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Cerebrovascular Accident Risk in Women

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81. ESC/EACTS Guidelines on Myocardial Revascularization

for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease COURAGE Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation CPG ESC Committee for Practice Guidelines CT Computed tomography CT-FFR CT-derived fractional flow reserve CTO Chronic total occlusion CTSN Cardiothoracic Surgical Trial Network CULPRIT-SHOCK Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock CVA Cerebrovascular accident CvLPRIT Complete Versus Lesion-Only Primary PCI (...) 14.2 Atrial arrhythmias 128 14.2.1 Atrial fibrillation complicating percutaneous coronary intervention 128 14.2.2 Atrial fibrillation complicating coronary artery bypass grafting 128 14.2.3 Postoperative atrial fibrillation and stroke risk 128 14.3 Gaps in the evidence 129 15 Procedural aspects of coronary artery bypass grafting 129 15.1 Surgical techniques 129 15.1.1 Completeness of revascularization 129 15.1.2 Conduit selection 130 15.1.3 Mammary artery harvesting 130 15.1.4 Radial artery

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2018 European Society of Cardiology

82. 2018 Update on Diagnosis, Treatment, Chemoprophylaxis, and Institutional Outbreak Management of Seasonal Influenza

of illness duration prior to hospitalization (A-II) . Outpatients of any age with severe or progressive illness, regardless of illness duration (A-III) . Outpatients who are at high risk of complications from influenza, including those with chronic medical conditions and immunocompromised patients (A-II) . Children younger than 2 years and adults ≥65 years (A-III) . Pregnant women and those within 2 weeks postpartum (A-III) . Clinicians can consider antiviral treatment for adults and children who (...) sequelae, but some persons are considered to be at increased risk for severe and fatal influenza, including children aged <5 years (but especially <2 years), adults aged ≥65 years, pregnant and postpartum women, people with certain chronic medical conditions including pulmonary, cardiac, and metabolic disease, people with immunosuppression, people with extreme obesity, residents of nursing homes, and American Indians and Alaska Natives [2–8] (Table 4). Elderly persons have the highest mortality rates

2019 Infectious Diseases Society of America

83. AACE/ACE Comprehensive Type 2 Diabetes Management Algorithm

status. Other considerations include antihyperglycemic efficacy; mechanism of action; risk of inducing hypoglycemia; risk of weight gain; other adverse effects; tolerability; ease of use; likely adherence; cost; and safety or risk reduction in heart, kidney, or liver disease. The choice of therapy depends on the individual patient's cardiac, cerebrovascular, and renal status. Combination therapy is usually required and should involve agents with complementary mechanisms of action. Comorbidities must (...) Diabetes Research & Care. Address correspondence to American Association of Clinical Endocrinologists, 245 Riverside Avenue, Suite 200, Jacksonville, FL 32202. E-mail: . Abbreviations: A1C = hemoglobin A1C; AACE = American Association of Clinical Endocrinologists; ACCORD = Action to Control Cardiovascular Risk in Diabetes; ACCORD BP = Action to Control Cardiovascular Risk in Diabetes Blood Pressure; ACE = American College of Endocrinology; ACEI = angiotensin-converting enzyme inhibitor; AGI = alpha

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2019 American Association of Clinical Endocrinologists

84. Male Sexual Dysfunction

in the general population. Urology, 2001. 57: 970. 6. Kulmala, R.V., et al. Priapism, its incidence and seasonal distribution in Finland. Scand J Urol Nephrol, 1995. 29: 93. 7. Furtado, P.S., et al. The prevalence of priapism in children and adolescents with sickle cell disease in Brazil. Int J Hematol, 2012. 95: 648. 8. Adeyoju, A.B., et al. Priapism in sickle-cell disease; incidence, risk factors and complications - an international multicentre study. BJU Int, 2002. 90: 898. 9. Emond, A.M., et al. Priapism (...) of general male health status? The case for the International Index of Erectile Function-Erectile Function domain. J Sex Med, 2012. 9: 2708. 31. Dong, J.Y., et al. Erectile dysfunction and risk of cardiovascular disease: meta-analysis of prospective cohort studies. J Am Coll Cardiol, 2011. 58: 1378. 32. Gandaglia, G., et al. A systematic review of the association between erectile dysfunction and cardiovascular disease. Eur Urol, 2014. 65: 968. 33. Gupta, B.P., et al. The effect of lifestyle modification

