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Management of hyperglycemia in type 2 diabetes - a patient-centered approach - position statement of the ADA and EASD
Glycemic management in type 2 diabetes mellitus has become increasingly complex and, to some extent, controversial, with a widening array of pharmacological agents now available, mounting concerns about their potential adverse effects and new uncertainties regarding the benefits of intensive glycemic control on macrovascular complications. Many clinicians are therefore perplexed as to the optimal strategies for their patients.
As a consequence, the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) convened a joint task force to examine the evidence and develop recommendations for antihyperglycemic therapy in nonpregnant adults with type 2 diabetes. Several guideline documents have been developed by members of these two organizations and by other societies and federations. However, an update was deemed necessary because of contemporary information on the benefits/risks of glycemic control, recent evidence concerning efficacy and safety of several new drug classes, the withdrawal/restriction of others, and increasing calls for a move toward more patient-centered care.
Intensive glycemic control and the prevention of cardiovascular events - implications of the ACCORD, ADVANCE, and VA diabetes trials
Diabetes is defined by its association with hyperglycemia-specific microvascular complications; however, it also imparts a two- to fourfold risk of cardiovascular disease. Although microvascular complications can lead to significant morbidity and premature mortality, by far the greatest cause of death in people with diabetes is CVD.
Because of ongoing uncertainty regarding whether intensive glycemic control can reduce the increased risk of CVD in people with type 2 diabetes, several large long-term trials were launched in the past decade to compare the effects of intensive versus standard glycemic control on CVD outcomes in relatively high-risk participants with established type 2 diabetes. In 2008, two of these trials, ADVANCE and VADT, were completed and showed no significant reduction in cardiovascular outcomes with intensive glycemic control. A third trial, ACCORD, terminated its glycemic control study early due to the finding of increased mortality in participants randomized to a strategy of very intensive glycemic control with a target A1C of <6%. The findings of these three major trials led the ADA, with representatives of the American Heart Association (AHA) and the American College of Cardiology (ACC), to reexamine the recommendations for glycemic targets in patients with diabetes, the majority of whom have type 2 diabetes.
Diabetes mellitus is a complex, chronic illness requiring continuous medical care with multifactorial risk reduction strategies beyond glycemic control. Ongoing patient self-management education and support are critical to preventing acute complications and reducing the risk of long-term complications. Significant evidence exists that supports a range of interventions to improve diabetes outcomes.
The Standards of Care recommendations are not intended to preclude clinical judgment and must be applied in the context of excellent clinical care and with adjustments for individual preferences, comorbidities, and other patient factors.
Estão estas inovações terapêuticas ao dispor dos diabéticos portugueses? A resposta é sim e não. Segundo o Observatório da Diabetes 2015 a prevalência da diabetes é de 13,1% da população portuguesa (20-70 anos) dos quais 5,7% não sabem que são diabéticos. A diabetes tipo 1 é o tipo menos frequente de diabetes mas atinge pessoas em idades mais frágeis (crianças e adolescentes), e obriga à administração diária de várias injecções de insulina para toda a vida. A diabetes tipo 2 é mais comum em pessoas adultas e obesas e o tratamento inicial é emagrecer e antidiabéticos orais.
European Society of Endocrinology Clinical Practice Guideline for long-term follow-up of patients operated on for a phaeochromocytoma or a paraganglioma
Phaeochromocytomas and paragangliomas (PPGLs) are rare neuroendocrine tumours. Standard treatment is surgical resection. Following complete resection of the primary tumour, patients with PPGL are at risk of developing new tumoural events. The present guideline aims to propose standardised clinical care of long-term follow-up in patients operated on for a PPGL. The guideline has been developed by The European Society of Endocrinology and based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) principles. We performed a systematic review of the literature and analysed the European Network for the Study of Adrenal Tumours (ENS@T) database. The risk of new events persisted in the long term and was higher for patients with genetic or syndromic diseases. Follow-up in the published cohorts and in the ENS@T database was neither standardised nor exhaustive, resulting in a risk of follow-up bias and in low statistical power beyond 10 years after complete surgery. To inform patients and care providers in this context of low-quality evidence, the GuidelineWorking Group therefore prepared recommendations on the basis of expert consensus. Key recommendations are the following: we recommend that all patients with PPGL be considered for genetic testing; we recommend assaying plasma or urinary metanephrines every year to screen for local or metastatic recurrences or new tumours; and we suggest follow-up for at least 10 years in all patients operated on for a PPGL. High-risk patients (young patients and those with a genetic disease, a large tumour and/or a paraganglioma) should be offered lifelong annual follow-up.
