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Medication Causes of Dyspepsia

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181. Giardia lamblia infection increases risk of chronic gastrointestinal disorders (Full text)

with documented G. lamblia infection were assessed for the subsequent risk of developing a chronic GI disorder including irritable bowel syndrome (IBS), dyspepsia and gastroesophageal reflux disease (GERD). Post-giardia chronic GI disorder risk was compared to risk in uninfected personnel matched on several demographic characteristics and medical encounter information. Data were obtained from the Defense Medical Surveillance System and exposures (1998-2009) with outcomes identified based on documented medical (...) Giardia lamblia infection increases risk of chronic gastrointestinal disorders Giardia lamblia is a common parasitic cause of infectious gastroenteritis in the United States and the world and may be linked to an increased risk of chronic gastrointestinal (GI) disorders. We sought to assess the risk of several chronic GI disorders following Giardia infection among active duty US military personnel.This study was designed as a retrospective cohort study in which active duty military personnel

2016 Tropical diseases, travel medicine and vaccines PubMed

182. Dimethyl fumarate (Skilarence) - plaque psoriasis

. Clinical safety 76 2.6.1. Discussion on clinical safety 87 2.6.2. Conclusions on the clinical safety 90 2.7. Risk Management Plan 91 2.8. Pharmacovigilance 97 2.9. Product information 97 Assessment report EMA/412737/2017 Page 3/108 2.9.1. User consultation 97 3. Benefit-Risk Balance 98 3.1. Therapeutic Context 98 3.1.1. Disease or condition 98 3.1.2. Available therapies and unmet medical need 98 3.1.3. Main clinical studies 98 3.2. Favourable effects 99 3.3. Uncertainties and limitations about (...) Analysis of covariance AST Aspartate aminotransferase ATC Anatomical Therapeutic Chemical AUC0-8 Area under the plasma concentration-time curve from time zero to infinity AUC0-t Area under the plasma concentration-time curve from time zero to time t, where t is the time of the last concentration measured BfArM Bundesinstitut für Arzneimittel und Medizinprodukte (the German Federal Institute for Drugs and Medical Devices) BID Twice Daily BSA Body surface area CHMP Committee for Medicinal Products

2017 European Medicines Agency - EPARs

183. Pentosan polysulfate sodium (Elmiron) - Interstitial Cystitis

. Conclusions on the clinical efficacy 96 2.6. Clinical safety 97 2.6.1. Discussion on clinical safety 102 2.6.2. Conclusions on the clinical safety 103 2.7. Risk Management Plan 104 2.8. Pharmacovigilance 106 2.9. Product information 106 Assessment report EMA/287422/2017 Page 3/115 2.9.1. User consultation 106 3. Benefit-Risk Balance 106 3.1. Therapeutic Context 106 3.1.1. Disease or condition 106 3.1.2. Available therapies and unmet medical need 107 3.1.3. Main clinical studies 107 3.2. Favourable effects (...) bladder. Up to 50% of patients with symptoms of interstitial cystitis will have spontaneous resolution in time. 2.1.3. Aetiology and pathogenesis There are many and different hypotheses about the causes of IC, including infection, inflammation, autoimmune mechanisms, hormonal troubles, defects in the urothelial glycosaminoglycan layer, hypoxia, and central neurologic mechanisms. Assessment report EMA/287422/2017 Page 10/115 The aetiology is unknown but some triggering factors such as certain acid

