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First Generation Sulfonylurea

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141. Empagliflozin/Metformin

referred to as “the company”) presented a study of direct comparison and 2 indirect comparisons for research question A (empagliflozin/metformin in comparison with metformin plus sulfonylurea). All studies used for this were already known from the first assessment A14-26 [3]. The data presented by the company were incomplete, however. In addition, there were noticeable discrepancies between the company’s analyses in Module 4 A and the corresponding clinical study reports (CSRs). Furthermore (...) in the first benefit assessment of empagliflozin [3]. In its dossier on empagliflozin/metformin [2], the company presented results of study 1245.28 on the subpopulation of patients who received a daily dose of at least 1700 mg metformin. This corresponded to the relevant subpopulation for the assessment of empagliflozin/ metformin. It comprised about 70% of the total study population. In its dossier, the company did not present results on several patient-relevant outcomes, however, although it was already

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

142. Saxagliptin/metformin (type 2 diabetes) - Benefit assessment according to §35a Social Code Book V

approved in June 2017: ? saxagliptin/metformin in combination with other medicinal products for the treatment of diabetes (except insulin and sulfonylurea) (as an adjunct to diet and exercise in patients with type 2 diabetes mellitus inadequately controlled with metformin and these medicinal products) The assessment was conducted in comparison with the G-BA’s ACT. This ACT is shown in Table 2. Table 2: Research question of the benefit assessment of saxagliptin/metformin in type 2 diabetes mellitus (...) Subindication ACT a Saxagliptin/metformin plus other drugs for the treatment of diabetes (except insulin and sulfonylurea) ? Human insulin b plus metformin or ? human insulin plus empagliflozin c or ? human insulin if, according to the SPC, metformin and empagliflozin are unsuitable or not sufficiently effective due to intolerance or contraindication a: Presentation of the respective ACT specified by the G-BA. In cases where the company, because of the G-BA’s specification of the ACT, could choose

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

143. Lyxumia (lixisenatide)

Lyxumia (lixisenatide) Report on the Deliberation Results May 31, 2013 Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare [Brand name] Lyxumia Subcutaneous Injection 300 µg [Non-proprietary name] Lixisenatide (JAN*) [Name of applicant] Sanofi K.K. [Date of application] June 11, 2012 [Results of deliberation] In the meeting held on May 24, 2013, the First Committee on New Drugs concluded that the product may be approved (...) and elderly patients (limited numbers of these patients were included in clinical studies), the safety and efficacy of the product in combination with a sulfonylurea and high-dose metformin, and the long-term safety and efficacy of the product in combination with basal insulin, etc. need to be further investigated via post-marketing surveillance. As a result of its regulatory review, the Pharmaceuticals and Medical Devices Agency has concluded that the product may be approved for the following indication

2013 Pharmaceuticals and Medical Devices Agency, Japan

144. Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada : Diabetes in the elderly

, side effects and adverse drug interactions . Drugs that can be considered first for deprescribing in these individuals include statins and sulfonylureas, because of lack of benefit in people with limited life expectancy and concerns about hypoglycemia, respectively. Diabetes in Long-Term Care The prevalence of diabetes is high in institutions and individuals frequently have established microvascular and CV complications, as well as substantial comorbidity . Canadian data shows over 25% of residents (...) because the risk of hypoglycemia increases substantially with age [Grade D, Level 4 ]. DPP-4 inhibitors should be used over sulfonylureas as second-line therapy to metformin because of a lower risk of hypoglycemia [Grade B, Level 2 ] In general, initial doses of sulphonylureas in the older person should be half of those used for younger people, and doses should be increased more slowly [Grade D, Consensus] Gliclazide and gliclazide MR [Grade B, Level 2 ] and glimepiride [Grade C, Level 3 ] should

2013 CPG Infobase

145. Vestibular neuronitis

is healthcare professionals working within the NHS in the UK, and providing first contact or primary health care. How up-to-date is this topic? How up-to-date is this topic? Changes Changes November 2017 — reviewed. A literature search was conducted in August 2017 to identify evidence-based guidelines, UK policy, systematic reviews, and key RCTs published since the last revision of this topic. Minor changes have been made to the sections on diagnosis and symptomatic treatment and a link to patient (...) of vertigo). Complications What are the complications? Benign paroxysmal positional vertigo (BPPV) can develop following vestibular neuronitis in around 1 in 10 people [ ; ; ]. For more information on the features of this condition, see the CKS topic on . A prospective cohort study found that of 51 people with vestibular neuronitis, five (10%) were subsequently affected with BPPV, more than would be expected in the general population. BPPV occurred in the posterior canal of the ear affected by vestibular

