FDA Requests Removal of Strongest Warning Against Using Cholesterol
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Case-Scenario-10-FINAL.Pdf
Case scenario 10 – Magdalena Part 1 • Magdalena is 26 years old. She is 13 weeks pregnant and had a high chance combined test result of 1 in 140 for trisomy 13 with an NT measurement of 2.4mm. • After a lengthy discussion about her options, she decided to have NIPT. • The results reported a greater than 60% chance of the baby having Patau’s syndrome. She decided to have an invasive test. A CVS was performed. Would you have offered a CVS to this patient? a) No - she should be offered an amniocentesis only, due to the chance of placental factors affecting a result. b) Yes - the patient should be informed of risks and benefits of both CVS and amniocentesis. Answer b) Yes - the patient should be informed of the risks and benefits of a CVS and amniocentesis. Additional note A patient/couple should be informed of the options of both forms of diagnostic procedures. They should be informed of the benefits and limitations of each test, this should include timing of testing, possible results and risks of miscarriage. This discussion should also include the couples ethical, religious, social and individual beliefs. Name the type of mosaicism that can cause a false-positive result with NIPT. a) Feto-placental mosaicism b) Placental mosaicism c) Fetal mosaicism Answer b) Placental mosaicism Additional note There is a discrepancy of the cell line in the placenta and baby. The abnormal cell lines are seen in the placenta and not on the fetus. There is a small chance that a 'high chance report is caused by 'placental mosaicism', therefore a CVS may also report 'mosaicism’. -
What Precautions Should We Use with Statins for Women of Childbearing
CLINICAL INQUIRIES What precautions should we use with statins for women of childbearing age? Chaitany Patel, MD, Lisa Edgerton, PharmD New Hanover Regional Medical Center, Wilmington, North Carolina Donna Flake, MSLS, MSAS Coastal Area Health Education Center, Wilmington, NC EVIDENCE- BASED ANSWER Statins are contraindicated for women who are on its low tissue-penetration properties. pregnant or breastfeeding. Data evaluating statin Cholesterol-lowering with simvastatin 40 mg/d did use for women of childbearing age is limited; how- not disrupt menstrual cycles or effect luteal phase ever, they may be used cautiously with adequate duration (strength of recommendation: C). contraception. Pravastatin may be preferred based CLINICAL COMMENTARY Use statins only as a last resort Before reading this review, I had not been for women of childbearing age ® Dowdenaware Health of the serious Media effects of statin medications I try to follow the USPSTF recommendations and on the developing fetus. In conversations with not screen women aged <45 years without coro- my colleagues, I found that the adverse effects nary artery disease riskCopyright factors for Fhyperlipidemia.or personalof usestatins onlyduring pregnancy are not readily When a woman of any age needs treatment, my known. Such information needs to be more first-line therapy is lifestyle modification. Given the widely disseminated. risks of statin drugs to the developing fetus, Ariel Smits, MD women with childbearing potential should give Department of Family Medicine, Oregon Health & Science fully informed consent and be offered reliable University, Portland contraception before stating statin therapy. I Evidence summary anal, cardiac, tracheal, esophageal, renal, Hydroxymethyl glutaryl coenzyme A and limb deficiency (VACTERL associa- (HMG CoA) reductase inhibitors, com- tion), intrauterine growth retardation monly called statins, have been on the (IUGR), and demise in fetuses exposed market since the late 1980s. -
Effect of Statins and ACE Inhibitors Alone and in Combination on Clinical Outcome in Patients with Coronary Heart Disease
