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First Generation Sulfonylurea

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121. 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

122. Empagliflozin - Benefit assessment

empagliflozin. The pharmaceutical company (hereinafter referred to as “the company”) submitted a first dossier of the drug to be evaluated on 15 August 2014 for the early benefit assessment. This dossier was assessed in dossier assessment A14-26 and in the corresponding addendum A14-50. The company now requested a new benefit assessment because of new scientific findings. The assessment was based on a dossier compiled by the company. The dossier was sent to IQWiG on 29 February 2016. Research question (...) of empagliflozin Research question Subindication a ACT specified by the G-BA A Monotherapy when diet and exercise alone do not provide adequate glycaemic control and the use of metformin is considered inappropriate due to intolerance Sulfonylurea (glibenclamide, glimepiride) B Combination with another blood-glucose lowering drug (except insulin), when this, together with diet and exercise, does not provide adequate glycaemic control Metformin plus sulfonylurea (glibenclamide, glimepiride) (note: if metformin

2016 Institute for Quality and Efficiency in Healthcare (IQWiG)

123. Dulaglutide: benefit assessment according to §35a Social Code Book V (dossier assessment)

of the study = 850 mg/day (within the first 26 weeks) BMI: body mass index; HbA1c: haemoglobin A1c Conducting sensitivity analyses generally is a meaningful approach. The company also used relevant parameters. However, the company conducted no complete sensitivity analyses. In the LAPTOP study, patients were included who received either 3 or 4 mg glimepiride (no change in dosing in the course of the study was envisaged). In the AWARD-2 study, patients were included who received at least 4 mg glimepiride (...) , supplementary outcome) – RCT, indirect comparison: dulaglutide + metformin vs. glimepiride + metformin (research question B) 36 Table 14: Extent of added benefit at outcome level: dulaglutide + metformin vs. metformin + sulfonylurea (glibenclamide or glimepiride) (research question B) 40 Table 15: Positive and negative effects from the assessment of dulaglutide in comparison with metformin + sulfonylurea (glibenclamide or glimepiride) (research question B) 41 Table 16: Dulaglutide – extent and probability

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

124. Insulin degludec/liraglutide: benefit assessment according to §35a Social Code Book V (dossier assessment)

control Metformin + human insulin (Note: If metformin is considered inappropriate according to the SPC, human insulin is to be used as treatment option.) A2 ? When oral antidiabetics in combination with basal insulin do not provide adequate glycaemic control Human insulin + metformin if applicable (Additional administration of metformin is not generally indicated in the framework of an ICT.) a: Subdivisions of the therapeutic indication according to the G-BA. G-BA: Federal Joint Committee; ICT (...) continuation of inadequate treatment), but not the research question of the benefit assessment (added benefit: escalation with insulin degludec/liraglutide versus escalation with the ACT). Study DUAL II Adult patients with type 2 diabetes mellitus and inadequate glycaemic control (7.5% = HbA1c = 10%) despite treatment with a stable dose of a basal insulin + 1 to 2 OADs (metformin ± sulfonylurea or glinides) were included in the DUAL II study. The patients were randomly assigned to basal insulin treatment

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

125. Addendum to Commission A14-12 (canagliflozin)

blood glucose level) in the target population had a mean value of about 7.7% at the start of the study. In the total population (no corresponding data were available for the target population), the HbA1c value was below 6 mg). Figure 3: Time to first hypoglycaemia (symptomatic and documented [ 6 mg [dose level 5] were censored); level 1: 1 mg, level 2: 2 mg, level 3: 4 mg, level 4: 6 mg glimepiride For the majority of patients with hypoglycaemia in the glimepiride group, the first hypoglycaemia (...) was documented in the first study phase, in which titration of glimepiride took place (Figure 3). The mean number of hypoglycaemias over the total course of the study was higher in the glimepiride group than in the canagliflozin groups (Figure 4). The hypoglycaemias were mainly documented in patients with a daily dosage of 6 mg glimepiride (Figure 5). It therefore remains unclear whether and to which extent this increased number of hypoglycaemias was caused by the drug glimepiride or by the therapeutic

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

126. Vildagliptin - Benefit assessment according to §35a Social Code Book V (dossier assessment)

and contraindication or intolerance to metformin who had achieved no sufficient glycaemic control despite treatment Extract of dossier assessment A14-46 Version 1.0 Vildagliptin – Benefit assessment acc. to §35a Social Code Book V 25 February 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - 8 - with sulfonylurea during at least 12 weeks (HbA1c at the first visit = 7.0% and = 8.5%). Moreover, the sulfonylurea had to be the drug glimepiride in a stable dosage of 4 mg daily or, in case (...) indication: dual oral therapy of vildagliptin in combination with a sulfonylurea in patients with insufficient glycaemic control despite monotherapy with maximal tolerated dose of a sulfonylurea and for whom metformin is inappropriate due to contraindications or intolerance. The assessment was based on a dossier compiled by the company. The dossier was sent to IQWiG on 3 December 2014. Research question The aim of the present report was the assessment of the added benefit of vildagliptin in dual oral

