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Cerebrovascular Accident Risk in Women

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181. Menopausal Symptoms: Comparative Effectiveness of Therapies

alone 119 Table 70. Summary of the impact of gap time on breast cancer risk in included studies. 120 Table 71. Gallbladder disease incidence among women treated with estrogen/progestin 121 Table 72. Gallbladder disease incidence among women treated with estrogen alone 121 Table 73. Overall colorectal cancer incidence among women treated with estrogen/progestin . 122 Table 74. Overall colorectal cancer incidence among women treated with estrogen alone 122 Table 75. Coronary heart disease, stroke (...) ) are as follows: SMD, -0.2 (OR, 0.7); -0.3 (0.6); -0.4 (0.5); -0.5 (0.4); 0.3 (2); 0.6 (3); and 0.75 (4). Although the ORs exceed relative risks when placebo group event rates exceed 10 percent, they provide a rough guide to the relative effect. For example, the placebo response rate of women with vasomotor symptoms can vary between approximately 20 and 40 percent. For analytical purposes, estrogen doses were classified as low/ultralow, standard, and high. For oral treatment, which was the most common route

2015 Effective Health Care Program (AHRQ)

182. Adalimumab (Cyltezo) - Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Crohn Disease, Hidradenitis Suppurativa, Psoriasis, Ankylosing Spondylitis, Uveitis

23 2.2.6. Recommendations for future quality development 23 2.3. Non-clinical aspects 23 2.3.1. Pharmacology 23 2.3.2. Pharmacokinetics 24 2.3.3. Toxicology 24 2.3.4. Ecotoxicity/environmental risk assessment 25 2.3.5. Discussion on non-clinical aspects 26 2.3.6. Conclusion on the non-clinical aspects 26 2.4. Clinical aspects 27 2.4.1. Introduction 27 2.4.2. Pharmacokinetics 28 2.4.3. Pharmacodynamics 44 2.4.4. Discussion on clinical pharmacology 44 2.4.5. Conclusions on clinical pharmacology 47 (...) 2.5. Clinical efficacy 47 2.5.1. Discussion on clinical efficacy 69 2.5.2. Conclusions on the clinical efficacy 72 2.6. Clinical safety 72 2.6.1. Discussion on clinical safety 96 2.6.2. Conclusions on the clinical safety 98 2.7. Risk Management Plan 98 2.8. Pharmacovigilance 105 2.9. Product information 106 2.9.1. User consultation 106 2.9.2. Additional monitoring 106 3. Benefit-Risk Balance 106 3.1. Therapeutic Context 106 3.1.1. Disease or condition 106 Medicinal product no longer authorised

2017 European Medicines Agency - EPARs

183. Pembrolizumab (Keytruda) - non-small cell lung cancer (NSCLC)

) 99 (3.5) Dehydration 1 (1.6) 3 (3.6) 24 (0.9) Musculoskeletal and connective tissue disorders 3 (4.8) 1 (1.2) 75 (2.7) Back pain 1 (1.6) 0 (0.0) 15 (0.5) Flank pain 1 (1.6) 0 (0.0) 2 (0.1) Musculoskeletal pain 1 (1.6) 0 (0.0) 8 (0.3) Neck pain 0 (0.0) 1 (1.2) 3 (0.1) Neoplasms benign, malignant and unspecified (incl cysts and polyps) 0 (0.0) 1 (1.2) 96 (3.4) Malignant pleural effusion 0 (0.0) 1 (1.2) 4 (0.1) Nervous system disorders 2 (3.2) 3 (3.6) 106 (3.8) Cerebrovascular accident 1 (1.6) 0 (...) aspects 10 2.2.1. Ecotoxicity/environmental risk assessment 10 2.3. Clinical aspects 10 2.3.1. Introduction 10 2.3.2. Pharmacokinetics 10 2.3.3. Pharmacodynamics 11 2.3.4. PK/PD modelling 11 2.3.5. Discussion and Conclusions on clinical pharmacology 15 2.4. Clinical efficacy 16 2.4.1. Dose response study(ies) 17 2.4.2. Main study(ies) 17 2.4.3. Discussion on clinical efficacy 47 2.4.4. Conclusions on the clinical efficacy 49 2.5. Clinical safety 49 2.5.1. Discussion on clinical safety 76 2.5.2