2017 NICE Clinical Knowledge Summaries

146. Breastfeeding problems

on the diagnosis and management of mastitis or breast abscess. There are separate CKS topics on , , , and . The target audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact or primary healthcare. How up-to-date is this topic? How up-to-date is this topic? Changes Changes May 2017 — minor update. Recommendations on use of soft paraffin or purified lanolin cream revised to reflect evidence-base. December 2016 to January 2017 — reviewed. A literature (...) effectively and frequently. Engorgement Primary engorgement occurs in the first few days after birth when there has been no or insufficient milk removal, for example due to delayed initiation of breastfeeding. This leads to venous or lymphatic stasis before the onset of milk secretion. Secondary engorgement occurs when breastfeeding is less frequent or restricted, or infant demands have decreased, leading to obstruction of the lactiferous ducts following the onset of breastfeeding. If milk is not removed

2017 NICE Clinical Knowledge Summaries

147. Meniere's disease

, or tinnitus. There are separate CKS topics on , , , and . The target audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact or primary health care. How up-to-date is this topic? How up-to-date is this topic? Changes Changes October to November 2017 — reviewed. A literature search was conducted in August 2017 to identify evidence-based guidelines, UK policy, systematic reviews, and key RCTs published since the last revision of this topic (...) hearing loss, and tinnitus and is associated with a feeling of fullness in the affected ear [ ; ; ]. Cause What causes it? In most people with Meniere's disease, the cause is unknown [ ]. There is a general view that abnormal endolymph production and/or absorption is associated with Meniere's disease [ ]. The volume of endolymph in the membranous labyrinth increases and the volume of perilymph filling the bony labyrinth and around the membranous labyrinth decreases (endolymphatic hydrops

2017 NICE Clinical Knowledge Summaries

148. Vertigo

audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact or primary health care. How up-to-date is this topic? How up-to-date is this topic? Changes Changes December 2017 — revised. A literature search was conducted in August 2017 to identify evidence-based guidelines, UK policy, systematic reviews, and key RCTs published since the last revision of the topic. There have been structural changes to the topic and a new section has been created (...) in the community, around a third were found to have vertigo, this proportion increasing with age [ ]. In a community study of more than 2000 randomly sampled adults, 7% had reported true vertigo in the previous year [ ]. A systematic review of 20 studies of the epidemiology of balance symptoms and disorders in the community estimated the lifetime prevalence of vertigo to be 3–10% [ ]. A full-time general practitioner is likely to see 10–20 people with vertigo in 1 year [ ]. A German study found that, in a year

2017 NICE Clinical Knowledge Summaries

149. Candida - skin

of oral or systemic candidiasis, nappy rash, candidal balanitis, candidal nail infections, or dermatophyte skin and nail infections. It also does not cover the prevention of candidal infections in susceptible groups. There are separate CKS topics on , , , , , , , , , , , , and . The target audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact or primary healthcare. How up-to-date is this topic? How up-to-date is this topic? Changes (...) of immunosuppressive drugs [such as corticosteroids]). General debility, for example from cancer or malnutrition. Recent or concurrent use of drugs that promote candidal growth, particularly broad-spectrum antibiotics and inhaled or oral corticosteroids. Extremes of ages — due to immature or weakened immunity. Diseases in which the barrier function of the skin is disturbed (such as psoriasis and seborrhoeic eczema). Endocrine disorders, such as: Diabetes mellitus — see the CKS topics on and for more information

2017 NICE Clinical Knowledge Summaries

150. Candida - oral

. Miconazole oral gel is recommended first-line for children aged 4 months and over (unlicensed for use in a child aged younger than 4 months, or 5–6 months for an infant born pre-term). Care should be taken when applying the gel to the mouth of infants and young children due to the risk of choking. If miconazole oral gel is unsuitable, nystatin suspension (unlicensed for use in neonates) should be offered. If topical treatment is ineffective, infection is extensive or severe, or the person (...) , and providing first contact or primary healthcare. How up-to-date is this topic? How up-to-date is this topic? Changes Changes September 2019 — minor update. The section on management of oral candida in children, and the prescribing section have been updated to clarify that the use of oral miconazole gel in children aged under 4 months is unlicensed. August 2017 — minor update. Changes to the drug interactions section for miconazole gel in accordance with changes to the manufacturer's summary of product