Diagnosis and Treatment of Primary Adrenal Insufficiency: An Endocrine Society Clinical Practice Guideline
Objective: This clinical practice guideline addresses the diagnosis and treatment of primary adrenal insufficiency.
Participants: The Task Force included a chair, selected by The Clinical Guidelines Subcommittee of the Endocrine Society, eight additional clinicians experienced with the disease, a methodologist, and a medical writer. The co-sponsoring associations (European Society of Endocrinology and the American Association for Clinical Chemistry) had participating members. The Task Force received no corporate funding or remuneration in connection with this review.
2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer
Background Thyroid nodules are a common clinical problem, and differentiated thyroid cancer is becoming increasingly prevalent. Since the American Thyroid Association's (ATA's) guidelines for the management of these disorders were revised in 2009, significant scientific advances have occurred in the field. The aim of these guidelines is to inform clinicians, patients, researchers, and health policy makers on published evidence relating to the diagnosis and management of thyroid nodules and differentiated thyroid cancer. Methods: The specific clinical questions addressed in these guidelines were based on prior versions of the guidelines, stakeholder input, and input of task force members. Task force panel members were educated on knowledge synthesis methods, including electronic database searching, review and selection of relevant citations, and critical appraisal of selected studies.
Acromegaly: An Endocrine Society Clinical Practice Guideline
This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. The Task Force reviewed primary evidence and commissioned two additional systematic reviews.
Using an evidence-based approach, this acromegaly guideline addresses important clinical issues regarding the evaluation and management of acromegaly, including the appropriate biochemical assessment, a therapeutic algorithm, including use of medical monotherapy or combination therapy, and management during pregnancy.
Interdisciplinary European Guidelines on Metabolic and Bariatric Surgery
In 2012, an outstanding expert panel derived from IFSO-EC (International Federation for the Surgery of Obesity – European Chapter) and EASO (European Association for the Study of Obesity), composed by key representatives of both Societies including past and present pres- idents together with EASO’s OMTF (Obesity Management Task Force) chair, agreed to devote the joint Medico-Surgical Workshop of both institutions to the topic of metabolic surgery as a pre-satellite of the 2013 European Congress on Obesity (ECO) to be held in Liverpool given the extraordinarily advancement made specifically in this field during the past years. It was further agreed to revise and update the 2008 Interdisciplinary European Guidelines on Sur- gery of Severe Obesity produced in cooperation of both Societies by focusing in particular on the evidence gathered in relation to the effects on diabetes during this lustrum and the sub- sequent changes that have taken place in patient eligibility criteria. The expert panel compo- sition allowed the coverage of key disciplines in the comprehensive management of obesity and obesity-associated diseases, aimed specifically at updating the clinical guidelines to re- flect current knowledge, expertise and evidence-based data on metabolic and bariatric surgery.
Diagnosis and Treatment of Polycystic Ovary Syndrome: An Endocrine Society Clinical Practice Guideline
We suggest using the Rotterdam criteria for diagnosing PCOS (presence of two of the following criteria: androgen excess, ovulatory dysfunction, or polycystic ovaries). Establishing a diagnosis of PCOS is problematic in adolescents and menopausal women. Hyperandrogenism is central to the presentation in adolescents, whereas there is no consistent phenotype in postmenopausal women. Evaluation of women with PCOS should exclude alternate androgen-excess disorders and risk factors for endometrial cancer, mood disorders, obstructive sleep apnea, diabetes, and cardiovascular disease. Hormonal contraceptives are the first-line management for menstrual abnormalities and hirsutism/acne in PCOS. Clomiphene is currently the first-line therapy for infertility; metformin is beneficial for metabolic/glycemic abnormalities and for improving menstrual irregularities, but it has limited or no benefit in treating hirsutism, acne, or infertility. Hormonal contraceptives and metformin are the treatment options in adolescents with PCOS. The role of weight loss in improving PCOS status per se is uncertain, but lifestyle intervention is beneficial in overweight/obese patients for other health benefits. Thiazolidinediones have an unfavorable risk-benefit ratio overall, and statins require further study.
American Association of Clinical Endocrinologists’ Comprehensive Diabetes Management Algorithm 2013
This new algorithm for the comprehensive manage- ment of persons with type 2 diabetes mellitus (T2DM) has been developed to provide clinicians with a practical guide that considers the whole patient, the spectrum of risks and complications for the patient, and evidence-based approaches to treatment. In addition to advocating for gly- cemic control so as to reduce microvascular complications, this document focuses on obesity and prediabetes as the underlying risk factors for diabetes and associated macro- vascular complications.
