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First Generation Sulfonylurea

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121. Bites - human and animal

prophylaxis for rabies. 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 2018 — minor update. Adverse effects updated within prescribing information - metronidazole. February 2018 — minor update. New guidance from Public Health England regarding Rabies: administration (...) 1 December 2017. Changes in product availability Changes in product availability No changes in product availability since 1 December 2017. Goals and outcome measures Goals and outcome measures Goals Goals To support primary healthcare professionals to: Offer immediate first aid. Reduce the risk of infection. Treat any established infection. Achieve satisfactory wound healing with good cosmetic outcome. Prevent tetanus and rabies where appropriate. Appropriately manage a person's risk

2018 NICE Clinical Knowledge Summaries

122. Dyspepsia - proven functional

, and depression, and managing these appropriately. Reviewing and stopping any drugs which may be exacerbating symptoms, if possible and appropriate. Testing for Helicobacter pylori infection should be arranged if the person's status is not known or uncertain. Ideally a carbon-13 urea breath test or stool antigen test should be used — ensuring the person has not taken a proton pump inhibitor (PPI) in the past 2 weeks, or antibiotics in the past 4 weeks. First-line H. pylori eradication therapy should (...) [ ]. This CKS topic covers the management of adults with endoscopically-determined functional (non-ulcer) dyspepsia. 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 October 2018 — minor update. Adverse effects updated within prescribing information - metronidazole. September 2017

2018 NICE Clinical Knowledge Summaries

123. Impetigo

onwards. This CKS topic covers the management of impetigo. This CKS topic does not cover the management of infected wounds and burns, infected eczema, or cellulitis. 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. CKS gratefully acknowledges the contribution of the British Association of Dermatologists in the development of this topic. How up (...) include skin trauma or pre-existing skin disease, hot/humid weather, poor hygiene, and crowding. [ ; ; ; ; ; ; ; ; ; ; ; ] Incidence How common is it? Impetigo affects all age groups but is most common in young children. A retrospective study using morbidity data from a sentinel general practice network (Royal College of General Practitioners Weekly Returns Service) found the weekly rates of impetigo in England and Wales to be highest in children aged 0–4 years (84 per 100,000) and children aged 5–14

2018 NICE Clinical Knowledge Summaries

124. Otitis media - acute

serious illness or condition. People who have a high risk of complications. If an antibiotic is required, a 5–7 day course of amoxicillin is recommended first-line. Clarithromycin or erythromycin are alternatives for people who are allergic to penicillin (erythromycin is preferred in pregnant women). The following groups of people should be admitted to hospital for immediate specialist assessment: People with a severe systemic infection. People with suspected complications of AOM, such as meningitis (...) , mastoiditis, intracranial abscess, sinus thrombosis, or facial nerve paralysis. Children younger than 3 months of age with a temperature of 38°C or more. Management of persistent AOM involves: Reassessing the person. Considering the need for paediatric or ENT referral or admission, depending on the clinical situation. Considering a first-line antibiotic (if not already prescribed) or a second-line antibiotic if the initial treatment was ineffective. Measures to prevent recurrent AOM include: In children

2018 NICE Clinical Knowledge Summaries

125. Balanitis

? From age 1 month onwards (Male). This CKS topic covers the management of balanoposthitis (otherwise known as balanitis) in boys and adult men presenting in primary care. This CKS topic does not cover the specific management of sexually transmitted infections which may cause or be associated with balanoposthitis. 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 (...) for recommendation The recommendations on assessment are based on expert opinion in the 2013 European guideline for the management of balanoposthitis [ ], expert opinion in the Royal College of General Practitioners and British Association of Sexual Health and HIV (RCGP/BASHH) publication Sexually transmitted infections in primary care [ ], and expert opinion in a review article on benign male genital skin conditions [ ] and penile inflammatory skin disorders [ ]. The European guideline states a sub-preputial

2018 NICE Clinical Knowledge Summaries

126. Dyspepsia - unidentified cause

4 weeks. If the person tests positive for H. pylori infection, first-line eradication therapy should be offered. If symptoms persist or recur, the alternative strategy should be offered. For people with persistent or recurrent symptoms following initial management: Alternative acid suppression therapy with a histamine (H 2 )-receptor antagonist (H 2 RA) may be considered. Long-term acid suppression therapy can be considered if symptoms have previously responded. H. pylori re-testing should (...) symptoms of unknown cause, who have not had an endoscopy. It does not cover the diagnosis or management of upper gastrointestinal malignancy. 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 October 2018 — minor update. Adverse effects updated within prescribing information

