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Medication Causes of Dyspepsia

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141. Evidence Map of Acupuncture

Evidence Map of Acupuncture Evidence-based Synthesis Program Department of Veterans Affairs Health Services Research & Development Service January 2014 Prepared for: Department of Veterans Affairs Veterans Health Administration Quality Enhancement Research Initiative Health Services Research & Development Service Washington, DC 20420 Prepared by: Evidence-based Synthesis Program (ESP) Center West Los Angeles VA Medical Center Los Angeles, CA Paul G. Shekelle, MD, PhD, Director Investigators (...) citation: Hempel, S., Taylor, S. L., Solloway, M., Miake-Lye, I. M., Beroes, J. M., Shanman, R., Booth, M. J., Siroka, A. M., Shekelle, P. G. Evidence Map of Acupuncture. VA- ESP Project #05-226; 2013 This report is based on research conducted by the Evidence-based Synthesis Program (ESP) Center located at the West Los Angeles VA Medical Center, Los Angeles, CA funded by the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Quality Enhancement Research

2014 Veterans Affairs Evidence-based Synthesis Program Reports

142. Aspirin for prophylactic use in the primary prevention of cardiovascular disease and cancer: a systematic review and overview of reviews

for prophylactic use in the primary prevention of cardiovascular disease and cancer: a systematic review and overview of reviews P Sutcliffe, M Connock, T Gurung, K Freeman, S Johnson, N-B Kandala, A Grove, B Gurung, S Morrow and A Clarke* Warwick Evidence, Warwick Medical School, University of Warwick, Coventry, UK * Corresponding author Declared competing interests of authors: none Published September 2013 DOI: 10.3310/hta17430 This report should be referenced as follows: Sutcliffe P, Connock M, Gurung T (...) Journals Library (www.journalslibrary.nihr.ac.uk), produced by Prepress Projects Ltd, Perth, Scotland (www.prepress-projects.co.uk).Editor-in-Chief of Health Technology Assessment and NIHR Journals Library Professor Tom Walley Director, NIHR Evaluation, Trials and Studies and Director of the HTA Programme, UK NIHR Journals Library Editors Professor Ken Stein Chair of HTA Editorial Board and Professor of Public Health, University of Exeter Medical School, UK Professor Andree Le May Chair of NIHR

2013 NIHR HTA programme

143. 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 (...) interactions and other interactions 127 Discontinuation due to AES 127 Post marketing experience 127 2.5.6. Discussion on clinical safety 127 2.5.7. Conclusions on clinical safety 135 2.6. Risk Management Plan 135 2.7. New Active Substance 139 2.8. Product information 139 2.8.1. User consultation 139 2.8.2. Additional monitoring 139 3. Benefit risk assessment 139 3.1. Therapeutic Context 139 3.1.1. Disease or condition 139 3.1.2. Available therapies and unmet medical need 139 3.1.3. Main clinical studies

2018 European Medicines Agency - EPARs

144. Budesonide (Jorveza) - to treat adults with eosinophilic oesophagitis

Balance 76 3.1. Therapeutic Context 76 3.1.1. Disease or condition 76 3.1.2. Available therapies and unmet medical need 76 3.1.3. Main clinical studies 77 3.2. Favourable effects 77 3.3. Uncertainties and limitations about favourable effects 78 3.4. Unfavourable effects 79 3.5. Uncertainties and limitations about unfavourable effects 79 3.6. Effects Table 80 3.7. Benefit-risk assessment and discussion 81 3.7.1. Importance of favourable and unfavourable effects 81 3.7.2. Balance of benefits and risks (...) Assessment report EMA/774645/2017 Page 10/83 involved in the oesophageal barrier function (Desmoglein-1, Filaggrin). The damage caused by the chronic inflammation of the oesophageal epithelium promotes oesophageal remodelling processes which result in sub-epithelial fibrosis and the formation of strictures. 2.1.4. Clinical presentation, diagnosis and prognosis In adults and adolescents the disease is mainly diagnosed after presentation of the patients with dysphagia, pain on swallowing (odynophagia