2017 European Medicines Agency - EPARs

184. Niraparib (Zejula) - Fallopian Tube Neoplasms, Ovarian Neoplasms, Peritoneal Neoplasms

in the first-line setting is platinum (cisplatin or carboplatin) plus a taxane (paclitaxel or docetaxel) with or without bevacizumab. However, platinum-based chemotherapy can cause serious side effects this may negatively impact patients’ ability to lead a productive life. Once a patient has recurrence of their ovarian cancer, chemotherapy is an option for reducing disease-related symptoms. Both the National Comprehensive Cancer Network and European Society for Medical Oncology guidelines recommend re (...) . Discussion on clinical safety 106 2.6.2. Conclusions on the clinical safety 110 2.7. Risk Management Plan 110 2.8. New Active Substance 113 2.9. Product information 113 2.9.1. User consultation 113 2.9.2. Additional monitoring 113 Assessment report EMA/648982/2017 Page 3/122 3. Benefit-Risk Balance 114 3.1. Therapeutic Context 114 3.1.1. Disease or condition 114 3.1.2. Available therapies and unmet medical need 114 3.1.3. Main clinical studies 115 3.2. Favourable effects 115 3.3. Uncertainties

2017 European Medicines Agency - EPARs

187. Maviret (glecaprevir / pibrentasvir) - chronic (long-term) hepatitis C

. Conclusions on clinical efficacy 103 2.6. Clinical safety 103 2.6.1. Discussion on clinical safety 111 2.6.2. Conclusions on the clinical safety 112 2.7. Risk Management Plan 113 2.8. Pharmacovigilance 116 2.9. New Active Substances 116 2.10. Product information 117 Assessment report EMA/449689/2017 Page 3/126 2.10.1. User consultation 117 2.10.2. Additional monitoring 117 3. Benefit-Risk Balance 117 3.1. Therapeutic Context 117 3.1.1. Disease or condition 117 3.1.2. Available therapies and unmet medical (...) persons are chronically infected with HCV throughout Europe. The prevalence of HCV in the general adult population ranges from =0.5% (Northern European countries) to =3% (Greece, Italy, and Eastern European countries). It is the most common single cause of liver transplantation in the European Union. Depending on various risk factors, between 10-40% of patients with chronic HCV infection will develop cirrhosis over time. Death related to the complications of cirrhosis (mainly liver decompensation

2017 European Medicines Agency - EPARs

188. Tofacitinib (Xeljanz) - Rheumatoid arthritis

component summary MedDRA Medical Dictionary for Regulatory Activities MMF Mycophenolate mofetil MOA mechanism of action MTX Methotrexate MTX-IR Methotrexate-inadequate responder mTSS modified Total Sharp Score NHL non-Hodgkin's lymphoma NMSC nonmelanoma skin cancer NK natural killer NSAID(s) Nonsteroidal Anti-Inflammatory Drug(s) PBO placebo PD Pharmacodynamics PK Pharmacokinetic PRAC Pharmacovigilance Risk Assessment Committee PRL prolactin PRO patient reported outcomes PT Preferred Term PT LD post (...) active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs. Xeljanz can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. Rheumatoid arthritis (RA) is a chronic immune-mediated inflammatory disease that causes progressive damage to small and large joints (termed structural progression). 2.1.2. Epidemiology and risk factors Rheumatoid arthritis

2017 European Medicines Agency - EPARs

189. Miglustat (Yargesa) - Gaucher Disease

is an autosomal recessive disorder caused by mutations in the GBA (glucosidase, beta, acid) gene (on chromosome 1q21) which results in a deficiency of the lysosomal enzyme beta-glucocerebrosidase. Beta- glucocerebrosidase is an enzyme that helps break down a large molecule called glucocerebroside (=glucosylceramide) into a sugar (glucose) and a simpler fat molecule (ceramide). This enzymatic deficiency results in an accumulation of glucocerebroside, primarily in macrophages, in the liver, spleen, bone marrow (...) of the root cause was conducted and as a result the manufacturing process was modified accordingly as discussed previously. No significant changes to any of the measured parameters were observed under either storage condition and all remained within specification. The active substance was subjected to induced degradation under the following stress conditions: hydrolytic and oxidative degradation, thermal degradation, photolytic degradation with UV light and photolytic degradation with sun light. It has

