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Cerebrovascular Accident Risk in Women


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101. Istradefylline (Nourianz) - Parkinson's disease

that would preclude Regulatory Action approval. If efficacy is demonstrated and the benefits of istradefylline outweight the risks, then I recommend that approval include appropriate labeling language addressing any adverse reactions of concerns. Recommended Adults Indication(s)/Population(s) (if applicable) CDER Clinical Review Template Version date: September 6, 2017 for all NDAs and BLAs Reference ID: 4482736 Reference ID: 4484018 1 Clinical Review Natalie Branagan, MD NDA 022075 Nourianz (...) /istradefylline Table of Contents Glossary 9 1. Executive Summary 11 1.1. Product Introduction 11 1.2. Conclusions on the Substantial Evidence of Effectiveness 11 1.3. Benefit-Risk Assessment 11 1.4. Patient Experience Data 15 2. Therapeutic Context 15 2.1. Analysis of Condition 15 2.2. Analysis of Current Treatment Options 15 3. Regulatory Background 15 3.1. U.S. Regulatory Actions and Marketing History 15 3.2. Summary of Presubmission/Submission Regulatory Activity 15 3.3. Foreign Regulatory Actions

2019 FDA - Drug Approval Package

102. Crizanlizumab, Voxelotor, and L-Glutamine for Sickle Cell Disease: Effectiveness and Value

crises, or even to the better known acute and chronic organ effects. Pain crises are, of course, horrible to experience, and their accumulated impact over many years has effects on physical and mental health as well as the potential risks associated with opioid treatment 12 In addition, the range of acute adverse effects of the condition includes almost every organ system, with strokes, ACS, and other life-threatening events a constant threat. These acute effects contribute to long-term risks (...) - Crizanlizumab, Voxelotor, and L-Glutamine for SCD Return to Table of Contents who was not a trained clinician, told us about needing to adjust a patient’s oxygen level while in the hospital out of fear that inadequate attention from the attending providers would prove fatal to the patient. While the management of pediatric patients with SCD has improved dramatically in recent years, the transition from pediatric to adult care presents a major risk for many patients. There is a significant shortage of adult

2020 California Technology Assessment Forum

103. Treatment of Depression in Children and Adolescents

. • However, SSRIs may be associated with a higher risk of serious adverse events and with a higher risk of withdrawal. Paroxetine may be associated with a higher risk of suicidal ideation or behaviors. Evidence to judge the risk of suicidal ideation or behavior for SSRIs other than paroxetine is insufficient for major depressive disorder. However, this report excluded data on inpatients and those without depressive disorders whom the Food and Drug Administration included in finding an increased risk (...) Fristad, Ph.D. The Ohio State University Lima, OH Brian Hepburn, M.D. National Association of State Mental Health Program Directors Alexandria, VA viii Treatment of Depression in Children and Adolescents: A Systematic Review Structured Abstract Background. Depressive disorders can affect long-term mental and physical health functioning among children and adolescents, including increased risk of suicide. Despite access to several nonpharmacological, pharmacological, and combined treatment options

2020 Effective Health Care Program (AHRQ)

104. WHO recommendation on Calcium supplementation before pregnancy for the prevention of pre-eclampsia and its complications

includes health professionals who are responsible for developing national and local health protocols (particularly those related to pre-eclampsia and eclampsia, and nutrition for non-pregnant and pregnant women and adolescent girls), and those directly providing care to pregnant women and their newborns, including midwives, nurses, general medical practitioners, obstetricians, managers of maternal and child health programmes, and relevant staff in ministries of health, in all settings. It aims to help (...) for the prevention of pre-eclampsia and its complications Pre-pregnancy calcium supplementation for the prevention of pre-eclampsia and its complications is recommended only in the context of rigorous research. (Recommendation in research context) Justification • Low-certainty evidence suggests that starting calcium supplementation before and/or early in pregnancy (compared to placebo or no treatment) may make little or no difference to women’s risk of developing hypertensive disorders during pregnancy