Journal of Human Hypertension (2004) 18, 781–788 & 2004 Nature Publishing Group All rights reserved 0950-9240/04 $30.00 www.nature.com/jhh ORIGINAL ARTICLE Effect of statins and ACE inhibitors alone and in combination on clinical outcome in patients with coronary heart disease VG Athyros1, DP Mikhailidis3, AA Papageorgiou2, VI Bouloukos1, AN Pehlivanidis1, AN Symeonidis4 and M Elisaf5, for the GREACE Study Collaborative Group 1Atherosclerosis Unit, Aristotelian University, Hippocration Hospital, Thessaloniki, Greece; 2Department of Clinical Biochemistry, Royal Free Hospital, Royal Free and University College Medical School, Pond Street, London, UK; 32nd Propedeutic Department of Internal Medicine, Aristotelian University, Hippocration Hospital, Thessaloniki, Greece; 4Greek Society of General Practitioners, Thessaloniki, Greece; 5Department of Internal Medicine, Medical School, University of Ioannina, Greece We assessed the ‘synergy’ of statins and angiotensin- point in group A was 31%, (95% CI À48 to À6%, P ¼ 0.01) converting enzyme inhibitors (ACEI) in reducing vascu- in comparison to group B, 59% (95% CI À72 to À48%, lar events in patients with coronary heart disease (CHD). Po0.0001) to group C and 63% (95% CI À74 to À51%, The GREek Atorvastatin and CHD Evaluation (GREACE) Po0.0001) to group D. There was no significant Study, suggested that aggressive reduction of low difference in RRR between groups C and D (9%, CI density lipoprotein cholesterol to 2.59 mmol/l À27–10%, P ¼ 0.1). Other factors (eg the blood pressure) (o100 mg/dl) significantly reduces morbidity and mor- that can influence clinical outcome did not differ tality in CHD patients, in comparison to undertreated significantly between the four treatment groups. -
Get the Facts: What You Need to Know About Statins
Get the Facts: What You Need to Know About Statins We hear a lot about lowering our cholesterol by eating a low-fat diet and getting regular exercise. But for some people, making healthy changes isn’t enough. That’s when statins come in. Statins are medicines that reduce the risk of heart disease and stroke, two of the leading causes of death in the United States. These medicines keep the liver from making cholesterol and help it get rid of cholesterol in the blood. Statins may help if you have high cholesterol, heart disease or are at high risk for heart disease or stroke. Things that can put you at high risk include being a current or former smoker, stress, having diabetes and/or high blood pressure, having a family history of heart disease or stroke, or being overweight. This means you do not have to have high cholesterol to benefit from taking statins. What Are Some Examples of Statins? Below is a list of statins you may have heard of and where you can find them on the SCAN Health Plan® Formulary (Note: The SCAN Formulary and the Formulary tier are subject to change, especially from year to year.): Statin Formulary Status Brand Name Generic Name Lipitor® Atorvastatin Tier 1 Mevacor® Lovastatin Tier 1 Pravachol® Pravastatin Tier 1 Zocor® Simvastatin Tier 1 Crestor® Rosuvastatin Tier 2 Lescol® Fluvastatin Not available Livalo® Pitavastatin Not available Statins can also be combined with other cholesterol-lowering and blood pressure drugs into one pill but may have higher copays. If you have questions about these combination pills and their copays, please talk to your pharmacist. -
Survivors of Acute Leukemia Are Less Likely to Have Liveborn Infants Than Are Their
CHILDHOOD CANCER SURVIVOR STUDY ANALYSIS PROPOSAL STUDY TITLE: Fertility Rates in Long-Term Survivors of Acute Lymphoblastic Leukemia WORKING GROUP AND INVESTIGATORS: Name Telephone Number E-mail Daniel M. Green, M.D. 901-595-5915 [email protected] Vikki Nolan, Ph.D. 901-595-6078 [email protected] Liang Zhu, Ph.D. 901-595-5240 [email protected] Marilyn Stovall, Ph.D. 713-792-3240 [email protected] Sarah Donaldson, M.D. 650-723-6195 [email protected] Les Robison, Ph.D. 901-595-5817 [email protected] Chuck Sklar, M.D. 212-717-3239 [email protected] BACKGROUND AND RATIONALE: Survivors of acute leukemia are less likely to have liveborn infants than are their female siblings (relative risk (RR) =0.63, 95% confidence interval (CI) 0.52 to 0.76). The risk of miscarriage was increased among Childhood Cancer Survivor Study (CCSS) female participants who received craniospinal (RR=2.22, 95% CI 1.36 to 3.64) or cranial irradiation (RR=1.40, 95% CI 1.02 to 1.94). The risk of miscarriage was increased in survivors of acute lymphoblastic leukemia (ALL) (RR=1.60, 95% CI 0.85 to 3.00) and central nervous system tumors (RR=1.33, 95% CI 0.61 to 2.93) although neither risk achieved statistical significance 1. Winther et al. reported that the risk of spontaneous 2 abortion was not increased in survivors of leukemia compared to their sisters (proportion ratio (PR) 1.2, 95% CI 0.7 to 2.0). However those female survivors who received low doses of radiation to the uterus and ovaries, but high doses of radiation to the pituitary had an increased risk of spontaneous abortion (PR 1.8, 95% CI 1.1 to 3.0). -