2017 European Medicines Agency - EPARs

184. Cardiac Arrest in Pregnancy

fetal viability should be made in collaboration with the obstetrician, neonatologist, and family. The decision depends on the gestational age and, to a significant degree, the neonatal facilities available. This information should be clearly documented. Severity of Illness and Early Warning Scores The British Center for Maternal and Child Enquiries report of 2011 (2006–2008 triennium) has stated that timely recognition of pregnant women at risk of potentially life-threatening conditions plays (...) warning score chart based on the score developed by Carle et al. A score ≥6 should trigger a call for support from the intensive care unit or rapid response team and initiation of continuous monitoring of vital signs. BP indicates blood pressure; Fio2, fraction of inspired oxygen; GCS, Glasgow Coma Scale score; and Sat, saturation. Recommendations Pregnant women who become ill should be risk stratified by the use of a validated obstetric early warning score ( Class I; Level of Evidence C ). Hospital

2015 American Heart Association

185. Scientific rationale for the inclusion and exclusion criteria for intravenous alteplase in acute ischemic stroke

and evaluate the science behind individual eligibility criteria (indication/inclusion and contraindications/exclusion criteria) for intravenous recombinant tissue-type plasminogen activator (alteplase) treatment in acute ischemic stroke. This will allow us to better inform stroke providers of quantitative and qualitative risks associated with alteplase administration under selected commonly and uncommonly encountered clinical circumstances and to identify future research priorities concerning (...) impact of each exclusion criterion varies not only with the evidence base behind it but also with the frequency of the exclusion within the stroke population, the probability of coexistence of multiple exclusion factors in a single patient, and the variation in practice among treating clinicians. Introduction For our exclusion criteria, we elected to focus only on American Heart Association (AHA)/American Stroke Association (ASA) guidelines and exclusions, warnings, risks, and contraindications based

2015 American Academy of Neurology

186. Brodalumab (Kyntheum) - plaque psoriasis

. Ecotoxicity/environmental risk assessment 24 2.3.6. Discussion on non-clinical aspects 24 2.3.7. Conclusion on the non-clinical aspects 25 2.4. Clinical aspects 25 2.4.1. Introduction 25 2.4.2. Pharmacokinetics 29 2.4.3. Pharmacodynamics 34 2.4.4. Discussion on clinical pharmacology 36 2.4.5. Conclusions on clinical pharmacology 37 2.5. Clinical efficacy 37 2.5.1. Dose response study 37 2.5.2. Main studies 40 2.5.3. Discussion on clinical efficacy 93 2.5.4. Conclusions on the clinical efficacy 96 2.6 (...) . Clinical safety 96 2.6.1. Discussion on clinical safety 113 2.6.2. Conclusions on the clinical safety 121 2.7. Risk Management Plan 121 2.8. Pharmacovigilance 125 2.9. New Active Substance 125 2.10. Product information 125 Assessment report EMA/381484/2017 Page 3/135 2.10.1. User consultation 125 2.10.2. Additional monitoring 126 3. Benefit-Risk Balance 126 3.1. Therapeutic Context 126 3.1.1. Disease or condition 126 3.1.2. Available therapies and unmet medical need 126 3.1.3. Main clinical studies 126

2017 European Medicines Agency - EPARs

187. Adalimumab (Imraldi) - psoriasis, psoriatic arthritis, axial spondyloarthritis, Crohn?s disease, ulcerative colitis

risk assessment 24 2.3.5. Discussion on non-clinical aspects 25 2.3.6. Conclusion on the non-clinical aspects 25 2.4. Clinical aspects 25 2.4.1. Introduction 25 2.4.2. Pharmacokinetics 26 2.4.3. Pharmacodynamics 32 2.4.4. Discussion on clinical pharmacology 33 2.4.5. Conclusions on clinical pharmacology 36 2.5. Clinical efficacy 37 2.5.1. Dose response study(ies) 37 2.5.2. Main study 37 2.5.3. Discussion on clinical efficacy 63 2.5.4. Conclusions on the clinical efficacy 67 2.6. Clinical safety 68 (...) 2.6.1. Discussion on clinical safety 90 2.6.2. Conclusions on the clinical safety 93 2.7. Risk Management Plan 93 2.8. Pharmacovigilance 102 2.9. Product information 102 2.9.1. User consultation 102 2.9.2. Additional monitoring 102 3. Benefit-Risk Balance 102 3.1. Therapeutic Context 102 Assessment report EMA/CHMP/559383/2017 Page 3/111 3.1.1. Disease or condition 102 3.1.3. Main clinical studies 103 3.2. Favourable effects 103 3.3. Uncertainties and limitations about favourable effects 104 3.4