2019 European Association of Urology

85. Neuro-urology

of lower urinary tract symptoms (LUTS) in stroke patients: a cross-sectional, clinical survey. Neurourol Urodyn, 2008. 27: 763. 13. Marinkovic, S.P., et al. Voiding and sexual dysfunction after cerebrovascular accidents. J Urol, 2001. 165: 359. 14. Rotar, M., et al. Stroke patients who regain urinary continence in the first week after acute first-ever stroke have better prognosis than patients with persistent lower urinary tract dysfunction. Neurourol Urodyn, 2011. 30: 1315. 15. Lobo, A., et al (...) for primary care physicians. Med Clin North Am, 2011. 95: 111. 48. Çetinel, B., et al. Risk factors predicting upper urinary tract deterioration in patients with spinal cord injury: A retrospective study. Neurourol Urodyn, 2017. 36: 653. 49. Elmelund, M., et al. Renal deterioration after spinal cord injury is associated with length of detrusor contractions during cystometry-A study with a median of 41 years follow-up. Neurourol Urodyn., 2016. 50. Ineichen, B.V., et al. High EDSS can predict risk for upper

2019 European Association of Urology

86. Treatment of Diabetes in Older Adults

University of Colorado Denver Anschutz Medical Campus, Aurora, Colorado Search for other works by this author on: Jeffrey B Halter University of Michigan, Ann Arbor, Michigan National University of Singapore, Singapore, Singapore Search for other works by this author on: Irl B Hirsch University of Washington Medical Center–Roosevelt, Seattle, Washington Search for other works by this author on: Marie E McDonnell Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts Search for other (...) remark: This recommendation is most applicable to high-risk patients with any of the following characteristics: overweight or obese, first-degree relative with diabetes, high-risk race/ethnicity ( e.g. , African American, Latino, Native American, Asian American, Pacific Islander), history of cardiovascular disease, hypertension (≥140/90 mm Hg or on therapy for hypertension), high-density lipoprotein cholesterol level <35 mg/dL (0.90 mmol/L) and/or a triglyceride level >250 mg/dL (2.82 mmol/L), sleep

2019 The Endocrine Society

87. Management of Stroke Rehabilitation

associated with stroke risk more commonly seen in the older population (e.g., uncontrolled hypertension, atrial dysrhythmias, cerebrovascular disease). Research is ongoing to try to identify patients with the highest risk of cryptogenic stroke recurrence; however, risk factors are difficult to quantify given the lack of a clearly identifiable primary etiology. This is of particular importance in the active duty military population, in which both residual disability and the likelihood of recurrence can (...) in the form of medical, surgical, or rehabilitation interventions is essential to help reduce disability severity, decrease the risk of further complications, and lessen potentially life-long deficits.[5,6] Unfortunately, in approximately 30% of ischemic stroke cases, the cause of the stroke remains unknown.[7] Ischemic strokes with no obvious cause are labelled as “cryptogenic” strokes and are more common in younger patients than in the elderly.[8] This is largely due to the lack of comorbidities