Role of Maternal Age and Pregnancy History in Risk of Miscarriage
RESEARCH Role of maternal age and pregnancy history in risk of BMJ: first published as 10.1136/bmj.l869 on 20 March 2019. Downloaded from miscarriage: prospective register based study Maria C Magnus,1,2,3 Allen J Wilcox,1,4 Nils-Halvdan Morken,1,5,6 Clarice R Weinberg,7 Siri E Håberg1 1Centre for Fertility and Health, ABSTRACT Miscarriage and other pregnancy complications might Norwegian Institute of Public OBJECTIVES share underlying causes, which could be biological Health, PO Box 222 Skøyen, To estimate the burden of miscarriage in the conditions or unmeasured common risk factors. N-0213 Oslo, Norway Norwegian population and to evaluate the 2MRC Integrative Epidemiology associations with maternal age and pregnancy history. Unit at the University of Bristol, Introduction Bristol, UK DESIGN 3 Miscarriage is a common outcome of pregnancy, Department of Population Prospective register based study. Health Sciences, Bristol Medical with most studies reporting 12% to 15% loss among School, Bristol, UK SETTING recognised pregnancies by 20 weeks of gestation.1-4 4Epidemiology Branch, National Medical Birth Register of Norway, the Norwegian Quantifying the full burden of miscarriage is Institute of Environmental Patient Register, and the induced abortion register. challenging because rates of pregnancy loss are Health Sciences, Durham, NC, USA PARTICIPANTS high around the time that pregnancies are clinically 5Department of Clinical Science, All Norwegian women that were pregnant between recognised. As a result, the total rate of recognised University of Bergen, Bergen, 2009-13. loss is sensitive to how early women recognise their Norway pregnancies. There are also differences across countries 6 MAIN OUTCOME MEASURE Department of Obstetrics and studies in distinguishing between miscarriage and and Gynecology, Haukeland Risk of miscarriage according to the woman’s age and University Hospital, Bergen, pregnancy history estimated by logistic regression. -
Practice Guidelines for Molecular Diagnosis of Fragile X Syndrome
Practice Guidelines for Molecular Diagnosis of Fragile X Syndrome Prepared and edited by James Macpherson 1 and Abid Sharif 2 following a CMGS Workshop held on 10 th July 2012. 1. Wessex Regional Genetics Laboratory, Salisbury NHS Foundation Trust, Salisbury, Wiltshire, SP2 8BJ, U.K. 2. East Midlands Regional Molecular Genetics Service, Nottingham University Hospitals NHS Trust, City Hospital Campus, Nottingham, NG5 1PB, U.K. Guidelines updated by the Association for Clinical Genetic Science (formally Clinical Molecular Genetics Society and Association of Clinical Cytogenetics) approved November 2014. 1. NOMENCLATURE and GENE IDs OMIM Condition Gene name Gene map locus 309550 Fragile X Syndrome FMR1 Xq27.3 309548 FRAXE FMR2 Xq28 2. DESCRIPTION OF DISEASE 2.1 Fragile X Syndrome Fragile X Syndrome is thought to be the commonest single-gene cause of learning disability features in humans with an estimated prevalence of 1 in 4000- 1 in 6000 males, where it causes moderate to severe intellectual and social impairment together with syndromic features including large ears and head, long face and macroorchidism 1. A fragile site (FRAXA) is expressible at the gene locus at Xq27.3, typically in 2-40 % of blood cells in affected males. The pathogenic mutation in most cases is a large expansion (‘full mutation’) in a CGG repeat tract in the first untranslated exon of the gene FMR1, which normally encodes the RNA-binding protein FMRP. Full mutations (from approximately 200 repeats upwards) result in hypermethylation of the DNA in and around the CGG tract, curtailed gene expression and no FMRP being produced 2-4. Smaller expansions of the CGG repeat, or ‘premutations’ are not hypermethylated and hence do not cause Fragile X syndrome, but may show expansion into full mutations over one or more generations. -
ART and Miscarriage Risk Assoc