2017 European Medicines Agency - EPARs

188. Adalimumab (Solymbic)

Product 17 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 22 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 24 2.2.6. Recommendations for future quality development 24 2.3. Non-clinical aspects 24 2.3.1. Introduction 24 2.3.2. Pharmacology 25 2.3.3. Pharmacokinetics 33 2.3.4. Toxicology 34 2.3.5. Ecotoxicity/environmental risk assessment 35 2.3.6. Discussion on non-clinical aspects 35 2.3.7. Conclusion on the non-clinical aspects 36 2.4. Clinical (...) aspects 36 2.4.1. Introduction 36 2.4.2. Pharmacokinetics 37 2.4.3. Pharmacodynamics 45 2.4.4. Discussion on clinical pharmacology 46 2.4.5. Conclusions on clinical pharmacology 47 2.5. Clinical efficacy 47 2.5.1. Dose response study(ies) 47 2.5.2. Main study(ies) 48 2.5.3. Discussion on clinical efficacy 85 2.5.4. Conclusions on the clinical efficacy 88 2.6. Clinical safety 89 Immunological events 97 2.6.1. Discussion on clinical safety 101 2.6.2. Conclusions on the clinical safety 103 2.7. Risk

2017 European Medicines Agency - EPARs

189. Adalimumab (Amgevita)

13 General information 13 Manufacture, characterisation and process controls 13 2.2.3. Finished Medicinal Product 16 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 21 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 23 2.2.6. Recommendations for future quality development 23 2.3. Non-clinical aspects 23 2.3.1. Introduction 23 2.3.2. Pharmacology 24 2.3.3. Pharmacokinetics 31 2.3.4. Toxicology 32 2.3.5. Ecotoxicity/environmental risk assessment 33 (...) ) 51 Assessment report Amgevita EMA/106922/2017 Page 3/120 Statistical methods 51 Participant flow 52 Recruitment 53 Conduct of the study 53 Baseline data 54 Numbers analysed 57 Outcomes and estimation 57 2.5.3. Discussion on clinical efficacy 85 2.5.4. Conclusions on the clinical efficacy 89 2.6. Clinical safety 89 Immunological events 97 2.6.1. Discussion on clinical safety 101 2.6.2. Conclusions on the clinical safety 103 2.7. Risk Management Plan 103 2.8. Pharmacovigilance 114 2.9. Product

2017 European Medicines Agency - EPARs

190. Venetoclax (Venclyxto) - Chronic, B-Cell Lymphocytic Leukemia

2.2.3. Finished Medicinal Product 14 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 17 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 18 2.2.6. Recommendations for future quality development 18 2.3. Non-clinical aspects 18 2.3.1. Introduction 18 2.3.2. Pharmacology 19 2.3.3. Pharmacokinetics 23 2.3.4. Toxicology 25 2.3.5. Ecotoxicity/environmental risk assessment 31 2.3.6. Discussion on non-clinical aspects 33 2.3.7. Conclusion on the non-clinical (...) aspects 35 2.4. Clinical aspects 36 2.4.1. Introduction 36 2.4.2. Pharmacokinetics 37 2.4.3. Pharmacodynamics 41 2.4.4. Discussion on clinical pharmacology 46 2.4.5. Conclusions on clinical pharmacology 49 2.5. Clinical efficacy 49 2.5.1. Dose response study(ies) 49 2.5.2. Main study(ies) 59 2.5.3. Discussion on clinical efficacy 80 2.5.4. Conclusions on the clinical efficacy 82 2.6. Clinical safety 82 2.6.1. Discussion on clinical safety 109 2.6.2. Conclusions on the clinical safety 114 2.7. Risk

2017 European Medicines Agency - EPARs

191. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer

regarding the initial management of thyroid cancer include those relating to screening for thyroid cancer, staging and risk assessment, surgical management, radioiodine remnant ablation and therapy, and thyrotropin suppression therapy using levothyroxine. Recommendations related to long-term management 1 University of Colorado School of Medicine, Aurora, Colorado. 2 Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts. 3 The Mayo Clinic, Rochester, Minnesota. 4 Boston Medical (...) : We have developed evidence-based recommendations to inform clinical decision-making in the management of thyroid nodules and differentiated thyroid cancer. They represent, in our opinion, contemporary optimal care for patients with these disorders. INTRODUCTION T hyroid nodules are a common clinical problem. Epidemiologic studies have shown the prevalence of palpable thyroid nodules to be approximately 5% in women and 1% in men living in iodine-suf?cient parts of the world (1,2). In contrast

