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101. Olysio - simeprevir

report Page 2/129 Medicinal product no longer authorised 3. Benefit-Risk Balance 121 4. Recommendations 128 Assessment report Page 3/129 Medicinal product no longer authorised List of abbreviations AASLD American Association for the Study of Liver Diseases ADR adverse drug reaction AE adverse event ALP alkaline phosphatase ALT alanine aminotransferase AST aspartate aminotransferase BCRP1 breast cancer resistance protein 1 b.i.d. bis in die; twice daily BMI body mass index BSEP bile salt export pump (...) granted an indication in GT1-infected patients, in combination with peginterferon alfa and ribavirin. At the time of the approval of these medicines in Europe, there were no large studies on-going with different combinations e.g. interferon-free regimens. Moreover, it had indeed only very recently been demonstrated for products in development that SVR could be reached without an interferon. Thus, the only drugs for which combination therapy could be relevant for these DAAs, were PEG+RBV, both of which

2014 European Medicines Agency - EPARs

102. State-of-the-Art Methods for Evaluation of Angiogenesis and Tissue Vascularization

State-of-the-Art Methods for Evaluation of Angiogenesis and Tissue Vascularization State-of-the-Art Methods for Evaluation of Angiogenesis and Tissue Vascularization | Circulation Research Search Hello Guest! Login to your account Email Password Keep me logged in Search March 2019 March 2019 February 2019 February 2019 January 2019 January 2019 This site uses cookies. By continuing to browse this site you are agreeing to our use of cookies. Free Access article Share on Jump to Free Access (...) and sprouting assays Very reproducibleAllows the study of EC tube formation and sprouting in physiologically relevant 3D matrix environmentsCan be reproducibly performed under serum-free conditions with defined recombinant growth factorsCan be performed with various human ECs (eg, HUVECs) that can be genetically manipulatedEC tubes that are formed can be subjected to flow forces EC only conditions without mural cellsThus far, isolated rodent ECs have not worked well in these assay modelsVariable growth

2015 American Heart Association

103. The Agenda for Familial Hypercholesterolemia Full Text available with Trip Pro

The Agenda for Familial Hypercholesterolemia The Agenda for Familial Hypercholesterolemia | Circulation Search Hello Guest! Login to your account Email Password Keep me logged in Search March 2019 March 2019 March 2019 March 2019 March 2019 February 2019 February 2019 February 2019 February 2019 January 2019 January 2019 January 2019 January 2019 January 2019 This site uses cookies. By continuing to browse this site you are agreeing to our use of cookies. Free Access article Share on Jump (...) to Free Access article The Agenda for Familial Hypercholesterolemia A Scientific Statement From the American Heart Association , MD, FAHA, Chair , RN, MSN, FAHA , MD, MPH , PhD , PharmD , MD, PhD, FAHA , MD, MPH, FAHA , MD, PhD , MD, FAHA , MD, PhD , MD, PhD, FAHA , and DSc, MD, PhD MD, PhD, FAHAon behalf of the American Heart Association Atherosclerosis, Hypertension, and Obesity in the Young Committee of the Council on Cardiovascular Disease in the Young, Council on Cardiovascular and Stroke Nursing

2015 American Heart Association

104. Management Guidelines for Children with Thyroid Nodules and Differentiated Thyroid Cancer

-stimulatedTgafter surgery and 131 I identi?es patients with a high probability of being disease-free (286,287,298–300). Therefore, an unde- tectable TSH-stimulated Tg in children is similarly consid- eredtobeanindicatorofdiseaseremission,althoughamildly positive stimulated Tg ( 2ng/mL but 10ng/mL) warrant further evaluation to localize disease and inform the decision as to whether addi- tional surgery and/or 131 I therapy would be bene?cial or whether one should pursue continued observation. Recommendation