2018 European Medicines Agency - EPARs

145. Sodium zirconium cyclosilicate (Lokelma) - Hyperkalemia

with S-K levels between 3.5 and 4.5 mmol/L but, more importantly, S-K levels between 4.5 and 5.0 mmol/L, which is within the normal range, were associated with a 2-fold increased risk of mortality compared with S-K between 3.5 and 4.5 mmol/L. 2.1.2. Epidemiology Hyperkalemia develops when there is insufficient elimination, excessive intake, or shift of potassium from the intracellular space. Insufficient elimination, which is the most common cause of hyperkalaemia, can be hormonal (as in aldosterone (...) deficiency), pharmacologic (e.g. treatment with angiotensin-converting enzyme inhibitors [ACEs], angiotensin-receptor blockers [ARBs], mineralocorticoid receptor antagonists) or, most commonly, due to reduced kidney function. Often, the cause is multifactorial (e.g. reduced kidney function combined with drug treatment such as ACEs or ARBs). Increased extracellular potassium levels result in depolarization of the membrane potential of cells. This depolarization opens some voltage gated sodium EMA/93250

2018 European Medicines Agency - EPARs

146. Rucaparib camsylate - Ovarian Neoplasms

2.10. Product information 157 2.10.1. User consultation 157 2.10.2. Additional monitoring 158 3. Benefit-Risk Balance 158 3.1. Therapeutic Context 158 3.1.1. Disease or condition 158 3.1.2. Available therapies and unmet medical need 158 3.2. Favourable effects 158 3.3. Uncertainties and limitations about favourable effects 159 3.4. Unfavourable effects 159 3.5. Uncertainties and limitations about unfavourable effects 160 3.6. Effects Table 160 3.7. Benefit-risk assessment and discussion 161 3.7.1 (...) acid DSB double-strand breaks DSC differential scanning calorimetry DVS dynamic vapour sorption EC European Commission ECG(s) electrocardiogram(s) ECOG Eastern Cooperative Oncology Group EMA European Medicines Agency EOC epithelial ovarian cancer ESMO European Society for Medical Oncology EU European Union EU-RMP European Union Risk Management Plan FDA Food and Drug Administration FeSSIF Fed state simulated intestinal fluid Assessment report EMA/CHMP/238139/2018 Page 5/167 FFPE formalin-fixed

2018 European Medicines Agency - EPARs

147. Glibenclamide (Amglidia) - Diabetes Mellitus

4/60 3.1.1. Disease or condition 49 3.1.2. Available therapies and unmet medical need 49 3.1.3. Main clinical studies 50 3.2. Favourable effects 51 3.3. Uncertainties and limitations about favourable effects 52 3.4. Unfavourable effects 52 3.5. Uncertainties and limitations about unfavourable effects 52 3.6. Effects Table 53 3.7. Benefit-risk assessment and discussion 56 3.7.1. Importance of favourable and unfavourable effects 56 3.8. Balance of benefits and risks 57 3.9. Additional (...) in the short term for patients with diabetes caused by KCNJ11 mutations and is probably more effective than insulin therapy. This pharmacogenetic response to sulphonylureas may result from the closing of mutant KATP channels, thereby increasing insulin secretion in response to incretins and glucose metabolism." The conclusion of the second article (Babenko et al. NEJM, 2006) was that "Dominant mutations in ABCC8 accounted for 12 percent of cases of neonatal diabetes in the study group. Diabetes results

2018 European Medicines Agency - EPARs

148. Dolutegravir sodium rilpivirine hydrochloride (Juluca) - HIV Infections

. Conclusions on the clinical efficacy 75 2.6. Clinical safety 75 2.6.1. Discussion on clinical safety 98 2.6.2. Conclusions on the clinical safety 100 2.7. Risk Management Plan 100 2.8. Pharmacovigilance 103 2.9. Product information 103 2.9.1. User consultation 103 Assessment report EMA/243517/2018 Page 3/109 3. Benefit-Risk Balance 103 3.1. Therapeutic Context 103 3.1.1. Disease or condition 103 3.1.2. Available therapies and unmet medical need 104 3.1.3. Main clinical studies 104 3.2. Favourable effects (...) and that the mean duration of use of the ART- regimen at screening was almost 4 years. Moreover, relevant comorbidities, such as CHB-infection and co-medications were excluded. Self-reported adherence to study medications was – with intake of 98% of the doses- unusually high. It is not clear, if outside a study setting and in a less stringently selected population the regimen’s efficacy would be the same. Study 201674 and Study 201676 The data indicate a difference in the relevant PK parameters of RPV