2015 Pediatric Endocrine Society

192. HTA of Chronic Disease Self-Management

and healthcare utilisation. The burden of chronic disease is increasing in part due to an aging population, with estimates that the number of adults with chronic diseases will increase to 40% by 2020. Many of these chronic conditions can be prevented or delayed by reducing key risk factors such as smoking, obesity, excessive alcohol consumption, physical inactivity, hypertension and high cholesterol. Self-management support interventions are any interventions that help patients to manage portions (...) a combination of individual and group sessions, may be at least cost-neutral in patients with mild to moderate disease. o nurse-led telephone review for patients with high-risk asthma is a relatively low cost intervention that may reduce costs by reducing healthcare utilisation, although evidence of effect in the included studies was mixed. Health technology assessment of chronic disease self-management support interventions Health Information and Quality Authority xii Based on these findings HIQA’s advice

2015 Health Information and Quality Authority

193. Urolithiasis

Urolithiasis Guidelines. 1.4.2 Summary of changes Key changes for the 2015 publication: • The literatur e for the complete document has been assessed and updated, whenever r elevant and 46 new references have been included. • A new intr oductory section was added to Section 3.1(section Pr evalence, aetiology , risk of recurrence), as well as a table. Additional data has been added to Table 1.2. • Diagnostic imaging during pr egnancy (section 3.3.3.1). Recommendation LE GR In pregnant women, ultrasound (...) 2.3 Peer review 8 2.4 Future plans 8 3. GUIDELINES 8 3.1 Prevalence, aetiology, risk of recurrence 8 3.1.1 Introduction 8 3.1.2 Stone composition 9 3.1.3 Risk groups for stone formation 9 3.2 Classification of stones 10 3.2.1 Stone size 10 3.2.2 Stone location 10 3.2.3 X-ray characteristics 10 3.3 Diagnostic evaluation 11 3.3.1 Diagnostic imaging 11 3.3.1.1 Evaluation of patients with acute flank pain 11 3.3.1.2 Radiological evaluation of patients for whom further treatment of renal stones

2015 European Association of Urology

194. Neuro-urology

lesions and diseases Neurological Disease Frequency in General Population Type and Frequency of Neuro- Urological Symptoms Cerebrovascular accident (Strokes) 450 cases/100,000/yr (Europe) [21] (10% of cardiovascular mortality) Nocturia - OAB - UUI - DO (other patterns less frequent) [22]. 57-83% of neuro-urological symptoms at 1 month post stroke, 80% of spontaneous recovery at 6 months [23]. Persistence of UI correlates with poor prognosis [24]. Dementias: Alzheimer’s disease (80%), Vascular (10 (...) with neuro-urological symptoms, and establish if they have a low or high-risk of subsequent complications. According to current knowledge, elevated storage pressure in the bladder, either alone or combined with vesicoureteric reflux (VUR), is the most important risk factor for renal damage [7]. Sustained elevated storage pressure in the bladder is mainly due to a combination of increased detrusor activity during the storage phase (detrusor overactivity [DO] or low compliance), combined with detrusor

2015 European Association of Urology

195. Clinical practice guideline on Systemic Lupus Erythematosus

and contraception 50. Are assisted reproduction procedures safe and efficient in systemic lupus erythe- matosus? Is ovarian stimulation safe in women with systemic lupus erythemato- sus? 51. What contraception methods are safe in women with systemic lupus erythemato- sus? COMORBIDITY Cardiovascular risk 52. Have people with systemic lupus erythematosus got a greater cardiovascular risk? Is this risk similar in different ethnic groups? Should the cardiovascular risk be evaluated in people with systemic lupus (...) antibodies should be known in order to plan the monitoring of specific complications (heart block, placental insufficiency, preeclampsia). v We suggest postponing pregnancy after a lupus flare until at least six months after remission, especially if the flare has affected vital organs. B We recommend advising against pregnancy in women with SLE with pulmonary hypertension or with severe organ damage (kidney, heart or lung) due to severe risk for the lives of mother and foetus. Monitoring pregnancy C We

2015 GuiaSalud

196. Management of Hip Fractures in the Elderly

Description: Evidence from two or more “Moderate” strength studies with consistent findings, or evidence from a single “High” quality study for recommending for or against the intervention. 8 SCREENING Limited evidence supports preoperative assessment of serum levels of albumin and creatinine for risk assessment of hip fracture patients. Strength of Recommendation: Limited Description: Evidence from two or more “Low” strength studies with consistent findings or evidence from a single study (...) Intertrochanteric Fractures 6 VTE Prophylaxis 6 Transfusion Threshold 6 Occupational and Physical Therapy 7 Intensive Physical Therapy 7 Nutrition 7 Interdisciplinary Care Program 7 Postoperative MultiModal Analgesia 7 Calcium and Vitamin D 7 Screening 8 Osteoporosis Evaluation and Treatment 8 Table of Contents 9 List of Tables 14 Table of Figures 18 II. Introduction 19 Overview 19 Goals and Rationale 19 Intended Users 19 Patient Population 20 Burden of Disease 20 Etiology 20 Incidence and Prevalence 20 Risk

