroke) and atherosclerotic mortality (death from coronary heart disease, cerebrovascular or other atherosclerotic disease). Higher free thyroxine (FT4) levels were associated with higher risk of subclinical atherosclerosis, atherosclerotic events and atherosclerotic mortality, independently of cardiovascular risk factors. The risk of atherosclerotic mortality increased with higher FT4 levels (HR; CI: 2.35; 1.61-3.41 per 1 ng/dl) and lower thyroid-stimulating hormone (TSH) levels (HR; CI: 0.92; 0.84-1.00 per 1 logTSH), with stronger estimates among participants with a history of atherosclerotic disease (HR; CI: 5.76; 2.79-11.89 for FT4 and 0.81; 0.69-0.95 for TSH).
Author Interviews, Pharmacology, Thyroid Disease, UCLA / 07.04.2017

MedicalResearch.com Interview with: Deborah Chon MD Endocrinology fellow UCLA David Geffen School of Medicine  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our study shows that drinking cow's milk concurrently with oral levothyroxine significantly reduces the absorption of the medication. Levothyroxine is used for the physiologic replacement of thyroid hormone in patients with hypothyroidism and for serum TSH suppression in patients with thyroid cancer. It is the mostly commonly prescribed medication in the United States as of 2014. Frequent dose adjustments of levothyroxine have been shown to be a costly burden to the national healthcare system. Previous studies have shown that certain foods and medication, such as calcium supplements, can interfere with levothyroxine absorption. However, this is the first study to demonstrate that ingesting cow?s milk, a common breakfast staple, affects oral levothyroxine absorption. To determine the possible effect of cow's milk ingestion, we measured levothyroxine absorption in humans with and without concurrent milk consumption. Pharmacokinetic studies were conducted in healthy adults without allergies to milk or levothyroxine, and who were not pregnant nor using oral contraceptives. All subjects had no history of known thyroid disease and normal thyroid hormone function at baseline. Following an overnight fast, serum total thyroxine T4 (TT4) concentrations were measured at baseline and at 1, 2, 4, and 6 hours after ingestion of 1,000 ?g of oral levothyroxine alone or when co-administered with 12 oz. of milk (2% fat). There was a four-week washout period between the two study visits. Ten subjects (mean age 33.7?10.2 years, 60% male) completed the study. The serum total T4 absorption over six hours, calculated as area under the curve (AUC), was significantly lower when taking cow?s milk concurrently with levothyroxine compared levothyroxine alone (mean?SD: 67.26?12.13 vs. 73.48?16.96; p = 0.02). Also, peak serum TT4 concentrations were significantly lower in those who ingested levothyroxine concurrently with milk, compared to taking levothyroxine alone (p=0.04).
Author Interviews, Environmental Risks, Thyroid, Thyroid Disease / 02.04.2017

MedicalResearch.com Interview with: [caption id="attachment_33607" align="alignleft" width="156"]Julie Sosa, MD MA FACS Professor of Surgery and Medicine Chief, Section of Endocrine Surgery Director, Surgical Center for Outcomes Research (SCORES) Leader, Endocrine Neoplasia Diseases Group Duke Cancer Institute and Duke Clinical Research Institute Durham, NC 2771 Dr. Sosa[/caption] Julie Sosa, MD MA FACS Professor of Surgery and Medicine Chief, Section of Endocrine Surgery Director, Surgical Center for Outcomes Research Leader, Endocrine Neoplasia Diseases Group Duke Cancer Institute and Duke Clinical Research Institute Durham, NC 2771 MedicalResearch.com: What is the background for this study? Response: The incidence of thyroid cancer has dramatically increased world-wide over the last several decades. In the United States, thyroid cancer is the fastest increasing cancer among women and men. This observation has been almost exclusively the result of an epidemic of papillary thyroid cancer, or PTC, which now comprises approximately 90% of new cases. The use of flame retardant chemicals, or Flame Retardant Chemicals, also increased over the last several decades due to the implementation of mandatory and voluntary flammability standards for furniture, electronics, and construction materials. Over time, FRs come out of these products and accumulate in indoor environments where humans are exposed. Animal studies suggest that FRs can disrupt thyroid function, and many contribute to cancer risk. But many human health endpoints have not been investigated. Our work was aimed at investigating whether exposure to Flame Retardant Chemicals could be associated with PTC. To address our research question, we recruited 140 adults, 70 with PTC and 70 who were healthy volunteers without evidence for thyroid cancer or thyroid disease. Then we visited participants’ homes and collected dust samples, a metric that we have previously shown is an indicator of long-term exposure to Flame Retardant Chemicals in the home.
ASCO, Author Interviews, Boehringer Ingelheim, Journal Clinical Oncology, NYU, Prostate Cancer, Testosterone / 16.03.2017