2019 VA/DoD Clinical Practice Guidelines

88. Urolithiasis

undergoing urologic surgery: is it still no man’s land? Eur Urol, 2013. 64: 101. 271. Eberli, D., et al. Urological surgery and antiplatelet drugs after cardiac and cerebrovascular accidents. J Urol, 2010. 183: 2128. 272. Razvi, H., et al. Risk factors for perinephric hematoma formation after shockwave lithotripsy: a matched case-control analysis. J Endourol, 2012. 26: 1478. 273. Rassweiler, J.J., et al. Treatment of renal stones by extracorporeal shockwave lithotripsy: an update. Eur Urol, 2001. 39: 187 (...) Int, 2003. 63: 1817. 10. Hesse, A., et al. Study on the prevalence and incidence of urolithiasis in Germany comparing the years 1979 vs. 2000. Eur Urol, 2003. 44: 709. 11. Sanchez-Martin, F.M., et al. [Incidence and prevalence of published studies about urolithiasis in Spain. A review]. Actas Urol Esp, 2007. 31: 511. 12. Zhe, M., et al. Nephrolithiasis as a risk factor of chronic kidney disease: a meta-analysis of cohort studies with 4,770,691 participants. Urolithiasis, 2017. 45: 441. 13. Yasui

2019 European Association of Urology

89. Left atrial appendage occlusion (LAAO) in patients with atrial fibrillation who have contraindications to oral anticoagulation

3.6 (1.5) CtE (2018) 15 Mixed 525 74.5 (8.0) 68.7 4.3 (1.5) 61.1% bleeding or embolic event on anticoagulation; 23.4% history of bleeding; 7.1% high bleeding risk; 6.9% intolerance Huang (2017) 22 LAmbre™ 153 69.3 (9.4) 56.2 4.0 (1.7) All contraindicated: history of cerebrovascular or gastrointestinal bleeding, poor compliance, warfarin allergy SHTG Advice | 13 Huang (2017) 26 WATCHMAN™ 106 64.2 (8.6) 59.4 3.6 (1.6) 77.3% failed to tolerate warfarin; 18.9% history of haemorrhage or embolism (...) fibrillation deemed to be at high risk of ischaemic stroke, who have absolute contraindications to oral anticoagulation with warfarin and direct oral anticoagulants. Prior to undergoing the LAAO procedure, an individual patient risk assessment must be carried out by a multidisciplinary team. The potential future benefits of LAAO, the risks associated with the procedure, and the need for long- term antiplatelet therapy, should be discussed with each patient prior to making a treatment decision. LAAO

2019 SHTG Advice Statements

90. Antipsychotics for the Prevention and Treatment of Delirium

-searched the reference lists of included articles, relevant reviews, and delirium-specific bibliographic repositories. Review methods. We included randomized controlled trials (RCTs) of antipsychotics that evaluated benefits or harms, and also observational studies that reported harms. Two reviewers independently screened search results for eligibility, serially abstracted data, and independently assessed the risk of bias of the studies and graded the strength of evidence (SOE) for prespecified (...) populations, there was no difference in delirium incidence for haloperidol versus placebo (relative risk [RR], 0.94; 95% confidence interval [CI], 0.77 to 1.16). Second-generation antipsychotics, compared with placebo, may decrease delirium incidence in postoperative patients at risk for delirium (RR, 0.36; 95% CI, 0.26 to 0.50). Antipsychotics (both haloperidol and second-generation), compared to placebo, demonstrated no differences for length of stay in hospital (low SOE for second-generation

2019 Effective Health Care Program (AHRQ)

91. Adalimumab (Hefiya) - Juvenile Rheumatoid Arthritis, Hidradenitis Suppurativa, Psoriasis, Ankylosing Spondylitis, Uveitis