2015 Pediatric Endocrine Society

105. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer

, laboratory pro- cess quality assurance score (for multiple relevant domains) was associated with the presence of CLIA certi?cation (188). In a large, international survey of medical genetic testing labo- ratory directors, accreditation of the laboratory was associated with a higher quality assurance index score (189). [A17] AUS/FLUS cytology & RECOMMENDATION 15 (A) For nodules with AUS/FLUS cytology, after consider- ation of worrisome clinical and sonographic features, in- vestigations such as repeat FNA

2015 Pediatric Endocrine Society

106. Long term follow up of survivors of childhood cancer

, 2008 edition (www.sign.ac.uk/guidelines/fulltext/50/index. html). More information on accreditation can be viewed at www.evidence.nhs.uk Healthcare Improvement Scotland (HIS) is committed to equality and diversity and assesses all its publications for likely impact on the six equality groups defined by age, disability, gender, race, religion/belief and sexual orientation. SIGN guidelines are produced using a standard methodology that has been equality impact assessed to ensure that these equality (...) in every detail at the time of publication. However, in the event of errors or omissions corrections will be published in the web version of this document, which is the definitive version at all times. This version can be found on our web site www.sign.ac.uk. This document is produced from elemental chlorine-free material and is sourced from sustainable forests.Scottish Intercollegiate Guidelines Network Long term follow up of survivors of childhood cancer A national clinical guideline March

2013 SIGN

107. Body Composition, Resting Energy Expenditure, and Metabolic Changes in Women Diagnosed with Differentiated Thyroid Carcinoma. Full Text available with Trip Pro

(euthyroid state), (2) at 2-3 weeks after thyroidectomy (hypothyroid state), (3) at 2-3 months of levothyroxine (LT4) treatment (exogenous euthyroid state), (4) after 6-9 months, and (5) after 1 year of TSH suppressive LT4 therapy (exogenous subclinical hyperthyroid state). A generalized estimating equation (GEE) analysis was performed to estimate the longitudinal correlations of the total triiodothyronine (TT3)/free thyroxine (fT4) ratio (as an independent variable) with body composition, metabolic (...) , and calorimetric parameter changes (as dependent variables). Results: REE, REE per kilogram of lean body mass (REE/LBM), pulse, and systolic and diastolic blood pressure were significantly higher after TSH suppressive LT4 therapy. The GEE analysis revealed longitudinal negative correlations between the TT3/fT4 ratio and systolic blood pressure, fasting blood glucose, body mass index, android (abdominal wall and visceral mesentery) fat distribution, trunk, and arm fat distribution, REE, and REE/LBM

2019 Thyroid

108. Reduction in Thyroid-Stimulating Hormone Correlated with Improved Inflammation Markers in Chinese Patients with Morbid Obesity Undergoing Laparoscopic Sleeve Gastrectomy. (Abstract)

changes after laparoscopic sleeve gastrectomy (LSG) in Chinese patients with morbid obesity.Eighty-eight patients with morbid obesity (56.8% female; age 30.9 ± 9.5 years; BMI 39.9 ± 5.7 kg/m2) submitted to LSG were selected. Patients were subdivided into euthyroid group and subclinical hypothyroidism (SH) group. Thyroid-stimulating hormone (TSH), free thyroxine (FT4), inflammatory markers, and related metabolic indexes were analyzed pre- and 12 months post-LSG.SH patients presented significantly

2019 Obesity Surgery

109. Patients Treated for Hyperthyroidism Are at Increased Risk of Becoming Obese: Findings from a Large Prospective Secondary Care Cohort. Full Text available with Trip Pro