Nonnutritive sweeteners - current use and health perspectives - a scientific statement from the AHA and ADA
By definition, NNS, otherwise referred to as very low-calorie sweeteners, artificial sweeteners, noncaloric sweeteners, and intense sweeteners, have a higher intensity of sweetness per gram than caloric sweeteners such as sucrose, corn syrups, and fruit juice concentrates. As a caloric sweetener replacement, they are added in smaller quantities; hence, they provide no or few calories. In our current food supply, NNS are widely used in thousands of beverages and other food products such as diet soft drinks, yogurts, desserts, and gum.
The present statement from the American Heart Association and the American Diabetes Association addresses the potential role of nonnutritive sweeteners (NNS) in helping Americans to adhere to this recommendation in the context of current usage and health perspectives. he focus of the statement is on the 6 NNS: aspartame, acesulfame-K, neotame, saccharin, sucralose and stevia.
Osteoporosis in Men: An Endocrine Society Clinical Practice Guideline
Osteoporosis in men causes significant morbidity and mortality. We recommend testing higher risk men [aged ≥70 and men aged 50–69 who have risk factors (e.g. low body weight, prior fracture as an adult, smoking, etc.)] using central dual-energy x-ray absorptiometry. Laboratory testing should be done to detect contributing causes. Adequate calcium and vitamin D and weight-bearing exercise should be encouraged; smoking and excessive alcohol should be avoided. Pharmacological treatment is recommended for men aged 50 or older who have had spine or hip fractures, those with T-scores of −2.5 or below, and men at high risk of fracture based on low bone mineral density and/or clinical risk factors. Treatment should be monitored with serial dual-energy x-ray absorptiometry testing.
Evaluation and Treatment of Hypertriglyceridemia: An Endocrine Society Clinical Practice Guideline
The Task Force recommends that the diagnosis of hypertriglyceridemia be based on fasting levels, that mild and moderate hypertriglyceridemia (triglycerides of 150–999 mg/dl) be diagnosed to aid in the evaluation of cardiovascular risk, and that severe and very severe hypertriglyceridemia (triglycerides of > 1000 mg/dl) be considered a risk for pancreatitis. The Task Force also recommends that patients with hypertriglyceridemia be evaluated for secondary causes of hyperlipidemia and that subjects with primary hypertriglyceridemia be evaluated for family history of dyslipidemia and cardiovascular disease. The Task Force recommends that the treatment goal in patients with moderate hypertriglyceridemia be a non-high-density lipoprotein cholesterol level in agreement with National Cholesterol Education Program Adult Treatment Panel guidelines. The initial treatment should be lifestyle therapy; a combination of diet modification and drug therapy may also be considered. In patients with severe or very severe hypertriglyceridemia, a fibrate should be used as a first-line agent.
Management of hyperglycemia in hospitalized patients in non-critical care setting - an endocrine society clinical practice guideline
Hyperglycemia is a common, serious, and costly health care problem in hospitalized patients. Observational and randomized controlled studies indicate that improvement in glycemic control results in lower rates of hospital complications in general medicine and surgery patients. Implementing a standardized sc insulin order set promoting the use of scheduled basal and nutritional insulin therapy is a key intervention in the inpatient management of diabetes. We provide recommendations for practical, achievable, and safe glycemic targets and describe protocols, procedures, and system improvements required to facilitate the achievement of glycemic goals in patients with hyperglycemia and diabetes admitted in non-critical care settings.
Continuous glucose monitoring - an Endocrine Society clinical practice guideline
he Task Force evaluated three potential uses of CGM: 1) real-time CGM in adult hospital settings; 2) real-time CGM in children and adolescent outpatients; and 3) real-time CGM in adult outpatients. The Task Force used the best available data to develop evidence-based rec- ommendations about where CGM can be beneficial in maintaining target levels of glycemia and limiting the risk of hypoglycemia. Both strength of recommendations and quality of evidence were accounted for in the guidelines.
AACE medical guidelines for developing a diabetes mellitus comprehensive care plan
This CPG will complement and extend existing CPGs available in the literature, as well as previously pub- lished American Association of Clinical Endocrinologists DM CPGs. When a routine consultation is made for DM management, these new guidelines advocate that a comprehensive approach is taken and suggest that the clinician should move beyond a simple focus on glycemic control. This comprehensive approach is based on the evi- dence that although glycemic control parameters (hemoglobin A1c, postprandial glucose excursions, fasting plasma glucose, glycemic variability) have an impact on cardiovascular disease risk, mortality, and quality of life, other factors also affect clinical out- comes in persons with DM.These are clinical practice guidelines for developing a diabetes mellitus comprehensive care plan. The mandate for this CPG is to provide a practical guide for comprehensive care that incorporates an integrated consideration of microvascular and macrovascular risk rather than an isolated approach focusing merely on glycemic control.