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

127. Albiglutide - Benefit assessment according to §35a Social Code Book V (dossier assessment)

the assessment of albiglutide in comparison with metformin + sulfonylurea (glibenclamide or glimepiride) 34 Table 18: Albiglutide + metformin – extent and probability of added benefit 35 Table 19: Albiglutide – extent and probability of added benefit 40 3 Table numbers start with “2” as numbering follows that of the full dossier assessment. Extract of dossier assessment A14-36 Version 1.0 Albiglutide – Benefit assessment acc. to §35a Social Code Book V 23 December 2014 Institute for Quality and Efficiency (...) to contraindications or intolerance Module A monotherapy with albiglutide Sulfonylurea (glibenclamide or glimepiride) B Combination with another blood-glucose lowering drug (except insulin) when this, together with diet and exercise, does not provide adequate glycaemic control Module B albiglutide + metformin Metformin + sulfonylurea (glibenclamide or glimepiride) (note: If metformin is inappropriate according to the SPC, human insulin is to be used as treatment option.) C Combination with at least 2 other blood

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

128. Empagliflozin / linagliptin (Glyxambi) - type 2 diabetes

. At the next stage ready-to-use mixtures of the same composition were introduced instead of individual dispensing of the components, and debossing was introduced. The general manufacturing process remained unchanged. Dissolution profiles remained unchanged. Comparative dissolution profiles between tablet cores and film-coated tablets show a slightly slower dissolution within first 15 minutes for the film-coated tablets but more than 85% of both active substances was dissolved after 15 minutes. All (...) on 29 October 2015. • The Rapporteur's first Assessment Report was circulated to all CHMP members on 10 January 2016. • The Co-Rapporteur's first Assessment Report was circulated to all CHMP members on 13 January 2016. • The PRAC Rapporteur’s assessment Report was circulated on 29 January 2016. • During the meeting on 25 February 2016, the CHMP agreed on the consolidated List of Questions to be sent to the applicant. The final consolidated List of Questions was sent to the applicant on 25 February

2016 European Medicines Agency - EPARs

129. Sex Effects in High-impact Conditions for Women Veterans - Depression, Diabetes, and Chronic Pain

. Center Directors are recognized leaders in the field of evidence synthesis with close ties to the AHRQ Evidence-based Practice Centers. The ESP is governed by a Steering Committee comprised of participants from VHA Policy, Program, and Operations Offices, VISN leadership, field-based investigators, and others as designated appropriate by QUERI/HSR&D. The ESP Centers generate evidence syntheses on important clinical practice topics. These reports help: · Develop clinical policies informed by evidence (...) in older adults More adverse effects on sexual dysfunction Paroxetine Depressive symptoms Antidepressants overall, quality improvement, self-help a Combined antidepressant and psychotherapy for dysthymia Adverse effects overall Antidepressants Diabetes Fracture risk Lower for sulfonylureas (compared with thiazolidinediones) Glycemic control Linagliptin a , vildagliptin a Weight loss Bariatric surgery Chronic pain b Greater improvement in CLBP Quality improvement CLBP Antidepressants a Findings are from

2016 Veterans Affairs Evidence-based Synthesis Program Reports

130. Acute and Chronic Heart Failure Full Text available with Trip Pro

and the patient's caregiver where appropriate and/or necessary. It is also the health professional's responsibility to verify the rules and regulations applicable to drugs and devices at the time of prescription. 2. Introduction The aim of all the ESC Guidelines is to help health professionals to make decisions in their everyday life based on the best available evidence. We will soon be celebrating the 30th anniversary of clinical trials that for the first time incontrovertibly demonstrated that the miserable (...) outcomes. Detailed summaries of the key evidence supporting generally recommended treatments have been provided. For diagnostic recommendations a level of evidence C has been typically decided upon, because for the majority of diagnostic tests there are no data from randomized controlled trials (RCTs) showing that they will lead to reductions in morbidity and/or mortality. Practical guidance is provided for the use of the important disease-modifying drugs and diuretics. When possible, other relevant