of obesity in male (odds ratio = 1.7 [95% confidence interval 1.3-2.2], p < 0.001) and female (1.3, 1.2-1.5, p < 0.001) patients with hyperthyroidism compared with the background population. Treatment with 131I was associated with additional weight gain (0.6 kg, 0.4-0.8, p < 0.001), compared with ATD treatment alone. More weight gain was seen if serum thyrotropin (TSH) was markedly increased (TSH >10 mIU/L; 0.5 kg, 0.3-0.7, p < 0.001) or free thyroxine (fT4) was reduced (fT4 ≤ 10 pmol/L (0.8 ng/dL); 0.3 (...) if weight gain seen following treatment for hyperthyroidism represents replenishment of premorbid weight or "overshoot" beyond expected regain and, if there is excessive weight gain, whether this is associated with the applied treatment modality. Methods: We calculated the risk of becoming obese (body mass index [BMI] >30 kg/m2) following treatment for hyperthyroidism by comparing BMI of 1373 patients with overt hyperthyroidism seen in a secondary care setting with the age- and sex-matched background

2019 Thyroid

110. Thyroid Function Screening in Children and Adolescents With Mood and Anxiety Disorders. (Abstract)

with elevated TSH measures, 12.9% (n = 8, mean ± SD age = 16.5 ± 1.5 years, 87.5% female) had an abnormal free/total thyroxine (T₄) level or other biochemical findings consistent with thyroid disease. Patients with thyroid disease (compared to those patients with elevated TSH and normal active thyroid hormone concentrations) were older (16.5 ± 1.5 vs 14.6 ± 2.3 years, P = .020) but did not differ in sex distribution (87.5% vs 63.6% female, P = .444).TSH concentrations are abnormal in approximately 6 (...) of age), and 7 patients had a TSH concentration < 0.36 μIU/mL. Elevated TSH concentrations were associated with a recent weight gain (odds ratio [OR] = 3.60; 95% CI, 1.13-9.61; P = .017), a history of thyroid disease (OR = 6.88; 95% CI, 2.37-10.7; P ≤ .0001), abnormal menstrual bleeding/menometrorrhagia (OR = 2.03; CI, 1.04-3.63; P = .024), and benzodiazepine treatment (OR = 2.29; 95% CI, 1.07-4.52; P = .02). No association was observed for sex, age, or body mass index z score. Among patients

2019 Journal of Clinical Psychiatry

111. Somatropin Biopartners

Hormone (Antibodies) AO Adulthood Onset AP Aminopeptidase AST Aspartate aminotransferase AUC Area under the Curve AUCinf Area under the plasma concentration-time profile from time zero extrapolated to infinite time AUCinfcorr Corrected AUCinf AUClast Area under the concentration-time profile from time zero to the time of the last quantifiable concentration AUClastcorr Corrected AUClast BA Bone Age BHT Butylhydroxytoluene BMD Bone Mineral Density BMI Body mass index BRP Biological reference preparation (...) Reverse Phase HPLC s.c. Subcutaneous(ly) SAE Serious Adverse Event(s) SC Subcutaneous SD Standard deviation SDS Standard Deviation Score SEC Size Exclusion chromatography SmPC Summary of Product Characteristics SOC System Organ Class SR-hGH Sustained-Release Human Growth Hormone t½ Terminal Half Life T3 Triiodothyronine T4 Thyroxin TEAE Treatment Emergent Adverse Event tmax Time of Occurrence for Cmax TSH Thyroid Stimulating Hormone UF Ultrafiltration USP United States Pharmacopoeia UV Ultraviolet vs

2013 European Medicines Agency - EPARs

112. Opsumit - macitentan

EMA/CHMP/457699/2013 Page 5/105 4. Benefit-Risk Balance 96 5. Recommendations 102 Assessment report EMA/CHMP/457699/2013 Page 6/105 List of abbreviations 6MWD 6-minute walk distance 6MWT 6-minute walk test AE adverse event ALT alanine aminotransferase APAH Associated PAH AST aspartate aminotransferase AUC area under the curve BP blood pressure BSEP Bile salts export pump CEC Clinical Event Committee CHMP Committee for Medicinal Products for Human Use (Europe) CL Confidence limit CI cardiac index (...) identified in humans: ACT-132577 (active metabolite M6) and ACT-373898 (inactive metabolite on endothelin receptors M5). ACT-132577 is approximately 8-fold less potent than macitentan on ET A and 2-fold less potent on ET B . Similar to macitentan, the free therapeutic plasma concentrations of ACT-132577 (7.4 nM) is lower than the IC 50 and Kb values for the ET B (IC 50 total=987 nM, Kb total=319 nM, IC 50 free=94 nM, Kb free=139 nM). Based on the high exposure, and prolonged half-life this metabolite