2017 European Medicines Agency - EPARs

190. The Cytosponge: An Alternative to Endoscopy in Detecting Barrett Esophagus

Practice As BE does not cause symptoms, most patients are being investigated for symptoms of gastroesophageal reflux or dyspepsia (indigestion, nausea, bloating, or upper abdominal pain). 20 The evidence on the benefits of screening for BE is currently unclear, but both US and UK guidelines recommend screening patients with chronic gastroesophageal reflux and other risk factors. 18,26 Endoscopy (upper gastrointestinal endoscopy or gastroscopy) with sedation, followed by tissue biopsy, is the standard (...) of BE: Trefoil factor 3 (TFF3). 6,11,13,14 Regulatory Status The Cytosponge does not have Health Canada licencing approval and when it may become available in Canada is not yet known. The Cytosponge has a CE Marking, which allows it to be marketed in Europe, 15 and received United States (US) Food and Drug Administration 510(k) approval as a Class II device in 2014. 16 The sponge was developed by a United Kingdom (UK) research group at the University of Cambridge/Medical Research Council (MRC) and is now

2015 CADTH - Issues in Emerging Health Technologies

191. Vagal Nerve Blockade for Obesity: VBLOC Therapy Using the Maestro RC2 Device

% of the population in developed countries could be overweight, with more than 22.0% potentially being considered obese. 32 Obesity-related conditions such as hypertension, stroke, cardiovascular disease, dyslipidemia, metabolic syndrome, type 2 diabetes mellitus, obstructive sleep apnea, mood and self-esteem difficulties, osteoarthritis, and increased cancer risk are leading causes of morbidity, decreased life expectancy, and preventable death in developing countries. 2,9,33-36 Moreover, in 2011, the risk (...) , electrically powered medical device, or gastrointestinal device or prosthesis (e.g., pacemaker, implanted defibrillator, neurostimulator) Patients for whom shortwave, microwave, or therapeutic ultrasound diathermy (treatment using high- frequency electromagnetic radiation, electric currents, or ultrasonic waves to produce heat in body tissues) is planned To conduct a 5-year post- approval study to collect follow-up effectiveness and safety data (e.g., weight loss, adverse events, surgical revisions

2015 CADTH - Issues in Emerging Health Technologies

192. The Agenda for Familial Hypercholesterolemia (Full text)

Disease in the Young, Council on Cardiovascular and Stroke Nursing, Council on Functional Genomics and Translational Biology, and Council on Lifestyle and Cardiometabolic Health Originally published 28 Oct 2015 Circulation. 2015;132:2167–2192 You are viewing the most recent version of this article. Previous versions: Introduction Familial hypercholesterolemia (FH) is an autosomal-dominant genetic disease present in all racial and ethnic groups and has long been recognized as a cause of premature (...) atherosclerotic coronary heart disease. Heterozygous FH has the highest prevalence of genetic defects that cause significant premature mortality (≈1:200 to 1:500 or higher in founder populations). The genetic basis of the disorder, impaired functioning of the low-density lipoprotein (LDL) receptor, was first recognized by Goldstein and Brown in their Nobel Prize–winning work. Studies of LDL receptor function have identified additional mechanisms for the pathogenesis of FH (defects in apolipoprotein [apo] B

2015 American Heart Association PubMed

193. The Cytosponge: An Alternative to Endoscopy in Detecting Barrett Esophagus

Practice As BE does not cause symptoms, most patients are being investigated for symptoms of gastroesophageal reflux or dyspepsia (indigestion, nausea, bloating, or upper abdominal pain). 20 The evidence on the benefits of screening for BE is currently unclear, but both US and UK guidelines recommend screening patients with chronic gastroesophageal reflux and other risk factors. 18,26 Endoscopy (upper gastrointestinal endoscopy or gastroscopy) with sedation, followed by tissue biopsy, is the standard (...) of BE: Trefoil factor 3 (TFF3). 6,11,13,14 Regulatory Status The Cytosponge does not have Health Canada licencing approval and when it may become available in Canada is not yet known. The Cytosponge has a CE Marking, which allows it to be marketed in Europe, 15 and received United States (US) Food and Drug Administration 510(k) approval as a Class II device in 2014. 16 The sponge was developed by a United Kingdom (UK) research group at the University of Cambridge/Medical Research Council (MRC) and is now