Pituitary Incidentaloma: An Endocrine Society Clinical Practice Guideline
We recommend that patients with a pituitary incidentaloma undergo a complete history and physical examination, laboratory evaluations screening for hormone hypersecretion and for hypopituitarism, and a visual field examination if the lesion abuts the optic nerves or chiasm. We recommend that patients with incidentalomas not meeting criteria for surgical removal be followed with clinical assessments, neuroimaging (magnetic resonance imaging at 6 months for macroincidentalomas, 1 yr for a microincidentaloma, and thereafter progressively less frequently if unchanged in size), visual field examinations for incidentalomas that abut or compress the optic nerve and chiasm (6 months and yearly), and endocrine testing for macroincidentalomas (6 months and yearly) after the initial evaluations. We recommend that patients with a pituitary incidentaloma be referred for surgery if they have a visual field deficit; signs of compression by the tumor leading to other visual abnormalities, such as ophthalmoplegia, or neurological compromise due to compression by the lesion; a lesion abutting the optic nerves or chiasm; pituitary apoplexy with visual disturbance; or if the incidentaloma is a hypersecreting tumor other than a prolactinoma.
Diagnosis and Treatment of Hyperprolactinemia: An Endocrine Society Clinical Practice Guideline
This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence.
Practice guidelines are presented for diagnosis and treatment of patients with elevated prolactin levels. These include evidence-based approaches to assessing the cause of hyperprolactinemia, treating drug-induced hyperprolactinemia, and managing prolactinomas in nonpregnant and pregnant subjects. Indications and side effects of therapeutic agents for treating prolactinomas are also presented.
Statement by the AACE Consensus Panel on continuous glucose monitoring
￼daysT.Over the past 10 years, continuous glucose monitoring (CGM) has evolved from being a research tool to a device useful in daily clinical practice. Designed to successfully improve glucose control without the addition of medica- tion, CGM provides information about glucose concentration, direction, and rate of change over a period of several days.
Statement by the AACE Consensus Panel on insulin pump management
Insulin pumps have come of age. With their prolifera- tion in medical practices, some guidance is necessary for prospective and current prescribers to ensure their optimal and safe use. This document summarizes the current state- of-the-art of continuous subcutaneous insulin delivery available to patients requiring intensive insulin manage- ment to control their diabetes mellitus. Appropriate patient selection is critical and must be followed by thorough as- sessment of their knowledge of diabetes management prin- ciples. Likewise, selection of a provider is critical and only those whose practice can assume full responsibility for the comprehensive pump management program should offer it. Patient diabetes education and a pump training plan must be implemented by a multidisciplinary team under direction of an experienced endocrinologist/diabetologist to address gaps in patient knowledge. The importance of periodic reevaluation and retraining is stressed. Physicians prescribing insulin pumps for their patients should have a round-the-clock system in place to answer patients’ con- cerns about pump problems.
2010 consensus statement on the worldwide standardization of the hemoglobin A1C measurement
Glycated hemoglobin concentrations (most commonly hemoglobin A1C; HbA1c) reflect time-averaged blood glucose during the previous 2–3 months and are used as the gold standard for long-term follow-up of glycemic control. Standardization with common calibration was first proposed in 1984. It was only after the publication of the Diabetes Control and Complications Trial (DCCT) study in 1993, however, that the issue of international standardization of HbA1c measurements became an important objective for scientists and clinicians.
AACE Statement on the Use of Hemoglobin A1c for the Diagnosis of Diabetes
The American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) have evaluated the role of hemoglobin A1c (A1C) for the diagnosis of type 2 diabetes (diabetes). The American Diabetes Association 2010 Clinical Practice Recommendations endorse the use of A1C of 6.5% or higher as the primary criterion for the diagnosis of diabetes. The rationale for the use of A1C for diagnosis of diabetes is based on data showing that retinopathy occurs in individuals with an A1C ≥6.5% at approximately the same rate as in individuals who are diagnosed on the basis of the current fasting and postchallenge glucose criteria. A 10% risk for retinopathy has historically served as the benchmark for diagnosing the presence of diabetes.