2013 European Medicines Agency - EPARs

113. Stivarga - regorafenib

maximum tolerated dose NSCLC non-small cell lung cancer NOAEL no observed adverse effect level OATP Organic anion-transporting polypeptide ORR objective response rate OS overall survival OVAT One Variable At a Time PK pharmacokinetics PFS progression free survival PR partial response RECIST response evaluation criteria in solid tumours RPES Posterior reversible encephalopathy syndrome SAE serious adverse event SD stable disease SJS Stevens-Johnson-Syndrome TEN Toxic epidermal necrolysis TG (...) aminotransferase, BUN: blood urea nitrogen, BW: body weight, chol: cholesterol, crea: creatinine, Ery: erythrocytes, FC: food consumption, GLDH: glutamate lactate dehydrogenase, Glu: glucose, HB: haemoglobin, HCT: haematocrit, hQuick: hepato Quick test, LYM: lymphocytes, MCH: mean corpuscular haemoglobin, MCHC: mean corpuscular haemoglobin concentration, ND: not determined, T4: Thyroxine, TG: triglycerides, TSH: thyroid stimulating hormone, WI: water intake Genotoxicity Regorafenib was tested in vitro

2013 European Medicines Agency - EPARs

114. Labazenit - budesonide / salmeterol

of salmeterol xinafoate is equivalent to 25 µg of salmeterol free base. Salmeterol xinafoate is a white or almost white crystalline powder, which is slightly soluble in ethanol, chloroform and isopropanol and sparingly soluble in water. Two polymorphs of salmeterol xinafoate are described in the literature. All the proposed suppliers synthesise the polymorph I which is the most thermodynamically stable form at room temperature. The chemical structure of salmeterol xinafoate is: CHMP assessment report EMA

2013 European Medicines Agency - EPARs

115. Tasimelteon (Hetlioz)

melatonin metabolite concentration in the urine occurs about 3.5 hours prior to waking. The main metabolite of melatonin in the urine is 6-sulfatoxymelatonin (aMT6s). Non-24 Hour Disorder is a chronic disorder that occurs when individuals are unable to synchronize their endogenous body clock to the 24-hour light-dark cycle. The Applicant states that Non-24 Hour Disorder is also known as: Circadian rhythm sleep disorder – nonentrained type; Free running disorder; Non-24-hour circadian rhythm disorder (...) ; Non-24-hour sleep-wake disorder; Circadian rhythm sleep disorder – free-running type; and Hypernychthemeral disorder. The majority of reported cases occur in blind patients with no perception of light. In these blind individuals the pacemaker may revert to its endogenous non-24-hour rhythm leading to periodic desynchronization of timing of melatonin and cortisol production, and the sleep-wake cycle with respect to the external 24-hour day. For example, consider a blind individual who has

2013 FDA - Drug Approval Package

116. Genetic testing for hereditary mutations in the RET gene

susceptibility to MEN2. RET mutation testing is a part of the current clinical pathway. It was compared with a hypothetical algorithm that included a mix of historical treatment and current tests (other than the RET test), which outlines the approach to the diagnosis, surveillance and management of suspected MEN2 in a setting without genetic testing. Two clinical management algorithms were provided for RET mutation testing in index cases with an MTC and without an MTC, and for their close family members (...) of MTC or phaeochromocytoma in a close relative) who are found not to have an MTC would be assumed not to have MEN2. Therefore, the index case and their family members would not 4/18 be screened or undergo surveillance. However, in the current setting where genetic testing is available, patients with this clinical profile who have a RET mutation would be diagnosed with MEN2 and therefore undergo prophylactic total thyroidectomy and lifelong surveillance. Their family members would also undergo