2017 NICE Clinical Knowledge Summaries

151. Candida - female genital

(such as soaps and shower gels). General care of the vulval skin (for example moisturising with a simple emollient). Specialist advice should be sought, or referral arranged, if: The diagnosis is unclear. Symptoms do not improve following treatment. Non-albicans Candida species infection is present. Systemic symptoms occur. Have I got the right topic? Have I got the right topic? From age 12 years onwards (Female). This CKS topic covers the primary care management of vulvovaginal candidiasis (genital thrush (...) ). This CKS topic does not cover the management of other causes of vaginal discharge and itching. There are separate CKS topics on , , , , , , and . The target audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact or primary healthcare. How up-to-date is this topic? How up-to-date is this topic? Changes Changes May 2017 — minor update. The prescribing information section has been simplified. Minor typographical errors have been corrected

2017 NICE Clinical Knowledge Summaries

152. Update on Prevention of Cardiovascular Disease in Adults With Type 2 Diabetes Mellitus in Light of Recent Evidence

further research. Throughout, we emphasize that this document is not a comprehensive review of the literature but rather a focus on the major new trials that have led to recent guideline changes in the area of primary prevention of CVD in type 2 diabetes mellitus. New Diagnostic Criteria for Diabetes Mellitus and Prediabetes In 2010, the ADA included A 1c for the first time among the tests recommended for the diagnosis of diabetes mellitus. This recommendation has also been adopted by the European (...) , legumes, vegetables, whole grains, and dairy products in place of other carbohydrate sources ( ADA Level of Evidence B ).Mediterranean-style dietary pattern may improve glycemic control and CVD risk factors ( ADA Level of Evidence B ).Limit of sodium to <2300 mg/d, similar to recommendations for the general population ( ADA Level of Evidence B ; note that the AHA differs and recommends sodium <1500 mg/d). Obesity “2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults

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2015 American Heart Association

153. Sex Differences in the Cardiovascular Consequences of Diabetes Mellitus

in CVD Risk Factors and Outcomes in DM Sex Differences Risk factor Sex hormones: testosterone High bioavailable or unbound testosterone predicts incident coronary events Low levels of total testosterone predict incident coronary events Generalized obesity Higher prevalence of obesity in women, particularly postmenopausal women, than men HDL-C Women have higher HDL-C compared with men Hypertension Women with DM have more hypertension at >60 y of age (ie, postmenopausal) Men with DM and hypertension (...) in DM? For years, it has been recognized that the incidence of coronary heart disease (CHD) in women lags behind that of men by ≈10 years, thus generating hypotheses that differences in endogenous sex steroid levels contribute to sex differences in CHD. It also has been recognized for years that DM confers greater risk for CHD death in women compared with men. Early Rancho Bernardo Study publications noted that men with DM by history or by fasting plasma glucose had a 2.4-fold excess risk

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2015 American Heart Association

154. Second and Third-line Therapies for Type 2 Diabetes

nutrition, and adequate exercise), medications, such as metformin and sulfonylureas, play an important role in achieving glycemic control in patients with diabetes mellitus: Metformin is a popular first-line oral antidiabetes drug that is used to help control glycemic levels in patients with diabetes when lifestyle modifications alone are insufficient. Because diabetes is a progressive disease, metformin monotherapy may eventually fail to adequately control glycemic levels. At this point, most patients (...) need one or more oral antidiabetes drug, or insulin, added as a second-line therapy to their treatment regimen. If, after time, second-line therapy fails, most patients will need one or more additional drugs added as a third-line therapy to achieve target glycemic levels. In Canada, seven classes of antidiabetes drugs are available that may be used as second- and third-line therapy: sulfonylureas, meglitinides, alpha-glucosidase inhibitors, thiazolidinediones, incretin agents, weight loss agents

2015 CADTH - Optimal Use

155. Second- and Third-line Therapies for Type 2 Diabetes

nutrition, and adequate exercise), medications, such as metformin and sulfonylureas, play an important role in achieving glycemic control in patients with diabetes mellitus: Metformin is a popular first-line oral antidiabetes drug that is used to help control glycemic levels in patients with diabetes when lifestyle modifications alone are insufficient. Because diabetes is a progressive disease, metformin monotherapy may eventually fail to adequately control glycemic levels. At this point, most patients (...) need one or more oral antidiabetes drug, or insulin, added as a second-line therapy to their treatment regimen. If, after time, second-line therapy fails, most patients will need one or more additional drugs added as a third-line therapy to achieve target glycemic levels. In Canada, seven classes of antidiabetes drugs are available that may be used as second- and third-line therapy: sulfonylureas, meglitinides, alpha-glucosidase inhibitors, thiazolidinediones, incretin agents, weight loss agents