2018 European Medicines Agency - EPARs

149. Adalimumab (Hyrimoz) - Juvenile Rheumatoid Arthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Crohn Disease, Papulosquamous Skin Diseases, Hidradenitis Suppurativa, Ankylosing Spondylitis, Uveitis

5.1 and 5.2). 4 Crohn’s disease Hyrimoz is indicated for treatment of moderately to severely active Crohn’s disease in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Paediatric Crohn's disease Hyrimoz is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who (...) to or have medical contraindications for such therapies. Uveitis Hyrimoz is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Paediatric uveitis Hyrimoz is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate

2018 European Medicines Agency - EPARs

150. Sufentanil citrate (Dzuveo) - Pain

2.8.2. Labelling exemptions 79 3. Benefit-risk balance 80 3.1. Therapeutic Context 80 3.1.1. Disease or condition 80 3.1.2. Available therapies and unmet medical need 80 3.1.3. Main clinical studies 80 3.2. Favourable effects 80 3.3. Uncertainties and limitations about favourable effects 81 3.4. Unfavourable effects 81 3.5. Uncertainties and limitations about unfavourable effects 82 3.6. Effects Table 82 3.7. Benefit-risk assessment and discussion 83 3.7.1. Importance of favourable and unfavourable (...) : Sufentanil 30 µg sublingual tablet is indicated for the management of acute moderate to severe pain in adult patients in a medically supervised setting (see section 4.2.). The legal basis for this application refers to: Hybrid application (Article 10(3) of Directive No 2001/83/EC). The application submitted is composed of administrative information, complete quality data, a bioavailability study with the reference medicinal product Sufenta Forte Solution for injection 0.05mg/ml and appropriate non

2018 European Medicines Agency - EPARs

151. The opioid ‘crisis’: the pendulum swings again by Amelia Swift

The opioid ‘crisis’: the pendulum swings again by Amelia Swift The opioid 'crisis': the pendulum swings again by Amelia Swift | Evidence-Based Nursing blog by The term ‘opioid epidemic’ or ‘opioid crisis’ refers to a surge in the rate of substance use disorder and escalation of overdose deaths that has been declared a Public Health Emergency in the US (Roehr 2017). Drug overdose has become the leading cause of preventable death in the US, and the rate of opioid overdose deaths has increased (...) century. Opium, morphine, and later heroin were widely available and marketed for a host of disorders and ailments including the control of insanity, alleviation of cough, treatment of communicable diseases such as malaria, management of asthma, dyspepsia and hypochondriasis (Leigh 1785). Medicine was a highly competitive field and doctors needed to impress and retain patients to make a living. Effective remedies and treatments were limited, and morphine often alleviated troubling symptoms meaning

2018 Evidence-Based Nursing blog

152. Lonoctocog alfa (haemophilia A) - Benefit assessment according to §35a Social Code Book V

– Addendum to Commission A16-32 9 November 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - v - List of figures Page Figure 1: Kaplan-Meier curve for the outcome “all-cause mortality” – RCT, direct comparison: elotuzumab + lenalidomide + low-dose dexamethasone vs. lenalidomide + low-dose dexamethasone (data cut-off: 29 October 2015) 25 Addendum A16-66 Version 1.0 Elotuzumab – Addendum to Commission A16-32 9 November 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - vi (...) infection 32 (10.1) 18 (5.7) Gastrointestinal disorders 256 (80.5) 214 (67.5) Diarrhoea 152 (47.8) 118 (37.2) Constipation 114 (35.8) 88 (27.8) Nausea 78 (24.5) 70 (22.1) Vomiting 52 (16.4) 29 (9.1) Abdominal pain 44 (13.8) 29 (9.1) Dyspepsia 33 (10.4) 19 (6.0) Musculoskeletal and connective tissue disorders 223 (70.1) 217 (68.5) Muscle spasms 96 (30.2) 84 (26.5) Back pain 95 (29.9) 91 (28.7) Arthralgia 63 (19.8) 46 (14.5) Pain in extremity 56 (17.6) 32 (10.1) Musculoskeletal pain 45 (14.2) 30 (9.5

