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Japanese Clinical Practice Guideline for Diabetes 2016

2018; Asian Association for the Study of Diabetes; Volume: 9; Issue: 3 Linguagem: Inglês

10.1111/jdi.12810

2040-1124

Masakazu Haneda, Mitsuhiko Noda, Hideki Origasa, Hiroshi Noto, Daisuke Yabe, Yukihiro Fujita, Atsushi Goto, Tatsuya Kondo, Eiichi Araki,

Diabetes Management and Research

Since its inception in 2004, the 'Clinical Practice Guidelines for the Treatment of Diabetes' has attempted to promote evidence-based, rational, efficient and standardized clinical practice for diabetes in Japan and has undergone revisions every 3 years. Thus, the current edition represents the fifth revision. Of note, in recent years, breakthroughs have been made in the management of diabetes and its complications, which include the approval of glucose-lowering agents with novel mechanisms of action for clinical use and the introduction and adoption of novel diagnostic and therapeutic modalities, such as continuous glucose monitoring (CGM) and sensor-augmented insulin pumps (SAP), in clinical practice. Again, renewed interest in diabetes-associated diseases has led to the accumulation of new evidence, as well as new developments at the Japan Diabetes Society (JDS), such as ongoing efforts directed toward the revision of the Classification of Diabetic Nephropathy, ensuring consistency between glucose metabolic disorders and the diagnostic criteria for diabetes in pregnancy, and establishing glycemic control goals for older patients with diabetes. Indeed, these developments have gone hand in hand with the emergence of high-quality evidence from numerous studies conducted in countries throughout the world, including Japan. Thus, the current edition aims to incorporate these new insights and findings, as well as new lines of evidence, in diabetes treatment. With regard to the revision of the guideline, the current edition has newly adopted a clinical question (CQ)/question (Q) format, instead of the 'statement' format of the earlier editions, in the hope that this new format will help improve the ease of use of the guidelines in clinical practice. The grades of recommendation have also been revised. It is hoped that the current guidelines will serve as a guide to implementing evidence-based medicine (EBM) for diabetes in Japan and thereby contribute to prolonging the longevity and improving the quality of life (QOL) of patients with diabetes. The present guideline, which is divided into 21 chapters, consists of important statements intended to assist in clinical practice, which are also intended as recommendations. These statements were developed separately as general questions and clinical questions based on published clinical evidence as well as expert consensus. This guideline offers key recommendations for clinical practice that are supported by scientific evidence from published studies. Studies of interest were obtained by a systematic search of the English and Japanese literature. The electronic databases used for literature search included at least MEDLINE and the Japanese ICHUSHI database (http://www.jamas.or.jp/). The search strategies used were developed by each author. The studies of interest were critically appraised by the authors to determine their relevance to the statements of the guideline and whether they were worth citing. Each study was assigned a level of evidence using the approach described in Table 1. Each statement for the CQs was assigned a grade of recommendation based on the total body of evidence as well as the risk-benefit balance, value, patient preferences, cost, and resources. Statements were graded as A (strongly recommended) or B (recommended), followed by the agreement rate among authors. Grade A or B by consensus reflects a recommendation based solely on the consensus of professionals and indicates that the recommendation was adopted with a ≥70% agreement rate among the authors. A summary table, including an identifier, the research design, the level of evidence and population, methods, and results of the cited articles was attached at the end of each chapter in the original Japanese version (The Japan Diabetes Society: Japanese Clinical Practice Guideline for diabetes 2016. Tokyo: Nankodo, 2016.). Scientific reports supporting a statement were cited as 'References' and additional guidelines or review articles were listed as 'Additional reference materials'. The guideline will be