2016 European Society of Cardiology

131. Glucagon-Like Peptide-1 receptor analogues

Glucagon-Like Peptide-1 receptor analogues www.sps.nhs.uk | Published December 2016 1 London Medicines Evaluation Network Overview: Glucagon-Like Peptide-1 receptor analogues The first stop for professional medicines advice www.sps.nhs.uk | Published December 2016 2 Metformin Sulphonylurea Pioglitazone Sulphonylurea & Pioglitazone Metformin & Pioglitazone Basal Insulin + Metformin Basal Insulin + Sulphonylurea Basal Insulin + pioglitazone Basal Insulin + metformin + pioglitazone L L L L L NICE (...) monitoring and subsequent dose adjustment on an individual level Licensing(L)/NICE Approval(N) Hypoglycaemic events According to NICE's meta-analysis, three non- insulin based drug combinations (including 2nd intensification with GLP-1 analogues) were generally associated with less hypoglycaemic events compared to the metformin-NPH insulin combination. Not addressed by NICE guidance London Medicines Evaluation Network Overview: Glucagon-Like Peptide-1 receptor analogues Basal Insulin In adults with type

2017 Specialist Pharmacy Services

132. Diabetes Care

if patient presents with depression, falls, cognitive impairment, perceptual difficulties, or urinary incontinence. Use sulfonylureas (especially glyburide) with caution as the risk of hypoglycemia increases with age. Generally, initial doses can be half of those for younger people and increased more slowly. Monitor postural blood pressure. Consider less strict glycemic targets (7.1 - 8.5% A1C) if the individual has limited life expectancy, high functional dependency, extensive disease or multiple co (...) standard targets in people with hypertension and diabetes, although there may be a small reduction in risk for stroke. , Due to the lack of convincing evidence to support more intensive blood pressure control, this guideline recommends the same desirable blood pressure reading in adults with diabetes and hypertension as the general population. Controversies in Care: Sulfonylureas There is some conflicting evidence about the cardiovascular safety of sulfonylureas. Some studies suggest that sulfonylureas

2015 Clinical Practice Guidelines and Protocols in British Columbia

133. Edistride - dapagliflozin

-Rapporteur: Martina Weise • The application was received by the EMA on 3 July 2015. • The procedure started on 27 July 2015. • The Rapporteur's first Assessment Report was circulated to all CHMP members on 1 September 2015. The Co-Rapporteur's first Assessment Report was circulated to all CHMP members on 3 Sptember 2015. • The Rapporteur circulated an updated Assessment Report to all CHMP members on 18 September 2015. • During the meeting on 24 September 2015, the CHMP, in the light of the overall data (...) - interventional and “3” Based on Classification Primary objective: To compare, by insulin use at the index date, the sex-specific incidence of hospitalization or emergency department (ED) visit for severe complications of UTI, defined as pyelonephritis and urosepsis, among patients with T2DM who are new users of dapagliflozin with those who are new users of ADs in classes other than SGLT2 inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylurea monotherapy. Severe complications of UTI Ongoing

2015 European Medicines Agency - EPARs

134. Insulin degludec/Insulin aspart (Ryzodeg 70/30)

report CV cardiovascular CVOT cardiovascular outcomes trial DAMP Data Access Management Plan DBL data base lock DEVOTE Degludec Cardiovascular Outcomes Trial DMC data monitoring committee DPP-4 dipeptidyl peptidase-4 EA event adjudication EAC event adjudication committee ECG electrocardiogram eCRF electronic case report form eGFR estimated glomerular filtration rate EX extension FAS full analysis set FDA Food and Drug Association FF fixed flexible FPFV first patient first visit FPG fasting plasma (...) multiplied by 100) SAE Serious adverse events SAP statistical analysis plan s.c. subcutaneous(ly) SCI Statistics Collaborative Inc. SD standard deviation SI subject information SMBG self-measured blood glucose SMQ standardized MEdDRA query SOC system organ class STC steering committee STEMI ST elevation myocardial infarction SU sulfonylurea SUSAR suspected unexpected serious adverse reaction T1DM type 1 diabetes mellitus T2DM type 2 diabetes mellitus TIA transient ischemic attack U unit UAP unstable

2015 FDA - Drug Approval Package

135. Corluxin - mifepristone

: mifepristone Procedure No. EMEA/H/C/002830/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Corluxin Withdrawal assessment report EMA/235012/2015 Page 2/42 Table of contents 1. Recommendation 6 2. Executive summary 7 2.1. The development programme/compliance with CHMP guidance/scientific advice 7 2.2. General comments on compliance with GMP, GLP, GCP 7 2.3. Type of application and other comments on the submitted dossier 7 3. Scientific (...) of the rapporteur (IMB) and co-rapporteur (ANSM). Discussion topics included quality, pre-clinical and clinical program questions. 2.2. General comments on compliance with GMP, GLP, GCP The CHMP has been assured that acceptable standards of GMP are in place for this product type at the sites responsible for the assembly and batch release of this product. However, such assurance has not been provided in respect of the site responsible for manufacture of the finished product; see section 1 above. A major