2015 CADTH - Issues in Emerging Health Technologies

194. Vagal Nerve Blockade for Obesity: VBLOC Therapy Using the Maestro RC2 Device

% of the population in developed countries could be overweight, with more than 22.0% potentially being considered obese. 32 Obesity-related conditions such as hypertension, stroke, cardiovascular disease, dyslipidemia, metabolic syndrome, type 2 diabetes mellitus, obstructive sleep apnea, mood and self-esteem difficulties, osteoarthritis, and increased cancer risk are leading causes of morbidity, decreased life expectancy, and preventable death in developing countries. 2,9,33-36 Moreover, in 2011, the risk (...) , electrically powered medical device, or gastrointestinal device or prosthesis (e.g., pacemaker, implanted defibrillator, neurostimulator) Patients for whom shortwave, microwave, or therapeutic ultrasound diathermy (treatment using high- frequency electromagnetic radiation, electric currents, or ultrasonic waves to produce heat in body tissues) is planned To conduct a 5-year post- approval study to collect follow-up effectiveness and safety data (e.g., weight loss, adverse events, surgical revisions

2015 CADTH - Issues in Emerging Health Technologies

195. Treatment of Idiopathic Pulmonary Fibrosis: An Official ATS/ERS/JRS/ALAT Guideline

of contents at www.atsjournals.org Am J Respir Crit Care Med Vol 192, Iss 2, pp e3–e19, Jul 15, 2015 Copyright© 2015 by the American Thoracic Society DOI: 10.1164/rccm.201506-1063ST Internet address: www.atsjournals.org American Thoracic Society Documents e3Question 6: Should Patients with IPF Be Treated with Pirfenidone? Question 7: Should Patients with IPF Be Treated with Antiacid Medication? Question 8: Should Patients with IPF Be Treated with Sildena?l, a Phosphodiesterase-5 Inhibitor? Question 9 (...) , but decisionsregardingarecommendationwere deferred until the next version of the guideline to gather additional information that was felt necessary before formulating a recommendation. Questions regarding newertreatments(e.g.,antibiotics)werenot addressed and were deferred until the next version of the guideline because of resource constraints. Introduction IPFisaspeci?cformofchronic,progressive ?brosinginterstitialpneumoniaofunknown cause occurring in adults. Radiologic and/or histopathologic patterns are consistentwith usual

2015 American Thoracic Society

196. Irritable Bowel Syndrome (IBS)

as being relevant to IBS [1]. • A transition of IBS to, and overlap with, other symptomatic gastrointestinal disorders (e.g., gastroesophageal reflux disease, dyspepsia, and functional constipation) may occur. • The condition usually causes long-term symptoms: — These may occur in episodes. — Symptoms vary and are often associated with food intake and, characteristically, with defecation. — Symptoms interfere with daily life and social functioning in many patients. — Symptoms sometimes seem to develop (...) for nongastrointestinal symptoms • History of previous medically unexplained symptoms • Aggravation after meals • Associated anxiety and/or depression Noncolonic complaints that often accompany IBS: • Dyspepsia—reported in 42–87% of IBS patients • Nausea • Heartburn Associated non-gastrointestinal symptoms: • Lethargy, fatigue • Backache and other muscle and joint pains • Fibromyalgia • Headache © World Gastroenterology Organization, 2015 WGO Global Guidelines IBS 13 • Urinary symptoms: — Nocturia — Frequency