2020 World Health Organisation Guidelines

105. Diagnosis and Treatment of Clinical Alzheimer’s-Type Dementia

Electronic Database Search 16 Grey Literature Search 16 Study Selection and Risk of Bias Assessment 16 Data Extraction 19 Data Synthesis 20 Strength of Evidence for Major Comparisons and Outcomes 21 Applicability 23 Peer Review and Public Commentary 23 Chapter 3. Search Results 24 Chapter 4. Key Question 1: Brief Cognitive Tests for Identifying CATD 27 Key Messages 27 Eligible Studies 27 Harms of Cognitive Testing 29 Brief Cognitive Tests Commonly Used as Individual Stand-Alone Tests 29 Baseline Study (...) Questions 1–2 13 Figure 1.2. Analytic framework for Key Questions 3–5 14 Figure 1.3. Analytic framework for Key Questions 6–8 15 Figure 3.1. Literature flow diagram for brief cognitive test identification of CATD 25 Figure 3.2. Literature flow diagram for biomarker identification of AD 25 Figure 3.3. Literature flow diagram for CATD drug treatment 26 Appendixes Appendix A. Search Strategy Appendix B. Risk of Bias Assessment Decision Aid Appendix C. Key Question 1: Accuracy, Comparative Accuracy

2020 Effective Health Care Program (AHRQ)

106. Opioid Treatments for Chronic Pain

of reproductive dysfunction in women prescribed long-term opioids for musculoskeletal pain: A matched cohort study in the Clinical Practice Research Datalink. Eur J Pain. 2018 Oct;22(9):1701- 8. doi: 10.1002/ejp.1256. PMID: 29873872. ES-19 30. Scherrer JF, Salas J, Copeland LA, et al. Prescription opioid duration, xose, and increased risk of depression in 3 large patient populations. Ann Fam Med. 2016 Jan-Feb;14(1):54-62. doi: 10.1370/afm.1885. PMID: 26755784. 31. Scherrer JF, Salas J, Sullivan MD, et al (...) , Pharm.D. Judith Turner, Ph.D. Ian Blazina, M.P.H. Brian Chan, M.D. Ximena Levander, M.D. Marian McDonagh, Pharm.D. Shelley Selph, M.D., M.P.H. Rongwei Fu, Ph.D. Miranda Pappas, M.A. AHRQ Publication No. 20-EHC011 April 2020 ii Key Messages Purpose of Review To assess the effectiveness and harms of opioid therapy for chronic noncancer pain, alternative opioid dosing strategies, and risk mitigation strategies Key Messages • Opioids are associated with small improvements versus placebo in pain

2020 Effective Health Care Program (AHRQ)

107. Clinical Management of Stable Coronary Artery Disease in Patients With Type 2 Diabetes Mellitus: A Scientific Statement From the American Heart Association

, recent acute coronary syndrome). , , As such, while all patients with T2DM and CAD certainly benefit from a blood pressure of <140/90 mm Hg, , , lower blood pressure targets of <130/80 mm Hg are likely appropriate for many patients—particularly those at higher risk of stroke (eg, black and Asian patients, those with cerebrovascular disease) and other microvascular complications such as chronic kidney disease. Choice of Antihypertensive Agents The choice of antihypertensive agents rests on a number (...) , a number of factors have shifted that have forced the cardiology community to reconsider the role of T2DM in CAD. First, in addition to being associated with increased cardiovascular risk, T2DM has the potential to affect a number of treatment choices for CAD. In this document, we discuss the role that T2DM has in the selection of testing for CAD, in medical management (both secondary prevention strategies and treatment of stable angina), and in the selection of revascularization strategy. Second

2020 American Heart Association

108. Obstetric Management of Patients with Spinal Cord Injuries

the ages of 16 and 30 years, and women comprise approximately 20% of injuries . Effective rehabilitation and modern reproductive technology may increase the number of these patients considering pregnancy. Women with SCIs who are considering pregnancy should have a prepregnancy evaluation , and the risks and benefits related to having an SCI while pregnant should be discussed. Chronic medical conditions and the woman’s adaptation to her disability should be addressed. Baseline pulmonary function (...) with SCI. However, autonomic dysreflexia may occur at any facility, and consultation with the appropriate specialists should occur antenatally. Neuraxial anesthesia should be used to reduce the risk of autonomic dysreflexia. Although neuraxial anesthesia can be technically difficult to administer in patients with SCIs, consideration should be given to the planned placement in early labor of an intravenous line and an epidural catheter or spinal catheter . Although pain perception is impaired in women