2018 NICE Clinical Knowledge Summaries

127. A new blood glucose management algorithm for type 2 diabetes: a position statement of the Australian Diabetes Society

and decrease BGL. Urinary glucose loss is the mechanism for the weight loss associated with these drugs. Side effects include dehydration, dizziness and increased risk of genitourinary infections. The first two can be prevented with adequate fluid intake, and the latter diminished with meticulous hygiene. Use with loop diuretics should be avoided. SGLT2 inhibitors have diminished efficacy in people with renal impairment. PBS reimbursement requires use with metformin or a sulfonylurea but not both. Glucagon (...) A new blood glucose management algorithm for type 2 diabetes: a position statement of the Australian Diabetes Society A new blood glucose management algorithm for type 2 diabetes: a position statement of the Australian Diabetes Society | The Medical Journal of Australia mja-search search Use the for more specific terms. Title contains Body contains Date range from Date range to Article type Author's surname Volume First page doi: 10.5694/mja__.______ Search Reset  close Individual Login

2014 MJA Clinical Guidelines

128. Central Mechanisms of Glucose Sensing and Counterregulation in Defense of Hypoglycemia. (PubMed)

Central Mechanisms of Glucose Sensing and Counterregulation in Defense of Hypoglycemia. Glucose homeostasis requires an organism to rapidly respond to changes in plasma glucose concentrations. Iatrogenic hypoglycemia as a result of treatment with insulin or sulfonylureas is the most common cause of hypoglycemia in humans and is generally only seen in patients with diabetes who take these medications. The first response to a fall in glucose is the detection of impending hypoglycemia

2019 Endocrine Reviews

129. Prospective Postmarketing Surveillance of Acute Myocardial Infarction in New Users of Saxagliptin: A Population-Based Study

August 2014, using data from 18 Mini-Sentinel data partners. We conducted seven sequential assessments comparing saxagliptin separately with sitagliptin, pioglitazone, second-generation sulfonylureas, and long-acting insulin, using disease risk score (DRS) stratification and propensity score (PS) matching to adjust for potential confounders. Sequential testing kept the overall chance of a false-positive signal below 0.05 (one-sided) for each pairwise comparison.We identified 82,264 saxagliptin users (...) and more than 1.5 times as many users of each comparator. At the end of surveillance, the DRS-stratified hazard ratios (HRs) (95% CI) were 1.08 (0.90-1.28) in the comparison with sitagliptin, 1.11 (0.87-1.42) with pioglitazone, 0.79 (0.64-0.98) with sulfonylureas, and 0.57 (0.46-0.70) with long-acting insulin. The corresponding PS-matched HRs were similar. Only one interim analysis of 168 analyses met criteria for a safety signal: the PS-matched saxagliptin-pioglitazone comparison from the fifth

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2017 EvidenceUpdates

130. Therapies for type 2 diabetes: improving outcomes that matter

, tolerability, effectiveness, prince, and simplicity) to . Their analysis confirmed that metformin should be first-line pharmacotherapy for most persons with type 2 diabetes. Other key points from include: Safety - Sulfonylureas, insulins, meglitinides, and pramlintide increase risk of hypoglycemia. Metformin and acarbose require monitoring, dose adjustments, or discontinuation in patients with chronic kidney disease. Tolerability - Side effects across different drug classes range from gastrointestinal (...) - Metformin, acarbose, sulfonylureas, and generic pioglitazone are the most affordable options. Simplicity - Acarbose and meglitinides are taken three times daily before meals, while insulins, GLP-1 receptor agonists, and pramlintide require subcutaneous injections. Posted by kennylin at Search This Blog Blog Archive (11) (2) (4) (5) (50) (3) (4) (5) (4) (4) (5) (3) (4) (5) (4) (4) (5) (49) (3) (4) (5) (4) (3) (5) (4) (5) (4) (4) (4) (4) (51) (3) (4) (5) (4) (5) (4) (4) (5) (4) (4) (5) (4) (50) (4) (5) (4