MedicalResearch.com Interview with: [caption id="attachment_15257" align="alignleft" width="199"]Dr. Stacy Loeb, MD, MScDepartment of Urology, Population Health, and Laura and Isaac Perlmutter Cancer CenterNew York University, New York Dr. Stacy Loeb[/caption] Dr. Stacy Loeb MD Msc Assistant Professor of Urology and Population Health New York University Langone Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: The association between exposure to testosterone replacement therapy and prostate cancer risk is controversial.  The purpose of our study was to examine this issue using national registries from Sweden, with complete records on prescription medications and prostate cancer diagnoses.  Overall, we found no association between testosterone use and overall prostate cancer risk. There was an early increase in favorable cancers which is likely due to a detection bias, but long-term users actually had a significantly reduced risk of aggressive disease.
Author Interviews, Endocrinology, Fertility / 15.03.2017

MedicalResearch.com Interview with: Matthias Straub Senior Director, Clinical Development Abbott MedicalResearch.com: What is the background for this study? What are the main findings? Response: The Lotus I study provides clinical evidence that oral dydrogesterone is a treatment option for women who undergo in vitro fertilization (IVF) treatment. The current standard of care for IVF globally is micronized vaginal progesterone (MPV), which is administered vaginally. The Lotus I study concludes that oral dydrogesterone is similarly well-tolerated and efficacious compared to MVP, while being easier to administer than MVP.
Author Interviews, Endocrinology, Lancet, OBGYNE, Pediatrics, Vitamin D / 07.03.2017

MedicalResearch.com Interview with: Audry H. Garcia PhD Scientist Department of Epidemiology Erasmus MC, University Medical Center Rotterdam Rotterdam, the Netherlands  MedicalResearch.com: What is the background for this study? Response: Fetal bone mineralisation requires an adequate transfer of calcium to the fetus by the end of the pregnancy. Considering that vitamin D is required to maintain normal blood concentrations of calcium, adequate 25-hydroxyvitamin D (25[OH]D) concentrations in pregnant women seem to be crucial for bone development of the offspring. Maternal vitamin D deficiency during pregnancy has been associated with abnormal early skeletal growth in offspring and might be a risk factor for decreased bone mass in later life. Several studies have linked vitamin D deficiency in fetal life to congenital rickets, craniotabes, wide skull sutures and osteomalacia. However, the evidence of long-lasting effects of maternal vitamin D deficiency during pregnancy on offspring’s skeletal development is scarce and inconsistent, and has led to contradictory recommendations on vitamin D supplementation during pregnancy.
Author Interviews, NEJM, OBGYNE, Thyroid Disease, UT Southwestern / 01.03.2017

MedicalResearch.com Interview with: [caption id="attachment_32419" align="alignleft" width="70"]Professor, Brian Casey, M.D. Gillette Professorship of Obstetrics and Gynecology UT Southwestern Medical Center Dr. Casey[/caption] Professor Brian Casey, M.D. Gillette Professorship of Obstetrics and Gynecology UT Southwestern Medical Center  MedicalResearch.com: What is the background for this study? Response: For several decades now, subclinical thyroid disease, variously defined, has been associated with adverse pregnancy outcomes.  In 1999, two studies are responsible for increasing interest in subclinical thyroid disease during pregnancy because it was associated with impaired neuropsychological development in the fetus.  One study showed that children born to women with the highest TSH levels had lower IQ levels.  The other showed that children of women with isolated low free thyroid hormone levels performed worse on early psychomotor developmental tests. Together, these findings led several experts and professional organizations to recommend routine screening for and treatment of subclinical thyroid disease during pregnancy. Our study was designed to determine whether screening for either of these two diagnoses and treatment with thyroid hormone replacement during pregnancy actually improved IQ in children at 5 years of age.