2013 Medical Services Advisory Committee

117. Pre-conception - advice and management

associated with first trimester maternal exposure to fluoxetine. Issued in June 2011. September 2010 — minor update. Text amended to include recommendations from the National Institute for Health and Care Excellence (NICE) public health guidance 27 about preparing for pregnancy for women with a body mass index (BMI) of 30 kg/m 2 or more. Issued September 2010. January 2009 — minor update to clarify the advice for folic acid supplementation in women with sickle-cell anaemia and thalassaemia. Issued (...) information about how to assess and manage individual components is provided by following the hyperlinks. Assess the following in a woman who is planning to become pregnant: Plans for timing of pregnancy. Previous obstetric history. Dietary habits and body mass index. Use of folic acid and dose taken in relation to her risk of neural tube defect . Cervical smear status. Smoking status. Amount of alcohol consumed. Use of illicit drugs and risk of hepatitis B. Immunity to rubella and chickenpox. Concerns

2017 NICE Clinical Knowledge Summaries

118. Signifor - pasireotide

Risks 86 Benefit-risk balance 88 4. Recommendations 89 Outcome 89 Page 3/90 Conditions or restrictions regarding supply and use 89 Conditions and requirements of the Marketing Authorisation 89 New Active Substance Status 90 Page 4/90 List of abbreviations ACTH Adrenocorticotropic hormone AE Adverse Event b.i.d. bis in die/twice a day BMI Body mass index CI Confidence interval CRH Corticotropin-releasing hormone HRQL Health related quality of life IPSS Inferior petrosal sinus sampling ITT Intent (...) to treat LLN Lower limit of normal MRI Magnetic resonance imaging mUFC Mean urinary free cortisol PD Pharmacodynamics PK Pharmacokinetics PT Prothrombin time PTT Partial thromboplastin time s.c. Subcutaneous SD Standard deviation SE Standard error SOC System organ class SOM230 Pasireotide sst Somatostatin receptor t.i.d. ter in die/three times a day UFC Urinary free cortisol ULN Upper limit of normal Page 5/90 1. Background information on the procedure 1.1. Submission of the dossier The applicant

2012 European Medicines Agency - EPARs

119. Mirabegron (Myrbetriq)

is required in patients with mild to moderate renal impairment according to the Sponsor. Volunteers with hepatic impairment were compared pharmacokinetically to healthy control volunteers who were matched for sex, age and body mass index (BMI). Following single dose administration of 100 mg mirabegron in volunteers with mild hepatic impairment (Child-Pugh Class A), mean mirabegron C max and AUC inf were increased by 9% and 19% relative to volunteers with normal hepatic function. In volunteers

2012 FDA - Drug Approval Package

120. Thyroid Function in Patients With a Fontan Circulation. (Abstract)

function (3.1 ± 0.1 vs 3.5 ± 0.1 pg/dl, p <0.01). The free triiodothyronine level was significantly and negatively correlated with the relaxation time constant (p = 0.03) and brain natriuretic hormone (p <0.01) level and positively correlated with the cardiac index (p = 0.04). In conclusion, venous congestion in Fontan patients may cause thyroid dysfunction, which can be responsible for decreased ventricular function and cardiac output in Fontan patients. Thus, thyroid function should be routinely (...) Thyroid Function in Patients With a Fontan Circulation. In this study, we tested our hypothesis that thyroid function is impaired and contributes to perturbed hemodynamics in patients after Fontan operation. Cardiac catheterization and blood tests for thyroid function were performed in 37 patients who underwent a Fontan operation. Among them, 12 patients (33%) had subclinical thyroid dysfunction with an elevated thyroid-stimulating hormone level despite normal thyroxine levels. Thyroid

2018 American Journal of Cardiology

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