27-28 January, Sofia, Bulgaria ART and miscarriage risk Assoc. Prof. Petya Andreeva, MD, PhD D-r Shterev Hospital Dr. Shterev Sofia, BULGARIA HOSPITAL Dr. Shterev Miscarriage rate HOSPITAL 10 % to 15 % of clinical pregnancies have resulted in miscarriage. 1-2% miscarriages / per couples who try to conceive. (Macklon NS et al, 2002; Rai R et al 2006) Dr. Shterev Monthly fecundity rate (MFR) HOSPITAL In humans even in optimal circumstances – clinical recognized pregnancy in one cycle or the so called monthly fecundity rate is around 30 % . In contrast MFR is 80% in baboons and 90% in rabbits. (Chard T, 1991; . Foote RH 1988; Stevens VC 1997) Dr. Shterev Ongoing pregnancy rate HOSPITAL Assisted reproductive technologies (ART) represent average 30 % pregnancy rate. Around 50% of human conception fails implantation. Up to half of implanted embryos fail to progress in ongoing pregnancy. (Macklon N 2002; Macklon N 2014) Dr. Shterev Conception to ongoing pregnancy HOSPITAL Live births -True incidence of pregnancy loss is 30% closer to 50%. Miscarriage - This renders miscarriage as the 40-50% 10 % most common complication of pregnancy Early pregnancy loss 30 % Implantation failure 30 % CONCEPTION Macklon et al, Hum Reproduction Update, 2002 Dr. Shterev Known reasons for miscarriage HOSPITAL Antiphospholipid syndrome Endocrine abnormalities Thyroid dysfunction Diabetes Chromosome aberrations Uterine structural malformation Trombophilias Unknown factors in 50 % of cases. Dr. Shterev Embryo HOSPITAL The enormous rate of early pregnancy loss in humans thought to be as a consequences of two key features of human embryos: 1. High prevalence of chromosomal abnormalities. 2. Invasiveness. Dr. Shterev HOSPITAL -Good-quality cleavage-stage embryos exhibit high rates of aneuploidy. -
Biases Inherent in Studies of Coffee Consumption in Early Pregnancy and the Risks of Subsequent Events
nutrients Review Biases Inherent in Studies of Coffee Consumption in Early Pregnancy and the Risks of Subsequent Events Alan Leviton ID Boston Children’s Hospital and Harvard Medical School, 1731 Beacon Street, Brookline, MA 02445, USA; [email protected]; Tel.: +1-617-485-7187 Received: 24 July 2018; Accepted: 21 August 2018; Published: 23 August 2018 Abstract: Consumption of coffee by women early in their pregnancy has been viewed as potentially increasing the risk of miscarriage, low birth weight, and childhood leukemias. Many of these reports of epidemiologic studies have not acknowledged the potential biases inherent in studying the relationship between early-pregnancy-coffee consumption and subsequent events. I discuss five of these biases, recall bias, misclassification, residual confounding, reverse causation, and publication bias. Each might account for claims that attribute adversities to early-pregnancy-coffee consumption. To what extent these biases can be avoided remains to be determined. As a minimum, these biases need to be acknowledged wherever they might account for what is reported. Keywords: epidemiology; bias; causation; coffee; pregnancy 1. Introduction Maternal consumption of coffee during early pregnancy has been viewed as increasing the risk of miscarriage [1–4], fetal growth restriction [2,5–11], and childhood leukemias [12–20]. Unfortunately, many of the epidemiologic studies have not acknowledged the potential biases that appear to have influenced these perceptions of risk. The list of potential biases is long [21]. In this essay, I review five of these biases, namely recall bias, misclassification, residual confounding, reverse causation, and publication bias. Each of these biases might account for some of what has been reported. -
Maternal Age, History of Miscarriage, and Embryonic/Fetal Size Are Associated with Cytogenetic Results of Spontaneous Early Miscarriages
Journal of Assisted Reproduction and Genetics (2019) 36:749–757 https://doi.org/10.1007/s10815-019-01415-y GENETICS Maternal age, history of miscarriage, and embryonic/fetal size are associated with cytogenetic results of spontaneous early miscarriages Nobuaki Ozawa1 & Kohei Ogawa1 & Aiko Sasaki1 & Mari Mitsui1 & Seiji Wada1 & Haruhiko Sago1 Received: 1 October 2018 /Accepted: 28 January 2019 /Published online: 9 February 2019 # Springer Science+Business Media, LLC, part of Springer Nature 2019 Abstract Purpose To clarify the associations of the maternal age, history of miscarriage, and embryonic/fetal size at miscarriage with the frequencies and profiles of cytogenetic abnormalities detected in spontaneous early miscarriages. Methods Miscarriages before 12 weeks of gestation, whose karyotypes were evaluated by G-banding between May 1, 2005, and May 31, 2017, were included in this study. The relationships between their karyotypes and clinical findings were assessed