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Myocardial Infarction Stabilization

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

and process controls Description of manufacturing process and process controls The manufacturing facility at Biogen Inc. (North Carolina, USA) is the intended site for commercial production. Imraldi active substance is manufactured, packaged, stability tested, and quality-control tested in accordance with EU good manufacturing practices. The manufacturing process begins with thawing of a vial of the working cell bank (WCB), which is a Chinese Hamster Ovary (CHO) cell line transfected with Imraldi (...) of these materials. Cell banking system The applicant is using a two-tiered cell bank system in overall accordance with ICH Q5A, Q5B, and Q5D guidelines. The host cell line is a Chinese Hamster Ovary cell line. Its safety is well established and it has been used as the host cell line in the production of numerous commercialised recombinant therapeutic antibodies. The generation of the expression is sufficiently detailed. The genetic stability of the Imraldi cell substrate was confirmed by genetic and phenotypic

2017 European Medicines Agency - EPARs

362. 2017 Focused update on Dual Antiplatelet Therapy (DAPT) (Full text)

therapy for the prevention of stent thrombosis 219 3.2 Dual antiplatelet therapy for the prevention of spontaneous myocardial infarction 219 3.3 Dual antiplatelet therapy and mortality rate 219 3.4 Safety of dual antiplatelet therapy 219 3.5 Risk stratification tools for ischaemia and bleeding risks 219 3.6 Type of P2Y 12 inhibitor and timing of initiation 221 3.7 Measures to minimize bleeding while on dual antiplatelet therapy 223 3.8 Switching between oral P2Y 12 inhibitors 225 4. Dual antiplatelet (...) Myocardial Infarction ACS Acute coronary syndrome ADP Adenosine 5'-diphosphate AF Atrial fibrillation ANTARCTIC Platelet Function Monitoring to Adjust Antiplatelet Therapy in Elderly Patients Stented for an Acute Coronary Syndrome ARCTIC-Interruption Assessment by a Double Randomisation of a Conventional Antiplatelet Strategy Versus a Monitoring-Guided Strategy for Drug-Eluting Stent Implantation and, of Treatment Interruption Versus Continuation 1 Year After Stenting-Interruption ART Arterial

2017 European Society of Cardiology PubMed abstract

363. Evidence Brief: Use of Performance Measures as Criteria for Selecting Community Cardiac and Orthopedic Surgical Providers for the Veterans Choice Program

for MI, stroke, deep sternal infection, multisystem failure, or atrial fibrillation Abbreviations: STS=Society of Thoracic Surgeons; SCIP=Surgical Care Improvement Project; NQF=National Quality Forum; MI=myocardial infarction; OR=odds ratio; SSI=Surgical Site Infection Evidence Brief: Performance Measure-based Provider Selection Evidence-based Synthesis Program 17 Orthopedic Surgery Adherence to orthopedic surgical standards was consistently not associated with health outcomes in all of 4 included (...) , wait times may present additional barriers to collection. Different wait time standards may be needed for different subgroups, as safe wait times may vary by patient subgroups and surgery types. 69 There is a risk that clinically-justified longer wait times may be penalized if medical records and/or databases lack a mechanism for recording supporting documentation. For example, frailer patients may be more likely to be delayed due to need for stabilization prior to surgery. 60,62 KEY QUESTION 3

2017 Veterans Affairs Evidence-based Synthesis Program Reports

364. Atezolizumab (Tecentriq) - Non-Small-Cell Lung Carcinoma or Transitional Cell Carcinoma

is routinely tested, tested through monitoring, or not tested. To meet the CQA-AC, restrictions have been included in the specifications of the finished product (release) and active substance (release and stability) based on the knowledge acquired on the process and stability for atezolizumab. For CQAs that are critical for bioactivity or pharmacokinetics (PK), CQA-ACs are established to ensure that CQA levels stay within the cumulative impact ranges for bioactivity and PK. Specification The release (...) . The secondary Reference Assessment report EMA/153102/2018 Page 19/205 Standard is used as the working Reference Standard for testing of the active substance and finished product in all assays requiring a Reference Standard. Qualification of the commercial Reference Standards was conducted by release testing and extensive characterisation. Stability A shelf life of 24 months at = -20 0 C is claimed for the active substance based on stability data obtained with four batches manufactured using the commercial