Disease or condition 12 2.2 Quality aspects 14 2.2.1 Introduction 14 2.2.2 Active Substance 14 2.2.3 Finished Medicinal Product 18 2.2.4 Discussion on chemical, pharmaceutical and biological aspects 28 2.2.5 Conclusions on the chemical, pharmaceutical and biological aspects 28 2.2.6 Recommendation(s) for future quality development 28 2.3 Non-clinical aspects 28 2.3.1 Pharmacology 29 2.3.2 Pharmacokinetics 30 2.3.3 Toxicology 31 2.3.4 Ecotoxicity/environmental risk assessment 32 2.3.5 Discussion on non (...) 2.7 Risk Management Plan 104 2.8 Pharmacovigilance 119 2.9 Product information 119 2.9.1 User consultation 119 2.9.2 Additional monitoring 119 3 Biosimilarity assessment 120 3.1 Comparability exercise and indications claimed 120 3.2 Results supporting biosimilarity 121 3.3 Uncertainties and limitations about biosimilarity 123 3.4 Discussion on biosimilarity 124 3.5 Extrapolation of safety and efficacy 125 Assessment report EMA/CHMP/520007/2018 Page 3/128 3.6 Conclusions on biosimilarity

2018 European Medicines Agency - EPARs

92. Adalimumab (Halimatoz) - Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Hidradenitis Suppurativa, Psoriasis, Ankylosing Spondylitis, Uveitis

/environmental risk assessment 32 2.3.5 Discussion on non-clinical aspects 33 2.3.6 Conclusion on the non-clinical aspects 33 2.4 Clinical aspects 34 2.4.1 Introduction 34 2.4.2 Pharmacokinetics 36 2.4.3 Pharmacodynamics 51 2.4.4 Discussion on clinical pharmacology 51 2.4.5 Conclusions on clinical pharmacology 53 2.5 Clinical efficacy 54 2.5.1 Main study GP17-301 54 2.5.2 Discussion on clinical efficacy 80 2.5.3 Conclusions on the clinical efficacy 83 2.6 Clinical safety 83 2.6.1 Discussion on clinical (...) safety 102 2.6.2 Conclusions on the clinical safety 104 2.7 Risk Management Plan 104 2.8 Pharmacovigilance 119 2.9 Product information 119 2.9.1 User consultation 119 2.9.2 Additional monitoring 119 3 Biosimilarity assessment 120 3.1 Comparability exercise and indications claimed 120 3.2 Results supporting biosimilarity 121 3.3 Uncertainties and limitations about biosimilarity 123 3.4 Discussion on biosimilarity 124 3.5 Extrapolation of safety and efficacy 125 Assessment report EMA/CHMP/519681/2018

2018 European Medicines Agency - EPARs

93. Caplacizumab (Cablivi) - thrombotic thrombocytopenic purpura (aTTP)

. Toxicology 25 2.3.4. Ecotoxicity/environmental risk assessment 31 2.3.5. Discussion on non-clinical aspects 31 2.3.6. Conclusion on the non-clinical aspects 33 2.4. Clinical aspects 33 2.4.1. Introduction 33 2.4.2. Pharmacokinetics 33 2.4.3. Pharmacodynamics 36 2.4.4. Discussion on clinical pharmacology 38 2.4.5. Conclusions on clinical pharmacology 39 2.5. Clinical efficacy 39 2.5.1. Dose response and main studies 39 2.5.2. Discussion on clinical efficacy 72 2.5.3. Conclusions on the clinical efficacy (...) 73 2.6. Clinical safety 73 2.6.1. Discussion on clinical safety 78 2.6.2. Conclusions on the clinical safety 80 2.7. Risk Management Plan 80 2.8. Pharmacovigilance 82 2.9. New Active Substance 83 2.10. Product information 83 2.10.1. User consultation 83 2.10.2. Additional monitoring 83 Assessment Report Cablivi - EMA/490172/2018 Page 3/88 3. Benefit-Risk Balance 83 3.1. Therapeutic Context 83 3.1.1. Disease or condition 83 3.1.2. Available therapies and unmet medical need 83 3.1.3. Main clinical