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

153. Brivaraceta

comparison: brivaracetam vs. lacosamide 17 Table 10: Results on all-cause mortality, side effects – RCT, indirect comparison: brivaracetam vs. lacosamide 20 Table 11: Positive and negative effects for brivaracetam in the indirect comparison with lacosamide 27 Table 12: Study N01254, common AEs (in the SOC and in the PT = 2% in at least one study arm) – RCT, indirect comparison: brivaracetam vs. lacosamide 29 Table 13: Study N01254, SAEs – RCT, indirect comparison: brivaracetam vs. lacosamide .. 31 Table (...) to be in place = 6 months before study inclusion ? Anxiolytic and hypnotic drugs were allowed in a stable and low dosage Rescue medication Benzodiazepines were allowed once each during the titration phase and the maintenance period (3 doses in a 24-hour period), except during the 8-week baseline period. During the down-titration phase, the investigator decided on the administration. Prohibited prior and concomitant treatment (4 weeks before screening and during the entire study period) ? non-oral AEDs

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

154. Cancer Pain (PDQ®): Health Professional Version

. (Refer to the section of this summary for more information). Is the pain acute or chronic? Is it secondary to cancer, cancer treatment, other causes, or a combination? Is it somatic, visceral, neuropathic, or mixed? Is there an incidental component? Is there breakthrough pain? Determining whether the pain requires pharmacologic and/or other modalities of treatment. Pain is often multifactorial in nature, so factors that may modulate pain expression, such as psychological distress and substance use (...) evaluation and intervention. There are many issues to consider when determining the most appropriate treatment, such as the following: Previous pain treatments. Patient prognosis. Predictive factors for pain control (e.g., psychological distress). Impact on function. Comorbidities (e.g., renal or hepatic failure). Risk of misuse of or addiction to pain medications. Patient preference. Providing proper education about treatment, including medication administration, expected side effects and associated

2017 PDQ - NCI's Comprehensive Cancer Database

155. Prevention of chemotherapy induced nausea and vomiting in adults: netupitant/palonosetron

and vomiting are distressing side effects of chemotherapy. Chemotherapy regimens vary in the extent to which they cause nausea and vomiting (usually classed as having a minimal, low, moderate or high degree of emetogenicity). For example, the Multinational Association for Supportive Care in Cancer (MASCC) and the European Society of Medical Oncology (ESMO) antiemetic guidelines classify the following (if given intravenously) as moderately emetogenic: cyclophosphamide (at doses of less than 1500 mg/m 2 (...) Effectiveness eness During the delayed phase of the first cycle of an anthracycline plus cyclophosphamide chemotherapy regimen, statistically significantly more participants taking netupitant/palonosetron 300 mg/500 microgram had a complete response (no emesis and no rescue medication) and no significant nausea compared with palonosetron 500 microgram (complete response: 76.9% compared with 69.5%; and no significant nausea: 76.9% compared with 71.3% respectively) [1 RCT; n=1455]. During the overall phase

2016 National Institute for Health and Clinical Excellence - Advice

156. Chronic prostatitis and chronic pelvic pain syndrome

Saxty, 8 Sarah Mee, 9 Alison Cooper, 10 Kirsty Haves, 11 and Jenny Lee 12 1 GP (Chair of Prostatitis Expert Reference Group), Backwell and Nailsea Medical Group, Bristol; 2 Pain Consultant, Addenbrooke’s Hospital, Cambridge; 3 Clinical Nurse Specialist – Prostate, University College London Hospitals, London; 4 Patient Representative; 5 Consultant Urologist, Addenbrooke’s Hospital, Cambridge; 6 Urology Clinical Nurse Specialist, South Warwickshire Foundation Trust; 7 Physiotherapist Specialist (...) , Addenbrooke’s Hospital, Cambridge; 8 Cognitive Behavioural Therapist, Addenbrooke’s Hospital, Cambridge; 9 Policy and Evidence Manager, Prostate Cancer UK; 10 Senior Research Analyst, Prostate Cancer UK; 11 Senior Account Manager, Hayward Medical Communications; 12 Project Manager, Hayward Medical Communications A quick reference guide version of this guideline can be downloaded from: www.prostatecanceruk.org/prostatitisguideline ENDORSED BY September 2014 (due for review September 2017) Diagnosis