2017 European Medicines Agency - EPARs

365. Padeliporfin (Tookad) - prostate cancer / Prostatic Neoplasms

anaesthesia) for the following reasons: withdrew consent after randomisation (3), discontinued by the Investigator for non-compliance (1), myocardial infarction (1), bladder cancer discovered on pre-treatment MRI (1), history of TURP- exclusion criterion (1), previous Gleason 3+4 biopsy - exclusion criterion (1) and unable to undergo pre-treatment MRI due to claustrophobia (1). One subject had an anaphylactic reaction to the anaesthesia and did not receive any Tookad; he was included in the mITT (...) . Management 9 2.2. Quality aspects 10 2.2.1. Introduction 10 2.2.2. Active Substance 11 Manufacture, characterisation and process controls 11 Specification 12 Stability 12 2.2.3. Finished Medicinal Product 13 Manufacture of the product and process controls 14 Product specification 14 Stability of the product 14 Adventitious agents 15 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 15 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 15 2.2.6. Recommendations

2017 European Medicines Agency - EPARs

366. Guselkumab (Tremfya) - Psoriasis

develop PsA 17,18,19 . Psoriasis has also been shown to be associated with a significantly increased risk of Crohn’s disease (relative risk, 3.86, 95% confidence interval [CI] 2.23 to 6.67), which is especially pronounced among psoriatic patients with concomitant PsA (relative risk, 6.43, 95% CI 2.04 to 20.32) 20 . Psoriasis is also associated with an increased risk of occlusive vascular disease, including myocardial infarction (MI) and stroke 21 . Multiple cardiovascular risk factors are associated (...) and occlusive vascular disease. Br J Dermatol. 1978;99(5):469-475. 22 Neimann AL, Shin DB, Wang X, Margolis DJ, Troxel AB, Gelfand JM. Prevalence of cardiovascular risk factors in patients with psoriasis. J Am Acad Dermatol. 2006;55(5):829-835 23 Gelfand JM, Neimann AL, Shin DB, Wang X, Margolis DJ, Troxel AB. Risk of myocardial infarction in patients with psoriasis. JAMA. 2006;296(14):1735-1741 24 Mallbris L, Akre O, Granath F, Yin L, Lindelof B, Ekbom A, Stahle-Backdahl M. Increased risk

2017 European Medicines Agency - EPARs

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

, characterisation and process controls Description of manufacturing process and process controls Adalimumab active substance (AS) is manufactured, stability tested, and quality-control tested in accordance with good manufacturing practice (GMP) at Boehringer Ingelheim Fremont, Inc. (BIFI), Fremont, California, USA. The active substance is expressed in a transfected Chinese Hamster Ovary (CHO) cell line. Main steps are thawing of working cell bank vials, cell culture and harvest, and purification. During (...) the potential re-filtration of the formulated active substance no other reprocessing is foreseen in the manufacturing process of BI 695501. Intermediate hold times which also included extended hold times under exceptional circumstances as well as media and buffer hold times have been appropriately validated taking into account chemical and microbial stability. Adalimumab (BI 695501) active substance manufacturing process has been adequately described. The ranges of critical process parameters

2017 European Medicines Agency - EPARs

368. Interventional Spine and Pain Procedures in Patients on Antiplatelet and Anticoagulant Medications

in this patient population. Low-dose ASA, when used for secondary prophylaxis, has been shown to reduce the risk of stroke and myocardial infarction in the range of 25% to 30%. Furthermore, the discontinuation of ASA for secondary prophylaxis is associated with significant risk. The lowest effective ASA daily dose for the prevention of TIA and ischemic stroke is 50 mg. For men at high risk of cardiovascular disease, the recommended dose increases to 75 mg. The routine long-term use of doses greater than 75 (...) inhibition of platelet aggregation in healthy volunteers taking an 81-mg dose, ASA demonstrated a 66.0% ± 18.6% inhibition measured with optical aggregometry with the agonist arachidonic acid. Aspirin also influences coagulation through non–TXA 2 -mediated effects, including dose-dependent inhibition of platelet function, suppression of plasma coagulation, and enhancement of fibrinolysis. Secondary hemostasis and thrombus stability are also impaired, because of ASA's acetylation of fibrinogen and its