2015 European Medicines Agency - EPARs

136. Type 2 diabetes: lixisenatide

in HbA 1c from baseline; 0.3% point greater reduction than placebo. Weight reduction or less weight increase compared with placebo. Safety Safety GLP-1 mimetics have been associated with a risk of developing acute pancreatitis. P Patient factors atient factors Once-daily administration by injection. Nausea, vomiting, diarrhoea and headache are very common (frequency 1 or more in 10), as is hypoglycaemia when lixisenatide is used in combination with a sulfonylurea and/or a basal insulin. When compared (...) adverse reactions during clinical studies of lixisenatide were nausea, vomiting and diarrhoea (very common: frequency 1 or more in 10). These reactions were mostly mild and transient. In addition, headache was also very common, as was hypoglycaemia when lixisenatide was used in combination with a sulfonylurea and/or a basal insulin. The SPC notes that GLP-1 mimetics have been associated with a risk of developing acute pancreatitis. Lixisenatide has a lower acquisition cost than the other GLP-1

2013 National Institute for Health and Clinical Excellence - Advice

137. Type 2 diabetes: insulin degludec

weekly in a treat-to-target approach, and the mean insulin dose increased throughout the trial, these results may be expected. Insulin degludec is given once daily at any time of the day, preferably at the same time every day. On occasions when this is not possible, there can be some flexibility in the timing of insulin administration. The Summary of product Characteristics states that a minimum of 8 hours between injections should always be ensured. Insulin degludec is the first insulin approved (...) approach that addresses blood pressure, blood lipids, and lifestyle issues (for example, smoking cessation, exercise, losing weight and a healthy diet). Controlling blood glucose requires a careful balance between the intensity of the treatment regimen and avoiding hypoglycaemia. The NICE clinical guideline recommends that patients should be involved in setting their individualised HbA 1c target level, which may be above the general target of 48 mmol/mol (6.5%). The guideline also recommends

2013 National Institute for Health and Clinical Excellence - Advice

138. Type 2 diabetes: alogliptin

further DPP-4 inhibitors have been licensed in the UK: saxagliptin and linagliptin. All 4 currently available DPP-4 inhibitors (but not alogliptin) will be included in an update of this guideline. The current NICE clinical guideline on type 2 diabetes recommends the following relating to the use of DPP-4 inhibitors: Consider adding a DPP-4 inhibitor (sitagliptin, vildagliptin) instead of a sulfonylurea as second- line therapy to first-line metformin when control of blood glucose remains or becomes (...) ) as second-line therapy to first-line sulfonylurea monotherapy when control of blood glucose remains or becomes inadequate (HbA1c =6.5% [=48 mmol/mol], or other higher level agreed with the individual) if: the person does not tolerate metformin, or metformin is contraindicated. Consider adding sitagliptin [1] as third-line therapy to first-line metformin and a second-line sulfonylurea when control of blood glucose remains or becomes inadequate (HbA1c =7.5% [=58 mmol/mol] or other higher level agreed

2013 National Institute for Health and Clinical Excellence - Advice

139. Diabetes - type 2

diabetes have a twofold increased risk of stroke within the first five years of diagnosis compared with the general population. About 20% of hospital admissions for heart failure, myocardial infarction, and stroke are in people with diabetes (type 1 or 2). Microvascular complications — nephropathy, retinopathy, and neuropathy. Nephropathy — kidney damage is the largest cause of renal failure in people of working age in the UK. About 3 in 4 people with diabetes will develop some stage of chronic kidney (...) , planning a pregnancy, or breastfeeding. It also does not cover the diagnosis and management of impaired glucose regulation, or make detailed recommendations on the diagnosis and management of other types of diabetes. 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 September 2019 — minor

2019 NICE Clinical Knowledge Summaries

140. Chronic kidney disease

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 February to March 2019 — reviewed. A literature search was conducted in February 2019 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials published since the last revision of this topic. The topic has been updated in line with the National Institute for Health (...) found during the review of this topic. QOF indicators QOF indicators Table 1. Indicators related to chronic kidney disease (CKD) in the Quality and Outcomes Framework (QOF) of the General Medical Services (GMS) contract. Indicator Points CKD005 The contractor establishes and maintains a register of patients aged 18 or over with CKD with classification of categories G3a to G5 (previously stage 3 to 5) 6 SMOK002 The percentage of patients with any or any combination of the following conditions: CHD

2019 NICE Clinical Knowledge Summaries

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