2014 American Academy of Orthopaedic Surgeons

197. 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes

of cardiovascular disease in women AHA/ACC 2011 Percutaneous coronary intervention ACC/AHA/SCAI 2011 Secondary prevention and risk reduction therapy for patients with coronary and other atherosclerotic vascular disease AHA/ACC 2011 Assessment of cardiovascular risk in asymptomatic adults ACC/AHA 2010 Myocardial revascularization ESC 2010 Unstable angina and non–ST-elevation myocardial infarction NICE 2010 Guidelines for cardiopulmonary resuscitation and emergency cardiovascular care–part 9: postcardiac arrest (...) CAD. Women with suspected ACS are less likely to have obstructive CAD than men. When obstructive CAD is present in women, it tends to be less severe than it is in men. It has been suggested that coronary microvascular disease and endothelial dysfunction play a role in the pathophysiology of NSTE-ACS in patients with nonobstructive CAD. Older adults have increased risks of underlying CAD, , multivessel CAD, and a worse prognosis (Section 7.1). A family history of premature CAD is associated

2014 American Heart Association

198. The Non-Surgical Management of Hip & Knee Osteoarthritis (OA)

Summary According to the Centers for Disease Control and Prevention (CDC), 13.9 percent of adults age 25 years and older and 33.6 percent of adults age 65 years and older are affected by osteoarthritis (OA). Arthritis appears to be a significant burden among Veterans of the United States (US) Armed Forces. [1] Research suggests that military service-related overuse and injuries may be a contributing factor for the increased risk of developing OA. One study examined the incidence of OA among active (...) regarding pharmacological therapy should be based on a risk benefit assessment, patient preference, and resource utilization. This process will allow selection of pharmacologic agents with proven benefit to be used in conjunction with non-pharmacologic interventions. Non-pharmacologic therapies (i.e., physical therapy (including aquatic therapy, land-based strength therapy, and manual physical therapy), as well as acupuncture and chiropractic care) should also be considered during the development

2014 VA/DoD Clinical Practice Guidelines

199. Management of Obesity and Overweight

-Glycemic Index Diets 122 Low-Energy Density Diets 122 Mediterranean Diets 123 Meal Replacement 123 Commercial Diet Programs 125 Supplemental Tables 126 Page 4 of 17 8 Appendix I: Physical Activity and Exercise: Intensity and Duration 13 2 Appendix J: Pharmacotherapy 13 3 Orlistat 13 3 Phentermine/Topiramate Extended-Release 13 4 Lorcaserin 13 7 Appendix K: Bariatric Surgery 14 8 Most Common Types of Bariatric Procedures Performed in the US 1 49 Mortality Risk 1 49 Morbidity Risk 15 0 Suicide Risk 15 2 (...) (BMI > 40 kg/m 2 ). Measurement of waist circumference may also be useful to predict risk in overweight and obese patients as it is considered a comorbidity equivalent. In these patients, the presence of obesity-associated chronic health conditions should be identified. Normal weight and overweight patients without obesity-associated chronic health conditions may be offered education, information, and counseling about a healthy lifestyle and maintaining or achieving a healthy weight. Comprehensive

2014 VA/DoD Clinical Practice Guidelines

200. Blunt Chest Trauma ? Suspected Aortic Injury

, and cerebrovascular disease as a cause of death in the United States [1]. Seventy-five percent of deaths from blunt trauma are due entirely or in part to chest injuries. Although reported incidence of aortic injury is approximately 5% [2], only 20% of patients with isolated aortic rupture will survive the initial injury [3]. Of those who survive the initial injury, approximately 30% will die within first 6 hours and 49% within 24 hours [4]. With advanced imaging technology leading to accurate diagnosis, coupled (...) results in death at the accident site and is seen at autopsy. Such rare cases of survival are often due to contained pseudoaneurysm by periaortic tissue. Chronic pseudoaneurysm may arise years after the traumatic event. To add to difficulties of correctly identifying patients with aortic injury, there is great variability in presentation. Patients may present in full cardiovascular collapse or complain of chest pain, midscapular pain, abdominal pain, dyspnea, tachycardia, hemoptysis, and cyanosis

2014 American College of Radiology

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