reviewed every 3 years, as there will be considerable advances in clinical research and practice that will require a re-evaluation of the scientific evidence as it becomes available. All potential conflicts of interest were disclosed by authors. For each patient with type 2 diabetes, the IBW is to be calculated consistent with a body mass index (BMI) value of 22, and his/her total energy intake is to be calculated by the following equations: (Consensus between the Japanese Society of Hypertension and the Japan Diabetes Society) Individuals are to be diagnosed with gestational diabetes mellitus if they meet any of the following criteria in a 75 g oral glucose tolerance test (OGTT): ① Fasting glucose value: ≥92 mg/dL (5.1 mmol/L) ② 1-h post-OGTT glucose value: ≥180 mg/dL (10.0 mmol/L) ③ 2-h post-OGTT glucose value: ≥153 mg/dL (8.5 mmol/L) Individuals are to be diagnosed with overt diabetes in pregnancy if they meet either of the following during pregnancy: ① Fasting glucose: ≥126 mg/dL (7.0 mmol/L) ② HbA1c: ≥6.5% * Individuals with casual glucose values of ≥200 mg/dL (11.1 mmol/L) or 2-h post-75 g OGTT glucose values of ≥200 mg/dL (11.1 mmol/L) in pregnancy are to be examined to see if they meet either ① or ② with the potential diagnosis of overt diabetes in pregnancy in mind.b Individuals are to be diagnosed with pre-gestational diabetes mellitus if they meet either of the following: ① Diabetes mellitus diagnosed before pregnancy ② Pregnancy associated with unequivocal evidence of diabetic retinopathy Given that there is a clear association between diabetes and the risk of cancer1-9, experts from the Japan Diabetes Society (JDS) and the Japanese Cancer Association (JCA) launched a Joint Committee on Diabetes and Cancer, published a report in 2013 and provided its recommendations for physicians and other healthcare providers as well as for the general public, including patients10. A pooled analysis of eight cohort studies conducted in Japan reported that the hazard ratio (HR) for the total cancer risk among patients with diabetes was 1.19 in comparison to those without, with the HR among men being 1.19 (95% confidence interval [CI], 1.12–1.25) and that among women being 1.19 (95% CI, 1.12–1.27)1. The mechanisms through which diabetes is likely to promote oncogenesis include insulin resistance and associated hyperinsulinemia, hyperglycemia, and chronic inflammation. However, whether diabetes is a causal risk factor for cancer remains to be elucidated. At present, the association between glucose-lowering agents and the cancer risk remains to be fully clarified. Thus, it is thought to be preferable that priority be given to maximizing the benefits of favorable glycemic control with these agents, with due consideration given to the warnings contained in their package inserts. The relative risk of proximal femoral fracture is increased 3- to 7-fold in patients with type 1 diabetes and 1.3- to 2.8-fold in patients with type 2 diabetes. Bone strength consists of two factors: bone mineral density (BMD) and bone quality. The bone mineral metabolism in type 2 diabetes is characterized by increased BMD and impaired bone quality. A meta-analysis demonstrated that thiazolidinedione (TZD) treatment was associated with a 1.45-fold increase in the risk of fracture2. A further analysis indicated that TZDs were associated with a 2.23-fold increase in the risk of fracture in women but not in men3. There is no consensus on the risk of fracture associated with the use of insulin, DPP-4 inhibitors, GLP-1 receptor agonists, or metformin. The US Food and Drug Administration (FDA) reported in its Drug Safety Communication that an SGLT-2 inhibitor, canagliflozin, has been associated with decreased BMD and an increased risk of fracture in comparison to a placebo1. The lumbar and femoral neck BMD have been reported to increase in patients with type 2 diabetes who receive alendronate2. Pancreas transplantation has become available as a radical therapy for severe diabetes, particularly type 1 diabetes. Pancreas transplantation is broadly divided into simultaneous pancreas and kidney transplantation (SPK), pancreas-after-kidney transplantation (PAK), and pancreas transplantation alone (PTA). SPK accounts for >80% of all pancreas transplants performed in Japan and the rest of the world. Data from the 210 brain-dead and non-heart-beating donor pancreas transplants performed in Japan as of the end of 2014 demonstrated a 5-year graft survival rate