2018 European Medicines Agency - EPARs

94. Ertugliflozin l-pyroglutamic acid / metformin hydrochloride (Segluromet) - Diabetes Mellitus, Type 2

. Non-clinical aspects 20 2.3.1. Introduction 20 2.3.2. Pharmacology 20 2.3.3. Pharmacokinetics 22 2.3.4. Toxicology 24 2.3.5. Ecotoxicity/environmental risk assessment 33 2.3.6. Discussion on non-clinical aspects 37 2.3.7. Conclusion on the non-clinical aspects 41 2.4. Clinical aspects 41 2.4.1. Introduction 41 2.4.2. Pharmacokinetics 45 2.4.3. Pharmacodynamics 50 2.4.4. Discussion on clinical pharmacology 53 2.4.5. Conclusions on clinical pharmacology 55 2.5. Clinical efficacy 55 2.5.1. Dose (...) response studies 55 2.5.2. Main studies 56 2.5.3. Discussion on clinical efficacy 101 2.5.4. Conclusions on the clinical efficacy 108 2.6. Clinical safety 108 2.6.1. Discussion on clinical safety 137 2.6.2. Conclusions on the clinical safety 143 2.7. Risk Management Plan 144 2.8. Pharmacovigilance 148 Assessment report EMA/86928/2018 Page 3/159 2.9. New Active Substance 149 2.10. Product information 149 2.10.1. User consultation 149 2.10.2. Additional monitoring 149 3. Benefit-Risk Balance 149 3.1

2018 European Medicines Agency - EPARs

95. Diagnosis and Treatment of Peripheral Arterial Diseases

. See . 3.3 Prognosis Atherosclerosis is often generalized. Patients affected at one site are overall at risk for fatal and non-fatal CV events. Beyond the risk of cerebrovascular events, patients with CAD are also at risk for myocardial infarction (MI) and cardiac death. In a systematic review of 17 studies including 11 391 patients with >50% asymptomatic carotid stenosis, 63% of late deaths were related to cardiac events, with a mean cardiac-related mortality rate of 2.9%/year. Many studies have (...) therapy as well as non-pharmacological measures such as smoking cessation, healthy diet, weight loss and regular physical exercise. 4.1 Diagnostic approach 4.1.1 Clinical history Personal and family clinical history should always be assessed. Family history includes CAD, cerebrovascular disease, aortic aneurysm as well as LEAD. Clinical history includes the evaluation of CV risk factors and comorbidities as well as a review of the symptoms related to different vascular territories (see ). Lifestyle

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2017 European Society of Cardiology

96. 2017 Focused update on Dual Antiplatelet Therapy (DAPT)

, MI at presentation, prior MI or PCI, diabetes, stent diameter <3 mm, smoking, and paclitaxel-eluting stent] resulting in a score ranging from −2 to + 10. Within the DAPT trial, a high-risk score (i.e. a score ≥2) selected patients who showed a reduction in MI/stent thrombosis and cardiovascular or cerebrovascular events risk [number needed to treat (NNT) for benefit for ischaemic event reduction = 34] after a prolonged, 30-month DAPT, with only a modest increase in bleeding risk (NNT for harm (...) for the recommendations see . Table of Contents Abbreviations and acronyms 215 1. Preamble 216 2. Introduction 218 2.1 Short- and long-term outcomes after percutaneous coronary intervention 219 2.2 Risk of stent thrombosis in relation to stent type 219 2.3 Short- and long-term outcomes after coronary artery bypass surgery 219 2.4 Short- and long-term outcomes after medically managed acute coronary syndrome 219 3. Efficacy and safety of dual antiplatelet therapy and risk stratification tools 219 3.1 Dual antiplatelet

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2017 European Society of Cardiology

97. Identifying and Assessing Core Components of Collaborative-care Models for Treating Mental and Physical Health Conditions