using trend or chi-square/Fisher’s exact tests and multivariate logistic analyses. Results Three hundred of 364 miscarriage specimens (82.4%) had abnormal karyotypes. An older maternal age was significantly associated with the frequency of abnormal karyotype (ptrend < 0.001), particularly autosomal non-viable and viable trisomies (ptrend 0.001 and 0.025, respectively). Women with ≥ 2 previous miscarriages had a significantly lower possibility of miscarriages with abnormal karyotype than women with < 2 previous miscarriages (adjusted odds ratio [aOR], 0.48; 95% confidence interval [95% CI], 0.27–0.85). Although viable trisomy was observed more frequently in proportion to the increase in embryonic/fetal size at miscarriage (ptrend < 0.001), non-viable trisomy was observed more frequently in miscarriages with an embryonic/fetal size < 10 mm (aOR, 2.41; 95% CI, 1.27–4.58), but less frequently in miscarriages with an embryonic/fetal size ≥ 20 mm (aOR, 0.01; 95% CI, 0.00–0.07) than in anembryonic miscarriages. -
Miscarriage in Early Pregnancy
Miscarriage in Early Pregnancy Obstetrics & Gynaecology Women and Children’s Group This leaflet has been designed to give you important information about your condition / procedure, and to answer some common queries that you may have. Introduction What has happened? This booklet has been written to give help Bleeding from the vagina in early pregnancy and guidance to parents who lose a baby in is very common. Most pregnancies will the early stages of pregnancy. continue as normal but sadly other Parents who have suffered such a loss by pregnancies will end in miscarriage. miscarriage find that they need to make a Miscarriage is the term used to describe the number of choices within a short space of sudden ending of a pregnancy, most often time, choices that they may rather not think within the first 12 weeks. about. With the help of the staff and the information in this booklet, we can help you Inevitable miscarriage through your period of grief, making this Some women find that the initial bleeding stressful time easier to cope with. becomes heavier, sometimes with blood At the moment you may be experiencing clots. There may also be severe period-type feelings of anxiety, distress and sadness. pains or cramps. What is happening is that Grief is a very natural reaction to the loss of the uterus is trying to push out, or expel, the your baby, and grief following a miscarriage pregnancy. may be just as strong as that occurring after the loss of someone we have known and Incomplete miscarriage loved. How a particular person copes with This is when the pregnancy is partially grief is unique to that person. -
Prevalence and Instability of Fragile X Alleles Implications for Offering Fragile X Prenatal Diagnosis
Prevalence and Instability of Fragile X Alleles Implications for Offering Fragile X Prenatal Diagnosis Amy Cronister, MS, Jennifer Teicher, MS, Elizabeth M. Rohlfs, PhD, Alan Donnenfeld, MD, and Stephanie Hallam, PhD OBJECTIVE: To document fragile X allele frequencies in a ranted for those women with a fragile X allele containing national referral population and evaluate CGG repeat 55 or more CGG repeats. expansion in mother-offspring transmissions. (Obstet Gynecol 2008;111:596–601) METHODS: Fragile X DNA analysis by Southern blot LEVEL OF EVIDENCE: III and polymerase chain reaction was completed for 14,675 women, aged 18 years or older, and 238 mother- offspring pairs between January 1999 and June 2004. ragile X syndrome is the leading inherited cause of Carrier frequencies were compared between groups re- Fmental retardation, affecting approximately 1 in 1 ferred for different clinical indications. Direct comparison 4,000 males and 1 in 8,000 females. Based on a of the FMR1 gene CGG repeat size in mother-offspring review of nine population-based studies among low- pairs determined intermediate and premutation allele risk women (those with no family history suspicious stability. for fragile X), the carrier frequency is estimated to be 2 RESULTS: Intermediate fragile X alleles (45–54 CGG re- 1 in 303. The prevalence is similar among most racial peats) occurred in 257 (1 in 57). The combined total and ethnic groups3. number of patients with a premutation (55–200 CGG In 1991, the fragile X mental retardation 1 repeats) or full mutation (more than 200 CGG repeats) (FMR1) gene and the underlying mutation associated numbered 208 (1 in 71).