2018 American Society of Regional Anesthesia and Pain Medicine

369. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Chronic Pain (Full text)

signaling, including TORC1 (mammalian target of rapamycin complex 1) and brain-derived neurotrophic factor pathways; (5) increased GABA-B levels; and (6) inhibition of brain glycogen synthase kinase 3 (GSK-3B). Inhibition of GSK-3 is a mechanism shared by the mood-stabilizing drug lithium, and the use of adjunct GSK-3B inhibitors such as lithium may augment and prolong ketamine's antidepressant effects. Clinical trials and anecdotal experience have demonstrated efficacy not only for depression, but also (...) channels that mediate “sag” currents, which help regulate and stabilize membrane potential. The mechanisms behind the amnestic effects of ketamine are multifactorial in nature and probably the result of interactions at an assortment of receptors that include NMDA, serotonin, and nicotinic cholinergic. There is growing evidence for ketamine as a treatment for refractory seizures as well as for its use during electroconvulsive therapy. The anticonvulsant effects may be attributable not only to its

2018 American Society of Regional Anesthesia and Pain Medicine PubMed abstract

370. CRACKCast E152 – Cardiovascular Drugs

such as tetrahydrozoline and oxymetazoline sedative-hypnotic drug overdose, hypoglycemic drug ingestion, opioid overdose, CNS injury or infection, endocrine-metabolic disorder, sepsis, and acute myocardial infarction. 2. List 6 non-cardiac symptoms of cardioactive steroid intoxication General Weakness Fatigue Malaise GI NV Anorexia AP Diarrhea Optho Blurred vision Photophobia Chromatopsia Transient amblyopia, diplopia, scotomas, blindness Neurologic Dizziness HA Confusion Visual or auditory hallucinations Paranoid (...) Adrenergic Blockers Have B1 effects: Competitively inhibit endogenous catecholamines such as epinephrine at beta-adrenergic receptors, blocking the catecholamine effects of inotropy (increased myocardial contraction), dromotropy (enhanced cardiac conduction), and chronotropy (increased heart rate). Have B2 effects: Complex β2 effects include vascular (smooth muscle relaxation and vasodilation), liver (glycogenolysis, gluconeogenesis), lung (bronchodilation), adipose tissue (release of free fatty acids

2018 CandiEM

371. Cardiovascular Disease and Breast Cancer: Where These Entities Intersect: A Scientific Statement From the American Heart Association (Full text)

supports the elevated risk that inactivity (<150 min/wk) poses for both CVD and breast cancer. , Globally, physical inactivity is believed to be responsible for 12.2% of the burden of myocardial infarction after accounting for other CVD risk factors including cigarette smoking, hypertension, obesity, dyslipidemia, alcohol, and psychosocial factors. A meta-analysis of longitudinal studies of women found that the RRs of incident CHD were 0.83 (95% CI, 0.69–0.99), 0.77 (95% CI, 0.64–0.92), 0.72 (95% CI (...) therapy when heart is in the field of treatment (<30 Gy) Presence of any of the following risk factors in addition to treatment with lower-dose anthracycline or trastuzumab alone: Older age at time of cancer treatment (≥60 y) ≥2 CVD risk factors during or after cancer treatment: diabetes mellitus, dyslipidemia, hypertension, obesity, smoking History of myocardial infarction, moderate valvular disease, or low-normal left ventricular function (50%–55%) before or during cancer treatment Cancer patients

2018 American Heart Association PubMed abstract

372. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm (Full text)

with dyspnea of unknown origin or worsening dyspnea. Level of recommendation 1 (Strong) Quality of evidence A (High) We suggest coronary revascularization before aneurysm repair in patients with acute ST-segment or non-ST-segment elevation myocardial infarction (MI), unstable angina, or stable angina with left main coronary artery or three-vessel disease. Level of recommendation 2 (Weak) Quality of evidence B (Moderate) We suggest coronary revascularization before aneurysm repair in patients with stable