2019 The AFP Community Blog

131. Richard Lehman’s journal reviews—23 July 2018

randomised controlled trials: even sham-controlled randomised trials. Knee arthroscopic procedures were the first to fail the criteria of evidence based medicine. . I say “now” although this Finnish study debunking subacromial decompression is only the latest of a succession. Deadoption is a slow process. To paraphrase Upton Sinclair, it is difficult to get a man to understand something when his new Porsche depends on his not understanding it. Sulfonylureas: dangerous drugs for diabetes “ , all cause (...) pathogens has become conflated with a general we’re-all-doomed narrative in which the culprits are doctors who show inadequate “antibiotic stewardship.” There’s more about this in JAMA Intern Med below. As a GP who fell under this cosh I used to long for the emergence of a reliable method for distinguishing between bacterial and viral infection. And then came procalcitonin. It’s a blood marker that goes up if you are fighting bacterial infection, and down when you are winning. It doesn’t respond

2018 The BMJ Blog

132. Richard Lehman’s journal review—23 April 2018

related to the drug product.” Ambulatory BP is most predictive The GP practice I worked in was one of the first in the world to have an ambulatory blood pressure machine (in the early 1990s) and we kept on producing measurements which in those days we had no means of interpreting. It struck me that it would probably be another 20 years before we knew their prognostic significance. Well, the 20+ years have gone by and this is the conclusion: “ ” This analysis was based on a national cohort (...) level and the outcomes desired.” Maybe. JAMA Int Med Apr 2018 Hypoglycaemia: look at patients not hospital data In primary care, we used to see sulfonylurea-induced hypoglycaemia in type 2 diabetic patients all the time, but very little of it reached hospital. The same is still true in America, : “ Surveillance of severe hypoglycemia in the United States is currently based on hypoglycemic events resulting in ED or hospital utilization recorded in the EMR. Although hypoglycemia-related ED visits

2018 The BMJ Blog

133. Semaglutide (Ozempic) - the treatment of adults with insufficiently controlled type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise

Information The starting dose is 0.25mg semaglutide once weekly. After 4 weeks the dose should be increased to 0.5mg once weekly. After at least 4 weeks with a dose of 0.5mg once weekly, the dose can be increased to 1.0mg once weekly to further improve glycaemic control. Semaglutide 0.25mg is not a maintenance dose. Weekly doses higher than 1.0mg are not recommended. When semaglutide is added to existing therapy of sulfonylurea or insulin, a reduction in the dose of sulfonylurea or insulin should (...) be considered to reduce the risk of hypoglycaemia. When initiating treatment with semaglutide in combination with a sulfonylurea or an insulin, blood glucose self-monitoring may become necessary to adjust the dose of the sulfonylurea or the insulin to reduce the risk of hypoglycaemia. Semaglutide is to be administered once weekly at any time of the day, with or without meals. Semaglutide is to be injected subcutaneously in the abdomen, in the thigh or in the upper arm. The injection site can be changed

2019 Scottish Medicines Consortium

134. Semaglutide (Ozempic) - Diabetes Mellitus

. However, the study groups and design of these trials were not identical. Therefore, the suggested dose regimen is questionable. As shown in trial 1821, the incidence of GI AEs generally decreased within the first 12 weeks of treatment. Therefore, a 12 week dose escalation regimen might improve the GI tolerability and reduce withdraws. In the answer, the Applicant, based on the data obtained in the phase 3a programme, presented a time course-model for nausea to describe the prevalence of nausea over (...) of exposure PYO patient year of observation RMP risk management plan RR rate ratio SAE serious adverse event SAP statistical analysis plan SBP systolic blood pressure s.c. sub cutaneous sema semaglutide SGLT-2 sodium-dependent glucose transporter two SMQ standardised MedDRA query SOC system organ class SU sulfonylurea SUSTAIN Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes T2D type 2 diabetes mellitus TNF-alpha tumour necrosis factor alpha TZD thiazolidinediones UACR urinary albumin

2018 European Medicines Agency - EPARs

135. Empagliflozin - Addendum to Commission A16-12

] of its dossier on empagliflozin, the pharmaceutical company (hereinafter referred to as “the company”) had presented a study of direct comparison and 2 indirect comparisons for research question B (empagliflozin plus another blood-glucose lowering drug except insulin 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 (...) presented study 1245.28 for the comparison of empagliflozin in combination with another blood-glucose lowering drug except insulin in comparison with metformin in combination with a sulfonylurea (glibenclamide, glimepiride). 2.1.2.1 Study design and study characteristics A detailed description of study 1245.28, its limitations, as well as tables presenting the study characteristics, the interventions, and the study population can be found in the first benefit assessment of empagliflozin [3]. 2.1.2.2