Hyperglycemic crises in adult patients with diabetes
Diabetic ketoacidosis (DKA) and the hyperosmolar hyperglycemic state (HHS) are the two most serious acute metabolic complications of diabetes. DKA is responsible for more than 500,000 hospital days per year at an estimated annual direct medical expense and indirect cost of 2.4 billion USD. The triad of uncontrolled hyperglycemia, metabolic acidosis, and increased total body ketone concentration characterizes DKA. HHS is characterized by severe hyperglycemia, hyperosmolality, and dehydration in the absence of significant ketoacidosis. These metabolic derangements result from the combination of absolute or relative insulin deficiency and an increase in counterregulatory hormones (glucagon, catecholamines, cortisol, and growth hormone). Most patients with DKA have autoimmune type 1 diabetes; however, patients with type 2 diabetes are also at risk during the catabolic stress of acute illness such as trauma, surgery, or infections. This consensus statement will outline precipitating factors and recommendations for the diagnosis, treatment, and prevention of DKA and HHS in adult subjects.
American Association of Clinical Endocrinologists and American Diabetes Association Consensus Statement on Inpatient Glycemic Control
People with diabetes are more likely to be hospitalized and to have longer durations of hospital stay than those without diabetes. A recent survey estimated that 22% of all hospital inpatient days were incurred by people with diabetes.
There is substantial observational evidence linking hyperglycemia in hospitalized patients (with or without diabetes) to poor outcomes. Cohort studies as well as a few early randomized controlled trials suggested that intensive treatment of hyperglycemia improved hospital outcomes.
Management of Obesity in Adults: European Clinical Practice Guidelines
The development of consensus guidelines for obesity is complex. It involves recommending both treatment interventions and interventions related to screening and prevention. With so many publications and claims, and with the awareness that success for the individual is short-lived, many find it difficult to know what action is appropriate in the management of obesity. Furthermore, the significant variation in existing service provision both within countries as well as across the regions of Europe makes a standardised approach, even if evidence-based, difficult to implement. In formulating these guidelines, we have attempted to use an evidence-based approach while allowing flexibility for the practicing clinician in domains where evidence is currently lacking and ensuring that in treatment there is recognition of clinical judgment and of regional diversity as well as the necessity of an agreed approach by the individual and family. We conclude that i) physicians have a responsibility to recognise obesity as a disease and help obese patients with appropriate prevention and treatment, ii) treatment should be based on good clinical care and evidence-based interventions and iii) obesity treatment should focus on realistic goals and lifelong management.
Evaluation and Treatment of Adult Growth Hormone Deficiency: An Endocrine Society Clinical Practice Guideline
The objective is to provide guidelines for the evaluation and treatment of adults with GH deficiency (GHD).
GHD can persist from childhood or be newly acquired. Confirmation through stimulation testing is usually required unless there is a proven genetic/structural lesion persistent from childhood. GH therapy offers benefits in body composition, exercise capacity, skeletal integrity, and quality of life measures and is most likely to benefit those patients who have more severe GHD. The risks of GH treatment are low. GH dosing regimens should be individualized. The final decision to treat adults with GHD requires thoughtful clinical judgment with a careful evaluation of the benefits and risks specific to the individual.
Evaluation and Treatment of Hirsutism in Premenopausal Women: An Endocrine Society Clinical Practice Guideline
We suggest testing for elevated androgen levels in women with moderate or severe hirsutism or hirsutism of any degree when it is sudden in onset, rapidly progressive, or associated with other abnormalities such as menstrual dysfunction, obesity, or clitoromegaly. For women with patient-important hirsutism despite cosmetic measures, we suggest either pharmacological therapy or direct hair removal methods. For pharmacological therapy, we suggest oral contraceptives for the majority of women, adding an antiandrogen after 6 months if the response is suboptimal. We recommend against antiandrogen monotherapy unless adequate contraception is used. We suggest against using insulin-lowering drugs. For women who choose hair removal therapy, we suggest laser/photoepilation.
American College of Endocrinology position statement on the insulin resistance syndrome
The clinical consequences of insulin resistance and compensatory hyperinsulinemia, the Insulin Resistance Syndrome, are increasingly appreciated as posing a major public health problem. Currently recognized clinical man- ifestations of the Insulin Resistance Syndrome include atherosclerotic cardiovascular disease (CVD), hyperten- sion, polycystic ovary syndrome (PCOS), and nonalco- holic steatohepatitis, and the list continues to expand. Despite the recognition of the importance of this syn- drome, identifying individuals who have the Insulin Resistance Syndrome is difficult, as there is no simple clinically available test to diagnose it. Our task force was created by AACE and the American College of Endocrinology (ACE) to work toward this consensus and so to provide guidance to clinicians and the many others involved in and affected by the Insulin Resistance Syndrome. This is an area in rapid evolution, so progress will consist of many small incremental steps, of which the efforts of our task force are but one.