2018 Society for Vascular Surgery PubMed abstract

373. Out-of-Hospital Cardiac Arrest Resuscitation Systems of Care: A Scientific Statement From the American Heart Association

of cases occur without any prior recognized heart disease; half occur without any prodromal symptoms. Despite robust systems of care for patients with trauma and rapidly evolving systems of care for patients with ST-segment–elevation myocardial infarction (STEMI) and stroke, the majority of communities do not achieve optimal survival after OHCA because of large discrepancies in resuscitation-related processes of care. As a result, survival to hospital discharge varies significantly both across (...) the STEMI system coverage ( ). Figure. Coverage of ST-segment–elevation myocardial infarction (STEMI) systems of care in the United States. STEMI plus cardiac resuscitation system coverage as of April 16, 2015 (848 STEMI systems, 83.67% population coverage; 83 cardiac resuscitation systems, 92.5% population coverage). All systems data, including coverage are, are self-reported data. Note: Cardiac resuscitation coverage areas listed are also indicative of an STEMI system in place. Mission: Lifeline does

2018 American Heart Association

374. Outcome Measures Framework: Information Model Report

and an echocardiography study. Medical treatment of valve disease has been limited for the most part to palliation of heart failure (HF) immediately preceding surgical intervention. It does not alter its course or delay the need for surgery. The importance of medical treatment lies in stabilizing the patient’s condition when the disease is due to abnormal valve structure, and in treating the underlying condition when the condition is due to a functional abnormality. 3 This information supports an assessment of how (...) . Within these 35 VHD registries, there were 143 reported outcome measures. In the review process, reviewers mapped these 143 outcomes to 187 various components of the OMF model (some outcomes were mapped to more than one component of the OMF model, resulting in greater than 100% mapping rate). As an example, some outcomes held a mapping to more than one place within the OMF, thus the mapping ratio of outcomes: OMF placement sometimes exceeded and equivalent 1:1 mapping structure (e.g. myocardial

2018 Effective Health Care Program (AHRQ)

375. ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay

-elevation acute coronary syndromes AHA/ACC 2014 (S1.4-9) Heart failure ACC/AHA 2013 (S1.4-10) ST-elevation myocardial infarction ACC/AHA 2013 (S1.4-11) Device-based therapy for cardiac rhythm abnormalities ACC/AHA/HRS 2013 (S1.4-2) Coronary artery bypass graft surgery ACC/AHA 2011 (S1.4-12) Hypertrophic cardiomyopathy ACC/AHA 2011 (S1.4-13) Percutaneous coronary intervention ACC/AHA/SCAI 2011 (S1.4-14) Guidelines for CPR and emergency cardiovascular care—part 9: post-cardiac arrest care AHA 2010 (S1.4 (...) ). The intrinsic sinus and atrioventricular nodal diseases present in a similar clinical manner to extrinsic/secondary processes that can injure the sinus node, atrioventricular node or conduction system tissues. Multiple pathophysiologic processes (e.g., myocardial ischemia or infarction, infiltrative diseases, collagen vascular disease, surgical trauma, endocrine abnormalities, autonomic effects, neuromuscular disorders (S2.1-2, S2.1-8–S2.1-10), individually or in combination, can compromise impulse