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

136. Saxagliptin - Benefit assessment according to §35a Social Code Book V

identified the SAVOR-TIMI 53 study and, on the other, 2 studies for an indirect comparison: study CV181040 (saxagliptin versus placebo) and study Tovi 1998 (sulfonylurea versus placebo). Together with 4 other studies on the ACT, the company had already presented the 2 studies CV181040 and Tovi 1998 for the first assessment of saxagliptin. Based on this, the company had conducted an indirect comparison, which was irrelevant for the benefit assessment. The indirect comparison now presented on the basis (...) D1680L00006 (saxagliptin plus metformin plus sulfonylurea versus placebo plus metformin plus sulfonylurea). The company had already presented the D1680L00006 study and an indirect comparison based on it for the first assessment of saxagliptin. This was irrelevant for the benefit assessment because the studies on the ACT were unsuitable. The analysis of the SAVOR-TIMI 53 study presented by the company for research question D was unsuitable for the present benefit assessment. From the total population

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

137. Sitagliptin - Benefit assessment according to §35a Social Code Book V

[glibenclamide, glimepiride]) (research question A1) and, additionally, versus glipizide (research question A2) in this assessment in 2 separate research questions. Research question A1: sitagliptin versus sulfonylurea (glibenclamide, glimepiride) As in the first assessment, the company included one study of direct comparison (P251) for research question A1. This study was unsuitable for the assessment of the added benefit because it can be assumed that the majority of the patients enrolled did not fulfil (...) a joint consideration of all studies versus sulfonylurea, the company also derived an added benefit for all-cause mortality. 2.4.3.3 Subgroups and other effect modifiers As in the first assessment, the subgroup analysis on all-cause mortality is presented according to sex in the present benefit assessment because all deaths occurred in the subgroup of men. In its new dossier, the company additionally presented data on possible effect modifications by region. It considered an influence of the effects

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

138. Saxagliptin/metformin - Benefit assessment according to §35a Social Code Book V

the treating physician apparently considered sulfonylureas to be unsuitable or not necessary. From the placebo group, however, only patients were chosen who received sulfonylureas for the first 3 months after randomization. These different selection criteria chosen by the company for both treatment arms were another reason why structural equality of the comparator groups formed by the company was not ensured. 4) The company selected post hoc patients in the placebo arm who received sulfonylureas within 3 (...) /metformin (type 2 diabetes mellitus) 29 September 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - 1 - 2 Benefit assessment 2.1 Executive summary of the benefit assessment Background In accordance with §35a Social Code Book (SGB) V, the Federal Joint Committee (G-BA) commissioned the Institute for Quality and Efficiency in Health Care (IQWiG) to assess the benefit of saxagliptin/metformin. The pharmaceutical company (hereinafter referred to as “the company” submitted a first dossier

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

139. Sitagliptin/metformin - Benefit assessment according to §35a Social Code Book V

. In both cases, this added benefit is limited to patients in whom near-normal blood glucose levels are aimed at. For patients without such a treatment goal, there is no proof of added benefit of sitagliptin/metformin. Research question B: sitagliptin/metformin plus sulfonylurea As in the first assessment, the company identified no study on the combination of sitagliptin/metformin plus sulfonylurea versus the ACT. Hence the added benefit of sitagliptin/metformin plus sulfonylurea is not proven. Research (...) comparisons from the steps of information retrieval mentioned: HARMONY 3, P803 and P024. Two of these studies investigated the comparison of sitagliptin/metformin versus the ACT specified by the G-BA (sulfonylurea [glibenclamide, glimepiride] plus metformin) and one study (P024) investigated the comparison of sitagliptin/metformin versus glipizide plus metformin. The studies P803 and P024 had already been presented for the first benefit assessment of sitagliptin (see Commission A13-02 [8]). The multi-arm

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

140. Empagliflozin/metformin - benefit assessment

specified by the G-BA. These are shown in Table 2. Table 2: Research questions of the benefit assessment of empagliflozin/metformin Research question Subindication a ACT specified by the G-BA A Fixed combination of empagliflozin and metformin in patients inadequately controlled on their maximally tolerated dose of metformin alone as an adjunct to diet and exercise Metformin plus sulfonylurea (glibenclamide, glimepiride) B Combination therapy with other blood-glucose lowering drugs except insulin (...) in the first dossier and in the corresponding commenting procedure on empagliflozin (single agent). Irrespective of the question whether the data presented by the company were at all relevant for the benefit assessment, the company’s assessment was incomplete with regard to content because it did not analyse all relevant outcomes. Moreover, the documents presented by the company were self-contradictory. Direct comparison The company presented study 1245.28 to prove the added benefit of empagliflozin

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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