2020 American College of Obstetricians and Gynecologists

109. Sleep Disorder Management

on night one is likely to recur on night two; OR b. Two nights of study attempted, but the study remains suboptimal after 2 nights 9. Previous 2-night home sleep study did not diagnose OSA in a patient with ongoing clinical suspicion of OSA 10. Patient is oxygen dependent for any reason 11. History of stroke/cerebrovascular accident (CVA) within the preceding 30 days 12. Chronic opiate narcotic use, when discontinuation is not an option. Diagnostic sleep testing for patients using opiate narcotics (...) or more antihypertensive medications). Because of daytime sleepiness, deaths related to motor vehicle accidents are also more common in patients with OSA. Diagnosis of OSA: Although OSA may be suspected based on the symptoms described above, physical exam findings (e.g., obesity, increased neck circumference, retrognathia, etc.), or presence of comorbidities, the diagnosis must be confirmed by a sleep test. During sleep testing, various physiological parameters are monitored while the patient sleeps

2020 AIM Specialty Health

110. Carfilzomib (multiple myeloma) - Addendum to Commission A17-38

disorders 39 (9.9) 24 (6.2) Pulmonary embolism 12 (3.1) 8 (2.1) General disorders and administration site conditions 35 (8.9) 28 (7.2) Pyrexia 14 (3.6) 11 (2.8) Progression of a disease 4 (1.0) 8 (2.1) Gastrointestinal disorders 25 (6.4) 20 (5.1) Diarrhoea 7 (1.8) 9 (2.3) Blood and lymphatic system disorders 21 (5.4) 23 (5.9) Anaemia 8 (2.0) 10 (2.6) Febrile neutropenia 8 (2.0) 4 (1.0) Nervous system disorders 21 (5.4) 27 (6.9) Cerebrovascular accident 4 (1.0) 10 (2.6) Vascular disorders 18 (4.6) 15 (...) , benefit assessment, NCT01080391, NCT01568866 Addendum A18-04 Version 1.1 Carfilzomib – Addendum to Commission A18-04 1 February 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - iii - Table of contents Page List of tables iv List of figures vi List of abbreviations vii 1 Background 1 2 Assessment 3 2.1 Assessment of the data on the ASPIRE study subsequently submitted 3 2.1.1 Risk of bias 3 2.1.2 Results 5 2.1.3 Probability and extent of added benefit 10 Assessment of the added

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

111. Diagnosis and management of epilepsy in adults

or intranasally, or y lorazepam 4 mg IV if midazolam is unavailable, or y diazepam 10 mg if midazolam and lorazepam are unavailable. B Administer a repeat dose of benzodiazepine in hospital after 10 minutes if there is no response. Diagnosis and management of epilepsy in adults| 5 2.4 EPILEPSY AND WOMEN’S HEALTH C T o minimise the risk of contraceptive failure, a woman using any combined hormonal contraception, or a combined oral contraceptive pill, or a progesterone-only pill should be prescribed (...) epilepticus 23 4.11 Patients with recurrent prolonged or serial seizures in the community 26 4.12 Drugs which exacerbate epileptic seizures 27 4.13 Management of patients with epilepsy in the perioperative period 27 4.14 Management of older people with epilepsy 27 4.15 Management of people with learning disability and epilepsy 29 5 Epilepsy and women’s health 31 5.1 Contraception 31 5.2 Preconceptual counselling 35 5.3 Risks of inheriting epilepsy 36 5.4 Pregnancy 38 5.5 Labour and birth 40

2018 SIGN

112. Excess mortality and life expectancy of individuals with type 1 diabetes: a rapid review

Nervous System CVA Cerebrovascular Accident CV Cardiovascular CVD Cardiovascular disease DKA Diabetic Keto-Acidosis eLE estimated LE ESM Electronic Supplementary Material ESRD End Stage Renal Disease eYLL estimated YLL FU Follow-Up (e)GFR (estimated) Glomerular Filtration Rate HbA1c glycated Haemoglobin A1 HR Hazard ratio IHD Ischaemic Heart Disease LDL-c LDL cholesterol LE Life Expectancy M-A Meta-Analysis MA Micro-Albuminuria OBS Opvolgingsbureau voor tarificatie – Bureau de suivi de la tarification (...) . 3.2.3. The Swedish registry-based cohort study by Petrie et al. From June 2002 till November 2007 the LE at age 20 of Swedes with T1D increased by approximately 2 years for men but minimally for women (not significant). 12 These changes have been driven by a decrease in cardiovascular mortality. The strengths of this study are the large representative sample, the relatively long length of follow-up and the measurement of clinical risk factors. Data on age at diagnosis, HbA1c, presence/absence