2018 American College of Cardiology

376. Stroke Prevention in Patients With Atrial Fibrillation: A Systematic Review Update

—dabigatran 150mg and 110mg vs. warfarin 122 Table 52. Observational studies: myocardial infarction—dabigatran 150mg or 110mg vs. warfarin 123 viii Table 53. Strength of evidence—thrombin inhibitor (dabigatran) vs. warfarin 126 Table 54. Outcomes of interest within rct studies evaluating factor Xa inhibitors: apixaban, rivaroxaban, or edoxaban vs. warfarin 132 Table 55. Observational studies: stroke or systemic embolism—apixaban, rivaroxaban, or edoxaban vs. warfarin 137 Table 56. Observational studies (...) , or edoxaban vs. warfarin 156 Table 61. Observational studies: GI bleeding—apixaban, rivaroxaban, or edoxaban vs. warfarin 158 Table 62. Observational studies, all-cause mortality—apixaban, rivaroxaban, or edoxaban vs. warfarin 161 Table 63. Observational studies: myocardial infarction—apixaban, rivaroxaban, or edoxaban vs. warfarin 164 Table 64. Observational studies: medication non-persistence—apixaban, rivaroxaban, or edoxaban vs. warfarin 166 Table 65. Strength of evidence—factor Xa inhibitors vs

2018 Effective Health Care Program (AHRQ)

378. Sirens to Scrubs: Acute Coronary Syndromes Part Three – Diagnosis and ED Management

in the Emergency Department? Diagnosis of ACS Myocardial infarction (STEMI or nSTEMI) In 2018 the Fourth Universal Definition of Myocardial Infarction was published, which defined an acute myocardial infarction as “Acute myocardial injury with clinical evidence of myocardial ischaemia”. 1 Myocardial injury and myocardial ischemia are further defined… Unstable angina As we explained in Part One, Unstable Angina describes symptoms of myocardial ischemia +/- ECG changes in the absence of elevated serum troponin (...) about the types of MI, including criteria for a Silent MI (page 5 of the document). Below are some nice images from the Fourth Universal Definition of Myocardial Infarction that demonstrate ways in which a Type 1 or 2 MI can occur: 1 Cardiac biomarkers Cardiac biomarkers are proteins that are identified on bloodwork that are suggestive of myocardial injury. Biomarkers have been used in the diagnosis of MI since the 1960s, however, the first biomarkers (aspartate transaminase [AST], lactate

2018 CandiEM

379. Length of stay following percutaneous coronary intervention: An expert consensus document update from the society for cardiovascular angiography and interventions

following PCI has declined. The overall incidence of in‐hospital complications in the most recent report of the NCDR CathPCI registry (2016 Q4–2017 Q3) comprising over 600,000 patients without ST‐segment elevation myocardial infarction (STEMI) or coronary artery bypass surgery (CABG) was 4.8%. Specifically, stroke was 0.2%, bleeding within 72 hr was 1.4%, pericardial tamponade was 0.1%, heart failure was 0.9%, and acute kidney injury (AKI) requiring hemodialysis was 0.2%. PCI complications that resulted (...) for pain, tenderness, numbness, bruising • No difference in adverse events at 7 and 30 days • 6/7 events were related to femoral access site complications 3 hr after PCI • ≤75 years of age • Type A or B lesion • Femoral access siteamenable to vascularclosure device • >2 hr since PCI • Life expectancy <12 months • Acute myocardial infarction • Anticoagulants besides heparin or bivalirudin used during procedure • PCI to nonnative vessel • Evidence of thrombus • Implantation of >3 stents • INR ≥2

2018 Society for Cardiovascular Angiography and Interventions

380. ILCOR Scientific Knowledge Gaps and Clinical Research Priorities for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care: A Consensus Statement (Full text)

postcardiac arrest physiology could be significant. Emergency Angiography in Comatose Patients After ROSC Numerous observational studies have shown the consistent benefit of emergency angiography and primary percutaneous coronary intervention in comatose patients with ST-segment–elevation myocardial infarction who have achieved ROSC, and a meta-analysis supports use for patients with a mixed pathogenesis of OHCA. The most recent systematic review completed as part of the 2015 CoSTR also confirmed (...) capabilities and survival outcomes. Consistent with other emergent conditions such as trauma and acute myocardial infarction, the concept of cardiac arrest centers that deliver evidence-based postresuscitation care is intuitively appealing. However, as identified in the 2010 and 2015 , CoSTR, there are multiple specific knowledge gaps: the particular treatments to be provided by a cardiac arrest center, the safe patient transport interval (time taken to travel from scene to hospital), the optimal mode

2018 American Heart Association PubMed abstract

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