2015 CADTH - Optimal Use

156. Clinical Practice Guideline on management of patients with diabetes and chronic kidney disease stage 3b or higher (eGFR <45 mL/min)

dialysis or haemodialysis as a first modality? Statements 1.1.1 We recommend giving priority to the patient's general status and preference in selecting renal replacement therapy as there is an absence of evidence of superiority of one modality over another in patients with diabetes and CKD stage 5 (1C). 1.1.2 We recommend providing patients with unbiased information about the different available treatment options (1A). 1.1.3 In patients opting to start haemodialysis (HD), we suggest prefering high (...) is this guideline for? This guideline intends to support clinical decision making by any health care professional caring for patients with diabetes and CKD stage 3b or higher (eGFR <45 mL/min), i.e. for general practitioners, internists, surgeons and other physicians dealing with this specific patient population in both an outpatient and an in-hospital setting. The guideline also aims to inform about the development of standards of care by policy-makers. 5.3. What is this guideline about? The intended scope

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2015 European Renal Best Practice

157. Empagliflozin (Jardiance) - type 2 diabetes mellitus

measures is a prerequisite to drug treatment for glycaemic control. Drug strategy: According to the HAS guidelines, if the glycaemic target is not met despite the implementation of lifestyle and dietary measures, monotherapy should be started with metformin as the first-line treatment or, if there are contraindications, with sulfonylureas. If both these drugs are contraindicated, the alternatives are: - repaglinide in patients who eat at irregular intervals, since it is administered with every meal (...) (short half-life); - alpha-glucosidase inhibitors if episodes of hypoglycaemia give cause for concern. If there are symptoms or very poorly controlled diabetes with recurrent blood glucose levels above 3 g/l or with an HbA1c greater than 10%, dual therapy or insulin therapy may be initiated from the start. Combinations recommended as dual therapy: If the glycaemic target is not achieved with monotherapy, dual therapy is recommended, combining metformin and sulfonylureas as first-line treatment

2015 Haute Autorite de sante

158. Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes

Recommendations Recommendations 1.1 Canagliflozin, dapagliflozin and empagliflozin as monotherapies are recommended as options for treating type 2 diabetes in adults for whom metformin is contraindicated or not tolerated and when diet and exercise alone do not provide adequate glycaemic control, only if: a dipeptidyl peptidase-4 (DPP-4) inhibitor would otherwise be prescribed and a sulfonylurea or pioglitazone is not appropriate. 1.2 Adults whose treatment with canagliflozin, dapagliflozin or empagliflozin (...) that given the infrequency of reported hypoglycaemia, the similar outcomes between active and placebo arms, and the cut-off level used, it was reasonable to assume that the SGLT-2 inhibitors did not cause hypoglycaemia. For cholesterol, not all trials reported all outcomes. Generally, the SGLT-2 inhibitors led to increases in all types of cholesterol. Adverse effects of treatment 3.9 The AG reviewed outcomes related to adverse effects of treatment in the clinical trials. The SGLT-2 inhibitors were

2016 National Institute for Health and Clinical Excellence - Technology Appraisals

159. Cardiovascular Disease Risk Factors in Youth With Diabetes Mellitus

pediatric T2DM should be associated with weight loss or at least should have a weight-neutral effect. According to recent guidelines from the American Academy of Pediatrics, metformin should be the first-line therapy for the treatment of pediatric T2DM. In general, metformin is associated with modest weight loss. Three randomized, placebo-controlled trials conducted in obese youth without diabetes mellitus reported a BMI reduction of ≈3% over a treatment period of 6 to 12 months. Neither glucagon-like (...) and require further study. In the general population, female individuals have lower CVD risk than male individuals. However, this protective effect of female sex is lost with T1DM; CVD risk in female individuals approaches that of male individuals. , CVD risk factor management in T1DM needs to be improved. Type 2 Diabetes Mellitus Before the 1990s, T2DM was rarely diagnosed in youth, but increased rates now parallel the increasing rates of pediatric obesity. Although rates of T2DM in youth have increased

2014 American Heart Association

160. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for CYP2C9 and HLA-B Genotype and Phenytoin Dosing

contains three classes (I, II, and III). Major histocompatibility complex class I contains three genes: HLA-B, HLA-A, and HLA-C. HLA-B encodes a cell surface protein that binds peptides generated by proteolysis and extruded from proteasomes. The presentation of these peptides on the cell surface enables the immune system to distinguish self-proteins from foreign proteins typically intro- duced by infectious organisms (e.g., viruses and bacteria) (see Supplementary Material online for further discussion (...) by the gene name, which is followed by an asterisk and up to an eight-digit (four pairs) identifier giving information about the allele type (designated by the first two digits) and specific protein subtypes (second set of digits). For more information and a diagram outlining the description of the current HLA allele nomenclature, see http://hla.alleles.org/ Received 10 June 2014; accepted 31 July 2014; advance online publication 17 September 2014. doi:10.1038/clpt.2014.159 Clinical Pharmacology

2014 Clinical Pharmacogenetics Implementation Consortium

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