of 95.8%, with the 5-year pancreas and kidney survival rates of 70.4% and 89.2%, respectively. The first living donor pancreas transplant in Japan was performed in January 20041; and as of the end of 2014, a total of 27 transplants had been performed. Islet transplantation is a form of tissue transplantation that involves the injection of islets isolated from donor(s) into the recipient's portal vein and is thus less invasive than pancreas transplantation. In Japan, 34 islet transplantation procedures (from non-heart-beating donors) were performed in 18 patients (male, n = 5; female, n = 13) between 2004 and 2007; the procedures were performed in accordance with the Edmonton protocol2. Among these patients, 8, 4 and 6 patients received one, two and three transplants, respectively. One of the patients who received two transplants and 2 who received three transplants were shown to have achieved a temporary withdrawal of insulin therapy3, 4. The 1-, 2- and 3-year graft survival rates in these patients were 72.2%, 44.4%, and 22.2%, respectively. The 1-year graft survival rate among those who received multiple transplants was 100%3, 4. In 2005, the Ministry of Health, Labor and Welfare (MHLW) of Japan launched a framework for the Health Frontier Strategic Plan as a large-scale MHLW research project. Thus, as a part of the project, the Strategic Research Projects for Prevention of Diabetes was initiated, consisting of three research themes (J-DOIT 1, 2, and 3, respectively). To prove that intensive lifestyle intervention is effective in preventing the onset of diabetes in patients at high risk of developing diabetes in real-world settings (i.e., facilities offering health check-ups and health instruction services), a cluster randomized trial entitled, the 'Japan Diabetes Outcome Intervention Trial 1 (J-DOIT 1)', was conducted between March 2007 and March 2012. The 'Japan Diabetes Outcome Intervention Trial 2 (J-DOIT 2)' was an interventional study intended to address how best decrease treatment and consultation interruptions by patients with type 2 diabetes. The interventional measures implemented in the study included encouraging patients who were being treated by their family physicians to seek treatment/consultation, providing healthcare instructions, and providing their family physicians with assistance in their treatment/consultations. The results of the study demonstrated that treatment/consultation interruptions had been decreased by 63%, suggesting that the interventional measures were significantly effective in decreasing treatment/consultation interruptions. The J-DOIT3 (Japan Diabetes Optimal Integrated Treatment study of three major risk factors for cardiovascular diseases [J-DOIT 3]) aimed to investigate whether or not integrated tight glycemic control, blood pressure control and lipid control may reduce the onset of macroangiopathy among patients with type 2 diabetes. J-DOIT 3 was conducted from 2006 until March 2016. The study involved a total of 81 sites nationwide and enrolled a total of 2,532 type 2 diabetes patients who were considered to have a high risk of developing macroangiopathy. The patients were randomly allocated to receive intensive therapy or conventional therapy. The JDCP study was a large-scale prospective observational study of Japanese patients with type 1 and type 2 diabetes. The study was conducted to identify the risk factors that patients with type 1 and 2 diabetes develop during follow-up. The JDCP study enrolled a total of 6,338 patients of 40–74 years of age who were being treated at participating sites nationwide between June 2007 and November 2009. The primary endpoints of the study included the onset/progression of nephropathy, retinopathy, neuropathy, macroangiopathy, and periodontal disease. The Japan Diabetes comprehensive database project based on an advanced electronic medical record system (J-DREAMS) is a large-scale database project that was launched by the Japan Diabetes Society (JDS) and the National Center for Global Health and Medicine (NCGM). Given that all JDS-qualified educational facilities for certificated diabetologists are participating and that hundreds of thousands of patients are expected to be registered, this study will be expected to show the control status of each parameter, the frequency of complications, and the correlations between complications and the glycemic control status or therapeutic agents in patients treated by certified diabetologists.