2019 Belgian Health Care Knowledge Centre

113. ESC/EACTS Guidelines on Myocardial Revascularization Full Text available with Trip Pro

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

2018 European Society of Cardiology

114. Baclofen

a . Please encourage all women to complete an . A corresponding patient information leaflet on is available at . Summary Baclofen is a gamma-aminobutyric acid (GABA) agonist licensed for oral (...) or intrathecal administration to alleviate voluntary muscle spasticity in patients with multiple sclerosis, spinal cord lesions, cerebral palsy, cerebrovascular accidents, traumatic head injury and meningitis. Data on the use of baclofen in human pregnancy consist of case reports and two small case series (one (...) This study is currently recruiting participants. (see ) Verified August 2016 by Denver Health and Hospital Authority Sponsor: Denver Health and Hospital (...) Withdrawal Scale (SEWS) is tool used to assess severity and is the current standard of care for both monitoring and treating AWS at Denver Health. Moderate/severe AWS (i.e., SEWS ≥ 7) has important clinical implications and requires pharmacological treatment. At present, there are no safe and effective options for preventing AWS in at-risk

2018 Trip Latest and Greatest

115. Hip fracture

consecutively from January 2005 to December 2010 with inclusion criteria. The total number was 138 and allocated to two groups: treated (...) with the Gamma nail (n=72,group A) and continuous skin traction (n=66,group B). Preoperative variables including patient age, gender, duration of cerebrovascular accident, duration of hypertension, ASA risk score, Harris hip score and fracture type were recorded and compared. After treatment, time of patients activity on the bed, ambulation time, Harris hip score (...) Injury in Older Adults. 2242-2250 10.1111/jgs.14439 To investigate the role of a fall risk assessment, using the Downton Fall Risk Index (DFRI), in predicting fall-related injury, fall-related head injury and hip (...) fracture , and death, in a large cohort of older women and men residing in Sweden. Cross sectional observational study. Sweden. Older adults (mean age 82.4 ± 7.8) who had a fall risk assessment using the DFRI at baseline (N = 128,596). Information on all fall-related injuries, all fall

2018 Trip Latest and Greatest

116. 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

117. 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

118. 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

119. Multimorbidity: a priority for global health research

that it is often more prevalent in those of lower socioeconomic status, and may be influenced by other variables such as sex, ethnicity, and several health-related behaviours already known to increase the risk of single chronic conditions. Multimorbidity also appears to be increasingly common in low- and middle- income countries (LMICs), where the burden of chronic physical conditions (or non-communicable diseases (NCDs)) such as diabetes and heart conditions is rising and augmenting existing burdens (...) conditions, such as coronary heart disease and cerebrovascular disease, which share a common aetiology (e.g. high blood pressure), frequently co-exist. In other cases – termed discordant multimorbidity – the co-existing conditions appear to be unrelated to each other or require different management approaches. In this regard, it is notable that there are data indicating that chronic physical and mental health conditions commonly co-exist. Some common clusters of conditions appear to vary by region

2018 Academy of Medical Sciences

120. Semaglutide (Ozempic) - Diabetes Mellitus

9 2.1.2. Epidemiology and risk factors 10 2.1.3. Biologic features 10 2.1.4. Available therapies and unmet medical need 10 2.1.5. About the product 11 2.2. Quality aspects 11 2.2.1. Introduction 11 2.2.2. Active Substance 12 2.2.3. Finished Medicinal Product 15 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 18 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 19 2.2.6. Recommendation for future quality development 20 2.3. Non-clinical aspects 20 (...) 2.3.1. Introduction 20 2.3.2. Pharmacology 20 2.3.3. Pharmacokinetics 23 2.3.4. Toxicology 26 2.3.5. Ecotoxicity/environmental risk assessment 29 2.3.6. Discussion on non-clinical aspects 29 2.3.7. Conclusion on non-clinical aspects 30 2.4. Clinical aspects 30 2.4.1. Introduction 30 2.4.2. Pharmacokinetics 33 2.4.3. Pharmacodynamics 40 Cardiac repolarisation by QT interval evaluation 44 Exposure-response analyses 46 2.4.4. Discussion on clinical pharmacology 48 2.4.5. Conclusions on clinical

2018 European Medicines Agency - EPARs

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