2015 Prostate Cancer UK

157. Stretta System for gastro-oesophageal reflux disease

://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 2 of 15Current NHS options The NICE guideline on gastro-oesophageal reflux disease and dyspepsia in adults recommends lifestyle modifications such as weight reduction or smoking cessation, and gastric acidity-lowering medication to improve symptoms. People whose symptoms do not respond to medication or lifestyle changes, who develop complications despite medication, or who develop intolerance to medication may be considered for anti-reflux surgery (...) Heartburn commented that reflux is a very common complaint, but when it is persistent and longstanding there should be careful investigation to find the underlying causes. This is especially important for conditions such as Barrett's oesophagus, which can develop into oesophageal adenocarcinoma. The organisation stated that there is concern about the long-term effects of PPI medication on some people, despite their short-term effectiveness, and also concern about patients for whom PPI medication does

2016 National Institute for Health and Clinical Excellence - Advice

158. Anticoagulation - oral

of a bleeding complication in secondary care consists of stopping treatment and general haemostatic measures, such as mechanical compression and surgical haemostasis with bleeding control procedures, fluid replacement and haemodynamic support, blood products (packed red cells or fresh frozen plasma, depending on associated anaemia or coagulopathy), or platelets. People taking oral anticoagulants should be advised: To seek immediate medical advice if spontaneous bleeding occurs and does not stop, or recurs (...) . This includes bruising, bleeding gums, nosebleeds, prolonged bleeding from cuts, blood in the urine or stools, haemoptysis, subconjunctival haemorrhage, and vaginal bleeding in a postmenopausal woman. To seek medical advice if they get sudden severe back pain (which may indicate spontaneous retroperitoneal bleeding). Not to take over-the-counter medicines such as nonsteroidal anti-inflammatory drugs. What to do if there has been a missed dose or if a double dose has been taken. The duration of treatment

2017 NICE Clinical Knowledge Summaries

159. Palliative care - nausea and vomiting

and vomiting What should I ask about the nausea and vomiting? Ask about: Features of: Nausea: onset, frequency, intensity, relieving and exacerbating factors, and relationship to vomiting. Vomiting: onset, frequency, quantity, force, colour, timing, and pattern. Other symptoms such as: Dyspepsia, heartburn, fullness, early satiety, constipation, diarrhoea, flatus, cough, headache, or confusion. Treatment history, including: Simple measures — what has been tried and its effectiveness. Current medication (...) , and medication(s), and consider checking blood for signs of renal failure, hypercalcaemia, liver failure, or blood glucose abnormalities. If the cause is still uncertain or further investigation is not appropriate: Try haloperidol. Usual oral dose: 1.5 mg at night or twice daily and titrate up to a maximum of 10 mg daily (some experts suggest a lower starting dose of 0.5 mg). As-required dose: oral, 1.5 mg; subcutaneous injection,1.25–2.5 mg. Syringe driver dose per 24 hours: 2.5–10 mg. If haloperidol alone

2017 NICE Clinical Knowledge Summaries

160. Otitis externa

the application of topical medication. Follow up of otitis externa is not usually necessary, however, it is recommended for people with severe otitis externa, chronic otitis externa, diabetes mellitus or compromised immunity. Management of localized otitis externa includes: Advising people to apply local heat using a warm flannel — this may be sufficient, as folliculitis is usually mild and self-limiting. Considering incision and drainage if pus is causing severe pain and swelling — this usually requires (...) , or Candida albicans. Deeper infections (of the stratum corneum) are due to epidermophyton, trichophyton, or microsporum genera. Seborrhoeic dermatitis — this may affect the ears in isolation, or be associated with one or more of the following: dandruff, eyebrow scaling, blepharitis, or facial redness and scaling. Contact dermatitis — this is caused by a local irritant or allergen, such as topical medications (for example neomycin ear drops), hearing aids, or earplugs. Allergic contact dermatitis usually

2017 NICE Clinical Knowledge Summaries

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