2015 World Gastroenterology Organisation

197. Gastroesophageal Reflux Disease (GERD)

uninvestigated dyspepsia, eradication therapy has been found to be associated with a lower prevalence of reflux-like symptoms (36%) than control therapy (49%) [53]. • A subgroup of patients infected with more proinflammatory strains of H. pylori (virulence factors vacA and cagA) may be less likely to have severe esophagitis or BE. This may be because infection in these patients more often causes severe corpus gastritis with atrophy, resulting in reduced acid output. However, these patients are at much (...) -centered and, more importantly, is likely not to be cost-effective. • WGO Cascades are thus context-sensitive, and the context is not necessarily defined solely by resource availability. A standardized global approach would require that the epidemiology of GERD and reflux-like symptoms be comparable in all parts of the world, and that the full ranges of diagnostic tests and medical treatment options be generally available. However, neither the epidemiology of the condition, nor the availability

2015 World Gastroenterology Organisation

198. Are We Overusing Proton Pump Inhibitors?

to the FDA approval of over-the-counter omeprazole (Prilosec-OTC) in 2010, more individuals have access to PPIs. Advertised as “on-demand” relief medication for people with frequent heartburn, Prilosec-OTC has a label warning against its use for more than 14 days. What is troubling with this message is that it may promote chronic on-and-off usage, which is not optimal, given that PPIs take several days to take maximal effect and can cause rebound acid reflux when stopped abruptly. Hence, over-the-counter (...) overutilization in the medical setting, as exemplified by the patient case above. However, PPI use can have potentially serious medical consequences, including an increased risk of infections, malabsorption, and adverse drug-drug interactions. Physicians use empiric PPI therapy to diagnose GERD, one of the most common gastrointestinal diseases. If symptoms improve with empiric therapy, PPIs are then continued, often indefinitely, though it may be possible to step down to acid suppression with H-2 blockers

2015 Clinical Correlations

199. Acute Pain Management: Scientific Evidence

was the “Declaration of Montreal”, which called for “access to pain management as a fundamental human right” (Cousins 2011). This included the management of acute pain. This fourth edition sums up the evidence currently available to assist health professionals in the management of acute pain. Additional literature has been reviewed from August 2009 to August 2014. Levels of evidence have been documented according to the National Health and Medical Research Council (NHMRC) designation ( NHMRC 1999). The Jadad (...) scoring instrument was used to score the quality of all randomised controlled trials (RCTs) (Jadad 1996). Key iv Acute Pain Management: Scientific Evidence messages for each topic are specified with the highest level of evidence available to support them, or with a symbol showing that they are based on clinical experience or expert opinion. The volume of medical knowledge is doubling every 8 years (Carroll 2011). Such was the enormity of the challenge faced by Prof Stephan Schug and the other members

2015 Clinical Practice Guidelines Portal

200. Salazopyrine (A07EC01 (intestinal anti-inflammatory agents)) - Ulcerative colitis, Crohn's disease in the colon, Rheumatoid arthritis

Salazopyrine (A07EC01 (intestinal anti-inflammatory agents)) - Ulcerative colitis, Crohn's disease in the colon, Rheumatoid arthritis HAS - Medical, Economic and Public Health Assessment Division 1/15 The legally binding text is the original French version T TR RA AN NS SP PA AR RE EN NC CY Y C CO OM MM MI IT TT TE EE E Opinion 23 July 2014 SALAZOPYRINE 500 mg, tablet Bottle of 100 tablets - CIP code: 322 688-0 Applicant: PFIZER INN Sulfasalazine ATC Code (2014) A07EC01 (intestinal anti (...) -inflammatory agents) Reason for the review Renewal of inclusion List concerned National Health Insurance (French Social Security Code L.162-17) Indications concerned "Gastroenterology: Ulcerative colitis: treatment of attacks and prevention of relapses. Crohn's disease in the colon. Rheumatology: Rheumatoid arthritis." HAS - Medical, Economic and Public Health Assessment Division 2/15 01 ADMINISTRATIVE AND REGULATORY INFORMATION Marketing Authorisation (national procedure) Date initiated: 31 March 1992

2015 Haute Autorite de sante

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