. • The relationship between mental and physical health appears to be bi-directional, meaning that individuals experiencing a mental illness are at high risk of developing long-term chronic physical health conditions and conversely, the risk of developing a mental health condition greatly increases for individuals with long-term chronic physical health conditions. • One approach to addressing these concerns has been to develop models of collaborative care that address both mental and physical health conditions (...) of multimorbidity that include both mental health and physical health conditions are of particular concern. Although the clinical pathways are not well understood, the relationship between mental and physical health seems to be bi-directional. This means that individuals experiencing a mental illness are at high risk of developing long-term chronic conditions and, conversely, the risk of developing a mental health condition greatly increases for individuals with long-term chronic physical health conditions.(4

2017 McMaster Health Forum

98. Canadian Contraception Consensus Part 4 of 4 Chapter 9: Combined Hormonal Contraception

thromboembolism (II-2). Potential differences in the risk of venous thromboembolism attributable to different progestin types and estrogen dosing in low-dose COCs do not currently justify preferential prescribing (III). 5. Low-dose combined oral contraceptive pills (containing less than 50 μg of ethinyl estradiol) are not associated with an increased risk of myocardial infarction or cerebrovascular accident in women with no additional risk factors (II-2). 6. Current epidemiological studies suggest (...) ; however, a small increase in contraceptive failure in women with a body mass index greater than 30 cannot be excluded (II-2). 3. Combined oral contraceptive pills are associated with a number of non-contraceptive benefits, including but not limited to decreased menstrual bleeding, decreased acne, fewer endometriosis-related symptoms, and a decreased risk of ovarian and endometrial cancers (II-2). 4. Combined oral contraceptive pills (COCs) are associated with an increased risk of venous

2017 Society of Obstetricians and Gynaecologists of Canada

99. Canadian Contraception Consensus Part 4 of 4 Chapter 9: Combined Hormonal Contraception

oral contraceptive pills (COCs) are associated with an increased risk of venous thromboembolism (II-2). Potential differences in the risk of venous thromboembolism attributable to different progestin types and estrogen dosing in low-dose COCs do not currently justify preferential prescribing (III). 5. Low-dose combined oral contraceptive pills (containing less than 50 μg of ethinyl estradiol) are not associated with an increased risk of myocardial infarction or cerebrovascular accident in women (...) studies do not indicate decreased combined oral contraceptive pill efficacy in obese women; however, a small increase in contraceptive failure in women with a body mass index greater than 30 cannot be excluded (II-2). 3. Combined oral contraceptive pills are associated with a number of non-contraceptive benefits, including but not limited to decreased menstrual bleeding, decreased acne, fewer endometriosis-related symptoms, and a decreased risk of ovarian and endometrial cancers (II-2). 4. Combined

2017 Society of Obstetricians and Gynaecologists of Canada

100. What national and subnational interventions and policies based on Mediterranean and Nordic diets are recommended or implemented in the WHO European Region, and is there evidence of effectiveness in reducing noncommunicable diseases?

) and abdominal adiposity (waist circumference: >102 cm for men, >88 cm for women), which are key risk factors for CVD, diabetes and some cancers. 2.2.2. Swedish dietary guidelines The Swedish national dietary guidelines are based on the 2012 NNR, with consideration of Swedish food culture and the ability of local consumers to adhere to recommendations (62). The guidelines promote three key messages: (i) eat more berries, fish, fruit, nuts, seeds, shellfish and vegetables; (ii) switch to whole grains, healthy (...) ischaemic heart disease) (62). The study found that adherence to the high-quality diet may reduce the risk of CVD events (by 32% in men and 27% in women).WHAT NATIONAL AND SUBNATIONAL INTERVENTIONS AND POLICIES BASED ON MEDITERRANEAN AND NORDIC DIETS ARE RECOMMENDED OR IMPLEMENTED IN THE WHO EUROPEAN REGION, AND IS THERE EVIDENCE OF EFFECTIVENESS IN REDUCING NONCOMMUNICABLE DISEASES? HEALTH EVIDENCE NETWORK SYNTHESIS REPORT 26 Study Method Findings Cross-sectional study; 6717 aged 35–69 years (77% women

2018 WHO Health Evidence Network

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